StemCell Therapy

Patients who participated in the Beat AML Master clinical trial were found to have superior outcomes with precision medicine, compared to patients with acute myeloid leukemia (AML) who opted for standard chemotherapy treatment, according to a study published in Nature Medicine.1

Overall, the study demonstrated that a precision medicine therapy strategy in AML is feasible within 7days of sample receipt and before treatment selection, allowing patients and physicians to rapidly incorporate genomic data into treatment decisions without increasing early death or adversely impacting overall survival (OS).

The study shows that delaying treatment up to seven days is feasible and safe, and that patients who opted for the precision medicine approach experienced a lower early death rate and superior overall survival compared to patients who opted for standard of care, corresponding author John C. Byrd, MD, D. Warren Brown Chair of Leukemia Research of The Ohio State University, said in a press release.2 This patient-centric study shows that we can move away from chemotherapy treatment for patients who wont respond or cant withstand the harsh effects of the same chemotherapies weve been using for 40 years and match them with a treatment better suited for their individual case.

In the ongoing Beat AML trial, researchers prospectively enrolled untreated patients with AML who were60 years or older with the aims of providing cytogenetic and mutational data within 7days of the sample receipt and before treatment selection, followed by treatment assignment to a sub-study based on the dominant clone. In total, 487 patients with suspected AML were enrolled in the study and 395 were deemed eligible for analysis.

The median age of the participants was 72 years (range 60-92 years). Overall, 374 patients (94.7%) had genetic and cytogenetic analysis completed within 7days and were centrally assigned to a Beat AML sub-study, while 224 (56.7%) were enrolled on a Beat AML sub-study. The remaining 171 patients elected to receive either standard of care (n = 103), investigational therapy (n = 28), or palliative care (n = 40). Moreover, 9 patients died before treatment assignment.

Demographic, laboratory, and molecular characteristics were not found to be significantly different between patients on the Beat AML sub-studies and those receiving standard of care (induction with cytarabine+daunorubicin [7+3 or equivalent] or hypomethylation agent).

However, 30-day mortality was less frequent, and OS was significantly longer for patients enrolled on the Beat AML sub-studies versus those who elected to receive standard of care. The median OS for patients included in the Beat AML trial was 12.8 months versus 3.9 months for patients opting for standard of care.

To date, the trial has now screened more than 1000 patients at 16 cancer centers. The data presented herein represents patient enrollment during a slice of time between November 17, 2016 and January 30, 2018.

The study is changing significantly the way we look at treating patients with AML, showing that precision medicine, giving the right treatment to the right patient at the right time, can improve short and long-term outcomes for patients with this deadly blood cancer, Louis J. DeGennaro, PhD, president and CEO of the Leukemia & Lymphoma Society (LLS), the conductor of the trial, said in the release. Further, Beat AML has proven to be a viable model for other cancer clinical trials to emulate.

Recently, LLS launched itsBeat COVIDtrial, which leveraged the Beat AML infrastructure to quickly pivot to treat patients with blood cancer who are infected with the coronavirus disease 2019 (COVID-19) virus. The trial is testing the drug acalabrutinib (Calquence), which is currently approved to treat several types of blood cancers. The trial is open to patients diagnosed with all types of blood cancers.

Additionally, LLS is also planning other precision medicine trials modeled after Beat AML, including LLS PedAL, a global precision medicine trial for children with relapsed acute leukemia, currently on track to launch in summer 2021, and Stop MDS, a master trial for patients withmyelodysplastic syndromes.

References:

1. STUDY IN NATURE MEDICINE SHOWS SUPERIOR OUTCOMES FOR PATIENTS IN LLS'S PARADIGM-SHIFTING BEAT AML CLINICAL TRIAL [news release]. Rye Brook, NY. Published October 26, 2020. Accessed October 28, 2020. https://www.lls.org/news/study-in-nature-medicine-shows-superior-outcomes-for-patients-in-llss-paradigm-shifting-beat-aml-clinical-trial?src1=182886&src2=

2. Burd A, Levine RL, Ruppert AS, et al. Precision medicine treatment in acute myeloid leukemia using prospective genomic profiling: feasibility and preliminary efficacy of the Beat AML Master Trial. Nature Medicine. doi: 10.1038/s41591-020-1089-8

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Beat AML Master Clinical Trial Shows Promise for Precision Medicine in the Treatment of AML - Cancer Network

CAMBRIDGE, Mass., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report third quarter 2020 financial results after the Nasdaq Global Market closes on Thursday, November 5, 2020. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its third quarter 2020 financial results and to provide a corporate update.

The conference call may be accessed by dialing (844) 534-7313 for domestic callers and (574) 990-1451 for international callers. The passcode for the call is 9452027. Please specify to the operator that you would like to join the "Sarepta Third Quarter 2020 Earnings Call." The conference call will be webcast live under the investor relations section of Sarepta's website at http://www.sarepta.com and will be archived there following the call for 90 days. Please connect to Sarepta's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

About Sarepta Therapeutics At Sarepta, we are leading a revolution in precision genetic medicine and every day is an opportunity to change the lives of people living with rare disease. The Company has built an impressive position in Duchenne muscular dystrophy (DMD) and in gene therapies for limb-girdle muscular dystrophies (LGMDs), mucopolysaccharidosis type IIIA, Charcot-Marie-Tooth (CMT), and other CNS-related disorders, with more than 40 programs in various stages of development. The Company’s programs and research focus span several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit http://www.sarepta.com or follow us on Twitter , LinkedIn , Instagram and Facebook .

Internet Posting of Information

We routinely post information that may be important to investors in the 'Investors' section of our website at http://www.sarepta.com . We encourage investors and potential investors to consult our website regularly for important information about us.

Source: Sarepta Therapeutics, Inc.

Sarepta Therapeutics, Inc.

Investors: Ian Estepan, 617-274-4052, iestepan@sarepta.com

Media: Tracy Sorrentino, 617-301-8566, tsorrentino@sarepta.com

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Sarepta Therapeutics to Announce Third Quarter 2020 Financial Results and Recent Corporate Developments on November 5, 2020 - Stockhouse

Oct. 30, 2020 11:00 UTC

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced it has won the 2020 Prix Galien USA Award for Best Biotechnology Product for ONPATTRO (patisiran). The award, which recognizes excellence in scientific innovation that improves the state of human health, was presented by the Galien Foundation during the 50th Annual Prix Galien USA Awards ceremony yesterday.

We are thrilled to receive this prestigious recognition for ONPATTRO and want to share this award with the incredible patients, caregivers, scientists, healthcare professionals, and colleagues that helped us succeed in making RNAi therapeutics, an entirely new class of medicines, a reality for patients, said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. The breakthrough approval of ONPATTRO was a result of nearly two decades of determination to deliver the first-ever FDA-approved treatment to adult patients living with the polyneuropathy of hereditary ATTR (hATTR) amyloidosis. We also want to recognize the continued industry efforts in helping those living with this progressive, debilitating condition.

In 2019, ONPATTRO won the Prix Galien Award for Best Biotechnology Product in Italy and the Netherlands.

About ONPATTRO (patisiran)

ONPATTRO is an RNAi therapeutic that was approved in the United States and Canada for the treatment of the polyneuropathy of hATTR amyloidosis in adults. ONPATTRO is also approved in the European Union, Switzerland and Brazil for the treatment of hATTR amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy, and in Japan for the treatment of hATTR amyloidosis with polyneuropathy. ONPATTRO is an intravenously administered RNAi therapeutic targeting transthyretin (TTR). It is designed to target and silence TTR messenger RNA, thereby blocking the production of TTR protein before it is made. ONPATTRO blocks the production of TTR in the liver, reducing its accumulation in the bodys tissues in order to halt or slow down the progression of the polyneuropathy associated with the disease. For more information about ONPATTRO, visit ONPATTRO.com.

ONPATTRO (patisiran) lipid complex injection Important Safety Information

Infusion-Related Reactions

Infusion-related reactions (IRRs) have been observed in patients treated with ONPATTRO. In a controlled clinical study, 19 percent of ONPATTRO-treated patients experienced IRRs, compared to 9 percent of placebo-treated patients. The most common symptoms of IRRs with ONPATTRO were flushing, back pain, nausea, abdominal pain, dyspnea, and headache.

To reduce the risk of IRRs, patients should receive premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) at least 60 minutes prior to ONPATTRO infusion. Monitor patients during the infusion for signs and symptoms of IRRs. If an IRR occurs, consider slowing or interrupting the infusion and instituting medical management as clinically indicated. If the infusion is interrupted, consider resuming at a slower infusion rate only if symptoms have resolved. In the case of a serious or life-threatening IRR, the infusion should be discontinued and not resumed.

Reduced Serum Vitamin A Levels and Recommended Supplementation

ONPATTRO treatment leads to a decrease in serum vitamin A levels. Supplementation at the recommended daily allowance (RDA) of vitamin A is advised for patients taking ONPATTRO. Higher doses than the RDA should not be given to try to achieve normal serum vitamin A levels during treatment with ONPATTRO, as serum levels do not reflect the total vitamin A in the body.

Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g. night blindness).

Adverse Reactions

The most common adverse reactions that occurred in patients treated with ONPATTRO were upper respiratory-tract infections (29 percent) and infusion-related reactions (19 percent).

For additional information about ONPATTRO, please see the full Prescribing Information.

About hATTR Amyloidosis

Hereditary transthyretin (TTR)-mediated amyloidosis (hATTR) is an inherited, progressively debilitating, and often fatal disease caused by mutations in the TTR gene. TTR protein is primarily produced in the liver and is normally a carrier of vitamin A. Mutations in the TTR gene cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory-motor neuropathy, autonomic neuropathy, and/or cardiomyopathy, as well as other disease manifestations. hATTR amyloidosis, represents a major unmet medical need with significant morbidity and mortality affecting approximately 50,000 people worldwide. The median survival is 4.7 years following diagnosis, with a reduced survival (3.4 years) for patients presenting with cardiomyopathy.

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as a major scientific breakthrough that happens once every decade or so, and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, function upstream of todays medicines by potently silencing messenger RNA (mRNA) the genetic precursors that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylams commercial RNAi therapeutic products are ONPATTRO (patisiran), approved in the U.S., EU, Canada, Japan, Brazil, and Switzerland, and GIVLAARI (givosiran), approved in the U.S, EU, Brazil and Canada. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its Alnylam 2020 strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines to address the needs of patients who have limited or inadequate treatment options. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit http://www.alnylam.com and engage with us on Twitter at @Alnylam or on LinkedIn.

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Alnylam Wins Prestigious Prix Galien Award for Best Biotechnology Product with First-Ever Approved RNAi Therapeutic, ONPATTRO (patisiran) - BioSpace

Oct. 29, 2020 12:00 UTC

Rare disease and neurology expert Dr. Angela Genge to lead QurAlis clinical R&D for ALS and FTD

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- QurAlis Corporation, a biotech company focused on developing precision medicines for amyotrophic lateral sclerosis (ALS) and other neurologic diseases, today announced the appointment of Angela Genge, MD, FRCP(C), eMBA to the position of Chief Medical Officer (CMO). Dr. Genge is the Executive Director of the Montreal Neurological Institutes Clinical Research Unit and the Director of Montreal Neurological Hospitals ALS Global Center of Excellence.

The company also announced the formation of its Clinical Advisory Board, which will work closely with Dr. Genge on QurAlis clinical research and development programs in ALS and frontotemporal dementia (FTD) as the company prepares to move its pipeline to the clinical stage.

As QurAlis grows and advances quickly toward the clinic, we are proud to welcome to the team Dr. Genge, a world-renowned expert in ALS clinical drug development, and announce the highly esteemed group of ALS experts who will be forming our Clinical Advisory Board, said Kasper Roet, PhD, Chief Executive Officer of QurAlis. Dr. Genge has been treating patients and studying and developing therapeutics and clinical trials for ALS and other rare neurologic diseases for more than 25 years, diligently serving these vulnerable patient populations. Along with our newly formed Clinical Advisory Board, having a CMO with this extensive expertise, understanding and experience is invaluable to our success. Dr. Genge and our Board members are tremendous assets for our team who will undoubtedly help us advance on the best path toward the clinic, and we look forward to working with them to conquer ALS.

Previously, Dr. Genge directed other clinics at the Montreal Neurological Hospital including the Neuromuscular Disease Clinic and the Neuropathic Pain Clinic. In 2014, she was a Distinguished Clinical Investigator in Novartis Global Neuroscience Clinical Development Unit, and she has served as an independent consultant for dozens of companies developing and launching neurological therapeutics. Dr. Genge has served in professorial positions at McGill University since 1994.

At this pivotal period in its journey, QurAlis is equipped with a strong, committed leadership team and promising precision medicine preclinical assets, and I look forward to joining the company as CMO, said Dr. Genge. This is an exciting opportunity to further strengthen my work in ALS and other neurological diseases, and I intend to continue innovating and expanding possibilities for the treatment of rare neurological diseases alongside the dedicated QurAlis team.

QurAlis new Clinical Advisory Board Members are:

Dr. Al-Chalabi is a Professor of Neurology and Complex Disease Genetics at the Maurice Wohl Clinical Neuroscience Institute, Head of the Department of Basic and Clinical Neuroscience, and Director of the Kings Motor Neuron Disease Care and Research Centre. Dr. Al-Chalabi trained in medicine in Leicester and London, and subsequently became a consultant neurologist at Kings College Hospital.

Dr. Andrews is an Associate Professor of Neurology in the Division of Neuromuscular Medicine at Columbia University, and serves as the Universitys Director of Neuromuscular Clinical Trials. She currently oversees neuromuscular clinical trials and cares for patients with neuromuscular disease, primarily with ALS. Dr. Andrews is the elected co-chair of the Northeastern ALS (NEALS) Consortium and is also elected to the National Board of Trustees of the ALS Association.

Dr. Cudkowicz is the Julianne Dorn Professor of Neurology at Harvard Medical School and Chief of Neurology and Director of the Sean M. Healey & AMG Center for ALS at Mass General Hospital. As co-founder and former co-chair of the Northeast ALS Consortium, she accelerated the development of ALS treatments for people with ALS, leading pioneering trials using antisense oligonucleotides, new therapeutic treatments and adaptive trial designs. Through the Healey Center at Mass General, she is leading the first platform trial for people with ALS.

Dr. Shaw serves as Director of the Sheffield Institute for Translational Neuroscience, the NIHR Biomedical Research Centre Translational Neuroscience for Chronic Neurological Disorders, and the Sheffield Care and Research Centre for Motor Neuron Disorders. She also serves as Consultant Neurologist at the Sheffield Teaching Hospitals NHS Foundation Trust. Since 1991, she has led a major multidisciplinary program of research investigating genetic, molecular and neurochemical factors underlying neurodegenerative disorders of the human motor system.

Dr. Van Damme is a Professor of Neurology and director of the Neuromuscular Reference Center at the University Hospital Leuven in Belgium. He directs a multidisciplinary team for ALS care and clinical research that is actively involved in ALS clinical trials, but is also working on the genetics of ALS, biomarkers of ALS, and disease mechanisms using different disease models, including patient-derived induced pluripotent stem cells.

Dr. van den Berg is a professor of neurology who holds a chair in experimental neurology of motor neuron diseases at the University Medical Center Utrecht in the Netherlands. He also is director of the centers Laboratory for Neuromuscular Disease, director of the Netherlands ALS Center, chairman of the Neuromuscular Centre the Netherlands, and chairman of the European Network to Cure ALS (ENCALS), a network of the European ALS Centres.

About ALS

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrigs disease, is a progressive neurodegenerative disease impacting nerve cells in the brain and spinal cord. ALS breaks down nerve cells, reducing muscle function and causing loss of muscle control. ALS can be traced to mutations in over 25 different genes and is often caused by a combination of multiple sub-forms of the condition. Its average life expectancy is three years, and there is currently no cure for the disease.

About QurAlis Corporation

QurAlis is bringing hope to the ALS community by developing breakthrough precision medicines for this devastating disease. Our stem cell technologies generate proprietary human neuronal models that enable us to more effectively discover and develop innovative therapies for genetically validated targets. We are advancing three antisense and small molecule programs addressing sub-forms of the disease that account for the majority of patients. Together with a world-class network of thought leaders, drug developers and patient advocates, our team is rising to the challenge of conquering ALS. http://www.quralis.com

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QurAlis Announces Appointment of New Chief Medical Officer and Formation of Clinical Advisory Board - BioSpace

Angelika Amon, professor of biology and a member of the Koch Institute for Integrative Cancer Research, died on Oct. 29 at age 53, following a two-and-a-half-year battle with ovarian cancer.

"Known for her piercing scientific insight and infectious enthusiasm for the deepest questions of science, Professor Amon built an extraordinary career and in the process, a devoted community of colleagues, students and friends," MIT President L. Rafael Reif wrote in a letter to the MIT community.

Angelika was a force of nature and a highly valued member of our community, reflects Tyler Jacks, the David H. Koch Professor of Biology at MIT and director of the Koch Institute. Her intellect and wit were equally sharp, and she brought unmatched passion to everything she did. Through her groundbreaking research, her mentorship of so many, her teaching, and a host of other contributions, Angelika has made an incredible impact on the world one that will last long into the future.

A pioneer in cell biology

From the earliest stages of her career, Amon made profound contributions to our understanding of the fundamental biology of the cell, deciphering the regulatory networks that govern cell division and proliferation in yeast, mice, and mammalian organoids, and shedding light on the causes of chromosome mis-segregation and its consequences for human diseases.

Human cells have 23 pairs of chromosomes, but as they divide they can make errors that lead to too many or too few chromosomes, resulting in aneuploidy. Amons meticulous and rigorous experiments, first in yeast and then in mammalian cells, helped to uncover the biological consequences of having too many chromosomes. Her studies determined that extra chromosomes significantly impact the composition of the cell, causing stress in important processes such as protein folding and metabolism, and leading to additional mistakes that could drive cancer. Although stress resulting from aneuploidy affects cells ability to survive and proliferate, cancer cells which are nearly universally aneuploid can grow uncontrollably. Amon showed that aneuploidy disrupts cells usual error-repair systems, allowing genetic mutations to quickly accumulate.

Aneuploidy is usually fatal, but in some instances extra copies of specific chromosomes can lead to conditions such as Down syndrome and developmental disorders including those known as Patau and Edwards syndromes. This led Amon to work to understand how these negative effects result in some of the health problems associated specifically with Down syndrome, such as acute lymphoblastic leukemia. Her expertise in this area led her to be named co-director of the recently established Alana Down Syndrome Center at MIT.

Angelikas intellect and research were as astonishing as her bravery and her spirit. Her labs fundamental work on aneuploidy was integral to our establishment of the center, say Li-Huei Tsai, the Picower Professor of Neuroscience and co-director of the Alana Down Syndrome Center. Her exploration of the myriad consequences of aneuploidy for human health was vitally important and will continue to guide scientific and medical research.

Another major focus of research in the Amon lab has been on the relationship between how cells grow, divide, and age. Among other insights, this work has revealed that once cells reach a certain large size, they lose the ability to proliferate and are unable to reenter the cell cycle. Further, this growth contributes to senescence, an irreversible cell cycle arrest, and tissue aging. In related work, Amon has investigated the relationships between stem cell size, stem cell function, and tissue age. Her labs studies have found that in hematopoetic stem cells, small size is important to cells ability to function and proliferate in fact, she posted recent findings on bioRxiv earlier this week and have been examining the same questions in epithelial cells as well.

Amon lab experiments delved deep into the mechanics of the biology, trying to understand the mechanisms behind their observations. To support this work, she established research collaborations to leverage approaches and technologies developed by her colleagues at the Koch Institute, including sophisticated intestinal organoid and mouse models developed by the Yilmaz Laboratory, and a microfluidic device developed by the Manalis Laboratory for measuring physical characteristics of single cells.

The thrill of discovery

Born in 1967, Amon grew up in Vienna, Austria, in a family of six. Playing outside all day with her three younger siblings, she developed an early love of biology and animals. She could not remember a time when she was not interested in biology, initially wanting to become a zoologist. But in high school, she saw an old black-and-white film from the 1950s about chromosome segregation, and found the moment that the sister chromatids split apart breathtaking. She knew then that she wanted to study the inner workings of the cell and decided to focus on genetics at the University of Vienna in Austria.

After receiving her BS, Amon continued her doctoral work there under Professor Kim Nasmyth at the Research Institute of Molecular Pathology, earning her PhD in 1993. From the outset, she made important contributions to the field of cell cycle dynamics. Her work on yeast genetics in the Nasmyth laboratory led to major discoveries about how one stage of the cell cycle sets up for the next, revealing that cyclins, proteins that accumulate within cells as they enter mitosis, must be broken down before cells pass from mitosis to G1, a period of cell growth.

Towards the end of her doctorate, Amon became interested in fruitfly genetics and read the work of Ruth Lehmann, then a faculty member at MIT and a member of the Whitehead Institute. Impressed by the elegance of Lehmanns genetic approach, she applied and was accepted to her lab. In 1994, Amon arrived in the United States, not knowing that it would become her permanent home or that she would eventually become a professor.

While Amons love affair with fruitfly genetics would prove short, her promise was immediately apparent to Lehmann, now director of the Whitehead Institute. I will never forget picking Angelika up from the airport when she was flying in from Vienna to join my lab. Despite the long trip, she was just so full of energy, ready to talk science, says Lehmann. She had read all the papers in the new field and cut through the results to hit equally on the main points.

But as Amon frequently was fond of saying, yeast will spoil you. Lehmann explains that because they grow so fast and there are so many tools, your brain is the only limitation. I tried to convince her of the beauty and advantages of my slower-growing favorite organism. But in the end, yeast won and Angelika went on to establish a remarkable body of work, starting with her many contributions to how cells divide and more recently to discover a cellular aneuploidy program.

In 1996, after Lehmann had left for New York Universitys Skirball Institute, Amon was invited to become a Whitehead Fellow, a prestigious program that offers recent PhDs resources and mentorship to undertake their own investigations. Her work on the question of how yeast cells progress through the cell cycle and partition their chromosomes would be instrumental in establishing her as one of the worlds leading geneticists. While at Whitehead, her lab made key findings centered around the role of an enzyme called Cdc14 in prompting cells to exit mitosis, including that the enzyme is sequestered in a cellular compartment called the nucleolus and must be released before the cell can exit.

I was one of those blessed to share with her a eureka moment, as she would call it, says Rosella Visintin, a postdoc in Amons lab at the time of the discovery and now an assistant professor at the European School of Molecular Medicine in Milan. She had so many. Most of us are lucky to get just one, and I was one of the lucky ones. Ill never forget her smile and scream neither will the entire Whitehead Institute when she saw for the first time Cdc14 localization: You did it, you did it, you figured it out! Passion, excitement, joy everything was in that scream.

In 1999, Amons work as a Whitehead Fellow earned her a faculty position in the MIT Department of Biology and the MIT Center for Cancer Research, the predecessor to the Koch Institute. A full professor since 2007, she also became the Kathleen and Curtis Marble Professor in Cancer Research, associate director of the Paul F. Glenn Center for Biology of Aging Research at MIT, a member of the Ludwig Center for Molecular Oncology at MIT, and an investigator of the Howard Hughes Medical Institute.

Her pathbreaking research was recognized by several awards and honors, including the 2003 National Science Foundation Alan T. Waterman Award, the 2007 Paul Marks Prize for Cancer Research, the 2008 National Academy of Sciences (NAS) Award in Molecular Biology, and the 2013 Ernst Jung Prize for Medicine. In 2019, she won the Breakthrough Prize in Life Sciences and the Vilcek Prize in Biomedical Science, and was named to the Carnegie Corporation of New Yorks annual list of Great Immigrants, Great Americans. This year, she was given the Human Frontier Science Program Nakasone Award. She was also a member of the NAS and the American Academy of Arts and Sciences.

Lighting the way forward

Amons perseverance, deep curiosity, and enthusiasm for discovery served her well in her roles as teacher, mentor, and colleague. She has worked with many labs across the world and developed a deep network of scientific collaboration and friendships. She was a sought-after speaker for seminars and the many conferences she attended. In over 20 years as a professor at MIT, she has mentored more than 80 postdocs, graduate students, and undergraduates, and received the School of Sciences undergraduate teaching prize.

Angelika was an amazing, energetic, passionate, and creative scientist, an outstanding mentor to many, and an excellent teacher, says Alan Grossman, the Praecis Professor of Biology and head of MITs Department of Biology. Her impact and legacy will live on and be perpetuated by all those she touched.

Angelika existed in a league of her own, explains Kristin Knouse, one of Amons former graduate students and a current Whitehead Fellow. She had the energy and excitement of someone who picked up a pipette for the first time, but the brilliance and wisdom of someone who had been doing it for decades. Her infectious energy and brilliant mind were matched by a boundless heart and tenacious grit. She could glance at any data and immediately deliver a sharp insight that would never have crossed any other mind. Her positive attributes were infectious, and any interaction with her, no matter how transient, assuredly left you feeling better about yourself and your science.

Taking great delight in helping young scientists find their own eureka moments, Amon was a fearless advocate for science and the rights of women and minorities and inspired others to fight as well. She was not afraid to speak out in support of the research and causes she believed strongly in. She was a role model for young female scientists and spent countless hours mentoring and guiding them in a male-dominated field. While she graciously accepted awards for women in science, including the Vanderbilt Prize and the Women in Cell Biology Senior Award, she questioned the value of prizes focused on women as women, rather than on their scientific contributions.

Angelika Amon was an inspiring leader, notes Lehmann, not only by her trailblazing science but also by her fearlessness to call out sexism and other -isms in our community. Her captivating laugh and unwavering mentorship and guidance will be missed by students and faculty alike. MIT and the science community have lost an exemplary leader, mentor, friend, and mensch.

Amons wide-ranging curiosity led her to consider new ideas beyond her own field. In recent years, she has developed a love for dinosaurs and fossils, and often mentioned that she would like to study terraforming, which she considered essential for a human success to life on other planets.

It was always amazing to talk with Angelika about science, because her interests were so deep and so broad, her intellect so sharp, and her enthusiasm so infectious, remembers Vivian Siegel, a lecturer in the Department of Biology and friend since Amons postdoctoral days. Beyond her own work in the lab, she was fascinated by so many things, including dinosaurs dreaming of taking her daughters on a dig lichen, and even life on Mars.

Angelika was brilliant; she illuminated science and scientists, says Frank Solomon, professor of biology and member of the Koch Institute. And she was intense; she warmed the people around her, and expanded what it means to be a friend.

Amon is survived by her husband Johannes Weis, and her daughters Theresa and Clara Weis, and her three siblings and their families.

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Angelika Amon, cell biologist who pioneered research on chromosome imbalance, dies at 53 - MIT News

Merger and acquisition activities have heated up in recent months and the niche spaces are in the limelight. After the telemedicine industry, gene therapy stocks jumped on the bandwagon. Gene therapy is a technique that uses genes to treat or prevent disease.

German drugmaker Bayer has made a big bet on gene therapy by announcing the acquisition of U.S. biotech firm Asklepios BioPharmaceutical for as much as $4 billion. The proposed acquisition will provide Bayer access to the adeno-associated virus (AAV) gene therapy platform and a pipeline led by clinical-phase treatments for Parkinsons, Pompe disease and congestive heart failure. Notably, AAV therapies offer improved efficacy, immune response, and tissue and organ specificity.

Additionally, the transaction will complements Bayers 2019 acquisition of BlueRock Therapeutics and advances its efforts to create platforms with the potential to have an impact on multiple therapeutic areas (read: Genomics ETFs Surge on Nobel Prize for Gene-Editing Pioneers).

Under the terms of the deal, Bayer will pay an upfront consideration of $2 billion and potential success-based milestone payments of up to $ billion. About 75 % of the potential milestone-based contingent payments are expected to be due during the course of the next five years and the remaining amount thereafter.

The deal, pending regulatory approvals, is expected to close during the fourth quarter of 2020. Once the deal closes, Bayer will allow Asklepios, known as AskBio, to operate autonomously as part of a new cell and gene therapy unit in a bid to preserve its entrepreneurial culture. The cell and gene therapy unit will bundle Bayer's activities in this area moving forward in order to establish an innovation ecosystem for the participating partners, the German company said (see: all the Healthcare ETFs here).

The proposed deal will provide a boost to the gene therapy industry. Below, we have highlighted four ETFs that are expected to benefit from Bayers entrance into the gene therapy space:

ARK Genomic Revolution Multi-Sector ETF (ARKG - Free Report)

This actively managed ETF is focused on companies that are likely to benefit from extending and enhancing the quality of human and other life by incorporating technological and scientific developments, and advancements in genomics into their business. With AUM of $2.9 billion, the fund holds 47 stocks in its basket and has 0.75% in expense ratio. It trades in an average daily volume of 978,000 shares (read: 4 Sector ETFs That Have Doubled This Year).

Invesco Dynamic Biotechnology & Genome ETF (PBE - Free Report)

This fund follows the Dynamic Biotech & Genome Intellidex Index and provides exposure to companies engaged in the research, development, manufacture and marketing and distribution of various biotechnological products, services and processes and companies that benefit significantly from scientific and technological advances in biotechnology and genetic engineering and research. It holds 31 stocks in its basket and charges 57 bps in annual fees. The ETF has managed $229.9 million in its asset base while trades in a light volume of 6,000 shares per day. Expense ratio comes in at 0.57%. The product has a Zacks ETF Rank #3 (Hold) with a High risk outlook.

Global X Genomics & Biotechnology ETF (GNOM - Free Report)

This product seeks to invest in companies that potentially stand to benefit from further advances in the field of genomic science, such as companies involved in gene editing, genomic sequencing, genetic medicine/therapy, computational genomics and biotechnology. It follows the Solactive Genomics Index, holding 40 stocks in its basket. This ETF has accumulated $68 million in its asset base and charges 50 bps in annual fees. It trades in average daily volume of 31,000 shares (read: Why You Should Invest in Genomics ETFs).

iShares Genomics Immunology and Healthcare ETF (IDNA - Free Report)

This ETF provides access to companies at the forefront of genomics and immunology innovation by tracking the NYSE FactSet Global Genomics and Immuno Biopharma Index. Holding 46 stocks in its basket, the fund has gathered $166.2 million in AUM and trades in moderate average daily volume of 58,000 shares. It charges 47 bps in annual fees.

Zacks free Fund Newsletter will brief you on top news and analysis, as well as top-performing ETFs, each week. Get it free >>

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ETFs in Focus on Bayer's Bet on Gene Therapy - Zacks.com

There may be a better way of repairing the insulation surrounding damaged neurons that could lead to new treatments for multiple sclerosis (MS), a study suggests.

The data showed that blocking the protein sphingomyelin hydrolase neutral sphingomyelinase 2, or nSMase2, could improve the quality of the myelin surrounding nerve cell fibers, and stabilize its structure. nSMase2 is responsible for breaking down sphingomyelin, which is a type of lipid (fat) molecule present in that protective myelin sheath.

The study, Inhibition of neutral sphingomyelinase 2 promotes remyelination, was published in the journal Science Advances.

MS is caused by the attack by immune cells to the bodys own myelin, a fatty insulation provided by oligodendrocyte cells that cover the long branches that extend from nerve cells, which are called axons. When myelin is destroyed called demyelination the connections between neurons become defective and MS symptoms arise.

Most individuals with relapsing-remitting MS (RRMS), an intermittent form of multiple sclerosis, have acute episodes of demyelination. RRMS may evolve to secondary progressive MS (SPMS), in which progressive neurological deterioration occurs and myelin can no longer repair itself.

Suppressing the immune system has worked to treat relapsing-remitting MS, but it doesnt protect from the eventual advancement to progressive MS, for which there arent any good treatments on the market, Norman Haughey, PhD, professor of neurology at the Johns Hopkins University School of Medicine and the studys senior author, said in a press release.

Now, a team led by researchers at Johns Hopkins suggested that the use of certain compounds may be able to prevent RRMS from evolving to SPMS.

In previous studies, the team analyzed the composition of the myelin surrounding nerves near injury sites in the brain tissue of cadavers with MS. Compared with other nerves, these looked misshapen and had higher levels of ceramide and lower levels of sulfatide both lipid (fat) molecules.

Ceramide plays a role in MS by regulating the curvature and compaction of myelin. However, when in excess, it can form bumps on the surface of myelin preventing it from wrapping tightly around nerves.

In the new study, the team analyzed modifications in the lipid composition of myelin following remyelination in cuprizone-treated mice a mouse model of MS in which myelin loss and oligodendrocyte destruction are caused by the toxic agent cuprizone. Cuprizone was given to the mice through their diet for 26 days.

The results showed that the myelin was able to repair itself, although the increase of ceramide produced a disorganized and decompacted myelin structure. The researchers believe the overproduction of ceramide during remyelination is the result of the action of the enzyme nSMase2 that converts sphingomyelin to ceramide. nSMase2 is activated by brain inflammation.

Oligodendrocyte progenitor cells (OPCs) are activated and recruited to damaged sites following demyelination. These cells then differentiate into myelinating oligodendrocytes to repair denuded axons. For oligodendrocyte regeneration, inflammation is functionally important.

The scientists showed that inflammatory cytokines, namely tumor necrosis factor-alpha (TNF-alpha) and interleukin-1beta (IL-1beta), promote a protective and regenerative response in OPCs. However, that turns into a harmful response, promoting apoptosis (cell death) as the OPCs differentiate into oligodendrocytes.

Moreover, in experiments using antibodies (immunostaining), the researchers found that the response of OPCs and oligodendrocytes to inflammatory cytokines may be regulated by the nSMase2 enzyme. Through further investigation, the team found that the expression of nSMase2 modifies the cellular response to inflammatory cytokines such as TNF-alpha.

Our findings suggest that expression of nSMase2 modifies the cellular response to inflammation, from being protective in OPCs (when nSMase2 is not expressed) to damaging in myelinating oligodendrocytes, the researchers wrote.

The team then assessed whether pharmacological inhibition of nSMase2 protected myelinated axons. This was done by testing cambinol, a compound that blocks nSMase, in the cuprizone mouse model. The results showed that blocking nSMase2 prevented the increased production of ceramide and its incorporation in regenerated myelin.

Next, the researchers determined whether inhibition of nSMase2 during the remyelination process modified the lipid content of myelin. The mice were fed a cuprizone-containing diet for 28 days, to induce myelin damage. This was followed by cambinol for 28 days, after which the mice were returned to a normal diet.

Cambinol treatment caused the myelin to grow back tightly around the nerve cells; the myelin produced appeared as it did before the cuprizone-induced damage. The treatment did not completely restore the lipid composition of myelin, but appeared to increase its stability protecting neurons, the team noted.

Finally, genetic deletion of nSMase2 in myelinating oligodendrocytes also was found to normalize the amount of ceramide and increase the thickness and compaction of myelin, thus stabilizing the structure of remyelinated axons.

Pharmacological inhibition or genetic deletion of nSMase2 in myelinating oligodendrocytes normalized the ceramide content of remyelinated fibers and increased thickness and compaction. These results suggest that inhibition of nSMase2 could improve the quality of myelin and stabilize structure, the researchers wrote, adding that amore stable myelin structure is likely to be less susceptible to secondary demyelination.

We think these findings are a big step toward improving the quality and composition of myelin following a flare-up, Haughey said.

The team now plans to determine the impacts of other abnormal lipid levels, apart from ceramide, and determine if myelin maintains its function when returned to its correct structure. After this, the researchers hope it will be possible to consider inhibitors of nSMase2 for use in human trials.

Diana holds a PhD in Biomedical Sciences, with specialization in genetics, from Universidade Nova de Lisboa, Portugal. Her work has been focused on enzyme function, human genetics and drug metabolism.

Total Posts: 1,053

Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

See original here:
Better Repair of Nerve Insulation May Lead to New MS Treatments - Multiple Sclerosis News Today

In the first wave of the coronavirus disease 2019 pandemic, patients with axial spondyloarthritis, rheumatoid arthritis, and psoriatic arthritis didnt have an increase in disease activity despite an interruption in in-person interactions.

During the first wave of the coronavirus disease 2019 (COVID-19) pandemic, patients with axial spondyloarthritis (axSpA), rheumatoid arthritis (RA), and psoriatic arthritis (PsA) didnt see any increase in disease activity despite an interruption in in-person interactions, according to research published in Annals of Rheumatic Diseases.

The researchers analyzed patients in the Swiss Clinical Quality Management cohort to understand how partial or complete closure of rheumatology services impacted disease activity as remote consultations were used to partly compensate for the reduced in-person interaction.

Additional factors may also potentially contribute to disease worsening during the pandemic, the authors explained. Some patients may choose to preventively stop immunosuppression out of fear of complications. Moreover, the psychological stress (anxiety about a new disease, economic pressure, less recreational opportunities and so on) encountered during the pandemic should not be underestimated.

The researchers defined 3 study periods: a preCOVID-19 phase from January 1 to February 29, 2020; a COVID-19 phase from March 1 to April 30, 2020; and a postCOVID-19 phase from May 1 to June 30, 2020. Patients who had at least 1 patient-reported disease activity measure in each of the study periods were included.

A few disease activity assessments were used: the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for axSpA; the Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) in RA; and the Patient Global Assessment (PGA) visual analogue scale for disease activity in PsA. The researchers used the following to define a clinically important worsening:

The study looked at 287 patients with axSpA, 248 with RA, and 131 with PsA. The number of visits dropped 52% from 543 in February to 262 in April; however, there was a 129% increase in web-based application entries (521 to 1195) during this time.

In the preCOVID-19 phase, 15% of patients were nonadherent to their medication. While there was a slight increase in nonadherence during the COVID-19 phase, the researchers noted the increase only reached statistical significance among patients with axSpA.

Adherence returned to prepandemic levels in the postCOVID-19 phase, they wrote.

Over the first half of 2020, patient-reported disease activity outcomes were stable. There was a slight decrease during the COVID-19 phase; the decrease was only statistically significant for patients with axSpA (mean BASDAI 3.40 before the pandemic and 3.23 during the pandemic; P = .02). There was disease flare in less than 15% of patients for all 3 diseases, which was not statistically different from the preCOVID-19 phase.

The authors noted that the fact they could only evaluate patients with regular disease activity assessments was a limitation.

This subset using the smartphone app is probably more invested in disease management and the non-compliance figures might be under-represented, they wrote.

Reference

Ciurea A, Papagiannoulis E, Brki K, et al. Impact of the COVID-19 pandemic on the disease course of patients with inflammatory rheumatic diseases: results from the Swiss Clinical Quality Management cohort. Ann Rheum Dis. Published online September 22, 2020. doi:10.1136/annrheumdis-2020-218705

Read more from the original source:
Interruptions to In-Person Visits During Pandemic Did Not Negatively Impact Patients With Inflammatory Arthritis - AJMC.com Managed Markets Network

I harassed my GP enough to get it caught early

Meet Georgie.

At age 26, Georgie was diagnosed with rheumatoid arthritis, an autoimmune inflammatory condition that affects up to1% of the population worldwide.

Suffering from such incredible pain every morning that stopped her from doing simple things like getting dressed or brushing her teeth, Georgie sought help. And refused to stop until she got answers.

What we can learn from Georgies story

Georgies story is a positive one, one where the short time to diagnosis (23 months) meant that the disease was caught and treated early, causing minimal damage to her joints. So what contributed to this?

On the one hand, time-lags between initial symptoms and diagnosis for rheumatoid arthritis have universally decreased in recent years (egfrom 24 months in 20002002 to 6 months in 20092011). Key to this has probably been a shift in clinicians knowledge of the disease and the motivation to treat likely tied to their beliefs about the consequences of the disease and the impact of early diagnosis.

At the same time, patient empowerment remains an integral driver to accelerating diagnosis and treatment.

And Georgie is a great example of a patient who empowered herself by asserting her interests.

She had an awareness of her own body and what is normal. So when her doctors initially sent her home, she didnt give up within 2 weeks, she was back, asking for answers. When the blood tests came back normal, she wasnt demoralised. Her awareness, together with the desire to live pain-free, gave her the motivation and confidence to assert her interests in her interactions with healthcare professionals and persist until a referral and diagnosis were reached.

But she shouldnt have to empower herself

Georgies success comes from being assertive and not all patients will be. So what about them? Will they end up with a delayed diagnosis and the consequent joint damage that goes with it?

Communication is key here; and both parties need to be involved. The environment has to engage patients and give them the knowledge, confidence and skills they need to be active players in their care. Which will be necessary to bridgethe gap between patients and doctors and enable them to share the knowledge they each have and help them make informed mutual decisions.

Clearly great strides have been made in rheumatoid arthritis. But we cant pause now; by looking at stories like Georgies, we have to keep assessing the gaps and continuously evolve the environment.

See more here:
The other side of rheumatoid arthritis - PMLiVE

DelveInsight's Rheumatoid Arthritis report states that the therapeutic market is expected to grow because of the launch of emerging drugs in the pipeline however the growth during the forecast period will be dampened because of the entry of biosimilars of blockbuster drugs

LAS VEGAS, Oct. 29, 2020 /PRNewswire/ -- The Rheumatoid Arthritis market report delivers an in-depth understanding of the Rheumatoid Arthritis, historical and forecasted epidemiology as well as the Rheumatoid Arthritis market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan for the study period of 2017-2030.

Few of the key highlights from the report:

The Biologics segment holds the highest share in the market in terms of revenue; its approximately 90% of the market share. Among the biologics, its anti-TNFs (~68%) have captured the major portion of the market owing to well-established efficacy, safety profile, physicians familiarities, and their long presence in the market. Among the anti-TNFs, etanercept and adalimumab were holding around 50% of the total in the 7MM market share in 2017.

Among the currently approved advanced classes, the growth of anti-TNF, T cell inhibitor, and B cell Inhibitor are expected to be relatively flat mainly due to the entry of biosimilars which ultimately leads to erosion of sales value.

As per DelveInsight's analysts the JAK inhibitor class expected to grow with a significant CAGR during the forecast period owing to market penetration of already approved products, entry and adoption of emerging drugs, and increase in physicians familiarities, and placing of JAK as a treatment option in the first line.

The Biosimilars started entering the United States and EU (i.e. Remicade biosimilars) and due to this sales value has started declining and the impact will be more pronounced when biosimilars/ generics of some blockbuster drugs like Humira (i.e. 2023 in the US), Xeljanz (i.e. 2025 in the US) will going to hit into the market and this will impact the growth of RA market significantly.

Among the recently launched and upcoming therapies, upadacitinib and filgotinib have the potential to impact the market owing to more selective oral JAK1 inhibitors and better clinical profile compared to already approved JAKi. Although upadacitinib will have a slight edge over filgotinib owing to order of entry, slightly better efficacy data, and recent FDA rejection of filgotinib.

To know how the trends will be impacting the market, click on the link to download the sample: https://www.delveinsight.com/sample-request/rheumatoid-arthritis-ra-market

Story continues

Rheumatoid arthritis (RA) is a chronic, progressive, inflammatory autoimmune disease and is characterized by chronic pain and joint destruction that usually progress from distal to more proximal joints. Even after years of research, the cause of rheumatoid arthritis is still unknown. Rheumatoid Arthritis symptoms include joint pain, stiffness, swelling, and decreased movement of the joints. Rheumatoid arthritis diagnosis is done by a combination of patient's symptoms, results of doctor's examination, assessment of risk factors, family history, a joint assessment by ultrasound sonography, and assessment of laboratory markers such as elevated levels of CRP and ESR in serum and detection of Rheumatoid Arthritis -specific autoantibodies. Rheumatoid Arthritis has a predilection to affect women, that's why the incidence and prevalence rates in women for RA is 2- 3 times more as compared to men. The total prevalent cases of Rheumatoid Arthritis in the 7MM were observed to be 4,356,793 in 2017 which are estimated to rise during the study period (20172030). The United States accounted for the highest number of cases in the 7MM.

The report provides an in-depth historical and forecasted analysis of Rheumatoid Arthritis Epidemiology segmented by:

Total Prevalent Cases

Total Diagnosed Prevalent Cases

Gender-specific Prevalent Cases

Age-specific Prevalent Cases

Severity-specific Prevalent Cases

Patients on targeted therapies

Line-Wise Treated Cases

Rheumatoid Arthritis Treatment Market

The Rheumatoid Arthritis treatment paradigm includes medicine, supportive treatment and surgery. Currently, there are three primary treatment options for severe and advancing Rheumatoid Arthritis which include DMARDs, NSAIDs, and corticosteroids. Rheumatoid market consists of many different drug target agents forming different drug classes. Conventional DMARDs are a group of drugs (i.e. methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) that have been shown to affect the underlying cause of RA by damping down over-activity of the immune system, which helps to ease pain, swelling and stiffness, and prevent changes occurring within the joint. Among csDMARDS, methotrexate (MTX) is considered as a part of the first treatment strategy. MTX remains the anchor drug in RA; along with usage as monotherapy, it is also the basis for combination therapies, either with GC or with other csDMARDs, bDMARDs or tsDMARDs.Patients refractory to csDMARDS or with severe symptoms usually treated with a wide variety of biologics DMARDs classes like anti-TNF, T cell inhibitor, B cell Inhibitor, Interleukin Inhibitors and targeted synthetic DMARDs like JAK Inhibitors. The drug classes include blockbusters Anti-TNF (Etanercept, Infliximab, Adalimumab, Certolizumab-pegol) JAK inhibitors (tofa citinib, baricitinib, upadacitinib, Peficitinob) B-cell inhibitors (Rituximab), Interleukin Inhibitors (Tocilizumab, Sarilumab), T-cell inhibitors (Abatacept), DMARDs, other novel inhibitors, etc.

Biological DMARDs showed promising results in treating RA patients and market penetration is expected to be more in the future and this class is expected to drive the growth of the market. Oral classes such as JAKi and upcoming BTKi due to patient convenient RoA are also expected to contribute to the Rheumatoid Arthritis market growth. The market for Rheumatoid Arthritis possesses fierce competition but still, there is a high demand for new therapies having similar or better efficacy, however, improved safety profile as well as patient adherence. Because of high competition, the new entrants are expected to be met with some resistance and will experience slow uptake, as the market is currently dominated by the anti-TNFs and entry of biosimilars will further pose significant challenges to new and upcoming treatment. It goes without saying that the dynamics of the Rheumatoid Arthritis market is expected to change because of the launch of emerging therapies, companies like GlaxoSmithKline [Otilimab (MOR103/GSK3196165)], Taisho Pharmaceutical [Ozoralizumab (TS-152)], Gilead and Galapagos NV [Filgotinib (GS-6034; Jyseleca)], and R-Pharm (Olokizumab) with their key candidates are in registrational or late clinical-stage. In addition to this, companies like Merck KGaA (Evobrutinib), Pfizer (PF-06650833, and PF-06651600), Roche (Fenebrutinib), and several others in phase II clinical development stage with their investigational candidates.

As many potential therapies are being investigated for the management of Rheumatoid Arthritis, it is for sure that the treatment space will experience a significant impact during the forecast period of 20202030.

As the emerging drugs will be entering the market, to know what will be their impact on the existing market, which drug will be a blockbuster, and for which line of treatment these drugs will be used? Download the RA Report to know more:- https://www.delveinsight.com/report-store/rheumatoid-arthritis-ra-market

Scope of the Report

Geography Covered: 7MM - The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), Japan.

Study Period: 3-year historical and 11-year forecasted analysis (2017-2030).

Markets Segmentation: By Geographies, By Therapies (Forecasted + Historical).

Companies Covered: GlaxoSmithKline, Gilead, Galapagos NV, R-Pharm, Taisho Pharmaceuticals, Aclaris Therapeutics, Viela Bio, Bristol Myers Squibb, AbbVie, Pfizer, Philogen, Akros Pharma, Japan Tobacco, Merck KGaA, Genentech, Mesoblast, UCB Pharma, PRA HEALTH SCIENCES, Izana Bioscience, Takeda, Abivax S.A, Hope Biosciences, Genosco (Oscotec) and several others.

Analysis: Comparative and conjoint analysis of emerging therapies, Attribute Analysis

Market trends, pipeline analysis across different stages of development (Phase III and Phase II), and market size by therapies.

Tools used such as SWOT analysis, Porter's Five Forces, PESTLE analysis, BCG Matrix analysis methods.

Case Studies

KOL's Views

Analyst's View

Table of Contents

1. Key Insights

2. Executive Summary of Rheumatoid Arthritis

3. SWOT Analysis of Rheumatoid Arthritis

4. Rheumatoid Arthritis Market Share (%) Distribution Overview at a Glance: By Country

5. Rheumatoid Arthritis Market Share (%) Distribution Overview at a Glance: By Class

6. Rheumatoid Arthritis Disease Background and Overview

7. Rheumatoid Arthritis Epidemiology and Patient Population

8. Rheumatoid Arthritis Epidemiology Scenario: 7MM

9. The United States Rheumatoid Arthritis Epidemiology

10. EU-5 Rheumatoid Arthritis Epidemiology

10.1. Germany

10.2. France

10.3. Italy

10.4. Spain

10.5. The United Kingdom

11. Japan Rheumatoid Arthritis Epidemiology

12. Current Rheumatoid Arthritis Treatment Practices

12.1. Medications

12.2. Supportive Treatment

12.3. Surgery

12.4. Treatment Algorithm

12.5. Guideline of Rheumatoid Arthritis

13. Unmet Needs

14. Patient Journey of Rheumatoid Arthritis

15. Key Endpoints in Rheumatoid Arthritis Clinical Trials

16. Rheumatoid Arthritis Marketed Therapies

16.1. Marketed Therapies Key Cross

16.2. Olumiant (Barticinib): Eli Lilly and Company/Incyte Corporation

16.3. Rinvoq (Upadacitinib): AbbVie

16.4. Xeljanz (Tofacitinib): Pfizer/PV PRISM CV

16.5. Remicade (Infliximab): Janssen Biotech (Centocor)

16.6. Enbrel (Etanercept): Immunex/Amgen

16.7. Rituxan/MabThera (Rituximab): Genentech/Biogen

16.8. Certolizumab-pegol (Cimzia): UCB Inc.

16.9. Golimumab (Simponi): Janssen Biotech

16.10. Humira (adalimumab): AbbVie

16.11. Orencia (Abatacept): Bristol Myers Squibb

16.12. Smyraf (Peficitinib): Astella Pharma

16.13. Actemra (Tocilizumab): Roche

16.14. Kineret (Anakinra): Swedish Orphan Biovitrium (SOBI)

16.15. Kevzara (Sarilumab): Regeneron and Sanofi

17. Rheumatoid Arthritis Emerging Therapies

17.1. Key Cross

17.2. GSK3196165 (otilimab/MOR103): GlaxoSmithKline

17.3. Filgotinib (GS-6034; GLPG0634; Jyseleca): Gilead and Galapagos NV

17.4. Olokizumab: R-Pharm

17.5. TS-152 (Ozoralizumab): Taisho Pharmaceuticals

17.6. ATI-450 (CDD-450): Aclaris Therapeutics

17.7. VIB4920: Viela Bio

17.8. Branebrutinib: Bristol Myers Squibb

17.9. ABBV-3373 and ABBV-154: AbbVie

17.10. Dekavil (F8IL10): Pfizer/Philogen

17.11. PF-06651600 (Ritlecitinib): Pfizer

17.12. JTE 051: Akros Pharma/Japan Tobacco

17.13. Evobrutinib (M2951): Merck KGaA

17.14. PF-06650833: Pfizer

17.15. Fenebrutinib (GDC-0853, RG7845): Genentech (subsidiary of Roche)

17.16. MPC-300-IV (Allogeneic Mesenchymal Precursor Cells): Mesoblast

17.17. Bimekizumab: UCB Pharma/PRA HEALTH SCIENCES

17.18. Namilumab (IZN-101; AMG203): Izana Bioscience/Takeda

17.19. ABX464: Abivax S.A.

17.20. HB-AdMSCs: Hope Biosciences

17.21. SKI-O-703: Genosco (Oscotec)

18. Conjoint Analysis of Rheumatoid Arthritis

More here:
Rheumatoid Arthritis Market expected to increase with a decent CAGR of approx. 3% during the study period 2017-30 - Yahoo Finance

Anterior cruciate ligament, or ACL, injuries are one of the most common types of knee injury and occur particularly in athletes or people who exercise and play sport regularly. ACL injuries can be treated surgically or non-surgically, depending on the patient, but may lead to an increased risk of osteoarthritis in later life. A new study, published in October 2020 in Scientific Reports, suggests that production of a certain protein in the knee joint following ACL injury may indicate an increased risk of osteoarthritis in future, allowing clinicians to better predict and treat this condition at an earlier stage.

What is ACL injury?

The ACL is one of the ligaments in the knee, and helps to move the joint back and forward. It is most commonly injured during running or playing sport: injuries to the ACL are known as sprains or tears. They can range from being mild, where the ligament is just stretched, to severe, where it is completely torn in two.

Patients may become aware of their knee making a popping noise, suddenly giving way, being painful, swelling and/or not moving properly. ACL injury can usually be diagnosed on examination by a doctor, but imaging may be required to ascertain the severity of the injury.

Treatment of ACL injury

If the patient wishes to return to full mobility, ACL injuries tend to require surgery as the ligament cannot repair itself. This can usually be done via arthroscopy (commonly known as keyhole surgery), which is less invasive and has a quicker recovery time compared to open surgery. For some elderly or very inactive patients, who do not need to return to great knee mobility, surgery may not be required and they may be able to use a brace and/or have physiotherapy instead if the injury is not very severe.

ACL injury and osteoarthritis

Unfortunately, patients who suffer an ACL injury also have a higher risk of developing arthritis, and in particular osteoarthritis, in the knee as they grow older. Osteoarthritis, also known as wear-and-tear arthritis, is common in elderly people, and occurs when the surface of the joint wears away, causing pain, swelling and loss of mobility.

Osteoarthritis cannot be cured but can be treated and prevented from worsening through medications, lifestyle changes such as diet and exercise, and, in some cases, surgery.

The recent study in Scientific Reports has suggested that production of a specific protein that helps lubricate the knee joint may be a predictor of future arthritis in patients with ACL injury. The study was conducted on dogs that had suffered ACL injury but the protein, called lubricin, is present in healthy knee joints in all mammals, including humans. The results may therefore be useful in treating human patients as well, and further studies are taking place to confirm if this is the case.

The study found that levels of lubricin significantly increased in those dogs that had suffered an ACL tear, before any other signs of arthritis were detected. The researchers concluded that increased levels of this protein may therefore be a marker for predicting osteoarthritis earlier, thus allowing patients to seek treatment more promptly and to make the lifestyle changes that could prevent their osteoarthritis from deteriorating.

This study is an encouraging example of how research can aid the development of treatment for common injuries and prevent subsequent and damaging side-effects later on in life.

Read this article:
ACL injury and osteoarthritis: causes, symptoms and treatment - Lexology

CMI presents an in-depth overview of the Global Rheumatoid Arthritis Treatment Market Study, detailing the latest product/industry coverage and market forecasts and status by 2027. Market research is categorized as a key area to accelerate marketization. The current market is evolving its presence and some of the major players in the study are Pfizer, Inc., Johnson & Johnson, Abbvie, Inc., F. Hoffmann-La Roche AG, Merck & Co., Inc., and Amgen, Inc.,

This study focuses on the Global Rheumatoid Arthritis Treatment Market status, future forecast, growth opportunity, key market, and emerging players. The study objectives are to present the Rheumatoid Arthritis Treatment growth in Key regions. In order to provide valuable insight into each key element of the market, the highest and slowest growing market segment in the study is described. Newmarket participants are emerging and are accelerating the transition in the antistatic market. Merger and acquisition activities are expected to change the market environment for this industry.

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The Global Rheumatoid Arthritis Treatment is segmented by:

By Product Type: Global Rheumatoid Arthritis Treatment Market, By Application.

Regional Markets: United States, Europe, China, Japan, Southeast Asia, India & Central & South America

List of Companies Mentioned: Pfizer, Inc., Johnson & Johnson, Abbvie, Inc., F. Hoffmann-La Roche AG, Merck & Co., Inc., and Amgen, Inc.,

1) Does Study provide Latest Impact on Market due to COVID & Slowdown?

Yes, the study has considered a chapter on Impact Analysis and this 2020 Edition of the report provides detailed analysis and its impact on growth trends and market sizing to better understand the current scenario.

2) How companies are selected or profiled in the report?

The list of some players that are profiled in the report includes Pfizer, Inc., Johnson & Johnson, Abbvie, Inc., F. Hoffmann-La Roche AG, Merck & Co., Inc., and Amgen, Inc.,.. the list is sorted to come up with a sample size of at least 50 to 100 companies having greater topline value to get their segment revenue for market estimation.

** List of companies mentioned may vary in the final report subject to Name Change / Merger etc.

3) Is it possible to narrow down business segments by Application of this study?

Yes, depending upon the data availability and feasibility check by our Research Analyst, a further breakdown in business segments by end-use application in relation to type can be provided (If applicable) by Revenue Size or Volume*.

4) What is the base year of the study? What time frame is covered in the report?

Furthermore, the years considered for the study are as follows:

Historical year 2014-2019

Base year 2019

Forecast period** 2020 to 2027 [** unless otherwise stated]

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** We will also include opportunities to utilize in micro markets that stakeholders can invest in, a detailed analysis of key competitors, and key services. **

Global Rheumatoid Arthritis Treatment Market What to expect from this report:

Focused Study on Niche Strategy and Market Development & penetration Scenario

Top 10 Global Rheumatoid Arthritis Treatment Companies in Global Market Share Analysis: Leaders and Laggards in 2017, 2019

Gain strategic insights on competitor information to formulate effective R&D moves

Identify emerging players and create effective counter-strategies to outpace competitive edge

Identify important and diverse product types/services offering carried by major players for market development

And many more .

TABLE OF CONTENTS

PART 01: EXECUTIVE SUMMARY

PART 02: SCOPE OF THE REPORT

PART 03: RESEARCH METHODOLOGY

PART 04: Global Rheumatoid Arthritis Treatment MarketLandscape

PART 06: Global Rheumatoid Arthritis TreatmentMarket Sizing

PART 07: Global Rheumatoid Arthritis TreatmentMarket Segmentation

PART 08: CUSTOMER LANDSCAPE

PART 10: DECISION FRAMEWORK

PART 09: REGIONAL LANDSCAPE

PART 11: MARKET DYNAMICS: DRIVERS, TRENDS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES

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Rheumatoid Arthritis Treatment Market Opportunity and Business Industry By Forecast to 2026 | Coherent Market Insights.com - re:Jerusalem

A new report by XploreMR takes a deep dive into the Rheumatoid Arthritis Diagnosis Tests Market after conducting meticulous research, assessing each microscopic aspect of the market. The researches have connected the dots with minuscule details that shape into an intricate, immaculate yet elucidate study. The report presents a thoroughly scrutinized study of the Rheumatoid Arthritis Diagnosis Tests Market, leaving no stone unturned in offering market players a valuable and constructive tool that navigates them in the profitable path with the right set of objectives.

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The researchers have studied the factors that are expected to drive the growth of the Rheumatoid Arthritis Diagnosis Tests by creating revenue opportunities, directly and indirectly. Similarly, the emerging trends, both long-term and short-term, present factors that are likely to impact the markets growth and project the direction the whole market is moving. Economical, technological, or any other trend that could bestow opportunities, have been studied. Moreover, the researchers have expanded the analysis beyond growth prospects and analyzed the possible restraining factors to the growth of the Rheumatoid Arthritis Diagnosis Tests Market, thus enabling market players to foresee the likely challenges and emerge successful through the forecast period 2017 2025.

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To breakdown the vast study that spreads through geographies, products, and end-use segments, among other market-specific segments, the authors present CAGR (Compound Annual Growth Rate) of each segment throughout the years of forecast. CAGR is a simplistic representation of growth that clearly projects which segment registered the highest/least growth through the forecast period 2017 2025. Moreover, each segment is analyzed on the basis of volume and volume, also projected with year-on-year growth and CAGR.

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Overview: Presents a broad overview of the Rheumatoid Arthritis Diagnosis Tests market, acting as a snapshot of the elaborate study that follows.

Market Dynamics: A straight-forward discussion about key drivers, restraints, challenges, trends, and opportunities of the Rheumatoid Arthritis Diagnosis Tests market.

Product Segments: Explores the market growth of the wide variety of products offered by organizations, and how they fare with end-users.

Application Segments: This section studies the key end-use applications that contribute to the market growth and the emerging opportunities to the Rheumatoid Arthritis Diagnosis Tests market.

Geographical Segments: Each regional market with a region-specific study of each segment- is carefully assessed for understanding its current and future growth scenarios.

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Rheumatoid Arthritis Diagnosis Tests Market Projection By Top key Players, Share, Size, Demand, Opportunities, Sale Area, Revenue Analysis Forecast To...

Global Rheumatoid Arthritis Treatment Market Research Report offers a in-depth view on market trends, forecast statistics, company profile, growth drivers and latest industry insights. The report covers all the Rheumatoid Arthritis Treatment type, applications, deployment models, research regions. A deep-dive analysis on leading Rheumatoid Arthritis Treatment industry players, their market share, production volume, gross margin analysis from 2015-2019 is provided. Challenges to the Rheumatoid Arthritis Treatment development, growth opportunities, market drivers, restraints are described in this report.

The market value, market share, production and gross margin of Rheumatoid Arthritis Treatment is covered for every type, application, and geographical regions. Also, import-export scenario, regional SWOT analysis, and market status is elaborated. Rheumatoid Arthritis Treatment Forecast covers type, application and regional forecast for market value, volume, and consumption from 2020 to 2026. Industry barriers, investment feasibility, and opportunities to the new Rheumatoid Arthritis Treatment market players are analyzed in this report.

Global Rheumatoid Arthritis Treatment market is subdivided based on type, application and research regions. Top regions studied in this report include North America, Europe, Asia-Pacific, South America, Middle East & Africa. For each region, production value and growth rate is covered from 2015 to 2019. The information on market concentration and market maturity analysis will lead to investment feasibility.

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Major players covered in this report:

Johnson & JohnsonAmgen Inc.Sobi Inc.UCB S.A.Eli Lilly & CompanySanofi SAAbbVie Inc.Pfizer Inc.Bristol-Myers Squibb CompanyF. Hoffman-La Roche AG

Global Rheumatoid Arthritis Treatment Market Segmentation:

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Non-Steroidal Anti-inflammatory Drugs (NSAIDs)CorticosteroidsDisease-modifying anti-rheumatic drugs (DMARDs)

By Application:

HospitalRetail PharmaciesDrugstores

Market drivers explain the emerging countries and Rheumatoid Arthritis Treatment growth. Also, the limitations, opportunities, latest industry plans, and policies are offered. Industry chain analysis explains upstream raw material suppliers, key market players, production process analysis, Rheumatoid Arthritis Treatment manufacturing cost structures, and global market share of Rheumatoid Arthritis Treatment in 2019. This in-depth study explains the cost of raw materials, labor cost, marketing channels and major downstream buyers of Rheumatoid Arthritis Treatment.

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Global Rheumatoid Arthritis Treatment Market Expected To Witness The Highest Growth 2027 | Johnson & Johnson, Amgen Inc., Sobi Inc., UCB SA, Eli...

Objective:To compare the efficacy and safety of brodalumab, an interleukin-17 receptor subunit A inhibitor, with placebo, in patients with psoriatic arthritis (PsA).

Methods:Adult patients with active PsA and inadequate response to, or intolerance to, conventional treatment were enrolled into two phase III studies (NCT02029495andNCT02024646) and randomised 1:1:1 to receive subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks. About 30% of patients had prior use of biologics. The primary endpoint for both studies was the American College of Rheumatology 20 (ACR20) response at week 16.

Results:962 patients were randomised across the studies prior to early termination due to sponsor decision. The primary endpoint was met in both studies. Based on comparable design and eligibility criteria, data from both studies were pooled. Significantly more patients achieved ACR20 at week 16 in both brodalumab treatment groups (45.8% and 47.9% for 140 mg and 210 mg, respectively) versus placebo (20.9%) (p<0.0001). Similar results were observed at week 24. Significantly higher proportions of patients receiving brodalumab achieved ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis versus placebo (p<0.01). Adverse event rates were similar across treatments at week 16 (54.4%, 51.6% and 54.5% for placebo, brodalumab 140 mg and 210 mg, respectively). No new safety signals were reported.

Conclusion:Brodalumab was associated with rapid and significant improvements in signs and symptoms of PsA versus placebo. Brodalumab was well tolerated, with a safety profile consistent with other interleukin-17 inhibitors.

Keywords:DMARDs (biologic); autoimmune diseases; psoriatic arthritis.

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Brodalumab in psoriatic arthritis: results from the randomised phase III AMVISION-1 and AMVISION-2 trials - DocWire News

Non-contact, high-resolution imaging for uveitis surveillance in juvenile idiopathic arthritis (JIA) is feasible and acceptable to patients with the disease, according to study results published in Arthritis & Rheumatology.

Disease activity in anterior uveitis is traditionally assessed using slit lamp biomicroscopy; however, this modality is semiquantitative and image interpretation is subjective. Optical coherence tomography (OCT) may represent a better metric of measuring inflammatory disease, with recent modifications to OCT allowing the imaging of the anterior chamber.

In the current study, researchers sought to assess the feasibility and accuracy of cross-sectional anterior segment OCT (AS-OCT) for the diagnosis of active uveitis in JIA.

In the cross-sectional observational study, the researchers enrolled children with and without uveitis from a specialist pediatric uveitis center in England between 2017 and 2018. The 2 groups of participants included children with JIA and a diagnosis of chronic anterior uveitis; and children without both JIA and uveitis. All children received routine clinical assessment of the anterior chamber with a slit lamp. The ordinal Standardized Uveitis Nomenclature (SUN) anterior chamber activity cell count grade was used to diagnose inflammation.

The AS-OCT scans of the anterior chamber were then acquired. Patients were asked to focus their eye that was being tested on the machine fixation beam. Image acquisition time was measured, and participants were asked to rate the acceptability of the acquisition process. The AS-OCT images were analyzed manually for the presence of anterior chamber inflammation. Examiners were blinded to the results of the initial clinical examination. Correlation between imaging-acquired cell count and clinical assessment was calculated using a multilevel linear regression model. Sensitivity, specificity, and repeatability were also reported.

A total of 26 children received AS-OCT imaging, among whom 18 (69.2%) were girls. Median age was 8 years (age range, 3-15 years). Twelve children had active anterior inflammation during their initial clinical examination. Time taken to acquire AS-OCT images from both eyes ranged from 1.5 to 22 minutes, with a median value of 8 minutes. Patients rated image acquisition acceptability as high, with a median visual analog scale score of 9.5 of a possible 10.

Intraobserver image agreement was high with regard to manual cell count (intraclass observer coefficient, 0.81; 95% CI, 0.63-0.98). There was moderate agreement on cell count between observers (kappa statistic [], 0.46; 95% CI, 0.28-0.63), and between-observer disagreement on the presence of intraocular cells in 25 of the 377 reviewed images (6.6%). Anterior segment OCT had high correlation with active inflammation as diagnosed by slit lamp examination. Sensitivity for active inflammation was 91.7% (95% CI, 61.5%-99.8%); specificity was 85.7% (95% CI, 57.2%-89.2%); and accuracy was 88.5% (95% CI, 69.9%-97.6%). In multilevel regression modeling, there was high positive correlation between clinical assessment and image-based cell count (coefficient, 3.3; 95% CI, 1.3-5.2; P =.002). No children without uveitis had a positive result on AS-OCT imaging.

These results support the feasibility and acceptability of AS-OCT imaging for the assessment of uveitis in children with JIA.

The primary study limitation was the small sample size and the fact that the study results may not be generalizable to all children with anterior chamber inflammation. While AS-OCT correlated well with slit lamp examination, further study is necessary to standardize the imaging protocol.

Imaging-based metrics for uveitis holds the promise of providing sensitive, robust, validated measurement of disease status which, alongside [standardized] datasets and patient[-centered] metrics, can also improve service provision, prognostication and precision in disease management for affected or at-risk children, the researchers concluded.

Akbarali S, Rahi JS, Dick AD, et al. Imaging based uveitis surveillance in juvenile idiopathic arthritis: feasibility, acceptability and diagnostic performance. Arthritis Rheumatol. Published online September 25, 2020. doi:10.1002/art.41530

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Imaging-Based Uveitis Surveillance Feasible for Patients With Juvenile Idiopathic Arthritis - Rheumatology Advisor

- Researchers to share updates on long-term safety and efficacy of RINVOQ for the treatment of moderate to severe rheumatoid arthritis

- Presentations to highlight patient-reported outcomes of RINVOQ in people living with psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis

- New safety and efficacy data of RINVOQ through 64 weeks in treating ankylosing spondylitis, as well as an integrated safety analysis for psoriatic arthritis, will also be presented

NORTH CHICAGO, Ill., Oct. 28, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the presentation of new data on RINVOQ (upadacitinib) and HUMIRA (adalimumab) across multiple rheumatic diseases at the American College of Rheumatology's annual meeting (ACR Convergence 2020), to be held virtually November 5-9. A total of 38 abstracts, including seven oral presentations, will be presented from a broad range of studies in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

"At AbbVie, we have a focused vision of improving the care and advancing treatment options for people living with rheumatic diseases, which is illustrated by the body of research that will be presented at this year's ACR meeting," said Marek Honczarenko M.D., Ph.D., vice president, global immunology development, AbbVie. "These data underscore the potential for RINVOQ and HUMIRA to help more people living with rheumatic diseases reach their goals."

Data evaluating the long-term safety and efficacy of RINVOQ in rheumatoid arthritis will be presented, including:

84-week data on RINVOQ as a monotherapy in patients with inadequate response to methotrexate

72-week RINVOQ monotherapy data in methotrexate-nave patients

72-week data comparing RINVOQ versus HUMIRA in patients with inadequate response to methotrexate

An integrated safety update reflecting up to three years of treatment with RINVOQ

Oral presentations will also highlight the safety and efficacy of RINVOQ in the treatment of psoriatic arthritis (through 24 weeks) and ankylosing spondylitis (through 64 weeks), while a poster presentation will provide a new integrated safety analysis from two Phase 3 trials evaluating the safety profile of RINVOQ in psoriatic arthritis.

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Further, several presentations will show patient-reported outcomes for RINVOQ in the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, including its impact on pain reduction and physical function.

Key AbbVie rheumatology abstracts in the ACR Convergence 2020 program include:

Rheumatoid Arthritis

Safety Profile of Upadacitinib up to 3 Years of Exposure in Patients with Rheumatoid Arthritis. SB Cohen, et al. Abstract Number: 0237; Poster Session: Friday, November 6, 9 11 a.m. EST

Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 72 Weeks. R Fleischmann, et al. Abstract Number: 0212; Poster Session: Friday, November 6, 9 11 a.m. EST

Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks. JS Smolen, et al. Abstract Number: 0209; Poster Session: Friday, November 6, 9 11 a.m. EST

Incidence and Risk of Venous Thromboembolic Events Among Patients with Rheumatoid Arthritis Enrolled in the Upadacitinib Clinical Trial Program. E Choy, et al. Abstract Number: 0215; Poster Session: Friday, November 6, 9 11 a.m. EST

Upadacitinib Monotherapy in Methotrexate-nave Patients with Rheumatoid Arthritis: Results at 72 Weeks. R van Vollenhoven, et al. Abstract Number: 0207; Poster Session: Friday, November 6, 9 11 a.m. EST

Impact of Upadacitinib or Adalimumab as Initial Therapy on the Achievement of 48-week Treatment Goals in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: Post Hoc Analysis of a Phase 3 Study. E Mysler, et al. Abstract Number: 0228; Poster Session: Friday, November 6, 9 11 a.m. EST

Radiographic Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate: Results at 2 Years. CG Peterfy, et al. Abstract Number: 1231; Poster Session: Sunday, November 8, 9 11 a.m. EST

Patient-Reported Outcomes of Upadacitinib versus Abatacept in Patients with Rheumatoid Arthritis and an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: 12-Week Results of a Phase 3 Study. M Bergman, et al. Abstract Number: 1728; Poster Session: Monday, November 9, 9 11 a.m. EST

Evaluation of Response to Pneumococcal Vaccination in Patients with Rheumatoid Arthritis Receiving Upadacitinib: Results from a Phase 2 Open-Label Extension Study. K Winthrop, et al. Abstract Number: 1996; Oral Presentation: Monday, November 9, 10 10:50 a.m. EST

Incidence and Risk Factors for Herpes Zoster in Rheumatoid Arthritis Patients Receiving Upadacitinib. K Winthrop, et al. Abstract Number: 2002; Oral Presentation: Monday, November 9, 3 3:50 p.m. EST

Psoriatic Arthritis

Efficacy and Safety of Upadacitinib in Patients with Active Psoriatic Arthritis and Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomized Controlled Phase 3 Trial. MC Genovese, et al. Abstract Number: 0504; Oral Presentation: Friday, November 6, 3 3:50 p.m. EST

Impact of Upadacitinib on Reducing Pain in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Trials in Patients with Inadequate Response to Non-biologic or Biologic DMARDs. IB McInnes, et al. Abstract Number: 0896; Poster Session: Saturday, November 7, 9 11 a.m. EST

Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis with Inadequate Response to Non-Biologic DMARDs Treated with Upadacitinib versus Placebo or Adalimumab: Results from a Phase 3 Study. V Strand, et al. Abstract Number: 1341; Poster Session: Sunday, November 8, 9 11 a.m. EST

Improvement in Patient-Reported Outcomes for Upadacitinib Versus Placebo Among Patients With Psoriatic Arthritis and an Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drugs. V Strand, et al. Abstract Number: 1371; Poster Session: Sunday, November 8, 9 11 a.m. EST

Safety Profile of Upadacitinib in Psoriatic Arthritis: Integrated Analysis From Two Phase 3 Trials. GR Burmester, et al. Abstract Number: 1350; Poster Session: Sunday, November 8, 9 11 a.m. EST

Characterization of Remission in Patients with Psoriatic Arthritis Treated with Upadacitinib: Post-hoc Analysis from Two Phase 3 Trials. P Mease, et al. Abstract Number: 1355; Poster Session: Sunday, November 8, 9 11 a.m. EST

Efficacy and Safety of Upadacitinib versus Placebo and Adalimumab in Patients with Active Psoriatic Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomized Controlled Phase 3 Trial. IB McInnes, et al. Abstract Number: 2026; Oral Presentation: Monday, November 9, 11 11:50 a.m. EST

Ankylosing Spondylitis

Effect of Upadacitinib on Reducing Pain in Patients with Active Ankylosing Spondylitis and Inadequate Response to Nonsteroidal Anti-inflammatory Drugs. A Deodhar, et al. Abstract Number: 0369; Poster Session: Friday, November 6, 9 11 a.m. EST

Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 1-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension. A Deodhar, et al. Abstract Number: 2023; Oral Presentation: Monday, November 9, 11 11:50 a.m. EST

A full list of all 38 AbbVie abstracts accepted for presentation at ACR Convergence 2020 can be found here.

About RINVOQ (upadacitinib)Discovered and developed by AbbVie, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1-3 In August 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.4-12 Use of RINVOQ in ankylosing spondylitis and psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

Important Safety Information about RINVOQ (upadacitinib)13

RINVOQ U.S. Use and Important Safety InformationRINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

What is the most important information I should know about RINVOQ?RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).

Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.

Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.

Tears in the stomach or intestines and changes in certain laboratory tests can happen. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

What should I tell my HCP BEFORE starting RINVOQ?Tell your HCP if you:

Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:

Have TB or have been in close contact with someone with TB.

Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.

Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.

Live, have lived, or have traveled to parts of the country that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you've been to these areas, ask your HCP.

Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.

Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.

Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

What should I tell my HCP AFTER starting RINVOQ?Tell your HCP right away if you:

Have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.

Have any signs or symptoms of blood clots during treatment with RINVOQ, including:

Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are the common side effects of RINVOQ?These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for the Full Prescribing Information and Medication Guide.

About HUMIRA in the U.S.

UsesHUMIRA is a prescription medicine used:

To reduce the signs and symptoms of:

In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.

To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.

To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

Important Safety InformationHUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy, even if their TB test was negative. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated.

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA.

Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

Please click here for the Full Prescribing Information and Medication Guide.

About AbbVie in RheumatologyFor more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

AbbVie Data on File. ABVRRTI70713.

AbbVie Data on File. ABVRRTI70838.

AbbVie Data on File. ABVRRTI70869.

Pipeline Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on August 17, 2020.

Burmester G.R., et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on August 17, 2020

A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on August 17, 2020.

A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on August 17, 2020.

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on August 17, 2020.

A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03607422. Accessed on August 17, 2020.

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on August 17, 2020.

A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. 2020. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed on October 13, 2020.

RINVOQ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

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AbbVie Highlights Innovative Research for People with Rheumatic Diseases with New Data at ACR Convergence 2020 - Yahoo Finance

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Joint pain resulting in arthritis is a common health problem and if you are suffering from arthritis, there are certain foods you need to avoid to prevent from worsening your health conditions. Find out more.

Arthritis is a common health issue that occurs in many adults and younger people. It involves inflammation in your joints that leads to weakening the bones and damaging them. Some people believe that changes in diet are related to increased symptoms in arthritis. This change might be excess of fat and sugar or avoiding foods that are high in purines.

Let us have a look at five types of food that should be avoided if you are suffering from arthritis:

Inflammatory fats

Since inflammatory fats cause inflammation in the body, they are to be avoided by people with arthritis. Foods which include Omega 6 fatty acids like oil, corn, sunflower and vegetable oil. Saturated fat like meat, butter, cheese and trans fat. Trans fat is bad for health anyway as it increases the level of bad cholesterol in the body.

Sugar

People who have processed sugar regularly in their tea or coffee are highly prone to being at risk for having heart strokes. It leads to obesity, inflammation and other chronic diseases. Limit your intake of carbonated drinks, sugar in beverages, cereal bowls and other food items.

Tomatoes, eggplant, potatoes, bell peppers

Removing these food items from your diet or as part of key ingredients in your dishes might help. This improves in reducing the chances of developing any symptoms related to arthritis.

Purines

These are foods that are high in purines, which are substances in foods that the body converts to uric acid. The uric acid can accumulate in blood causing a gout attack. These types of foods include red meat, beer, ham and seafood.

Also Read:What are Shingles and is stress the real cause? Heres all you need to know

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THESE are the 5 foods people who suffer from arthritis must avoid - PINKVILLA

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Top Leading players operating in the market: Alteogen Inc., Bristol-Myers Squibb Company, Epirus Biopharmaceuticals, Inc., Johnson & Johnson, Momenta Pharmaceuticals, Inc., Mycenax Biotech Inc., Novartis AG, Oncobiologics, Inc.

Segmentation by Product:

Segmentation by Application:

Growth Dynamics and Geographical Landscape:

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