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Archive for the ‘Arthritis’ Category

Teva and Celltrion Healthcare Announce the Launch of TRUXIMA (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan…

Thursday, May 7th, 2020

TEL AVIV, Israel & PARSIPPANY, N.J. & INCHEON, South Korea--(BUSINESS WIRE)--Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Celltrion Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today announced that TRUXIMA (rituximab-abbs) injection is now available in the United States for the treatment of:

TRUXIMA is the only biosimilar to the reference product Rituxan1 (rituximab) available to treat rheumatoid arthritis in the United States. See important safety information below including Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.

We are proud to make TRUXIMA available to patients and providers as a treatment option for these indications, especially as this is the only rituximab biosimilar indicated for rheumatoid arthritis, said Brendan OGrady, Executive Vice President, North America Commercial, Teva. Following the launch of our other biosimilar earlier this year, we remain focused on our commitment to lower healthcare costs and increase price competition through the availability of biosimilars.

Celltrion Healthcare and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 for Teva to commercialize TRUXIMA in the U.S. and Canada. In May 2019, TRUXIMA was approved by the U.S. Food and Drug Administration (FDA) to match all of the reference products oncology indications described below.

We are pleased that patients in the United States can now have access to TRUXIMA for these new indications, said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We believe that the continued use of biosimilars in the U.S. market will contribute to addressing unmet needs for patients and providers.

Earlier this year, the Centers for Medicare and Medicaid Services (CMS) granted pass-through status for TRUXIMA in the hospital outpatient setting. The Wholesale Acquisition Cost (WAC or list price) for TRUXIMA will be 10 percent lower than the reference product. TRUXIMA is expected to be available through primary wholesalers at a WAC of $845.55 per 100mg vial and $4,227.75 per 500mg vial. Actual costs to individual patients and providers for TRUXIMA are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patients insurance payer and eligibility for participation in the assistance program.

Teva also offers dedicated patient support services through the CORE program. CORE is available to help eligible patients, caregivers and healthcare professionals navigate the reimbursement process. CORE offers a range of services, including benefits verification and coverage determination, support for precertification and prior authorization, assistance with coverage guidelines and claims investigation, and support through the claims and appeals process. A savings program is also available for eligible commercially insured patients. To learn more, please visit TevaCORE.com.

Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. For more information, please see the full prescribing information.

IndicationsTRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with:

Non-Hodgkins Lymphoma (NHL)

Chronic Lymphocytic Leukemia (CLL)

Rheumatoid Arthritis (RA)

Granulomatosis with Polyangiitis (GPA) (Wegeners Granulomatosis) and Microscopic Polyangiitis (MPA)

Important Safety Information

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion-Related Reactions: Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products

Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death

Premedicate patients with an antihistamine and acetaminophen prior to dosing. For RA, GPA, and MPA patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (25,000/mm3)

Severe Mucocutaneous Reactions - Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined

Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive)

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases increase in bilirubin levels, liver failure, and death can occur

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following TRUXIMA therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy

In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV

Progressive Multifocal Leukoencephalopathy (PML) - JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture

Discontinue TRUXIMA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML

Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of rituximab products in patients with NHL. A high number of circulating malignant cells ( 25,000/mm3) or high tumor burden, confers a greater risk of TLS

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated

Infections - Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections

Cardiovascular Adverse Reactions - Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina

Renal Toxicity - Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria

Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur

Immunization - The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment

Prior to initiating TRUXIMA physicians should ensure patients vaccinations and immunizations are up-to-date with guidelines. Administration of any non-live vaccines should occur at least 4 weeks prior to a course of TRUXIMA

Embryo-Fetal Toxicity - Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving TRUXIMA and for 12 months following the last dose of TRUXIMA

Concomitant Use With Other Biologic Agents and DMARDS Other Than Methotrexate

Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly as limited safety data is available.

Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with rituximab products

Use in RA Patients Who Have Not Had Prior Inadequate Response to TNF Antagonists

TRUXIMA should only be used in patients who have had a prior inadequate response to one or more TNF antagonist

Most common adverse reactions in clinical trials of NHL (25%) were: infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia

Most common adverse reactions in clinical trials of CLL (25%) were: infusion-related reactions and neutropenia

Most common adverse reactions in clinical trials of RA (10%) were: upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events)

Most common adverse reactions in clinical trials of GPA and MPA (15%) were: infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, and infusion-related reactions

Nursing Mothers - There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of TRUXIMA due to the potential for serious adverse reactions in breastfed infants

About TRUXIMA TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administration (FDA)-approved biosimilar to RITUXAN (rituximab) for the treatment of: adult patients with CD20-positive, B-cell NHL to be used as a single agent or in combination with chemotherapy or CLL in combination with fludarabine and cyclophosphamide (FC); for rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies; and granulomatosis with polyangiitis (GPA) (Wegeners Granulomatosis) and microscopic polyangiitis (MPA) in adult patients in combination with glucocorticoids

TRUXIMA has the same mechanism of action as Rituxan and has demonstrated biosimilarity to Rituxan through a totality of evidence.

About Celltrion Healthcare, Co. Ltd.Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcares products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.

About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.

Teva's Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of TRUXIMA Injection for Rheumatoid Arthritis in the United States, which are based on managements current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors and Forward Looking Statements. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1 RITUXAN is a registered trademark of Genentech and Biogen.

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Teva and Celltrion Healthcare Announce the Launch of TRUXIMA (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan...

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Down woman’s arthritis tracker app for young adults aims to help and connect sufferers during coronavirus pandemic – Belfast Telegraph

Thursday, May 7th, 2020

A Co Down woman is behind a mobile app to support teens and young adults living with arthritis during the coronavirus pandemic.

eading charity Versus Arthritis is launching the app today in the hope that it will help young people living with the debilitating condition, including the 15,000 children under the age of 16 who have juvenile idiopathic arthritis (JIA).

The arthritis tracker - which provides 24/7 access to trusted information and advice for young people between 13 and 25 - will help them to rate and record their arthritis symptoms in seconds and track their pain, medication side effects, fatigue, physical activity, sleep and emotional wellbeing.

Along with tracking their arthritis symptoms and wellbeing, the app also connects sufferers with other teenagers and young people who know what it is like to live with arthritis.

Hope Graham, from Warrenpoint, came up with the idea for the app as a result of her own painful experience of JIA.

She said: "Having an app that can help track symptoms is such a huge help.

"I have been in a lot of pain previously, but whenever I go to the doctor, I tend to say 'I'm okay, I'm not feeling that bad', but actually, I won't have been able to walk up the stairs a couple of weeks ago.

"I will be using the app all the time now. Being part of its development has already helped me to ensure I get the treatment I need when I visit my doctor. And being able to link up with other young people has completely changed the way I feel about my condition. I used to feel very alone.

"I hope that this app helps other young people to become part of a community, who are here to support each other."

An estimated 2.98m people under the age of 35 in the UK are living with a musculoskeletal condition like arthritis and the app will help young people enduring pain, fatigue and the isolation of arthritis, while also dealing with the everyday challenges of growing up.

Many people living with arthritis take immunosuppressant drugs and, as a result, they are amongst the 1.8m across the UK who currently have to shield themselves from Covid-19.

As a result, they have been unable to attend face-to-face hospital appointments and there are concerns this has made it more difficult to explain their symptoms. It is hoped the app, which is available from the Versus Arthritis website, will help to address this.

Belfast Telegraph

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Down woman's arthritis tracker app for young adults aims to help and connect sufferers during coronavirus pandemic - Belfast Telegraph

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COVID-19: Arthritis Drug Saves 72-year-old Critically Ill Patient with Grim Condition – Science Times

Thursday, May 7th, 2020

On March 16, Leonard Whitehurst was admitted to the Royal Cornwall hospital with a confirmed case of COVID-19. His doctor, Giorgio Gentile, said that Whithurst's condition has deteriorated, describing it as "very grim."

Thankfully, the 72-year-old was saved after his doctors decided to give him a promising arthritis drug that is under clinical trials by doctors worldwide. Tocilizumab showed promising results in treating COVID-19 patients in Italy.

The drug is marketed as RoZctemra or Actemra, used to suppress the immune system of patients with rheumatoid arthritis. Its effect on COVID-19 has the potential to halt the cytokine storm that happens when the immune system goes into overdrive and begins attacking the body.

Mr. Whitehurst's condition instantly improved after he received the drug as a last-ditch attempt, and is now recovering at home. Dr. Gentile believes that Whitehurst us the first to try the arthritis drug in the UK back in March following the advice of doctors from other countries.

The tocilizumab drug is now part of the three major trials on British coronavirus patients, expecting its first results by June or July.

Dr. Gentile is a consultant nephrologist from Italy who has worked at the Royal Cornwall Hospitals Trust since 2015.

He said that Mr. Whitehurst was in critical condition, needing 19 liters of oxygen but had not been put on a ventilator. The 72-year-old patient was deteriorating quickly, and putting him into the intensive care unit was not an option as the patient was not prepared to be artificially ventilated, his outlook was very grim at that time.

Dr. Gentile was so desperate to save his patient that he gave him tocilizumab, which seemed the only option left to try and save his patient's life. He regularly reads medical literature of COVId-19 from different countries that are also battling the disease.

Furthermore, he became aware of the drug's multiple anecdotal reports of people having severe conditions that had dramatically improved because of the medication. He said that the AIFA- Italian equivalent of the Medicines and Healthcare products Regulatory Agency- had just approved a large scale test trial with tocilizumab and was actively recruiting people.

Another promising study of 20 patients from China claimed the efficacy of the drug, which cured 95% of critically ill patients.

Read Also: This Drug Is Voted As the Most Effective Coronavirus Cure Possible By 6,000 Doctors Worldwide

According to Dr. Gentile, Mr. Whitehurst had all the laboratory signs of the so-called "cytokine storm." With approval from the hospital and the patient, he decided to give him tocilizumab, which was administered quickly.

Mr. Whitehurst received two infusions of tocilizumab 12 hours apart, but before he was given the drug, his oxygen saturation was 75%, which is below the normal reading that should be between 80 and 100. His oxygen saturation improved very quickly after receiving the drug and kept improving gradually and steadily over the next days.

Mr. Whitehurst was discharged from the hospital last week, smiling and overjoyed, after spending more than a month in the hospital.

Tocilizumab is part of three major trials involving British patients. Results are expected by June or July, reported by MailOnline.

One of the big trials is the Recovery trial, which is testing four promising treatments such as HIV, malaria, and antibiotic drugs. They have already recruited about 6,000 NHS patients, which makes it the most extensive study looking at repurposing existing therapies to treat COVId-19. The drug will be administered to patients whose lungs have been severely damaged due to the virus.

Meanwhile, Chinese doctors were the first to try tocilizumab on patients given routine therapies who were diagnosed as severe or critical. After a few days, the patients' fever returned to normal and improved dramatically, according to Dr. Xiaoling Xu and his colleagues.

CT also showed damage to the lungs reduced significantly around the fourth and fifth day of treatment. The authors concluded that tocilizumab is an effective treatment among patients with severe cases of COVID-19.

Read More: Italian Scientists Claim the World's First COVID-19 Vaccine That Can Neutralize Coronavirus in Human Cells

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COVID-19: Arthritis Drug Saves 72-year-old Critically Ill Patient with Grim Condition - Science Times

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Coronavirus: New app developed to help young arthritis sufferers through pandemic – The Courier

Thursday, May 7th, 2020

A Dundee University student is among those being helped by a new mobile app aimed at helping teenagers and young adults with arthritis through Covid-19 self-isolation.

Melissa Tavendale said she had already felt the benefit of the Arthritis Tracker which provides round-the-clock access to information and advice, helping those affected to rate and record symptoms in seconds and track their pain, medication side effects, fatigue, physical activity, sleep and emotional well-being.

An estimated 2.98 million people under the age of 35 in the UK are living with a musculoskeletal (MSK) condition and the charity Versus Arthritis has launched the app.

Versus Arthritis digital engagement officer, Sophie Mullen said; Arthritis is too often dismissed as an old persons disease, but it doesnt discriminate by age two thirds of people with arthritis are under 65.

Technology is helping us bridge the gap to those who were already isolated, and who face more restrictions to their life because of Covid-19.

Most will never have met other young people their age with the condition, who understand what theyre going through. This app will help us change that.

Melissa, 19, was recently diagnosed with Seronegative inflammatory arthritis after experiencing painful joints and stiffness for more than a year.

Now living with her parents in the north east during lockdown, she has already had one medical appointment cancelled during the pandemic.

The app is very easy to use and seems to be working very well. I like the extra info with tips and advice about managing my condition, she said.

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Coronavirus: New app developed to help young arthritis sufferers through pandemic - The Courier

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Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis…

Thursday, May 7th, 2020

AIMS:

Adalimumab-adbm is a monoclonal antibody developed as a biosimilar to adalimumab (Humira, AbbVie Inc.). The key objectives of this study were using a population pharmacokinetic (PPK) approach to assess pharmacokinetic (PK) similarity between adalimumab-adbm and Humira in patients with activerheumatoid arthritis(RA), to quantify the effects of potential covariates on adalimumab PK, and to assess the impact of switching treatment from Humira to adalimumab-adbm on PK.

A PPK model was firstly developed using intensive PK data from the phase 1 study in healthy subjects (NCT02045979). PPK models were developed separately for phase 3 base study (NCT02137226) and its extension study (NCT02640612) in patients with active RA.

PPK models were developed for adalimumab from adalimumab-adbm and Humira treatment in healthy subjects and RA patients. Weight and anti-drug antibodies (ADA) were found to be important predictors of adalimumab clearance. Adalimumab PK was similar between adalimumab-adbm and Humira. The estimated effect of Humira on clearance, relative to the adalimumab-adbm, was 1.02 (i.e., Humira has 0.02 greater clearance). Similarly, the effect of treatment arms (switching) on clearance was estimated to be 1.00 and 0.997 for Humira:Humira:BI and Humira:BI:BI arms, respectively, relative to the BI:BI:BI arm (BI refers to adalimumab-adbm) in the phase 3 extension study.

PK similarity between adalimumab-adbm and Humira in patients with active RA was demonstrated using PPK approach. Adalimumab PK was also similar when switching treatment from Humira to adalimumab-adbm at either week 24 or 48.

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Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis...

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How One Woman Found Freedom From RA – HealthCentral.com

Thursday, May 7th, 2020

In a sun-dappled dance studio with floor-to-ceiling windows in Summit, NJ, Teresa D'Angelo is leading a class full of female students through a series of graceful, flowing moves. They raise their arms to the sky and sway side to side, their heads tossed back with abandon. They bow down towards their bare feet, sweeping their hands along the floor as if gathering leaves from a garden, then transition into a series of sensual shoulder rolls.

Now, the pace changes. DAngelo, who rocks a blonde pixie cut and has a radiant, infectious smile, begins performing a series of sidekicks, upward blocks, and other martial arts-inspired moves. The women follow along, full of fierce determination, but the grins never once leaving their faces. After 60 minutes, they end class in a warm group embrace, beaming and trading words of support and encouragement.

After everyone had gone home, DAngelo spends a bit more time in the studio, this time dancing solo. In her hands is a pumpkin-colored silk scarf, which she traces through the air as she completes a series of balletic twirls, dipping down low then rising up on her tiptoes. With the sun streaming in and the scarf billowing in the air, she looks like a triumphant butterfly.

You would never know that several years prior, DAngelo spent her days lying on a couch in her living room, racked by excruciating joint pain and inflammation from rheumatoid arthritis (RA). She needed a cane to make it to another room and moved up and down the stairs by scooting on her bottom. Turning a doorknob was impossible.One day, she caught sight of herself hunched over in a mirror and thought, Oh my God, is this what the rest of my life is going to be like?

The answer, she ultimately decided: Hell, no. This is the story of her transformation, made possible by a chance encounter with a doctor and a decision DAngelo, now 58, made to listen to her body and start moving the way it wanted to.

In 2005, DAngelo was working for an international accounting and consulting firm in a job that paid well but required sitting at a desk for up to 10 hours a day and left her feeling boxed in and spiritually stifled. None of this was a great fit for the former ballet dancer who, as a young girl in the 70s, had aspired to become a prima ballerina. Her hopes were extinguished at the age of 15 by an instructor named Miss J, who always wore black leotards, black rock-star eyeliner, and raised her voice a lot. If she yelled at you, it meant she took interest, DAngelo recalls. I don't remember being yelled at a lot.

After that, she threw her energy into high school and college, where she discovered a new love, communications. She was a radio DJ in undergrad, a weekend weather anchor while earning her masters degree, and later, a managing editor. Im not shy, but Ive always been on the quieter side, so I loved how these jobs gave me the chance to speak out and communicate with many people at once, she says.

In May of 2005 DAngelo began experiencing some brain fog. I was having trouble absorbing information and struggling to react quickly at work, which was impacting my job because it was a stressful, high-performing environment, DAngelo recalls now. After a few months of mental fuzziness, another bizarre symptom hit. One day I noticed some swelling and pain in my left foot, she says. It came out of nowhere.

She told her naturopathic doctor, who directed her to a primary-care doctor, who in turn suggested she see a rheumatologist. That specialist diagnosed DAngelo with psoriatic arthritis (PsA), an autoimmune disease characterized by joint pain and stiffness plus psoriasis, a skin condition that causes red lesions that can burn, sting, or itch. (DAngelo didnt have lesions, but says her doctor based the diagnosis on bloodwork and her description of her pain. Some patients with PsA dont have the skin component.)

The doctor prescribed a biologic medication, a type of potent anti-inflammatory. DAngelo, who had for decades relied on herbal tinctures, green juices, probiotic-rich foods and other alternative therapies to maintain her health, initially balked at the suggestion. But when even her naturopathic doctor said he didnt think he could help her, DAngelo filled the prescription and, to her surprise and delight, began to feel better. The relief, she says, made her a bit cocky and she stopped taking the drug without asking her physician. It turned out to be the wrong move.

By the fall of 2005, pain and swelling began to hit her wrists and knees. The fact that her new symptoms were double-sided did not go unnoticed by her doctors. They said rheumatoid arthritis usually affects the joints symmetrically, but psoriatic arthritic tends to be just one-sided. That, along with further bloodwork, prompted DAngelos rheumatologist to change her diagnosis to RA and prescribe prednisone.

The powerful steroid worked intermittentlyDAngelo, at this point 43 years old, would have good days, going to work and the gym and playing catch outside with her son, Michaeland bad days, where her knees would swell with fluid, forcing her to use a cane.

At a routine appointment with her naturopath (I was still throwing everything I could at my RA in addition to my medication, she says), DAngelos doctor, noticing her increasing stiffness, said: You need to start moving your body. What do you like to do? She mentioned that she used to be a dancer. That prompted him to mention a movement-based mind-body practice called Nia.

Blending movements and philosophies from the worlds of dance, martial arts, and mindfulness, Nia is a non-impact workout thats performed barefoot, set to a diverse array of music (Latin, Jazz, Indian, and hip-hop, to name a few), and based on the premise that health can be discoveredor re-discoveredthrough conscious, meditative movement.

Exhilarated by the notion, DAngelo took a Nia class and instantly fell in love with it. It was like nothing Id ever done before. In ballet, I was always told exactly how to move. In Nia, youre given permission to move exactly how your body tells you.

During that first class, DAngelo noticed her body soften. The pain and stiffness were still there, but I felt peaceful and connected to myself. A sense of joy and relief flooded her body. I thought, Oh my gosh, Im moving again.

With more classes came more self-discovery and introspectionand some RA symptom relief. Like so many people, I started life as a vibrant soul with fantastic dreams and a creative imagination. But over time, the real me, the passionate and lively me, started to become quiet. My voice shut down and my body soon followed.

Now, dabbling in Nias 52 classic moveswhich at times resemble belly dancing, tai chi, ballet, and even salsa dancingthe old DAngelo was back. Through these shapes and movements, I could say and show what was going on inside of me. I was expressing through my body what had been bottled inside for many yearsmy voice.

Her love of dance rekindled, DAngelo signed up to become a Nia instructor herself. She made it halfway through her weeklong training in November of 2005, only to be sidelined by pain. I was on the floor of the studio, crying because it hurt to move, and a trainer, who I loved, said, Its OK, dont push yourself. Rest. It will be OK. Devastated, she reluctantly pulled out of training.

In early 2006, after a few months of rest combined with home Nia practice (I would pull myself together and practice one routine a night), DAngelo became officially certified as a Nia White Belt Instructor. (Like martial arts, Nia certification levels involve different colored belts). She soon began teaching a regular Saturday class at a local wellness center. Her dance dreams were finally coming to fruition.

One night shortly thereafter, DAngelo woke up screaming in pain. It felt like razor blades were cutting my wrists from the inside, she says. As her new husband Mike (they had married in August) tried to comfort her, she prayed out loud, begging for relief.

This cycle was the first of many highs and lows that were to come over the next two years, as DAngelo continued working for her firm and teaching Nia on Saturdays. On one hand, she had the satisfaction of knowing she was helping other womensome living with chronic illnessfind a release from stress, and often pain (many Nia practitioners discover the class during a chronic-pain journey). On the other hand, she would spend weeks off and on steroids and never knew when the inflammation would hit. I could have a great class one day, tons of energy, no pain, then wake up the next morning and have trouble getting out of bed.

Things took a turn for the worse between 2008 and 2011. Her wrists and occasionally ankles hurt. Her knee needed to be drained with a needle every few weeks to release fluid build-up. A headache so bad she feared it was a brain tumor sent her to the emergency room. When travelling on firm business, shed leave team dinners early to go to bed and strategically wore a neoprene arm brace so colleagues and new associates wouldnt shake her hand, as doing so would leave me screeching in pain. She took three leaves of absence from work between 2005-2011.

In 2011, after several months of being couch-bound and unable to teach Nia, let alone work, DAngelo had a doctors appointment. She was surprised to learn her rheumatologist was out and shed be seeing a different specialist that day. That fresh set of eyes turned out to be a blessing for DAngelo. She said, Lets take you off these high doses of prednisone and try to find another medication that actually will help you.

The next few months were spent experimenting with multiple RA drugs. No luck. Then, in January of 2012, the doctor wanted to try yet another. The whole process had been intimidating. But so was the thought of not being able to sway and twirl and be in her body the way Nia allowed her to be.

At home that day, lying on the couch, I remember asking God, What do you want me to do? she recalls. And like a waterfall of calm, I felt the words, Take the medicine wash over me.

Around the same time, a friend who is an integrative psychotherapist visited Teresa at home. She asked me, What is your vision of yourself? I said, I see myself as a ballet dancer, leaping over the moon. DAngelos friend replied, Hold that vision.

Together, those two key events convinced her to try the new treatment.Slowly, she began feeling less fatigued. Her joint inflammation lessened. Her pain reduced. By March, about two months after starting, she started to feel like herself again and was cleared by her rheumatologist to return to work.

Just a few days later, she received a call from human resources; she was being laid off. DAngelos response?

I put the phone on mute, pumped my fist, and said YES! That job had been so stressful for so many years. I thought maybe now I could start helping people who were like me and show them how to use movement to regain their life and wellness. Maybe, she thought, she could even turn it into a business.

In 2014, she launched Live Love Move, a company based in her hometown of Summit, NJ that offers mindful movement classes, workshops, and retreats for women, particularly those living with chronic pain. Now a first-degree black-belt instructor and certified massage instructor whos also working on her certification in dance movement therapy, DAngelo works with students who range from teachers and nurses to CEOs and stay-at-home moms. When they start to move, they sometimes cry simply because the act of lifting your hands to the sky can feel so empowering and releasing, she describes. The trauma of their illness has been locked inside. Now, they feel heard and seen.

DAngelo, is still taking the same medicine and is more or less pain-free. She does have osteoporosis in her right hip, which her doctor believes is a result of years of steroid use, and occasional morning stiffness, which she describes as crankiness in my knees and wrists.

Nutrition plays a big role in her life; she follows an anti-inflammatory diet, avoids gluten and tries to limit sugar to what she gets from fruit. My doctor tells me: Whatever youre doing, keep doing it.

Equally important has been recasting her RA diagnosis as a gift, something she says took her nearly a decade to do. Ultimately, though, the pain of not being able to move, of believing my body betrayed me, it helped me to seek and find the gift of my voice through dance. I not only feel better physically, but I handle stress better. Now, its my mission to educate and inspire othersanybody who hasnt moved in a long time or wants to move differently.

When meeting with a new group, she usually kicks things off with these words: Hi, Im Teresa DAngelo. I help support people who are in pain to help them feel better through healing movement. Even if you can just move a finger, ankle, or toe, know that pain is not the end of your story.

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Cover Corona Outbreak: Rheumatoid Arthritis Diagnosis Tests Market 2020 Industry Growth Analysis, Segmentation, Size, Share, Trend, Future Demand And…

Thursday, May 7th, 2020

The Latest Research Report on Rheumatoid Arthritis Diagnosis Tests Market size | Industry Segment by Applications, by Type, Regional Outlook, Market Demand, Latest Trends, Rheumatoid Arthritis Diagnosis Tests Industry Share & Revenue by Manufacturers, Company Profiles, Growth Forecasts 2025. Analyzes current market size and upcoming 5 years growth of this industry.

According to the report, the Rheumatoid Arthritis Diagnosis Tests market is projected to register high demand during the forecast period with increasing demand from major end-use industries such as increasing demand due to growing inclination towards the use of renewable energy during the forecast period.

Click here to get sample of the premium report: https://brandessenceresearch.com/requestSample/PostId/316

A combined cycle power plant is a heat engine assembly that works in conjunction from the same heat source, converting it into mechanical energy that generally drives electrical generators in turn. The concept is that the operating fluid temperature in the system is still high enough after completing its cycle that a second subsequent heat engine extracts energy from the heat generated by the first engine.

With an emphasis on both organic and inorganic growth strategies, there have been several primary developments done by major companies include

Antibodies Inc., Euro Diagnostica AB, Qiagen NV, Siemens Healthcare GmbH, Bio Rad Laboratories Inc., Genway Biotech, Inc., Abbott Diagnostics, Beckman Coulter, Inc., F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc. and others.

Key Factors Impacting Market Growth:

o Increasing demand due to growing inclination towards the use of renewable energy.

o Strict government regulations directing various industries towards reducing their carbon footprint

o New developments in the clean energy sector, prompting companies to expand the horizon for CCGT market globally

Market Segmentation:

By Type:Serology TestsErythrocyte Sedimentation rateAnti-Cyclic Citrullinated PeptideRheumatoid FactorAntinuclear AntibodyUric AcidOthersMonitoring Rheumatoid Arthritis Treatment Efficiency TestsMuscle Enzyme TestsSalicylate Level CountCreatinine TestBy End-User:HospitalsDiagnostics LaboratoriesAmbulatory Surgical Centers

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Customization:

We provide customization of the study to meet specific requirements:

o By Segment

o By Sub-segment

o By Region/Country

Regional segmentation and analysis to understand growth patterns:

The market has been segmented in major regions to understand the global development and demand patterns of this market.

Detailed information for markets like North America, Western Europe, Eastern Europe, Asia Pacific, Middle East, and Rest of the World is provided by the global outlook for the Rheumatoid Arthritis Diagnosis Tests market. During the forecast period, North America and Western Europe are projected as main regions for the shortwave infrared sector. As one of the developed regions, the energy & power sector is important for the operations of different industries in this area.

This is one of the key factors regulating Rheumatoid Arthritis Diagnosis Tests market growth in those regions. Some of the major countries covered in this region include the USA, Germany, United Kingdom, France, Italy, Canada, etc.

During the forecast period, the Asia Pacific is expected to be one of the fastest-growing regions for the Rheumatoid Arthritis Diagnosis Tests market. Some of the fastest-growing economies and increasing energy & power demand to cater for high population & industries are expected to drive demand in this area. During the forecast period, China and India are expected to record large demand. During the forecast period, the Middle East which includes the UAE, Saudi Arabia, Iran, Qatar, and others promises high market potential. In terms of market demand during the forecast period, the rest of the world including South America and Africa are developing regions.

This report provides:

1) An overview of the global market for Rheumatoid Arthritis Diagnosis Tests market and related technologies.

2) Analysis of global market trends, yearly estimates and annual growth rate projections for compounds (CAGRs).

3) Identification of new market opportunities and targeted consumer marketing strategies for global Rheumatoid Arthritis Diagnosis Tests market.

4) Analysis of R&D and demand for new technologies and new applications

5) Extensive company profiles of key players in the industry.

The researchers have studied the market in-depth and have developed important segments such as product type, application, and region. Each and every segment and its sub-segments are analyzed based on their market share, growth prospects, and CAGR. Each market segment offers in-depth, both qualitative and quantitative information on market outlook.

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Ixekizumab Superior to Secukinumab in Providing More Quality-Adjusted Life-Years in Psoriatic Arthritis – Rheumatology Advisor

Thursday, May 7th, 2020

Compared with secukinumab, ixekizumab provides more quality-adjusted life-years (QALYs) to patients with psoriatic arthritis (PsA) and concomitant moderate to severe plaque psoriasis at a marginally lower cost, according to study results published in PharmacoEconomics Open.

In this study, investigators in the United Kingdom conducted cost-effectiveness analyses comparing ixekizumab and secukinumab, 2 interleukin-17A antagonist biologic disease-modifying antirheumatic drugs (bDMARDs) with similar treatment efficacy of PsA. Researchers sought to determine the treatment arm that achieved maximal clinical improvement while minimizing health costs to both patients and the healthcare system.

Using a Markov model, which is based on the York model, the investigators included a hypothetical cohort of adult patients with PsA and concomitant moderate to severe plaque psoriasis and simulated 4 health states, including a bDMARD trial period, continuous therapy, best supportive care, and death, along with 4 treatment options that aligned with UKs National Health Service (NHS) practice guidelines. The population and characteristics of patients were modeled from data derived from previous intent-to-treat trial populations. Data for each treatment arm were extrapolated from a network of meta-analysis for both therapeutics. Researchers used 2 clinical scoring criteria, including PsA Response Criteria and Psoriasis Area and Severity Index (PASI), to determine response to treatment. Quality of life was assessed using a health assessment questionnaire, and resource cost included treatment cost, physician visit, and medication administration costs, and an algorithm estimating the cost of care depending on the PASI and health assessment questionnaire scores.

Results indicated that ixekizumab vs secukinumab demonstrated slightly lower total costs of care and higher total QALYs in both bDMARD-naive and -experienced patients (155,455 vs 155,530 and 8.127 vs 7.989, and 140,051 vs 140,264 and 3.996 vs 3.875, respectively). Consistent results were derived from the various sensitivity analyses carried out in this model, which the researchers noted can be adapted to countries with reimbursement and treatment practices different to those in the UK.

Study limitations included lack of data availability since rheumatoid arthritis data were used for health resource cost estimates instead of PsA data, the use of therapeutic list pricing instead of the confidential preferred price used by the NHS, and the exclusion of data on patient preferences of treatment options.

Researchers concluded, Although total costs and QALYs were quite similar for ixekizumab and secukinumab, with a modest advantage to ixekizumab for both parameters in bDMARD-naive and -experienced patients with PsA and concomitant moderate to severe psoriasis, we believe the findings of our analysis still provide insights that may be helpful for healthcare decision-makers when allocating resources.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors disclosures.

Reference

Schweikert B, Malmberg C, kerborg , et al. Cost-effectiveness analysis of sequential biologic therapy with ixekizumab versus secukinumab in the treatment of active psoriatic arthritis with concomitant moderate to severe psoriasis in the UK [published online on March 12, 2020]. Pharmacoecon Open. doi:10.1007/s41669-020-00202-1

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Cracking the Lyme disease code – WSU News

Thursday, May 7th, 2020

Abdul Lone

By Josh Babcock, College of Veterinary Medicine

The next time a tick feeds on you, Washington State University researchers hope to make sure persistent arthritis caused by Lyme disease doesnt linger for a lifetime.

Troy Bankhead, associate professor in WSUs Veterinary Microbiology and Pathology department, and his team have spent more than a decade analyzing an immune evasive protein of Borrelia burgdorferi, the bacterium that causes tick-borne Lyme disease.

With the labs latest finding, that work is beginning to pay off.

According to research recently published in Cell Reports, Bankhead and assistant research professor Abdul Lone discovered that a surface protein known as VlsE acts as a shield to prevent the immune system from effectively fighting the disease. In particular, the study examined how VlsE protects one of the main proteins responsible for Lyme diseases persistent arthritis.

This really has a significant impact in the development of vaccines, Bankhead said.If we can determine which proteins are shielded as opposed to which ones are not, then of course those that are not protected are going to be better candidates for a vaccine.

The Centers for Disease Control and Prevention estimates some 300,000 people may get Lyme disease each year in the United States alone. It is most prevalent in the northeast.

If not treated early with antibiotics, Lyme disease can cause lifelong arthritis, and in more severe cases, bladder infections, heart inflammation, and neurologic and cognitive issues like loss of memory and balance.

We chose the arthritis-related protein because arthritis is the most common symptom you see in North America, Lone said.

By engineering a strain of Borrelia burgdorferi in the lab without the surface lipoprotein VlsE, they were able to confirm it was protecting the arthritis-related protein from an antibody response.

Bankhead and Lone tested the new Borrelia strain in mice and found the animals were more easily able to clear the infection.

Then, Bankhead and Lone confirmed that the new Borrelia strain was susceptible to antibodies under the microscope.

By using fluorescence microscopy, a process that uses energy from electrons to emit light under a microscope, Bankhead and Lone watched as antibodies were unable to bind to the protein responsible for Lymes persistent arthritis when the VlsE protein was present. When the VlsE protein was removed, antibodies were able to recognize and bind to the arthritis-related protein.

When you dont have VlsE those bacteria light up and that is because those antibodies are able to bind and recognize that arthritis-related protein in the absence of that VlsE shield, Bankhead said. Thats exactly what we were seeing.

Understanding the VlsE protein is acting as a shield for the bacteriums arthritic-causing protein is significant for vaccine development and future research. While it is unknown if other surface proteins are protected, Bankhead said it is likely. He noted the scientific community is gaining ground on understanding these proteins but producing any vaccine is well into the future.

Still, the finding creates two avenues for researchers to eliminate Lyme disease: take down the VlsE shield, or, find a way for the antibody response to get in front of the ever-adapting bacterium and eliminate it.

HIV/AIDS persists for years in human beings. The same thing happens with Borrelia, it persists, Lone said. While this finding tells us a lot about Borrelia. Our next step is to understand how it persists. Once we understand the mechanism of persistence, we can eliminate the disease.

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Global Arthritis Therapeutic Market: Industry Analysis and forecast (2019 to 2026): By Type, Drug Class, Route of Administration, Distribution Channel…

Thursday, May 7th, 2020

Global Arthritis Therapeutics Market was valued USD XX Bn in 2018 and is expected to reach US$ XX Bn by 2026, at CAGR of 4.8 % during forecast period of 2019 to 2026.

The report study has analyzed revenue impact of COVID -19 pandemic on the sales revenue of market leaders, market followers and market disrupters in the report and same is reflected in our analysis.Arthritis is an inflammatory disorder affecting the joints cause redness, stiffness, resulting in pain and swelling in the joints. More than 100 categories of arthritis are affecting the global population. The most common arthritis conditions are psoriatic arthritis, rheumatoid arthritis, and osteoarthritis. The osteoarthritis affects a majority of the geriatric population, in severe joint pain and affecting their movement. Psoriatic Arthritis therapeutics contains drugs that help to reduce pain and inflammation.

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Global Arthritis Therapeutic Market Drivers and RestrainsThe significant growth of the global arthritis therapeutics market is credited to investments in research & development, strong product pipeline, increasing patient pool suffering from arthritis. Furthermore, rise in the geriatric population is another factor fueling the growth of the global arthritis therapeutics market. Patients gone under treatment with Disease-Modifying Antirheumatic Drugs (DMARDs) are unsatisfied because of poor therapeutic benefits. The dominance of rheumatoid arthritis globally, the launch of novel therapeutic agents, and favorable reimbursement policies for high-cost treatment products are the factors that boost the growth of global arthritis therapeutics market. In 2016, the International Federation of Psoriasis Association (IFPA) states that more than 125 Mn people were affected with psoriasis. It is estimated that between 11% and 32% of patients with psoriasis incline to develop psoriatic arthritis. Furthermore, nearly 52.2 million adults suffered from arthritis in U.S. alone in 2015. Developments in diagnostics and healthcare infrastructure in developing countries are projected to witness an increased number of diagnosed patients.

Manufacturers in the Arthritis Therapeutic are focusing on competitive pricing as the strategy to capture significant market share. Moreover, strategic mergers and acquisitions and technological innovations are also the key focus areas of the manufacturers.

Global Arthritis Therapeutic Market Segmentation AnalysisBy Arthritis Therapeutic Market is segmented into Psoriatic Arthritis, Rheumatoid Arthritis, Osteoarthritis, Gout and Others. Rheumatoid Arthritis and Psoriatic Arthritis segment is expected to exhibit highest global market share at a CAGR of xx% over forecast period. Increasing occurrence of arthritis diseases globally, is likely to drive key players to develop novel therapeutics treatment for the disease. Strong research and development by key companies supported by huge investments is projected to drive the global arthritis therapeutics market. In 2018, according to the WHO statistics 9.9 % of men AND 18.1 % of women over the age of 60 suffered from osteoarthritis, symptomatic, worldwide. About 80 % of those with osteoarthritis have limitations in movement, and 25 % of women over the age of 60 suffered from symptomatic osteoarthritis, globally.

Global Arthritis Therapeutic Market Regional AnalysisThe Global Arthritis Therapeutic Market has been classified into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East Africa. North America dominated the global arthritis therapeutics market, followed by Europe. Because of a large patient pool suffering from arthritis diseases, like osteoarthritis, rheumatoid arthritis and other conditions. Advantageous reimbursement policies, launching of novel biologics drugs, well-defined regulatory framework, and availability of biosimilars are boost up the market growth in the region. Furthermore, the presence of key players in the region and a strong product pipeline for arthritis treatment are projected to drive the arthritis therapeutics market in the region. This can be ascribed to awareness about arthritis, presence of key players, growing patient pool, favorable reimbursement policies, and availability of biosimilar and biologics arthritis drugs in the region.

The objective of the report is to present comprehensive analysis of Global Arthritis Therapeutic Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of industry with dedicated study of key players that includes market leaders, followers and new entrants by region. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors by region on the market have been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give clear futuristic view of the industry to the decision makers. The report also helps in understanding Global Arthritis Therapeutic Market dynamics, structure by analyzing the market segments, and project the Global Arthritis Therapeutic Market size. Clear representation of competitive analysis of key players by Arthritis Therapeutic Type, price, financial position, product portfolio, growth strategies, and regional presence in the Global Arthritis Therapeutic Market make the report investors guide.

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Scope of the Global Arthritis Therapeutic Market

Global Arthritis Therapeutic Market, by Type

Psoriatic Arthritis Rheumatoid Arthritis Osteoarthritis Gout OthersGlobal Arthritis Therapeutic Market, by Drug Class

TNF Inhibitors Interleukin Inhibitors NSAIDs Corticosteroids Xanthine Oxidase Inhibitors OthersGlobal Arthritis Therapeutic Market by Route of Administration

Oral Parenteral TopicalGlobal Arthritis Therapeutic Market, by Distribution Channel

Hospital Pharmacies Retail Pharmacies Online PharmaciesGlobal Arthritis Therapeutic Market, by Region

Asia Pacific North America Europe Latin America Middle East AfricaGlobal Arthritis Therapeutic Market, Major Players

Pfizer Inc. Bristol Myers Squibb Abbvie Inc. Astrazeneca Pharma Ucb Pharma Genentech Janssen Pharmaceutical Immunex Corp. Medac Pharma Boehringer Ingelheim Novartis, Biogen Eli Lilly And Company Astellas Pharma Mallinckrodt Roche Vertex Pharmaceutical

MAJOR TOC OF THE REPORT

Chapter One: Arthritis Therapeutic Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Arthritis Therapeutic Market Competition, by Players

Chapter Four: Global Arthritis Therapeutic Market Size by Regions

Chapter Five: North America Arthritis Therapeutic Revenue by Countries

Chapter Six: Europe Arthritis Therapeutic Revenue by Countries

Chapter Seven: Asia-Pacific Arthritis Therapeutic Revenue by Countries

Chapter Eight: South America Arthritis Therapeutic Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Arthritis Therapeutic by Countries

Chapter Ten: Global Arthritis Therapeutic Market Segment by Type

Chapter Eleven: Global Arthritis Therapeutic Market Segment by Application

Chapter Twelve: Global Arthritis Therapeutic Market Size Forecast (2019-2026)

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Polk doctors: Hand pain, stiffness from osteoarthritis can be treated – The Ledger

Thursday, May 7th, 2020

People often deal with the discomfort of osteoarthritis by taking over-the-counter nonsteroidal anti-inflammatory drugs. Over time, if the pain worsens, they may find themselves taking those drugs in regular, increasing doses. That isnt good for older people, Polk experts say.

Your fingers feel stiff.

Parts of your hands often hurt.

Simple acts like opening a jar become more difficult or painful.

Its highly possible these problems stem from osteoarthritis of the hands.

Half of women and one-fourth of men experience osteoarthritis hand stiffness and pain by the time they reach 85, according to the Arthritis Foundation.

"Hand arthritis is extremely common in women," said Dr. Stuart Patterson, an orthopaedic surgeon in South Lakeland who specializes in disorders of the hand and other parts of the upper limb.

"We see it in men, but it typically occurs earlier in women."

People often deal with the discomfort initially by taking over-the-counter nonsteroidal anti-inflammatory drugs. Over time, if the pain worsens, they may find themselves taking those drugs in regular, increasing doses.

That isnt good for older people, local hand experts said.

"Once you get into your 60s, theyre not a safe drug," Patterson said.

"There are many interactions between these meds and supplements, as well as blood thinners (prescription as well as aspirin)," Dr. Ann Licht said in an email response to a question about whether its OK to rely on NSAIDS.

"People with high blood pressure and kidney problems may have more severe reactions to NSAIDS," added Licht, a Watson Clinic surgeon specializing in hand surgery.

Osteoarthritis is most common in the small joints of the fingers, closest to the nails and the base of the thumb, Licht said. It can occur on one side and spread to the other.

Gnarly fingers, bumps, finger deformities, joint stiffness and bone formations, often called bone spurs, are some physical signs that occur in advanced osteoarthritis of the hand, Patterson said.

Osteoarthritis causes protective cartilage at the end of bones to break down and wear away. Pain occurs as the bones rub together.

Surgery isnt all these surgeons and other hand specialists have to offer when that happens.

"Surgery is when youre disabled, either disabling pain or impairing your ability to do things," Patterson said, "when youre miserable and youve exhausted your non-surgical options."

Its helpful to see a hand surgeon before that stage to rule out other causes of pain, such as rheumatoid arthritis or carpal tunnel syndrome, he said.

Licht recommends seeing a hand specialist when medicines dont work, arent indicated or when deformities are starting.

"Steroid injections to the joints can be a lifesaver for patients who are either not ready for surgery cant take arthritis meds or the meds arent working," Licht said.

Occupational therapists have an important role in treating osteoarthritis of the hand. They work with patients on hand exercises, devices like splints or braces and pain relief such as warm paraffin.

Some therapists, mostly occupational but also some physical therapists, take extra training to become certified hand therapists.

"Our main goal in hand therapy is to preserve the hand," said Jennifer Castelli, occupational and certified hand specialist. "We focus on what they need and adapt it from there."

If a joint is overworked, it causes tension in the tissue around it, affecting the amount of pain. Joint damage also occurs.

Splints can keep the joint from moving so it has time to rest, Castelli said.

She and her husband, John, founded The Hand Rehabilitation Center of Florida. It has clinics in Winter Haven, Lakeland and Sebring.

Their Lakeland clinic has connecting space with Pattersons Central Florida Orthopaedic Surgery Associates. Patterson collaborates with Judie Johnson, another of the rehabilitation centers occupational therapists/certified hand specialists.

"Getting people in here early, before they develop horrible stiffness and horrible pain can help them learn helpful management skills," Johnson said.

Hand therapists can offer a variety of alternatives, including exercises to increase the hands range of motion and ways to do everyday activities that put less stress on the joints. Examples would be avoiding doing heavy pinching with the thumb and lifting pots with two hands instead of one, Johnson said.

Assistive devices can make it easier to open jars or hold a spoon.

"It doesnt fix the arthritis but it makes it so you hopefully can live with it," said Johnson, who has dealt with hand osteoarthritis of her own for 20 years.

Hand specialists can help "cut through the confusion" of the volume of devices and tools to find the ones most effective for individual patients, Patterson said.

"Even if two people have the same type of arthritis, their needs and medical history/conditions may make treatment very different," Licht said.

"Evaluation by a qualified hand surgeon can offer options and treatment solutions tailored to the individual."

When surgery is needed, patients and their surgeons decide between fusion or joint replacement. Which works best depends on the location of the damaged joint and, to some extent, what patients need to do with their hands.

Patterson said joint replacement doesnt do well in the small joints at the end of the fingers. He prefers fusion for them.

But fusion typically doesnt do as well at the base of the thumb, he said, or in the middle joint of the long and ring fingers. Those middle joints, he said, need to be able to bend and fusion prevents that.

Overall, joints are best fused if they arent "vital motion" joints, Licht said, while some need to be replaced to preserve or improve motion.

"Fusions are most reliable and require minimal rehab," she said. "Joint replacements require a compliant/committed patient as (they) usually require several months of rehab."

Robin Williams Adams can be reached at robinwadams99@yahoo.com

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Plant viruses could be used to prevent and treat human autoimmune diseases – Mirage News

Thursday, May 7th, 2020

Researchers have taken positive steps towards using plant virus-based particles for the treatment of human autoimmune diseases such as type 1 diabetes and rheumatoid arthritis.

Viruses are natural, self-assembling nano-scale structures that have been exploited in the fields of electronics, agriculture and medicine.

The genetically encoded coat proteins of virus nanoparticles (VNPs) can be reprogrammed to incorporate new sequences for specific functions. Plant viruses have the advantage in that they are unable to replicate in mammals making them safer for medical applications.

In this study led by the University of Verona, Italy, researchers explored whether VNPs engineered to display a specific protein sequence could help to prevent or treat type 1 diabetes and rheumatoid arthritis.

They used cowpea mosaic virus (CPMV) constructs developed in the Lomonossoff lab at the John Innes Centre. These VNPs displayed peptides associated with type 1 diabetes in order to modulate immune system response. The researchers also used other VNPs, engineering tomato bushy stunt virus with peptides associated with rheumatoid arthritis.

Using animal models to analyse immune system responses, they reveal that the re-engineered nanoparticles offered therapeutic benefits in both cases: protection against type 1 diabetes and improved symptoms of rheumatoid arthritis.

More pre-clinical and clinical trials will follow up this work. If successful it could pave the way for the development of plant viruses for the clinical treatment of human autoimmune diseases.

The research: Prevention and treatment of autoimmune diseases with plant virus nanoparticles appears in Science Advances.

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Rheum Round-up: Are Arthritis Drugs the Holy Grail of COVID-19?, How The Pandemic Affected Rheumatic Patients, and more – DocWire News

Sunday, May 3rd, 2020

Here are the top stories recently covered by DocWire News in the Rheumatology section. In this edition, read about trials of rheumatoid arthritis (RA) drugs to treat COVID-19 patients, how rheumatic patients were affected during the early pandemic days, how the coverage gap closure in Medicare Part D between 2010 and 2019 decreased annual out-of-pocket costs for RA biologics, and an interview about the Autoimmune COVID-19 Project.

The results of a French study found favorable outcomes for COVID-19 patients with moderate to severe pneumonia treated with tocilizumab, a drug commonly prescribed to treat arthritis, according to reports. The French CORIMUNO-TOCI trial was conducted by the public assistance-hospitals of Paris (AP-HP). The results have yet to be published, but the outcomes were reported in a press release and by various news outlets. The main outcome measure was the need for ventilation or death at 14 daysfor which tocilizumab significantly reduced the risk. CORIMUNO is exploring other medicines in COVID-19 patients, too, including sarilumab. Although both are anti-IL-6 drugs, tocilizumab is administered intravenously, while sarilumab is administered subcutaneously. The results of a phase 2 trial studying sarilumab in COVID-19 patients found the drug was not beneficial for patients hospitalized but not on ventilators, according to results from Regeneron and Sanofi, who manufacture the drug.

A study evaluated how patients with rheumatic diseases were impacted by the COVID-19 pandemic during its initial stages in the United States. A total of 7,061 patients were invited to complete the questionnaire, of whom 530 responded. The most common diagnosis among the respondents was rheumatoid arthritis (RA) (61%). Of the 11 patients who met COVID-19 screening criteria, two sought testing unsuccessfully. An additional six patients sought testing, of whom three were successful, and all were negative. About two in five patients (42%) experienced a change to their care during the previous two weeks. Upon qualitative analysis, the researchers unearthed four key themes: emotions in response to the pandemic, perceptions of risks from immunosuppressive medications, protective measures to reduce risk of COVID19 infection, and disruptions in accessing rheumatic disease medications including hydroxychloroquine.

A new study assessed whether the coverage gap closure in Medicare Part D between 2010 and 2019 decreased annual out-of-pocket costs for biologic drugs used to treat RA. Each year, list prices increased for every product assessed in the drug and strength combinations. There were six drugs available for the whole study period; the mean increase for these drugs was 160%. Among the six drugs available for the entirety of the study, the projected mean annual out-of-pocket costs were 34% lower in 2011 than 2010 (2010: $6,108 vs. 2011: $4,026); however, they were only 21% lower by 2019 ($4,801) due to yearly list prices increases. There were four products with higher out-of-pocket costs in 2019 than the first year available that entered the market between 2011 and 2015. The percentage of money spent in the catastrophic phase increased each year for all products studied; the mean was 22% higher in 2019 than in 2010 or the first year the drug was available.

CreakyJoints and the Global Healthy Living Foundation collectively launched the Autoimmune COVID-19 Project, a longitudinal study with the goal of assessing the impact of COVID-19 on patients with multiple sclerosis, arthritis, Crohns and colitis, and vasculitis. DocWire News recently interviewed study lead Shilpa Venkatachalam, PhD, associate director of Patient-Centered Research at CreakyJoints and co-principal investigator of ArthritisPower, about the studys inception, its goals, and more.

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Rheum Round-up: Are Arthritis Drugs the Holy Grail of COVID-19?, How The Pandemic Affected Rheumatic Patients, and more - DocWire News

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How to deal with arthritis – Times of Malta

Sunday, May 3rd, 2020

The word arthritis derives from the Latin arthro meaning joint and ritis meaning inflammation.

There are broadly two main types of arthritis although one can classify 100 different types. The two main types are the degenerative (wear and tear) and the inflammatory types of arthritis.

Arthritis can affect any age group, not just the elderly. Juvenile inflammatory arthritis can be a disabling illness in young children.

In the vast majority of cases, degenerative arthritis is primary i.e. with no preceding cause. In rare cases, however, degenerative arthritis may be secondary to a fracture of the joint, infection or inflammation.

Arthritis can affect any joint; but those most commonly affected by degenerative arthritis are the hip, knee, neck and back.

The patient suffers from a variety of symptoms which may develop and progress over time into degenerative arthritis.

In contrast, in inflammatory arthritis, these symptoms may develop suddenly. The symptoms include pain which usually worsens with activity and stiffness mostly in the morning and following inactivity which might be accompanied by swelling. In advanced cases, there will be deformity and muscle-wasting. The symptoms cause lack of function of the joint and disability.

Diagnosis is aided by radiological investigations which, in degenerative disease, show loss of joint space, sclerosis which is whitening of the bones and bony projections called osteophytes. Interestingly, there is not always a direct correlation between the severity of radiological findings and the symptoms described.

Diagnosis is aided by radiological investigations which, in degenerative disease, show loss of joint space, sclerosis which is whitening of the bones and bony projections called osteophytes

Treatment of arthritis broadly falls into four categories:

1. Weight loss for lower limb arthritis, routine and regular exercise and physiotherapy helps build muscle, decrease stiffness, decrease pain and also improve psychological well-being. Cycling, swimming and the cross-trainer are ideal for hip, knee and foot arthritis.

2. Medications include cartilage-nutrient supplements such as glucosamine and chondroitin. Medications including anti-inflammatories shouldnt be prescribed on a long-term basis due to side effects. They should be used to allow the patient to exercise and undertake regular physiotherapy.

3. Other options for treatment include injections. There are principally three types of injections I use. These are not all necessarily adapted for each arthritic joint.

While steroid injections are a mixture of a local anaesthetic and steroid injected directly into the joint, viscosupplementation involves injecting a thick viscous fluid in the joint which is thought to act as a shock absorber.

On the other hand, PrP or platelet rich plasma involves extracting about 15ml of blood from the patient, centrifuging it and injecting the fluid left without the cells into the joint. This plasma contains nutrients and other factors that help regenerate cartilage, prevent its breakdown and decrease inflammation.

4. Surgery remains the best option for those patients who fail to improve with the other options. Different surgical techniques are adapted for different joints but broadly, these may include washout of the joints by keyhole or arthroscopic techniques. Examples of these techniques include excision of the joint (excision arthroplasty) such as the collar bone joint; fusion of the joint (arthrodesis) such as the foot big-toe joint and replacement (arthoplasty).

In the latter, the arthritic joint is excised and replaced by a metal and plastic artificial joint. In fact, most joints in the body may be replaced including the small joints of the hand, wrist, elbow, shoulder and, of course, hip and knee. Although these are fairly major procedures, the benefit they provide to the patients quality of life is tremendous.

Alistair Pace is a consultant orthopaedic surgeon and senior lecturer at the University of Malta.

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Simple tips and tricks to help manage arthritis pain – Defiance Crescent News

Sunday, May 3rd, 2020

(BPT) Arthritis joint pain is a daily reality for millions of people in the United States. For some, this pain is temporary due to an injury, but for others, it can be a persistent and even debilitating symptom of arthritis.

Osteoarthritis is the most common form of arthritis, according to the Centers for Disease Control and Prevention, affecting more than 30 million adults in the United States1. About one in four adults report experiencing severe joint pain related to arthritis, and nearly half of adults with arthritis experience persistent pain2.

Whether your arthritis pain is temporary or ongoing, its important to take steps to alleviate discomfort. We may not realize how much joy comes from the simplest everyday movements, until pain gets in the way. Here are four simple tips that may help lessen your arthritis joint pain so you can feel better and keep moving.

1. Use hot and cold therapy

Applying hot and cold compresses to your joints can help provide some much-needed relief. When joints feel stiff, use heat to help them relax and feel more agile. A morning bath or shower can make a world of difference for stiff joints after sleeping. For joint pain that involves swelling and inflammation, look to incorporate cold therapy into your routine. For instance, if your knee is sore and looks puffy, apply a cold compress or bag of frozen veggies wrapped in a towel.

2. Move your body

If you have arthritis symptoms, including wrist, hand or knee pain, the idea of getting up and exercising may seem counterintuitive. However, thoughtfully moving your body helps increase blood flow to joints and stretches muscles and ligaments, which can provide some relief. Regular movement helps increase flexibility while also building muscle, which is important for the health of the joints.

3. Use over-the-counter medicines

If you want an alternative to taking pills to manage pain, there is now an effective topical arthritis pain relief solution available without a prescription. The FDA recently approved Voltaren Arthritis Pain as the first and only full prescription-strength topical nonsteroidal anti-inflammatory (NSAID) gel available over the counter for the treatment of arthritis pain in adults in the hand, wrist, elbow, foot, ankle or knee. Visit http://www.voltarengel.com/what-is-voltaren/ now to preorder Voltaren Arthritis Pain (available nationwide next month). If you order now through May 12, 100% of profits from pre-order will be donated to the Arthritis Foundation to provide virtual care and connection for their patient community*. Additionally, for every donation made to the Arthritis Foundation between May 13 and May 31 in support of its goal to provide virtual care and connection to their patient community and mission, Voltaren will match up to $100,000.

4. Add glucosamine and omega-3s to your diet

Fish oil has been studied for dozens of inflammatory and autoimmune disorders, according to the Arthritis Foundation3. You can get the omega-3s by taking a high-quality fish oil supplement. Look for fish oil options with at least 30% EPA and DHA (both types of omega-3s). According to the Arthritis Foundation, taking up to 2.6 grams EPA/DHA twice a day may help relieve osteoarthritis pain.

If arthritis joint pain is a part of your life, try these simple strategies at home to help movement so you can live a full, healthy life.

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Dear Loved Ones: This Is What RA Feels Like – HealthCentral.com

Sunday, May 3rd, 2020

Dear family and friends,

I have rheumatoid arthritis (RA), a chronic autoimmune disease. Its not the wear-and-tear type of arthritis you might get with old age. This is different. It affects my whole body and chips away at my well-being. To be honest, Im still figuring it out myself. One thing I do know is that it will affect not just my life, but also yours. I want to help you understand how it feels to be me. If you know the basics, we have a place to start a conversation.

Remember the last time you had the flu? You felt sick and feverish, your body was hurting, and you were so tired that the idea of making a cup of tea or taking a shower was completely overwhelming.

RA makes me feel like that. This illness happens when the immune system malfunctions. Instead of protecting me against infection, it gets confused and attacks tissues and structures in my body. Arthritis in my joints is one of the symptoms, but being an autoimmune disease means it affects my entire body. Thats what makes me feel like I have the flu all the time. Sometimes, it gets better, usually through taking medications, but its no guarantee. RA can flare unpredictably, all my symptoms increasingsometimes a little, sometimes taking over my life. I have figured out a few triggers to the symptoms, but often, theres no rhyme or reason to why I flare. Often, there is no visible sign of the war inside my body. I need your support.

RA causes inflammation that affects all parts of my body, but the way it hits my joints is the most obvious symptom. Im sure youve seen my sausage fingers or noticed the time my knee swelled to the size of a volleyball. Its because the synovial membrane that protects my joints becomes inflamed.

And it hurts.

I thought I knew what it meant to have pain before. We have all had some lower back pain after moving to a new house, a sprained ankle, and maybe even broken a bone. None of those kinds of pain is like the pain of RA. When my joints swell, it can feel as if the bones are being pried apart. When the inflammation gets bad, it throbs to the rhythm of my heart and any weight or pressure is excruciating. Every step feels like walking barefoot on rocks, typing for a while means I cant use my hands later, and it can make it hard to do the simplest of tasks. Like dressing myself, squeezing the shampoo bottle, or chopping vegetables.

Yes, I know everyone is tired. But this kind of tired doesnt get better with rest. The fatigue that comes with having RA is always there, utterly soul-crushing, and it doesnt matter if I get two hours of sleep at night or 12. Im still tired. My body is in a constant state of inflammation and keeps trying to get me to go lie down until I get better.

The problem is, I dont get better.

I wake up with less energy than I had before and everything I do takes more energy than it used to. The Spoon Theory is a really good way to explain how careful I have to be about what I do and why sometimes, I have to crawl into bed before dinner. Think of measuring energy by the spoonful. I start the day with a handful of spoons that are taken away, one by one, as I do tasks like getting dressed, doing chores, or working. Most days, I have no spoons left at the end of the day.

I used to only see my doctor a few times a year. Now, I have medical appointments all the time. Blood tests, X-rays, ultrasounds, appointments with my family doctor (because RA makes it easier for me to catch colds and the flu), and regular appointments with my rheumatologist, who oversees my RA treatment.

I am taking medication to suppress this condition, to protect my joints and the rest of my body against the constant inflammation. Please dont try to persuade me to go off the meds because you think the chemicals are bad for me. Its really hard to take this much medication every day, and sometimes, it has side effects. But it does beat down my RA most of the time and I want thatI cant live my life without them.

Some of the medication I take may include one that suppresses my immune system, and therefore suppresses my RA. This means I have a much higher risk of infection and catching contagious illnesses. One of the best ways you can help me is by getting the flu shot and not coming over when youre sick. Between the RA and being on these drugs, if I get sick, it might hit me harder and take a lot longer for me to get better.

Everything about my life has changed and I am having a really hard time coping. I feel like the healthy me died and now instead, I have to learn to live in this body that has betrayed me. There are so many physical changes, so much time dedicated to medical appointments, and figuring out how to fit all of that into my life. Everything feels overwhelming.

I know Im not always coping well. To be honest, I am really sad and also really angry. Im doing my best to learn what to do so I can still be your family member and your friend, but Im struggling. I know its hard for you to understand it all and that its difficult watch me go through this. I need your help, but please dont try to fix me. Right now, the thing I need the most is your love, patience, and support. I need some hugsgentle ones, pleasesome laughs, and some practical help. A phone call or visit would be wonderful, maybe a freezer meal, a ride to the doctor, or help with some chores. But most of all, I need you to just listen and try to understand.

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Dear Loved Ones: This Is What RA Feels Like - HealthCentral.com

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Are Arthritis Drugs the Holy Grail of the COVID-19 Pandemic? Trials Rush to Find Solutions – DocWire News

Sunday, May 3rd, 2020

The results of a French study found favorable outcomes for COVID-19 patients with moderate to severe pneumonia treated with tocilizumab, a drug commonly prescribed to treat arthritis, according to reports.

The French CORIMUNO-TOCI trial was conducted by the public assistance-hospitals of Paris (AP-HP). The results have yet to be published, but the outcomes were reported in a press release and by various news outlets. It included patients who were hospitalized with COVID-19 moderate to severe pneumonia in intensive care or at high risk of requiring intensive care but did not need resuscitation upon admission. The study included 129 patients who were randomized to either usual treatment plus tocilizumab (n=65) or usual treatment alone (n=64). The main outcome measure was the need for ventilation or death at 14 daysfor which tocilizumab significantly reduced the risk.

The unpublished study will reportedly be submitted for journal publication. According to a press release, the researchers stated that the results must be peer-reviewed and confirmed in further trials, but given the emergent need created by the pandemic, they felt it was important to communicate the results.

CORIMUNO is exploring other medicines in COVID-19 patients, too, including sarilumab. Although both are anti-IL-6 drugs, tocilizumab is administered intravenously, while sarilumab is administered subcutaneously.

The results of a phase 2 trial studying sarilumab in COVID-19 patients found the drug was not beneficial for patients hospitalized but not on ventilators, according to results from Regeneron and Sanofi, who manufacture the drug.

The trial of sarilumab, manufactured and sold under the brand name Kevzara, was modeled off of a 21-person study in China of tocilizumab, which optimistically concluded that patients symptomsincluding feverwere significantly reduced and they were able to be discharged from the hospital. With these promising outcomes in mind, Regeneron and Sanofi moved rapidly to evaluate Kevzara in a prospective, randomized, placebo-controlled adaptively-designed U.S. Phase 2/3 trial, according to a press release from the companies.

Even in a pandemic setting, its both crucial and possible to obtain controlled data in adequately-sized trials to provide the evidence needed to inform optimal medical care, said George D. Yancopoulos, MD, PhD, co-founder, president, and chief scientific officer of Regeneron, in the release. Emerging evidence with Kevzara and other repurposed drugs in the COVID-19 crisis highlight the challenges of making decisions about existing medicines for new viral threats using small, uncontrolled studies. We await results of the ongoing Phase 3 trial to learn more about COVID-19, and better understand whether some patients may benefit from Kevzara treatment. In addition, there is an acute need for tailored approaches that specifically target this virus. To that end, Regeneron is rapidly advancing our targeted anti-SARS-CoV-2 antibody cocktail and we plan to initiate clinical trials in June.

The New York Times reported that Dr. Yancopoulos was not optimistic about the trial because the drugs in questioned were made to treat arthritis, not COVID-19.

Repurposing existing drugs has not had a history of success in the pharmaceutical industry, he reportedly said.

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Visual Functions in Psoriatic Arthritis Sine-Psoriasis May Be Linked to Systemic Inflammation – Rheumatology Advisor

Sunday, May 3rd, 2020

Dry eye and subclinical abnormalities in visual functions in patients with psoriatic arthritis (PsA) sine-psoriasis may be related to systemic inflammation, according to study results published in the Journal of Clinical Medicine.

In this noninterventional, cross-sectional study, the disease activity of patients aged 18 to 65 years with diagnosed PsA and no evidence of skin psoriasis (n=40) was assessed by an experienced rheumatologist; a healthy control group (n=35) was also included in the study. All patients received a standard ophthalmology exam, which included best-corrected visual acuity, ocular surface disease index questionnaire, Schirmer test, and tear film breakup time (BUT). Standard automated perimetry, spectral-domain optical coherence tomography, and fundus perimetry scans were performed in all patients.

Researchers evaluated 80 and 70 eyes from patients in the PsA group (72.5% women; mean age, 5214 years) and the healthy control group (60% women; 48.713.8 years) , respectively. The best-corrected visual acuity of patients in the PsA group and the healthy control group were similar, and an abnormal ocular surface disease index (OSDI) was observed in 60% of patients with PsA. Prevalence of dry eye was significantly greater in the PsA group compared with the healthy control group (P <.0001). Approximately 75% of patients in the PsA group (n=30) were definitively diagnosed with dry eye (39.9% with BUT <10 sec; 23.4% with Schirmer 5 mm; 36.7% with both BUT <10 sec and Schirmer 5 mm).

Researchers indicated a positive correlation between OSDI and erythrocyte sedimentation rate (ESR; r=0.6; P <.001), In terms of the Schirmer test values, a negative correlation was observed between the scale of wetness and ESR (r=-0.43; P =.007). Results from standard automated perimetry indicated a higher mean deviation and pattern standard deviation in the PsA group compared with the healthy control group (P <.0001 and P =.005, respectively). In addition, ESR and C-reactive protein (CRP) showed a positive association with pattern standard deviation (r=0.3 and r=0.4; P =.04 and P =.01, respectively), while CRP was also correlated with mean deviation (r=-0.4; P =.01). Patients with PsA and the control participants demonstrated a similar visual field index (range, 98%-100%).

Assuming that relevant signs of systemic disease may be revealed as abnormalities occurring in the eye, a clinical evaluation of retinal morphology and function should be performed in order to detect subclinical damage of the visual system early, the researchers advised. In addition, careful ophthalmologic examination of patients with PsA sine-[psoriasis] may produce valuable clinical information on disease activity status. Using either [standard automated perimetry] or [fundus perimetry] and [optical coherence tomography] assessment could allow the detection of early changes in visual function even before clinically detectable retinopathy. These ancillary tests may serve as a useful monitoring tool over the entire course of the disease.

Reference

Chimenti MS, Triggianese P, Salandri G, et al. A multimodal eye assessment in psoriatic arthritis patients sine-psoriasis: evidence for a potential association with systemic inflammation. J Clin Med. 2020;9(3):E719.

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Laser light used in targeted treatment of arthritis – New Atlas

Sunday, May 3rd, 2020

While there are drugs that help reduce the symptoms of rheumatoid arthritis in the joints, those medications can have unpleasant side effects in other parts of the body. An experimental new light-based system, however, is being designed to change that.

One of the problems with existing rheumatoid arthritis drugs lies in the fact that after they've been ingested or injected, they're distributed throughout (and are active within) the entire body. This means that if they're taken in the quantities needed to reduce inflammation of the joints, they may produce side effects such as stomach aches or insomnia.

If they could only become active when they were at the joints, then much smaller doses would be required, resulting in fewer side effects. That's where the new system comes in.

Developed by scientists at the University of North Carolina in Chapel Hill, it involves attaching an existing drug to specially-engineered vitamin B12 molecules. Those molecules are then loaded into red blood cells, which get injected into the bloodstream.

As long as those cells aren't subsequently exposed to long-wavelength tissue-penetrating laser light, the drug remains trapped and inactive within them for up to two hours. If a laser is held to the skin at an arthritic joint, however, even low levels of its light within that joint trigger the nearby B12 molecules to release their drug payload from within the red blood cells. As a result, the medication only kicks in once it's at the target joint.

In lab tests, the technology was successfully used to deliver the arthritis drug dexamethasone to the arthritic paws of mice. When compared to simply injecting pure dexamethasone straight into the bloodstream, the laser-activated system required a three-fold lower dose to achieve the same therapeutic effect.

"We hope that our drug delivery platform will better control drug delivery and decrease the amount of systemic exposure and off-target effects," says team member and doctoral candidate Emilia Zywot. "We envision that it will be useful for any drug that can be synthetically attached to our light-responsive system, making it amenable to applications beyond arthritis."

The abstract for a paper on the research was recently published in The FASEB Journal.

Source: Experimental Biology via EurekAlert

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GSK partners with Arthritis Foundation as it preps Voltaren for OTC switch – FiercePharma

Sunday, May 3rd, 2020

As GlaxoSmithKline prepares Voltaren Arthritis Pain for a sizable prescription-to-OTC switch next month, a new pre-order promotion will donate to the Arthritis Foundation.

Through May 12, the official Voltaren OTC availabilityday in the U.S., customers can order the NSAID osteoarthritis gelto getfirst-day at-home delivery through GSK Consumer Healthcare e-commerce partners. Profits from the sales will go to the Arthritis Foundation.

The awareness-buildingand pre-order effort is underway as behind the scenes, GSK is fine-tuning Voltarens prescription to OTC priority launch marketing push that will include TV, print, radio, in-store, digital and social advertising.

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GSK has the benefit of lessons learned from the Flonase allergy nasal spray prescription to OTC launch several years ago, said Jissan Cherian, Voltaren marketing director.Many of the same executives are still at GSK Consumer Healthcarechief marketing officer Amardeep Kahlon, in fact, oversaw the Flonase switch in 2015and while e-commerce has changed since then, other strategies have carried over.

In-store promotions, for instance, will follow the Flonase lead and use custom display units to educate consumers at point of sale, Cherian said. The multi-channel and extensive ad campaign looks to beanother nod to the Flonase model.

The campaign will seek to expand the Voltaren audience based on GSK research that found osteoarthritis begins for some people in their 30s. Without revealing specific creative, Cherian said a range of ages and life stages will be featured and that the brand will look to establish itself as a movement brand. The Voltaren website will be a first-ever for arthritis patients, created to be user friendly for their specific hand movement issues, he said.

RELATED:GlaxoSmithKline's spinoff plan is hereand it may not be limited to consumer health

As we saw with Flonase, once it becomes over the counter, we have an opportunity to engage a very large patient population and thats exactly what we want to do with Voltaren, Cherian said.

The Arthritis Foundation partnership began with GSK approaching the group to share research and validate its thinking for Voltaren. Thatevolved into the current awareness promotion, with the pre-order and e-commerce idea becoming even more relevant as the COVID-19 pandemic and stay-at-home orders developed.

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