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As part of the federal governmentsinvestment in domestic vaccine capability, a Vancouver company is taking their $25.1 million allotment to build a massive manufacturing facility in the Lower Mainland.

South Vancouver-basedPrecision Nanosystemsis building a $50.2 million biomanufacturing centre that could produce up to 240 million doses of vaccine every year in the 40,000 square foot facility. It's still assessing possible locations.

Its estimated completion date is March 2023, but the companys CEO says the investment is important on a number of levels.

"It's an investment in pandemic preparedness, an investment in the future, an investment in these critical technologies that are really the technologies of the future, said James Taylor in a Zoom interview. What were focussed on is the medium- to long-term pandemic responsiveness as well as developing capabilities and capacity around genetic medicine itself, so our facility will be able to utilize for programs that are involved in cancer, infectious diseases, rare diseases.

The same kind of messenger RNA technology that companies like Pfizer-BioNTech and Moderna have developed to quickly create and manufacture their successful COVID-19 vaccines is the same idea behind many local companies like Precision Nanosystems. Many members of the scientific community believe such genetic medicines that treat diseases at the molecular level are on the cusp of revolutionizing medicine.

"As long as you know how to create those instructions -- that genetic code you need to convince your body to create that target -- you can design an mRNA vaccine against any antigen," said Nicole Basta, an associate professor of epidemiology at McGill told the Canadian Press.

Vancouver-based Acuitas Therapeutics developed a lipid nanoparticle to protect the delicate messenger RNA strands that can be broken down by the body. https://www.ctvnews.ca/health/coronavirus/a-canadian-company-helped-make-one-of-the-most-promising-vaccine-candidates-1.5193860

Taylor described the Lower Mainland as a global hub in nano-medicines, pointing out the growing industry is deeply intertwined with researchers, scientists and experts working across borders on shared projects; Precision Nanosystems alone works with more than 160 other companies around the world.

This past a year has really shone a light on the importance of science and technology to solve deep problems globally, he said. It's important for us, as Canadians, to be strong participants in the development and innovation.

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Vaccine Production in BC's Future - AM 1150 (iHeartRadio)

As the battle against COVID-19 rages on, Canada is ramping up its vaccine producing capabilities at home in an effort to fill in the gaping hole in national security made evident by the pandemic.

Vancouvers Precision NanoSystems Inc. (PNI) announced this week it received $25.1 million from the federal governments Strategic Innovation Fund to create its domestic vaccine biomanufacturing capability.

The federal contribution covers half of the total $50.2 million cost of the new biomanufacturing centre that will be built in Vancouver, focusing on the production of ribonucleic acid (RNA) lipid nanoparticle vaccines and genetic medicines.

But the first vaccines made in this 40,000-sq-ft facility will not be ready for immediate pandemic needs; the project is not expected to reach completion until 2023, however, it will help secure the national supplies for critical medicines, future COVID-19 vaccine needs, and vaccines for future pandemics.

When operational, it will have a capacity to manufacture up to 240 million doses of vaccine each year. The RNA vaccine technology it will use is also currently being utilized by Pfizer-BioNTech and Moderna to rapidly develop and produce their COVID-19 vaccines.

PNIs centre of manufacturing excellence of nanomedicine will be a state-of-the-art facility for the development and manufacture of genetic therapeutics and vaccines, saidJames Taylor, the CEO of Precision NanoSystems, in a statement.

The centre will continueCanadasleadership in the creation of innovative solutions for the development and production of new medicines for the benefit of patients inCanadaand beyond.

Prior to COVID-19, PNI was already seeing quick growth in its business of developing genetic medicines by offering products and services to help create new treatments for infectious diseases, rare diseases, cancers, and other ailments.

PNI announced two separate COVID-19 vaccine development partnerships in May 2020, including a DNA vaccine with Edmonton-basedEntos Pharmaceuticals.

That same month, another partnership was entered with Chinese vaccine companyCanSino Biologics, with PNI responsible for the development of the mRNA vaccine and CanSino Biologics responsible for the pre-clinical testing, human clinical trials, regulatory approval, and commercialization. The Chinese company has the rights to commercialize the vaccine product in Asia, except in Japan, with PNI retaining the rights for the rest of the world.

A report in the Globe and Mail last summer indicated the federal governments National Research Council ended its partnership with CanSino, after the Chinese government refused to ship a vaccine to Canada for trials.

In October 2020, the federal government also provided $18.2 million in funding for PNI to advance a COVID-19 mRNA vaccine candidate to clinical trials.

Our government is bringing back the vaccine manufacturing capacity that Canadians expect and need. These investments will help to ensure thatCanadahas modern, flexible vaccine manufacturing capabilities now and in the future, saidFranois-Philippe Champagne, the federal Minister of Innovation, Science, and Industry, in a statement.

Our government is helping Canadian companies advance made-in-Canadavaccines and therapies, while securing domestic manufacturing options for international vaccine candidates.

The federal government is also funding new vaccine biomanufacturing facilities in Saskatchewan and Quebec.

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New facility to be built in Vancouver will produce 240 million vaccine doses annually | Urbanized - Daily Hive

In the fight against severe diseases like cancer, patients often endure a discomforting, weekslong gap between when treatment begins and when doctors can tell if its working. The problem often stems from an inability to track the diseases progression in anything close to real time.

Now Glympse Bio, a startup spun out of the lab of Sangeeta Bhatia, the John J. and Dorothy Wilson Professor of Electrical Engineering and Computer Science at MIT and director of the Marble Center for Cancer Nanomedicine, is working to shine a light on disease activity using tiny synthetic biosensors. After being injected into the body, the sensors travel to the disease site and measure protein changes associated with that disease. The sensors are then excreted in urine and analyzed using standard laboratory techniques.

The company believes its technology holds potential to transform disease detection, tracking, and by providing clinicians with data-driven insights treatment.

When a patient is put on a medicine, its really a waiting game, says Bhatia, Glympse Bio co-founder who is also a member of MITs Koch Institute for Integrative Cancer Research and the Institute for Medical Engineering and Science. Theres often nothing to do but wait to see if a disease is responding. We hope this technology can provide information to clinicians and patients earlier.

Glympse recently completed a Phase 1 trial of its sensors in patients with non-alcoholic steatohepatitis (NASH), a potentially deadly liver disease estimated to affect about 12 percent of adults in the U.S. Because the current process for diagnosing NASH involves sampling a piece of the liver through a biopsy, it often remains undetected until the disease is in its most advanced stages.

Glympse is also tuning its sensors to track the progression of certain cancers, infections, and inflammation. Success in those fields would give drug development companies, doctors, and patients a potent new tool in the fight against an array of life-threatening diseases.

With this platform you open up several different universes, Glympse CEO Caroline Loew says. For diseases that are harder to diagnose, you get to diagnose them faster, you get to be able to develop drugs for them more effectively, and you get to treat them faster.

Sensing an opportunity

Like many great scientific advances, the discovery that led to Glympse was serendipitous. Around 2008, Bhatias group was using tagged magnetic particles that travel to tumors in the body, where they could reveal their location through an MRI scan. In every cancer experiment, the researchers noticed the bladder lit up with the tag.

We realized we didnt need an imaging machine anymore, we could just give a shot and do a urine test, Bhatia says.

By 2012, Glympse co-founder Gabe Kwong, a postdoc in Bhatias lab between 2009 and 2014, had developed the tagging technology enough to map changes in protein activity to the progression of multiple diseases. Some of that early work was funded, in part, by the Koch Institute Frontier Research Program.

After some encouragement from her colleagues, Bhatia assembled a team of advisors including Institute Professor Robert Langer and secured a grant from MITs Deshpande Center to start the company. Bhatia eventually took a sabbatical from MIT to help the company identify its first target, NASH, raise venture capital, secure a partnership with the pharmaceutical company Gilead Sciences, and understand how the sensors would be regulated by the Food and Drug Administration.

The progress was enough to attract Loew, who had spent her career helping large pharmaceutical companies develop drugs. Loew says she was impressed by the breadth of insights Glympse could glean with its biosensor platform, which measures the activity of enzymes called proteases that are altered in a variety of serious diseases.

Loew led the company as its focus has broadened from diagnostics to precise disease tracking during treatment.

We began thinking about earlier cancer detection because you can save a lot of lives by finding cancer early, Bhatia says. Now were realizing that we can potentially understand whether new drugs are working and if the patients are on the right medicine.

The company believes it can understand not just if a specific drug is working but how it is working through protease data.

We can help determine whether the drug is activating at a site of engagement, we can tell mechanisms of action because theres specific protease activity thats associated with that, we can determine through a course of treatment whether the disease is increasing or decreasing, we can track all that through a protease signature, Loew says.

A platform with potential

Through its partnership with Gilead, Glympses technology is expected to move into efficacy trials with NASH patients later this year. The company hopes those trials show the power of its approach for gathering previously unattainable data.

Those insights could also transform treatment. Looking forward, Glympse hopes to help clinicians make care decisions for patients based on both real-time disease response and how the disease has responded in similar patients at similar stages of treatment.

That would represent a paradigm shift in areas like cancer immunotherapy, in which doctors often must make do with little information for months after treatment begins.

Many of these patients have very fast advancing cancers, Loew says. To get the patients quickly stratified to the right treatment is critically important. Days mean everything to these patients, and sometimes we see patients waiting around for nine to 12 weeks to see if theyre having a response to these drugs. In our preclinical data, were determining if theres a response in a week or two. If were able to pull that through, its game-changing.

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Faster tracking of treatment responses - MIT News

PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:

We believe that NBTXR3 could have a positive impact for patients with cancer in any case where radiotherapy is a part of the standard of care. Expansion into esophageal cancer represents not only another step toward achieving our goals, it also highlights the ongoing progress of our clinical collaboration agreement with The University of Texas MD Anderson Cancer Center. Laurent Levy, CEO of Nanobiotix

NANOBIOTIX (Euronext: NANO NASDAQ: NBTX the Company), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform the treatment of cancer, today announced that the first patient has been injected in a phase I study evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer. The trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson) as part of an ongoing clinical collaboration.

Background and Opportunity

According to the World Health Organization, esophageal cancer is currently the sixth most common cause of cancer death in the world and is estimated to have caused over 508,585 deaths in 2018. The American Cancer Society estimates that in 2020 in the United States, there were approximately 18,440 new esophageal cancer cases diagnosed, and approximately 16,170 deaths due to esophageal cancer. Approximately 20% of patients survive esophageal cancer at least five years after diagnosis.

Phase I Study of NBTXR3 Activated by Radiotherapy with Concurrent Chemotherapy for Patients with Esophageal Cancer (MD Anderson Study 2020-0122)

This study is an open-label, single-arm, prospective phase I study consisting of two parts: (i) dose-escalation to determine the RP2D of NBTXR3 activated by radiotherapy with concurrent chemotherapy, and (ii) expansion at RP2D with toxicity monitoring.

The patient population will include adults (age 18 years) with stage II-III adenocarcinoma of the esophagus that are treatment-nave and radiographically non-metastatic at screening. The number of participants enrolled will be determined based on the maximum number required to establish the RP2D of NBTXR3 activated by radiation therapy. Up to 24 subjects will be enrolled, including a maximum of 12 subjects for the dose-escalation part. Twelve additional subjects will be enrolled for the RP2D expansion part. Recruitment is ongoing and the planned enrollment period is 24 months.

Updates on this trial will be provided as they are made available by MD Anderson.

***

About NANOBIOTIX: http://www.nanobiotix.com

Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

Nanobiotixs novel, potentially first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotixs Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP) and on the Nasdaq Global Select Market (Nasdaq: NBTX). The Companys headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany

Disclaimer

This press release contains certain forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as at this time, anticipate, believe, expect, intend, on track, plan, scheduled, and will, or the negative of these and similar expressions. These forward-looking statements, which are based on our managements current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data, and our relationship with, and the performance of, our collaboration partners, and the funding of our operations. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption Risk Factors and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorit des Marchs Financiers) under number R.20-010 on May 12, 2020 (a copy of which is available on http://www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

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NANOBIOTIX Announces First Patient Injected With NBTXR3 in Esophageal Cancer - Business Wire

Rheumatoid arthritis (RA) is an autoimmune disease that damages joints and ligaments when the immune system attacks the bodys own tissues.

While the inflammation caused by RA can occur throughout your body, the effects of the disease are often most noticeable in the hands of people with RA.

This damage can result in twisted joints, gnarled ligaments, and ultimately destruction of the joints in later stages of the disease.

Joint deformities in people diagnosed with RA are becoming less frequent and less severe, thanks to earlier diagnosis and more effective treatments.

However, in addition to being painful, these changes in the hands can make it difficult to perform everyday tasks.

A major misconception about RA is that its solely a joint disease, according to Alejandro Badia, MD, FACS, founder of the Badia Hand and Shoulder Center in Miami, Florida.

Its largely a disease of the soft tissues, he explained. This includes ligaments and tendons, he said, although joints also are severely affected.

Thats especially true in your hands. They contain a large number of small bones, called phalanges and metacarpals, that are connected by joints. These joints are responsible for movement of your fingers.

In people with RA, the lining of these joints, called the synovium, is attacked by immune system cells. The synovium normally produces fluid that allows the joints to smoothly glide on their cartilage covers.

When inflammation causes the synovium to swell, a fibrous layer of abnormal tissue, called pannus, forms. In turn, this releases chemicals that cause:

The destruction makes ligaments and joint capsules dense, fibrous connective tissue that forms a sleeve around the joint less able to support the joints. This causes joints to lose their shape and alignment.

As a result, your joints:

People with RA generally have high levels of acute phase reactants C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) which are markers of inflammation in the body.

People with RA can also demonstrate positive antibodies, such as the rheumatoid factor (RF) and cyclic citrullinated peptide (CCP) antibodies. The presence of anti-CCP antibodies is associated with a risk of more severe disease.

Individuals with RA may experience different types of hand conditions, depending on the rate and manner in which their joints and ligaments deteriorate due to the disease.

All of these changes result from the inflammatory destruction to the joints of the fingers that occur with arthritis, causing increased pain, stiffness, swelling, and limited functional use of the hand for gripping, grasping, and pinching, said Kristen Gasnick, PT, DPT, whose outpatient rehabilitation practice includes people with RA.

The most common manifestations of RA-caused hand concerns identified by researchers include the following:

Boutonniere deformity occurs when the middle or proximal interphalangeal joint of a finger is flexed and the distal joint is extended.

Swan-neck deformity, the most common change in people with RA, occurs when theres weakness or tearing of a ligament due to inflammation. This results in laxity of the middle joint of the finger and flexion of the distal joint.

Hitchhikers thumb occurs when the thumb flexes at the metacarpophalangeal joint (connecting the thumb to the palm of the hand) and hyperextends at the interphalangeal joint (the one just below your thumbnail).

This is sometimes also called the Z-shaped deformity.

Rheumatoid nodules are hard lumps that form under the skin near the joints. These are another common symptom of RA in the hands.

They can also occur in multiple areas, most commonly near your elbows. The nodules usually arent painful or debilitating, but some people might not like how they look.

Less common among people with RA are Heberden nodes and Bouchard nodes. These are visible bumps at the joints that are more typical of osteoarthritis.

The availability of effective drugs that limit the progression of RA has helped reduce the severity of RA-related hand deformities.

Known as disease-modifying antirheumatic drugs (DMARDs), some of the medications commonly prescribed to treat RA include:

A subset of DMARDs, called biologic response modifiers, specifically target the areas of the immune system that trigger inflammation and joint damage.

These are usually prescribed in combination with other RA medications. Some examples include:

In some cases, rheumatoid nodules have been found to be more common among people receiving methotrexate treatment. They may be reduced in size by changing medications, receiving corticosteroid injections, or undergoing surgery.

In general, occupational therapy, including exercise and splinting, can slow the progression of hand deformities caused by RA. It can also improve function of your hands, fingers, and wrists.

Splints, including specially designed rings, can be used to stabilize affected finger joints.

Surgery is no longer common for people with RA because of the effectiveness of current treatment options. Plus, RA-related nodules often return after surgery.

However, surgery may be required to correct severe hand conditions. Options include finger joint replacement surgery, which is similar to the replacement surgery more commonly performed on knees and hips.

Such surgery can restore some functionality in the joints and improve appearance, although it doesnt cure the underlying RA condition.

Wrist surgery may be used to reduce ligament tension on the fingers. The wrist also can be surgically fused to keep it straight and reduce pain, although this results in loss of strength and function.

Wrist replacement surgery is an alternative for people with RA that may result in greater retention of wrist motion.

The damage from the systematic inflammation caused by RA can be particularly visible, painful, and debilitating in your wrists and hands.

However, joint deformities are less common than they used to be as a result of early diagnosis and the availability of more effective treatments, such as DMARDs and biologic response modifiers.

Read the rest here:
Rheumatoid Arthritis Hand Deformities: What to Do - Healthline

There is no specific diet for people with rheumatoid arthritis (RA). However, scientists believe that some foods may help ease the swelling that causes pain and stiffness.

This article explains what RA is and looks at some of the foods that might help relieve the symptoms. It also investigates whether some foods make RA worse and highlights some other ways that people can manage their symptoms.

RA is an autoimmune condition. This means that a malfunction of the immune system causes it.

More specifically, RA occurs when the bodys natural defenses attack the joints. This leads to painful swelling called inflammation. RA usually affects the joints in the hands, wrists, and knees. Sometimes, it can affect several joints at once.

The symptoms include painful aching or stiffness in the joints. People may feel extremely tired and weak, and occasionally, the condition can cause a low grade fever. Over time, RA can damage the joints permanently.

RA is a chronic, long-term condition, and there is currently no cure. Most people will have periods of remission, during which they have few or no symptoms. Other times, their symptoms will get worse. Doctors call these periods flare-ups.

People with RA can usually manage the condition by taking medications and making certain lifestyle changes.

Some experts believe that diet can help prevent flare-ups and manage the symptoms of RA. There is no specific diet that research has shown to help people with RA, but some foods may help control the painful swelling and support the immune system.

According to the Arthritis Foundation, many of these foods are part of the Mediterranean diet. They include:

Salmon, tuna, sardines, and anchovies are all rich in omega-3 fatty acids. According to the Arthritis Foundation, these fat molecules help fight the inflammation that causes joint pain in RA.

Fruits and vegetables are rich in antioxidants, which support the immune system. The fiber in fruits and vegetables may also help reduce inflammation.

Some of the best sources of antioxidants include blueberries, blackberries, cherries, strawberries, spinach, kale, onions, and broccoli.

Olive oil contains antioxidants, polyphenols, oleuropein, and oleocanthal. According to preclinical studies, these compounds have anti-arthritic and anti-inflammatory properties.

Nuts and seeds are useful for fighting inflammation. Walnuts, pine nuts, pistachios, and almonds are great sources of monounsaturated fat, protein, and fiber.

Experts recommend eating around one handful of nuts and seeds per day.

Beans are packed with antioxidants and anti-inflammatory compounds, including:

People with RA could try adding pinto beans, black beans, red kidney beans, or chickpeas to their diet.

Fiber is very important for heart and gut health. It can also help lower inflammation.

Some food sources of fiber include:

The Arthritis Foundation note that fats play a role in inflammation. As a result, people with RA should try to avoid trans fats. These are often present in baked goods, margarine, and fried foods.

Fats that people with RA should try to limit include:

Processed foods such as some ready-made meals, fast food, and cookies are often high in these fats. It is best to avoid these food items as much as possible.

The Arthritis Foundation also recommend that people with RA remove nightshade vegetables from their diet for 2 weeks to see whether or not they notice any difference in their RA symptoms.

Nightshade vegetables include eggplant, tomatoes, peppers, and potatoes. However, scientists need to do more research to investigate this theory before drawing any conclusions.

The Centers for Disease Control and Prevention (CDC) offer the following advice to people living with RA.

Many community and patient advocacy groups offer RA self-management courses and workshops. These tend to be free or inexpensive to attend.

During these workshops, people usually learn ways to manage pain, exercise safely, and stay in control of their condition.

When a person has RA, getting regular physical activity eases pain and helps the joints work better. It can also help people with the condition stay healthier for longer.

The CDC recommend getting at least 150 minutes of moderate intensity physical activity every week.

Having excess weight places pressure on the joints. In turn, this can make RA pain worse and prevent people from being active.

Losing just 1 pound (lb) (0.45 kilograms [kg]) of body weight will take 4 lb (1.8 kg) of pressure off the knee joints, for example.

The best way to lose weight and keep it off is by eating a healthful, balanced diet and exercising regularly.

People with RA should speak with a healthcare provider regularly. There are lots of treatment and management strategies available.

By working with their doctor, people with RA can usually maintain a high quality of life.

There is currently no cure for RA. It is a long-term condition that causes painful swelling in the joints.

Some scientists believe that certain foods can help with the symptoms. This is because some foods contain antioxidants, which support the immune system. Others contain compounds that may fight inflammation.

Some other ways to manage the symptoms of RA include staying active and maintaining a moderate weight.

Continue reading here:
What is the best diet for rheumatoid arthritis? - Medical News Today

Patients with early, undifferentiated arthritis may benefit from milder or stronger treatments, depending on the number of their risk factors for developing rheumatoid arthritis, researchers say.

If the finding is borne out by further research, clinicians could consider treating some of these patients with hydroxychloroquine, steroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) rather than methotrexate, said Pascal de Jong, MD, PhD, a rheumatologist at Erasmus Medical Center in Rotterdam, the Netherlands

"Maybe those patients with fewer risk factors should get less intensive treatment," he told Medscape Medical News. The study by de Jong and colleagues was published online January 23 in Rheumatology.

The European Alliance of Associations for Rheumatology recommends starting treatment with methotrexate for patients who are at risk for persistent arthritis, which it says is "factually synonymous" with rheumatoid arthritis.

But these recommendations are based on studies involving patients with established rheumatoid arthritis, de Jong said.

In an earlier study, he and his colleagues found that hydroxychloroquine can be just as effective as methotrexate for patients newly diagnosed with rheumatoid arthritis who dont have autoantibodies. This led them to wonder whether their findings might apply to some subgroups of patients with early arthritis.

As an initial test of this idea, they identified 130 patients from the Rotterdam Early Arthritis Cohort (tREACH) trial who had at least one swollen joint but who did meet the diagnostic criteria for rheumatoid arthritis.

They sorted the patients into groups on the basis of the number of risk factors for persistent arthritis. The risk factors were autoantibody positivity (rheumatoid factor and/or anticitrullinated protein antibody), polyarthritis (more than four swollen joints), erosive disease, and elevations in levels of acute-phase reactants.

Thirty-one patients had none of these risk factors, 66 patients had one risk factor, and the remaining 33 patients had at least two risk factors.

After 2 years of follow-up, 74% of the patients who had had no risk factors had recovered from their arthritis and had not taken disease-modifying antirheumatic drugs (DMARDs) for at least 6 months (DMARD-free remission). Among the patients who had had one risk factor, 48% achieved DMARD-free remission.Among those who had had two risk factors, 45% achieved DMARD-free remission. The differences between the group that had had no risk factors and the other two groups were statistically significant (P < .05).

The researchers found that those patients who had been experiencing their symptoms for fewer than 6 months were more likely to achieve disease-free remission.

They also sorted patients into different groups on the basis of the treatments they received. One group of 30 comprised all patients who had been initially treated with methotrexate and included patients who had also received other drugs. One group of 40 received hydroxychloroquine initially, and one group of 60 comprised patients who had received no DMARDs initially and included those who had received NSAIDs or glucocorticoids.

There was no statistically significant difference in DMARD-free remission rates among the treatment groups. However, among those patients who were not treated initially with DMARDs, the chance of sustaining DMARD-free remission for more than a year was lower in comparison with the patients who received methotrexate initially (odds ratio, 4.28; 95% CI, 1.34 13.72; P < .05).

Those patients who had fewer baseline risk factors were more likely to have their medication dosages tapered, and they were at lower risk for flares. Patients with more risk factors were more likely to require an intensificiation of treatment, such as with the use of biologicals.

Methotrexate is more likely to cause side effectssuch as nausea, fatigue, and hair loss than hydroxychloroquine, de Jong said. "If the medication is better tolerated, it also influences the compliance of the patient," he said.

The study could help rheumatologists determine which patients need the most aggressive treatment, agreed Kevin Deane, MD, PhD, associate professor of medicine, Division of Rheumatology, the University of Colorado Anschutz Medical Campus, Aurora, Colorado. "That's a common clinical problem," he said. "Somebody comes in with sort of mild arthritis, and you don't quite know what it is yet."

But he added that more research is needed to understand what treatment works best for those patients whose arthritis has not yet been differentiated. Primary care physicians who suspect inflammatory arthritis should refer their patients to rheumatologists and should test for rheumatoid factors and anticyclic citrullinated peptide, Deane said.

The authors and Deane have disclosed no relevant financial relationships.

Rheumatology. Published online January 23, 2021. Full text

Laird Harrison writes about science, health and culture. His work has appeared in magazines, newspapers, and online publications. He is at work on a novel about alternate realities in physics. Harrison has taught writing at San Francisco State University, UC Berkeley Extension, and the Writers Grotto. Visit him at lairdharrison.comor follow him on Twitter: @LairdH.

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Patients With Early Arthritis May Need Tailored Treatments - Medscape

One of the most common ailments afflicting modern society is the presence of joint pain, largely in knees but also experienced in hips and shoulders. While much of this discomfort can be attributed to repetitive motion compression brought on by either weight or gravity (e.g., repetitive running, weightlifting), a new perspective is offered in potentially alleviating the symptoms of bursitis or arthritis.

To understand how to deal with the joint pain, stiffness or soreness associated with arthritis, one first needs to recognize what is going on, or how the problem started. Multiple forms of arthritis exist, with osteoarthritis (OA) developing due to age and wear and tear within the joint, versus rheumatoid arthritis (RA), which is considered an autoimmune disease.

The symptoms of arthritis generally include stiffness and joint pain. The treatments commonly selected for nonprescription use are either the analgesics (aspirin or acetaminophen based) or are of a category of agents known as nonsteroidal anti-inflammatory drugs (NSAIDs). Topical applications with pharmaceutical compounds are also deployed to provide topical relief through transdermal action. In certain acute cases, corticosteroids are deployed either orally or by direct injection into the affected site where the pain is isolated.

New development in the past few years centers on disease-modifying anti-rheumatic drugs (DMARDs) designed to reduce a hyperactive immune or inflammatory process. The latest approach, which seems to have achieved wider acceptance, is the concept of introducing platelet-rich plasma (PRP) in regenerative medicine into the affected joints.

In addition to promising PRP therapies, research of natural products has yielded some very positive results. Studies indicate Terminalia chebula, collagen, curcumin and vitamin D show promise for joint health.

To read this article in its entirety, check out the Joint health across the life span digital magazine..

Mark A. LeDoux is founder, chairman and CEO of Natural Alternatives International Inc.,an organization established in 1980 with facilities in the U.S. and Switzerland engaged in the research, design and manufacture of nutritional supplement programs and products for multinational clients. He is a proud member and leader of many industry organizations.

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Fresh perspective in dealing with arthritis - Natural Products INSIDER

STEAMBOAT SPRINGS If you suffer from arthritis, its probably no surprise that cold weather can make it worse. But why does this happen? And what can you do about?

Dr. Nicole Cotter, a rheumatologist with UCHealth Rheumatology Clinic in Steamboat Springs, answers those questions and more below.

Arthritis, by definition, is inflammation of the joints, Cotter said. But there are probably more than a hundred different kinds of arthritis.

One main type is osteoarthritis, in which wear and tear breaks down the cartilage that cushions a joint, resulting in pain.

There are also various types of arthritis that are caused by abnormalities in the immune system. Rheumatoid arthritis, for instance, often strikes when someone is in their 30s or 40s.

Theres a misconception that arthritis is just a natural part of getting old, Cotter said. So many people come into my office and say, Im too young to be here, but unfortunately, theyre the perfect age to be there because of the type of arthritis they have.

If you experience joint stiffness and pain, see your health care provider. Early treatment can result in better long-term outcomes, and various treatments can help reduce pain.

Listen to your body, Cotter said. If you think that somethings not right, somethings probably not right.

Most of the time when people have arthritis, cold weather makes them feel worse, Cotter said. There are a lot of different theories as to why.

Cold weather is often preceded by a drop in barometric pressure, which can cause tissues to expand and pain to increase.

When temperatures drop, the fluid in the joint actually becomes thicker, which could worsen pain.

People also tend to be less active in cold weather, and joint pain is typically worse when people are more sedentary.

Its actually not an old wives tale that people with arthritis know when they weathers going to change, Cotter said. Its not clear why, but certainly, cold weather makes arthritis worse.

Cotter recommends three strategies to help decrease arthritis pain due to cold weather stay active, stay warm and stay healthy.

Staying active helps you increase blood flow and reduce stiffness.

For most people with arthritis when they wake up first thing in the morning or get up after being in a car, they feel stiff, Cotter said. By staying active, you help combat that stiffness.

Its also important to keep your body warm. Simply staying warm helps, Cotter said. When your joints are warmer, theres more blood flow to the joint and muscles are more relaxed.

Keep your home warm, use a heating blanket and wear appropriate clothing, including layers, gloves and warm socks. People with arthritis in their hands may find that paraffin wax treatments bring relief.

And you do your best to stay healthy. By getting enough sleep, eating a healthy diet, maintaining an optimal level of vitamin D and getting a flu shot, you will support your immune system, which in turn can help decrease pain.

Remember to be careful on the snow and ice.

If people have arthritis, their balance might not be optimal as joint pain here and there can affect your gait, Cotter said. The last thing we want is for somebody to fall on the ice, so just be cognizant of that.

The good news is that by staying active, warm and healthy, you can make a difference in your pain level in cold weather.

Lifestyle modifications can help to manage those symptoms in a cold environment, Cotter said.

Susan Cunningham writes for UCHealth Yampa Valley Medical Center. She can be reached at cunninghamsbc@gmail.com.

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Monday Medical: Arthritis and cold weather | SteamboatToday.com - Steamboat Pilot and Today

Dr. Sal Iaquinta

A friend says she doesnt do any strenuous exercise in order to keep her hip and knee joints like new for old age. She doesnt want to get arthritis and plans on going to the grave with all her original parts.

I give her credit for being amusing, but does her plan have any merit? Does exercise contribute to arthritis? And does anyone care what you go to the grave with?

When the time comes, the replacement parts Im buried with will be the least of my worries.

It would seem like exercise does contribute to arthritis. We all know the former football player with a bad knee from those years in high school or college. One of the most famous medical studies of all time actually looked at exercise and arthritis, but most people dont know it.

The Framingham study started in 1948 in Framingham, Massachusetts. This longitudinal study of just around 5,200 residents is most well known for its observations on heart disease and stroke. This study showed the risks of cigarette smoking, high cholesterol, high blood pressure and obesity. This landmark study is still going today and one of the things being followed is exercise and its effects. The participants reported exercise and injuries, and even had knee X-rays at the beginning of the study and then later points.

Over the decades, some of the group developed knee arthritis. There was no link between exercise (specifically jogging and walking) and arthritis in both symptoms and radiologic findings on follow-up X-rays. Jogging wasnt worse than walking. Obesity was found to be a risk factor for arthritis, but the more active overweight subjects didnt get arthritis any more than more slender active patients.

What about the flip side is strenuous exercise actually good for joints? An Australian study of about 300 adults found the participants who did the most vigorous weight-bearing (not swimming) exercise had the thickest knee cartilage with one exception those who had injuries.

Taking it another step forward, another study of more than 430 avid runners found no evidence that running caused arthritis throughout 20 years of observation. What they did find was that the runners had less musculoskeletal disabilities than the non-runners. And the runners had a mortality rate 39% lower than the non-runners. These studies have been repeated with college athletes and have not found exercise, even strenuous repetitive exercise, as a risk factor.

So, why is there so much knee arthritis? Injuries. Old injuries have been found to be a leading cause of joint arthritis. Getting back to the old football player, it was the trauma the sprains or cartilage tears or even fractures that contribute to arthritis. Another problem is age. Cartilage loses its ability to heal as you get older.

Your parents might be part of the problem. People inherit the growth pattern of their parents, this includes minor abnormalities in how bones are shaped and how they can lead to arthritis. Being female, women unfortunately are more likely to develop arthritis as they get older.

Lastly, as previously mentioned, being overweight adds a disproportionate amount of pressure on the knees. Every extra pound of weight adds 3 pounds of weight to the knees.

Once you have arthritis is when you switch to the exercises that improve muscle strength without significant weight impact. Walking and swimming are great, and even yoga and tai chi help with balance and flexibility.

So is my friend right? Probably not. Not exercising does not seem to help and another study found that weakness of the leg muscles around the knee seems to be its own risk for arthritis. The cardiovascular and other musculoskeletal benefits of exercise outweigh the risk for arthritis as long as you do it safely.

Having all your original parts in the grave doesnt seem worth it if you never really live. Take a hike theres a whole world out there.

Dr. Salvatore Iaquinta is a head and neck surgeon at Kaiser Permanente San Rafael and the author of The Year They Tried To Kill Me. He takes you on the Highway to Health every fourth Monday.

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Does exercise contribute to arthritis? Heres what research says - Marin Independent Journal

Objectives:Peripheral ulcerative keratitis (PUK) is a severe corneal condition associated with uncontrolled rheumatoid arthritis (RA). Tocilizumab (TCZ) is used to control RA, however, episodes of paradoxical ocular inflammation have been reported in TCZ-treated patients. We report a case series of PUK in TCZ-treated RA patients with ophthalmological and systemic findings and discuss the potential underlying mechanisms.

Methods:Four patients (6 eyes), aged 47-62 years were included. At the onset of PUK, the median duration of RA was 13 years (3-13), and the median treatment with TCZ was 9 months (3-14). Two patients had active disease (DAS 28 > 3.2) and the disease was controlled in 2 patients (DAS 28 3.2).

Results:TCZ was initially replaced by another immunomodulatory treatment in all patients and later reintroduced in 2 patients without PUK recurrence. Corneal inflammation was controlled in all cases with local and systemic treatments, with severe visual loss in one eye.

Conclusion:To summarize, PUK may occur in patients with long standing RA after a switch to TCZ and can be interpreted, depending on the context, as insufficient efficacy or a paradoxical manifestation. These cases highlight the urgent need for reliable biomarkers of the efficacy/paradoxical reactions for biologics.

Keywords:Peripheral ulcerative keratitis; paradoxical manifestations; rheumatoid arthritis; tocilizumab.

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Peripheral Ulcerative Keratitis in Rheumatoid Arthritis Patients Taking Tocilizumab: Paradoxical Manifestation or Insufficient Efficacy? - DocWire...

If youre living with rheumatoid arthritis (RA), your primary care physician can monitor many of your day-to-day healthcare needs. For more comprehensive assessment and treatment, however, you may need to see a rheumatologist.

Rheumatologists are doctors internists or pediatricians who receive special training in diagnosing and treating musculoskeletal disease and systemic autoimmune conditions like RA.

Known collectively as rheumatic diseases, these conditions can cause pain, swelling, stiffness, and deformities in your:

Becoming a rheumatologist requires completing 4 years of medical school, where they receive training as a medical doctor or osteopath. Thats followed by 3 years as a medical resident specializing in internal medicine, pediatrics, or both.

To complete their formal education, a rheumatologist spends 2 to 3 years in a rheumatology fellowship, learning about chronic musculoskeletal and autoimmune conditions and how to treat them.

Once theyve completed the fellowship, the rheumatologist must pass a certification exam administered by the American Board of Internal Medicine.

Rheumatologists must take a recertification exam every 10 years. Theyre also required to take continuing medical education classes to retain their board certification.

A rheumatologist can treat any of the more than 100 known rheumatic diseases and musculoskeletal conditions and injuries, including:

A rheumatologist will gather your complete medical and family history, perform a physical examination, and run certain types of testing.

Rheumatologists commonly test people for the presence of excessive antibody production for suspected autoimmune disorders. To assess musculoskeletal problems, they may order:

All of this information helps them work with you to develop the right treatment plan for you.

Treatment may include:

Rheumatologists also can talk with you about:

Muscle and joint pain are not uncommon, but if you have pain that lasts for more than a few days, visit your primary care physician.

Your doctor can evaluate whether youre experiencing temporary pain from an injury or other inflammatory causes, or if an underlying rheumatic condition may be involved that requires a referral to a rheumatologist.

If the pain youre experiencing gets worse over a short period of time, thats a good indicator that you should see a rheumatologist.

Likewise, if your symptoms decrease with initial treatment, like pain medication, but return once the treatment stops, it may be time to seek out a specialist.

You may want to schedule an appointment with a rheumatologist if you:

Many rheumatic conditions are hereditary, so you should also let your doctor and rheumatologist know if you have any family history of autoimmune or rheumatic disease.

If you have persistent joint, bone, or muscle pain, dont delay seeking treatment. Joint stiffness that lasts more than 30 minutes, especially if its worse in the morning after long periods of inactivity, or any joint swelling should also be promptly evaluated by a doctor.

Rheumatic diseases can lead to permanent damage over time if not addressed in a timely manner. Outcomes improve when these conditions are treated earlier, even for chronic and progressive diseases.

Rheumatologists and orthopedists both treat rheumatic diseases, but in different ways.

Generally speaking, rheumatologists treat rheumatic diseases with nonsurgical interventions, whereas orthopedists perform surgeries to improve function and quality of life.

You may want to see an orthopedist if you:

A good rule of thumb: Unless you have suffered a traumatic injury that requires surgery, see a rheumatologist before you consult an orthopedist.

Rheumatologists specialize in treating RA and other rheumatic conditions. They receive extensive training and education to assess and treat people with these conditions. They can also offer counseling for how to cope with diseases like RA.

You should see a rheumatologist if you have chronic joint or musculoskeletal pain that does not go away on its own or reoccurs after short-term treatment.

Your primary care physician may refer you to a rheumatologist. People with rheumatic diseases typically see rheumatologists for treatment rather than orthopedists, unless they have an acute injury requiring surgery or a chronic condition that does not respond to nonsurgical treatment.

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What Is a Rhuematologist and When Should You See One? - Healthline

MANHASSET, N.Y.--(BUSINESS WIRE)--The burgeoning scientific field of bioelectronic medicine, which features the use of electronic devices to stimulate nerves to treat disease, has shown great promise in alleviating serious health conditions. In a Lancet Rheumatology editorial published, Feinstein Institutes for Medical Research president and CEO Kevin J. Tracey, MD, discussed a recent clinical study that used a hand-held battery-operated electronic device to treat patients suffering from moderate to severe rheumatoid arthritis (RA).

Researchers in a multicenter, uncontrolled, open-label study led by Marsal S, Corominas H, et al., published their findings in Lancet Rheumatology which observed the effects of daily up to 30 minutes of sensory branch stimulation therapy of the vagus nerve. The results showed significant changes in the disease activity and ultrasound and magnetic resonance imaging (MRI) revealed significant improvements. The authors conclude that this alternative treatment should be evaluated in larger controlled studies for RA.

In a thorough review of the research paper, Dr. Tracey, who has been heralded as the founding father of bioelectronic medicine for his discovery of the bodys inflammatory reflex, weighed in on the new findings. Some points raised include the need to better understand what part of the body this stimulation activated and the need for larger controlled clinical trials to answer important questions, including the intensity of the stimulation and optimal length.

initial evaluation of evolving breakthroughs should not be based on what we do not know, but rather on whether the clinical trials are well defined and described, and whether others can replicate the results using appropriate statistics and analytics, notes Dr. Tracey in the Lancet Rheumatology editorial. Important new data from basic science and clinical trials can accelerate the pace of its evolution from alternative quackery to clinical adoption.

The Feinstein Institutes for Medical Research is known as the global scientific home of bioelectronic medicine. Bioelectronic medicine combines molecular medicine, neuroscience, and biomedical engineering to develop innovative therapies to treat various diseases and conditions through targeted stimulation of nerves, including paralysis, arthritis, pulmonary hypertension, and inflammatory bowel disease.

Feinstein Institutes researchers recently discovered that a small cluster of neurons within the brain is responsible for controlling the bodys immune response and the release of cytokines, which leads to inflammation in the body.

About the Feinstein Institutes

The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer in New York State. Home to 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health innovations and outcomes, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us on LinkedIn.

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Study Supports Bioelectronic Medicine to Treat Rheumatoid Arthritis - Business Wire

Regenerative therapies such as stem cells and platelet-rich plasma already play an important role in managing osteoarthritis (OA). Nonetheless, veterinarians have found that response to even these therapies is less than ideal in many cases, prompting researchers to continuously seek novel therapies for this all-too-common musculoskeletal disorder. One of the newest to be unveiled is called bone marrow mononuclear cell (BMNC) therapy. One researcher who presented at the 2020 American Association of Equine Practitioners Convention, held virtually, reported that the equine industry is in critical need for therapies that resolve joint inflammation but preserve tissue healing, and BMNC appears a promising candidate.

Much more than stem cells classically sought for cartilage healing, bone marrow is rich in macrophage progenitor cells, explained James B. Everett, DVM, MS, previously of the Virginia-Maryland College of Veterinary Medicine, who now works at the Equine Surgical Center at ThorSport Farm,in Murfreesboro, Tennessee. Macrophages are a type of white blood cell that play a role in tissue repair and cartilage integrity, and produce the anti-inflammatory mediators, including interleukin-10 (IL-10).

Everett said macrophages in the synovial (joint) membrane are essential for joint health, clearing aggressors, secreting key molecules required for optimal joint function, and forming a shield that protects tissues undergoing repair, similar to a wound scab. However, when the amount of tissue damage overwhelms these housekeeping functions, macrophages stimulate inflammation as a means of recruiting more cells, especially more macrophages, to cope with increased demands for repair.

If this response is efficiently accomplished, macrophages then produce, among other things, high concentrations of IL-10 and resolve the inflammatory process, returning the joint to a healthy state, he said.

Everett emphasized that not all inflammation is bad. This acute inflammation is essential to establish a resolving response, and anti-inflammatory therapies can negatively interfere.

As presented by Everetts colleague Bruno Menarim, DVM, PhD, in a separate session, studies show that BMNCs promote the endogenous resolution of experimentally induced inflammation. To see if these promising features translated to naturally occurring inflammation in live horses, Everetts research team studied 19 horses, dividing them into three treatment groups:

The selected horses were diagnosed with OA in a single joint, and the team injected those joints once with the saline, triamcinolone, or BMNCs. The BMNCs were autologous, meaning veterinarians collected them from each patients own bone marrow aspirate. They processed the aspirate in-house, and the isolated mononuclear cells, composed predominantly of macrophages, were ready to inject into the affected joint within three hours of aspiration.

We found that while objectively assessed lameness (via Lameness Locator) decreased in all three groups, it was only significant in the BMNC-treated horses, said Everett. Further, the treatment was well-tolerated with no adverse events appreciated in this study.

He said that using BMNCs can help reduce the need for chronic use of non-steroidal anti-inflammatory drugs and corticosteroids, which produces potentially harmful consequences. Further, BMNCs preserve the production of molecules such as interleukins and cytokines that are essential for restoring joint homeostasis. Corticosteroids often inhibit these molecules.

The researchers noted that these results support a larger clinical trial using BMNCs in clinical cases of equine OA.

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Novel Bone Marrow 'Ingredient' To Help Arthritic Horses The Horse - TheHorse.com

Arthritis is a condition that causes swelling in the joints. It generally occurs in older adults and has different treatments as per the type of it. So, here are the causes, symptoms and risk factors of this joint ailment.

Arthritis is the swelling of one or more of your joints. Severe joint pain is associated with this condition that becomes worse as we age. Osteoarthritis and rheumatoid arthritis are the two most common types of this condition. The first one causes cartilage to break down and the second one is a disease where the immune system attacks the joints. Treatments of arthritis depend on its type and the main goal of the treatments is to reduce the symptoms.

Symptoms and causes of arthritis

Symptoms of arthritis:

Pain.

Stiffness.

Swelling.

Redness.

Causes of arthritis

Osteoarthritis is caused by the damage in the joints cartilage and it affects the entire joints. It also causes changes in the bones and damages tissues. This disease also causes inflammation in the joint lining.

Rheumatoid arthritis is caused when the immune system attacks the lining of the joint capsule. This lining then becomes swollen and inflamed.

Risk factors of arthritis

A person who is already havinga family history of this condition.

Older adults are more prone to having this disease.

Women are at a greater risk of having rheumatoid arthritis and men are prone to have gout, another type of arthritis.

Any previous injury in the joint may cause this issue.

Obesity is also responsible for this condition as your joints have to take a lot of stress of your body weight.

Some early signs of arthritis:

These subtle signs can tell you if you are about to get diagnosed with this condition:

Fatigue.

Morning stiffness.

Joint pain and stiffness.

Minor joint swelling.

Fever.

Numbness and tingling.

Eye discharge.

Dry mouth.

Difficulty in sleeping.

Loss of appetite.

Weight loss.

Note

Arthritis may make it tough for you to do your daily tasks. So, whenever you see these symptoms persistently, consult your doctor right away.

Also Read:Colon Cancer: THESE are the symptoms, causes and risk factors of this chronic disease

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Arthritis: Symptoms, causes and risk factors of this joint ailment - PINKVILLA

SetPoint Medicals march toward getting its bioelectronic platform across the finish line obtained a huge boost this week through a financing.

The Valencia, CA-based company announced it had raised $64 million in a preferred stock financing to help in the development of its bioelectronic platform to treat rheumatoid arthritis (RA).

This financing was led by New Enterprise Associates (NEA) and included returning investors Action Potential Venture Capital, Boston Scientific, Topspin Fund, Morgenthaler, Euclidean Capital, and an undisclosed strategic investor.

New investors including ShangBay Capital, Richard King Mellon Foundation, Ascendum Capital, Asahi Kasei, Catalio Capital Management, BPC Fund, Midas Capital, Revelation Partners, Aethan Capital, Citta Capital, and SVE Capital also participated in this round. William Dai, Founding Managing Partner at ShangBay Capital, has joined SetPoint Medicals Board of Directors in conjunction with this financing. The financing included the conversion of approximately $21M in outstanding convertible debt.

This financing sets us up to start the pivotal trial, which will begin [soon], Murthy Simhambhatla, PhD, president and CEO of Setpoint, told MD+DI. The data from this pivotal trial, which will be from 250 patients at 40 sites, will be used to support a PMA submission.

Simhambhatla added, the pivotal trial is important in generating high-quality data. It is a double-blind sham-controlled trial. Its in patients that have failed one or more biologic drugs or are intolerant of them. Its a second-line therapy. Its not for patients that have failed methotrexate, but patients that have been exposed to at least one biologic drug and have had an inadequate response.

The company is forecasting three years before it can file a PMA submission.

SetPoints device, which is about the size of a coffee bean, won breakthrough device designation in October of 2020. The foundation of the technology is based on impacting the Inflammatory Reflex, a mechanism discovered by SetPoint co-founder Kevin Tracy, said David Chernoff, MD, SetPoints CMO.

The Inflammatory Reflex regulates the immune system by way of the central nervous system. By activatingthe Inflammatory Reflex with targeted electrical pulses to the vagus nerve, the body produces a systemic anti-inflammatory response.

SetPoint isnt stopping with RA and will explore using the platform to treat other disease states.

The same feedback loop that can potentially help patients with rheumatoid arthritis can potentially help patients with Inflammatory Bowel Disease, he said. Weve run a clinical trial in Crohns Disease where we saw reductions in disease activity that are comparable to best-in-class approved drugs.

Simhambhatla added, the immediate priority is to get Rheumatoid Arthritis across the finish line. Once we do that, well turn our attention to Crohns Disease, potentially ulcerative colitis, potentially Multiple sclerosis.

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SetPoint Gives a Jolt to RA Pivotal Trial with New Financing - Medical Device and Diagnostics Industry

TORONTO, Feb. 1, 2021 /CNW Telbec/ - Celltrion Healthcare Canada Limited announced today that Health Canada has granted a notice of compliance (NOC) for Remsima SC (CT-P13 SC) in Canada for the treatment of adult patients with rheumatoid arthritis (RA).

Rheumatoid arthritis is the most common chronic inflammatory joint disease and approximately 374,000 Canadians over the age of 16 live with rheumatoid arthritis.1

Remsima SC is approved in Canada for use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. Remsima SC should be usedas maintenance therapy after the completion of an induction period with intravenous infliximab.2The Health Canada NOC issued for Remsima SC is based on clinical evidence that showed the clinical response to Remsima subcutaneous (SC) formulation was comparable to CT-P13 IV up to 1 year. It was also shown that switching people with RA from the IV formulation to RemsimaTM SC at Week 30 was comparable to maintaining RemsimaTM SC up to Week 54 (up to Week 64 for safety profile).2,3

"Remsima SC has been shown to have a similar efficacy and safety profile to CT-P13 IV. Remsima SC may also enhance treatment options for the use of infliximab by providing high consistency in drug level and exposure," said Professor Edward Keystone, Professor of Medicine, University of Toronto, Toronto, Canada. "The approval of Remsima SC in Canada provides patients the opportunity to administer the treatment at home, giving physicians and patients more control over their treatment."

With the availability of the subcutaneous formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option. Remsima SC can be injected by patients themselves, which has the potential to save time since it will not require in-clinic administered IV treatment.

As part of Celltrion's strategy to expand its global presence and build a direct sales network, Celltrion Healthcare has established an entity in Canada to manage sales and marketing activities for Remsima SC.

"We are delighted to bring the first subcutaneous form of infliximab to patients, payers and clinicians in Canada. We are proud that RemsimaSC will be the first product to enter the Canadian market under our new direct sales marketing strategy. We plan to strengthen our presence in Canada and support the company's growth,"said Jovan Antunovic, Senior Vice President and Commercial Director at Celltrion Healthcare Canada.

Celltrion has applied for patent protection, until 2038, for Remsima SC in approximately 100 countries throughout North America, Europe and Asia.

Notes to Editors:

About CT-P13 (biosimilar infliximab)4-6

CT-P13 is developed and manufactured by Celltrion, Inc. and was the world's first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra. CT-P13 is approved in more than 94 countries (as of January 2021) including the US, Canada, Japan and throughout Europe.

CT-P13 IV is usually given as 3 mg per kg/body weight in RA and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options: via a pre-filled pen (auto-injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

CT-P13 SC has received EU marketing authorization for the treatment of people with RA and IBD in November 2019 and July 2020, respectively. In the United States, Remsima SC will be reviewed through the new drug pathway by the U.S. Food and Drug Administration (FDA) with the outcome expected by 2022.

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the U.S. FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us

References

1.

Government of Canada. Available at:https://www.canada.ca/en/public-health/services/publications/diseases-conditions/rheumatoid-arthritis.html.

2.

Remsima SC Product Monograph. Celltrion Healthcare Canada Limited, January 28, 2021.

3.

Westhovens R et al. Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial. Rheumatology (Oxford) 2020 Nov 23;keaa580: doi: 10.1093/rheumatology/keaa580.

4.

European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf. Last accessed January 2021.

5.

Yoo DH, Jaworski J, Matyska-Piekarska E et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019.

6.

Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170). Presented at EULAR 2019.

SOURCE Celltrion Healthcare

For further information: Media Relations Contact: [emailprotected], [emailprotected]

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Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the...

Pfizers Xeljanz, an oral JAK (Janus kinase) inhibitor rheumatoid arthritis treatment, has failed to catch up with the TNFi (tumor necrosis factor inhibitor) during a post-marketing study, reigniting the debate over its safety.

The post-marketing safety study, dubbed ORAL Surveillance, compared the safety of taking 5mg and 10mg of Xeljanz twice daily with TNFi in about 4,300 patients with rheumatoid arthritis aged 50 years or older with at least one cardiovascular risk factor.

The company set a co-primary endpoint of the study as the non-inferiority of Xeljanz compared to TNFi regarding major adverse cardiovascular events (MACE) and malignancies, excluding non-melanoma skin cancer. The results showed that the company failed to meet the prespecified non-inferiority criteria for the co-primary endpoints.

Analyzing 4,362 subjects, the number of patients with significant cardiovascular events was 135 (98 in the Xeljanz group and 37 in the TNFi group), and that of patients with malignant tumors was 164 (122 in the Xeljanz group and 42 in the TNFi group).

As Xeljanz failed to provide evidence that it was not inferior to TNFi in both cardiovascular and cancer risk, local industry officials expressed concerns that the U.S. Food and Drug Administration may put further restrictions on the drug or pressure the company to withdraw the drug from the market.

In 2019, the FDA had slapped a boxed warning on Xeljanz 10 mg's product label, cautioning against a higher risk of pulmonary embolism, a blood clot in the lungs that can be fatal. The European Medicines Agency also followed a few months later with a warning that patients with a high risk of blood clots should take caution with any dose of Xeljanz.

"Full study results, beyond the co-primary endpoints, including, but not limited to, secondary endpoints such as pulmonary embolism and mortality as well as efficacy data, are not yet available," Pfizer said. "We are working with the FDA and other regulatory agencies to review the full results and analyses as they become available."

Pfizer's study has also raised safety issues for other JAK inhibitors -- Lily's Olumiant and Abbvie's Rinvoq.

All JAK inhibitors publish boxed warnings regarding the occurrence of this blood clot on their product labels.

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Safety debate reignited over Pfizer's arthritis treatment Xeljanz - Korea Biomedical Review

Both Dr. Lisbet Haglund and Shawn Robbins have earned operating grants worth approximately $300,000 over three years

Dr. Lisbet Haglund and Shawn Robbins have both been awarded strategic operating grants from the Arthritis Society. These grants provide funding for projects that have great potential for improving the diagnosis, prevention and treatment of arthritis.

Both researchers are working on projects related to osteoarthritis. Dr. Haglund, Associate Professor of Surgery, Faculty of Medicine and Health Sciences, is studying therapies that may lead to the first disease-modifying drugs for osteoarthritis of the spine. Robbins, Associate Professor, School of Physical and Occupational Therapy, is conducting a randomized clinical trial aimed at identifying the most effective knee implants for patients with osteoarthritis.

These researchers and these projects hold great promise for the future of arthritis diagnosis, care and prevention, says Dr. SinBevan, Chief Science Officer at the Arthritis Society. We look forward to how this important work will help us solve the unanswered challenges of arthritis.

In 2019-20, the Arthritis Society committed over $4.5million to arthritis research and the development of researchers and clinicians.

Dr. Haglunds project, Senolytic drugs to treat back pain from spine OA, received $300,000 in funding over three years.

World-wide, low back pain due to osteoarthritis (OA) of the spine is the single largest cause of years lived with disability. Current treatments like physiotherapy or medication may reduce pain and slow degeneration of the intervertebral discs in the spine but do not stop the progression of the disease. Senolytic therapy destroys senescent (or arrested) cells that cause inflammation in old tissues, leading to rejuvenation and slower progression of many age-related conditions. Dr. Lisbet Haglund will study two promising senolytic therapies, a natural compound, o-Vanillin, and an approved drug, RG-7112. This study may lead to the first disease modifying drugs for low back pain resulting from OA of the spine.

Robbins project is titledThe effectiveness of medial pivot knee arthroplasty implants at improving gait and clinical outcomes in patients with knee osteoarthritis: A randomized controlled trial. It received $298,723 over three years.

Over 67,000 knee replacements are performed annually in Canada for knee arthritis and 20 per cent of patients remain unsatisfied after surgery. New implants have been designed, called medial pivot implants, which claim to more closely mimic normal knee movements. There has been limited testing of these implants, so their effectiveness and safety are not clear. Dr. Shawn Robbins will compare knee movement before and after surgery for walking and stair climbing, pain, and physical function between patients who had medial pivot or traditional knee replacement implants. A better understanding of the most effective knee implants will help to maximize patient outcomes, minimize negative side effects, and decrease demands on the healthcare system.

See the Arthritis Societys competition results page.

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McGill researchers receive grants from Arthritis Society - McGill Reporter - McGill Reporter

In patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure, a combination of filgotinib and MTX significantly improves signs and symptoms and physical function; however, filgotinib monotherapy is not superior to MTX monotherapy in achieving a 20% improvement in American College of Rheumatology criteria (ACR20), according to study results published in Annals of the Rheumatic Diseases.

Previous studies have reported that treatment with small-molecule Janus kinase (JAK) inhibitors, including baricitinib, upadacitinib, and tofacitinib, can significantly improve clinical signs and symptoms of RA and radiographic progression in patients with no prior MTX exposure. However, the safety profile and risk for adverse events should be considered.

The objective of the current study was to determine the efficacy and safety of JAK-1 inhibitor filgotinib in patients with active RA with limited or no prior MTX exposure.

The 52-week, multicenter, double-blind, phase 3 study (FINCH 3; ClinicalTrials.gov Identifier: NCT02886728) included 1252 patients with RA (mean age, 53 years, 77% women) who were randomly assigned to receive 2:1:1:2 filgotinib 200 mg with MTX (n=416), filgotinib 100 mg with MTX (n=207), filgotinib 200 mg monotherapy (n=210), or MTX monotherapy (n=416), respectively.

The primary study outcome was percentage of patients achieving ACR20 at week 24.

At week 24, compared with 71% of patients who received MTX only, 81% who received filgotinib 200 mg with MTX and 80% who received filgotinib 100 mg with MTX achieved an ACR20 response (P <.001 and P =.017, respectively). A total of 78% of patients who received filgotinib 200 mg monotherapy achieved an ACR20 response, which was not significantly different from those who received MTX monotherapy (71%; P =.058).

Researchers noted a significant improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) at week 24; the least-squares mean of the treatment difference in change in HAQ-DI from baseline vs MTX was -0.20 (95% CI, -0.27 to -0.12; P <.001) and -0.13 (95% CI, -0.23 to -0.03; P =.008) for filgotinib 200 mg with MTX and filgotinib 100 mg with MTX, respectively.

The percentage of patients who achieved 28-joint Disease Activity Score with C-reactive protein less than 2.6 was significantly higher for patients who received filgotinib 200 mg with MTX (54%) and filgotinib 100 mg with MTX (43%), compared with patients who received MTX monotherapy (29%; P <.001 for both) at week 24.

Overall, both filgotinib doses were well tolerated with an acceptable safety profile. Adverse event rates through week 52 were comparable between all treatments.

The study had several limitations, including the inability to adjust for MTX dose due to the study design, lack of a placebo group, and low progression rate of structural damage that compromised the ability to demonstrate a benefit between the filgotinib arms compared to MTX.

Filgotinib in combination with MTX could be considered as a treatment option for patients with moderately or severely active [RA] who have limited or no previous exposure to MTX, the researchers concluded.

Disclosure: This clinical trial was supported by Gilead Sciences. Please see the original reference for a full list of authors disclosures.

Westhovens R, Rigby WFC, van der Heijde D, et al. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. Published online January 15, 2021. doi:10.1136/annrheumdis-2020-219213

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Assessing the Safety and Efficacy of Filgotinib in Combination With Methotrexate or as Monotherapy in RA - Rheumatology Advisor