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FDA Approves Expanded Use of Enbrel (etanercept) to Treat Children with Chronic Moderate-To-Severe Plaque Psoriasis

Posted 13 Nov 2016 by Drugs.com

THOUSAND OAKS, Calif., Nov. 4, 2016 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of Enbrel (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis. "As many parents of children with moderate-to-severe plaque psoriasis can tell you, there is a need for FDA approved systemic therapies in the pediatric setting. Until now, no biologics — which are effective in treating adults with moderate-to-severe plaque psoriasis — had been approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in children," said Randy Beranek, president and chief executive officer of the National Psoriasis Foundation. "This new approval is an important dev ... Read more

Related support groups: Psoriasis, Enbrel, Plaque Psoriasis, Etanercept

FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel

Posted 1 Sep 2016 by Drugs.com

August 30, 2016 – The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. Erelzi is administered by injection for the treatment of: moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX); moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older; active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone; active ankylosing spondylitis (an arthritis that affects the spine); and chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy. Health care professionals should review the prescribing ... Read more

Related support groups: Rheumatoid Arthritis, Enbrel, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Juvenile Idiopathic Arthritis, Etanercept, Erelzi

FDA Approves New Biological Drug for Rheumatoid Arthritis

Posted 31 Aug 2016 by Drugs.com

WEDNESDAY, Aug. 31, 2016 – A new biological drug to treat rheumatoid arthritis and other inflammatory diseases has been approved by the U.S. Food and Drug Administration. The drug Erelzi (etanercept-szzs) is a "biosimilar" to Enbrel (etanercept), which was approved by the FDA in 1998. A biosimilar is a biological product approved on findings that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness, according to the FDA. It is similar to generic drugs in that it typically costs less than the original biological product. Biological products are typically derived from a living organism and include many sources, including humans, animals, microorganisms or yeast. "The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases," ... Read more

Related support groups: Rheumatoid Arthritis, Enbrel, Juvenile Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Still's Disease, Etanercept, Rheumatoid Lung, Erelzi, Felty's Syndrome

New Treatments Helping Kids With Juvenile Arthritis

Posted 20 Jul 2016 by Drugs.com

WEDNESDAY, July 20, 2016 – New treatments for juvenile arthritis offer hope to children with the chronic autoimmune condition, doctors say. Scientists are still working to understand what causes juvenile arthritis and how to stop its progression. But, kids coping with its effects have reason to be optimistic, according to Dr. Nikolay Nikolov, a rheumatologist and clinical team leader at the U.S. Food and Drug Administration. "We don't have a cure for juvenile arthritis – we're not there yet," Nikolov said in an FDA news release. "But we're making progress." But it's important to note that the drugs aren't risk-free. Juvenile arthritis is one of the most common chronic childhood conditions, affecting nearly 300,000 children in the United States, according to the FDA. The disease causes the immune system to attack its own tissues, resulting in pain, swelling, tenderness and stiffness in ... Read more

Related support groups: Rheumatoid Arthritis, Aspirin, Ibuprofen, Humira, Advil, Enbrel, Motrin, Excedrin, Alka-Seltzer, Vicoprofen, Aggrenox, Orencia, Fiorinal, Juvenile Rheumatoid Arthritis, Actemra, Excedrin Migraine, Advil PM, Ecotrin, Advil Cold and Sinus, Arthritis Pain

Gene Discoveries Could Help Rheumatoid Arthritis Treatment

Posted 28 Apr 2015 by Drugs.com

TUESDAY, April 28, 2015 – Genetic variations may hold clues to rheumatoid arthritis – suggesting not only who will develop the painful condition, but also predicting its severity and even who might die from it, a new study says. "Genetic factors predisposing to disease, to disease severity, and response to treatment will allow tailoring treatment to individual patients' needs," said lead researcher Dr. Sebastien Viatte, a research fellow at the University of Manchester in England. Using data from several sources on thousands of patients in the United Kingdom, researchers found that gene mutations at a location on a chromosome called HLA-DRBl were associated with rheumatoid arthritis severity and the response to treatment with tumor necrosis factor (TNF) inhibitor drugs. This study, Viatte said, is a potentially important first step toward personalized medicine for patients with the ... Read more

Related support groups: Rheumatoid Arthritis, Methotrexate, Humira, Enbrel, Remicade, Plaquenil, Hydroxychloroquine, Rituxan, Otezla, Imuran, Orencia, Rituximab, Simponi, Leflunomide, Cimzia, Arava, Juvenile Rheumatoid Arthritis, Azathioprine, Xeljanz, Infliximab

Some Arthritis Meds Cost Seniors Thousands Annually

Posted 21 Apr 2015 by Drugs.com

TUESDAY, April 21, 2015 – Arthritis medications known as biologic disease-modifying drugs can cost Medicare patients more than $2,700 in co-payments a year, a new report finds. Researchers say the tab is an immense burden on patients with disabling conditions such as rheumatoid arthritis, a chronic disorder that affects an estimated 1.3 million Americans. Biologic anti-rheumatic medications – which include drugs such as adalimumab (Humira), anakinra (Kineret) and etanercept (Enbrel) – have allowed patients to gain better control of rheumatoid arthritis when taken early in the course of disease, the researchers explained. But some of the new drugs top $20,000 annually, according to the April 21 online report in the journal Arthritis & Rheumatology. "Many patients face a growing and unacceptable financial burden for access to treatment," said study lead author Dr. Jinoos Yazdany of the ... Read more

Related support groups: Rheumatoid Arthritis, Methotrexate, Humira, Enbrel, Remicade, Plaquenil, Hydroxychloroquine, Rituxan, Otezla, Imuran, Rituximab, Orencia, Leflunomide, Arava, Azathioprine, Xeljanz, Infliximab, Adalimumab, Etanercept, Apremilast

Smokers May Get Less Benefit From Drugs for Arthritic Back Pain

Posted 10 Feb 2015 by Drugs.com

TUESDAY, Feb. 10, 2015 – Smoking may hamper the effects of certain drugs used to treat inflammatory arthritis in the lower back, a new study from Switzerland says. Researchers from University Hospital Zurich looked at how 700 people with this type of arthritis responded to treatment with a class of drugs called tumor necrosis factor (TNF) inhibitors. About two-thirds of the patients were smokers. After one to two years of treatment, the drugs were significantly less effective in smokers. The difference was particularly apparent among patients who had higher levels of an inflammatory marker called C-reactive protein at the start of the study. Former smokers did not experience reduced effectiveness from the drugs, according to the study. The research only saw an association between smoking and the drugs' benefits, not a cause-and-effect relationship. The results were published online ... Read more

Related support groups: Back Pain, Rheumatoid Arthritis, Smoking, Humira, Enbrel, Remicade, Simponi, Cimzia, Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab

Lower Doses of Rheumatoid Arthritis Drugs May Work for Some

Posted 5 Nov 2014 by Drugs.com

WEDNESDAY, Nov. 5, 2014 – Some people in the early stages of rheumatoid arthritis may be able to safely lower their medication doses once their symptoms are well under control, a new study suggests. In a clinical trial, British researchers found that many patients were able to remain in remission for months after their doctors lowered their doses of the drugs methotrexate and Enbrel (etanercept). What's more, some continued to do well when they were taken off the drugs altogether, the researchers said in the Nov. 6 issue of the New England Journal of Medicine. The findings suggest it's "reasonable" to lower, or even stop, certain patients' medication doses, wrote the researchers, led by Dr. Paul Emery of the University of Leeds. But experts not involved in the study stressed that there are some big unknowns. For one, it's not clear which patients would likely do well if their drug ... Read more

Related support groups: Rheumatoid Arthritis, Methotrexate, Enbrel, Etanercept, Methotrexate LPF Sodium, Trexall, Folex PFS, Rheumatrex Dose Pack, Rasuvo, Otrexup

Certain Autoimmune Drugs in Pregnancy May Up Newborn Infection Risk: Study

Posted 3 Oct 2014 by Drugs.com

FRIDAY, Oct. 3, 2014 – When given to pregnant women, a common treatment for ulcerative colitis may inadvertently lower their baby's ability to fight off infections at birth, new French research suggests. The treatment, called anti-TNF therapy, is an injected, artificial antibody. This type of medication is widely seen as a safe and effective way to tackle a wide range of autoimmune disorders, such as rheumatoid arthritis and inflammatory bowel conditions that include ulcerative colitis and Crohn's disease. It's not unusual for pregnant women to receive the treatment, given that inflammatory bowel diseases often strike women of childbearing age. However, this type of drug can cross the placenta and reach the fetus, the study authors said. And four French cases – all involving babies born to women exposed to Remicade (infliximab) during pregnancy – suggest the therapy may cause newborn ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Enbrel, Crohn's Disease, Remicade, Ulcerative Colitis, Inflammatory Bowel Disease, Simponi, Cimzia, Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab

Many Rheumatoid Arthritis Patients May Skip Meds: Study

Posted 3 Sep 2014 by Drugs.com

WEDNESDAY, Sept. 3, 2014 – Many patients with severe rheumatoid arthritis don't take their expensive medications as prescribed, a new British study finds. Failure to take the drugs correctly reduces their effectiveness and may lead to a worsening of symptoms, warned researchers from the University of Manchester. Rheumatoid arthritis develops when your immune system begins to attack itself, and symptoms include inflammation, pain and swelling in the joints and internal organs. The study included 286 patients who had rheumatoid arthritis for seven years and had been prescribed anti-TNF drugs, which cost about $13,000 to $20,000 a year per patient. Anti-TNF drugs include etanercept (Enbrel), adalimumab (Humira) and golimumab (Simponi). Twenty-seven percent of the patients said they didn't take the medications as directed at least once over the first six months after being prescribed the ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Enbrel, Simponi, Adalimumab, Etanercept, Golimumab

Popular Crohn's, Colitis Drugs Not Linked to Short-Term Cancer Risk: Study

Posted 18 Jun 2014 by Drugs.com

WEDNESDAY, June 18, 2014 – A popular class of drugs used to treat inflammatory bowel disease isn't linked to an increase in the short-term risk of cancer, Danish researchers report. Researchers found that people with Crohn's disease or colitis who received the drugs – tumor necrosis factor alpha (TNF-a) antagonists – had about the same risk of cancer as other people with these inflammatory bowel diseases who were not treated with the medication. The drugs work by interrupting the function of TNF-a, a substance used by the immune system to increase inflammation. "Treatment with these drugs inhibits the inflammatory response in the gastrointestinal tract thereby leading to reduced symptoms," said lead author Dr. Nynne Nyboe Andersen of the Statens Serum Institute in Copenhagen. The problem is that TNF-a also serves a key role in protecting the body against cancer, raising concerns that ... Read more

Related support groups: Humira, Enbrel, Crohn's Disease, Remicade, Ulcerative Colitis, Colorectal Cancer, Inflammatory Bowel Disease, Simponi, Cimzia, Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab

Certain Rheumatoid Arthritis Drugs May Also Protect Patients' Hearts, Studies Find

Posted 27 Oct 2013 by Drugs.com

SATURDAY, Oct. 26 – Drugs that people with rheumatoid arthritis use to help ease the symptoms of the disease might also help ward off heart trouble, two new studies find. Researchers in Sweden found that so-called "biologic" drugs, known as tumor necrosis factor inhibitors, or anti-TNFs, slightly reduce the risk for acute coronary syndrome – a condition that includes angina and heart attack in which blood supply to the heart muscle is suddenly blocked. In another study, British scientists also found taking these drugs was associated with a lower risk for heart attack in patients with rheumatoid arthritis. The findings were to be presented Saturday at the American College of Rheumatology's annual meeting in San Diego. Findings presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal. The roughly 1.3 million Americans affected by the ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Enbrel, Remicade, Simponi, Cimzia, Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab

Rheumatoid Arthritis Treatment May Not Work As Well for Heavier Patients

Posted 18 Jun 2013 by Drugs.com

TUESDAY, June 18 – Overweight and obese people with rheumatoid arthritis are less likely to go into remission in the early stages of the disease and require much more drug treatment than people with normal weight, according to a new study. The study included nearly 350 people with early rheumatoid arthritis (RA) who underwent a treatment meant to achieve remission of their disease. The strategy included strict follow-up visits, as well as treatment with steroids and the drug methotrexate, combined with anti-tumor necrosis factor (anti-TNF) therapy if a good response didn't occur. Anti-TNF drugs are used to reduce inflammation in a variety of conditions. At six and 12 months of follow-up, overweight and obese patients had lower rates of remission. After 12 months, a higher percentage of overweight and obese patients were still on anti-TNF therapy, compared to normal-weight patients. The ... Read more

Related support groups: Obesity, Rheumatoid Arthritis, Methotrexate, Humira, Enbrel, Remicade, Simponi, Cimzia, Infliximab, Adalimumab, Etanercept, Golimumab, Trexall, Certolizumab, Methotrexate LPF Sodium, Folex PFS, Rheumatrex Dose Pack

Many Stop Taking Rheumatoid Arthritis Meds Too Soon: Study

Posted 14 Jun 2013 by Drugs.com

FRIDAY, June 14 – About half of rheumatoid arthritis patients stopped taking their medications within two years after they started them, a new study finds. Rheumatoid arthritis affects about one in 100 people worldwide and can cause progressive joint destruction, deformity, pain and stiffness. The disease can reduce physical function, quality of life and life expectancy. The main reason about one-third of patients discontinued their medications was because the drugs lost their effectiveness, the study authors found. Other reasons included safety concerns (20 percent), doctor preference (nearly 28 percent), patient preference (about 18 percent) and access to treatment (9 percent), according to the study results, which were presented Thursday at the annual meeting of the European League Against Rheumatism (EULAR), in Madrid, Spain. Rheumatoid arthritis "is a progressive disease, which, ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Enbrel, Remicade, Simponi, Cimzia, Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab

Standard Rheumatoid Arthritis Therapy as Good as Costlier Newcomer: Study

Posted 12 Jun 2013 by Drugs.com

TUESDAY, June 11 – Newer, costlier treatment for rheumatoid arthritis appears no better than an older, less-expensive regimen for people who don't respond to the first-line drug methotrexate, a new study suggests. "Newer isn't always better," said researcher Dr. Ted Mikuls, an associate professor in the rheumatology division at the University of Nebraska Medical Center, in Omaha. "Some of the older medications can be effective." Rheumatoid arthritis causes inflammation in the joints, resulting in swelling, stiffness, pain and reduced joint function. It can also affect other parts of the body. "We compared two different ways of treating rheumatoid arthritis – one that included a new biologic [medication] with an older, more conventional oral medication," Mikuls explained. "We basically showed that at the end of the day patients, regardless of what they got, looked very similar in terms ... Read more

Related support groups: Rheumatoid Arthritis, Methotrexate, Enbrel, Plaquenil, Hydroxychloroquine, Sulfasalazine, Azulfidine, Etanercept, Sulfazine, Trexall, Methotrexate LPF Sodium, Azulfidine EN-tabs, Folex PFS, Quineprox, Plaquenil Sulfate, Rheumatrex Dose Pack

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