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FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira

Posted 30 Aug 2017 by Drugs.com

Ridgefield, Conn., August 29, 2017 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo, a biosimilar to Humira, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including: moderate to severe active rheumatoid arthritis moderate to severe polyarticular juvenile idiopathic arthritis** active psoriatic arthritis active ankylosing spondylitis (an arthritis that affects the spine) moderate to severe active adult Crohn’s disease moderate to severe active ulcerative colitis moderate to severe plaque psoriasis “Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, Senior Vice President and Head of The ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Psoriasis, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Active, Crohn's Disease - Acute, Juvenile Rheumatoid Arthritis, Ulcerative Colitis - Maintenance, Juvenile Idiopathic Arthritis, Humira Pen, Adalimumab, Amjevita, Cyltezo

Early Treatment Equals Better Results for Rheumatoid Arthritis

Posted 25 Apr 2017 by Drugs.com

TUESDAY, April 25, 2017 – Treating rheumatoid arthritis early may make for better outcomes, a new study suggests. Patients who were treated within six months of developing the first signs of the autoimmune disease did better in the long run and were less likely to suffer early death, British researchers found. The findings stem from an analysis of more than 600 patients who were initially diagnosed with rheumatoid arthritis (RA) between 1990 and 1994. They were tracked for over 20 years. Over the study time frame, investigators assessed key symptoms of RA, such as swollen and/or tender joints, and indications of disability. All deaths were also noted. The research team found that patients who started treatment for RA within the first half-year after the first symptoms surfaced tended to have no greater levels of disability over a 20-year period than patients who required no treatment. ... Read more

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

New Meds Make Inroads Against Crohn's Disease

Posted 13 Apr 2017 by Drugs.com

THURSDAY, April 13, 2017 – Fewer Americans with Crohn's disease are ending up in the hospital than in the past, according to a new federal study. Crohn's is a chronic inflammatory bowel disorder that often leads to surgery for most with the disease. Hospitalization rates for Crohn's disease remained stable in the United States between 2003 and 2013. That's a change from a study done from 1998 to 2004 that saw more than 4 percent increases in Crohn's hospitalizations each year, researchers with the U.S. Centers for Disease Control and Prevention said. The stable hospital rates are likely due to the 1998 introduction of a new class of biologic drugs. Examples of these medications used to treat Crohn's disease include: adalimumab (Humira), infliximab (Remicade), certolizumab (Cimzia) and ustekinumab (Stelara), according to the U.S. National Institute of Diabetes and Digestive and Kidney ... Read more

Related support groups: Humira, Crohn's Disease, Remicade, Ulcerative Colitis, Crohn's Disease - Maintenance, Stelara, Inflammatory Bowel Disease, Ulcerative Colitis - Active, Cimzia, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Infliximab, Adalimumab, Inflectra, Amjevita, Certolizumab, Ustekinumab

Could a Germ Link Gum Disease, Rheumatoid Arthritis?

Posted 15 Dec 2016 by Drugs.com

THURSDAY, Dec. 15, 2016 – A specific germ may help explain the long-noticed connection between gum disease and rheumatoid arthritis, a new study suggests. The discovery might also point to the potential origins of the painful joint illness. "If we're right, this will totally change the view of rheumatoid arthritis and treatment of patients," said study co-author Dr. Felipe Andrade. But, Andrade, an associate professor of medicine at the Johns Hopkins University School of Medicine in Baltimore, cautioned that this is "an early finding that needs confirmation by others." Rheumatoid arthritis is a chronic form of arthritis linked to an overactive immune system. It can affect a variety of body systems, not just the joints. The disease affects roughly 1.5 million U.S. adults, according to the U.S. Centers for Disease Control and Prevention. For more than a century, scientists have noticed ... Read more

Related support groups: Rheumatoid Arthritis, Methotrexate, Humira, Oral and Dental Conditions, Enbrel, Remicade, Plaquenil, Hydroxychloroquine, Rituxan, Otezla, Gingivitis, Imuran, Sulfasalazine, Orencia, Rituximab, Arava, Leflunomide, Azathioprine, Juvenile Rheumatoid Arthritis, Xeljanz

Amjevita Approved to Treat Inflammatory Diseases

Posted 27 Sep 2016 by Drugs.com

MONDAY, Sept. 26, 2016 – Amjevita (adalimumab-atto) – a biosimilar drug similar to the popular anti-inflammatory drug Humira – has been approved by the U.S. Food and Drug Administration. Amjevita has been approved for moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis (an arthritis that affects the spine); Crohn's disease; ulcerative colitis; plaque psoriasis and juvenile idiopathic arthritis, the FDA said in a news release. Biological drugs are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast, the FDA said. A biosimilar drug is a biological product that's sanctioned after its maker proves it is "highly similar" to an already-approved biologic drug. The manufacturer of the biosimilar drug must prove that the product has "no clinically meaningful differences" in safety, purity ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Active, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Juvenile Idiopathic Arthritis, Adalimumab, Amjevita

FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira

Posted 26 Sep 2016 by Drugs.com

September 23, 2016 – The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved for the following indications in adult patients: moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate to severe plaque psoriasis. Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. “This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new fr ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Psoriasis, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Maintenance, Adalimumab, Amjevita

Immune-Based Drug May Ease Chronic Eye Condition

Posted 8 Sep 2016 by Drugs.com

WEDNESDAY, Sept. 7, 2016 – People with chronic eye inflammation known as uveitis may be able to keep the condition at bay with the immune-suppressing drug Humira (adalimumab), a new study finds. "Humira doesn't cure uveitis, but it does cause it to become quiet," said lead researcher Dr. Glenn Jaffe. He's a professor of ophthalmology at Duke University School of Medicine in Durham, N.C., and a consultant for Humira's maker, AbbVie. "The hope is while the disease is in a quiet state, the disease activity just burns itself out – but it can also come back," he said. The U.S. Food and Drug Administration approved Humira for the treatment of uveitis in June. The results of the study were published Sept. 8 in the New England Journal of Medicine. The study was funded by AbbVie. Uveitis – a term used to describe a group of inflammatory diseases inside the eye – can cause loss of vision and ... Read more

Related support groups: Prednisone, Eye Conditions, Humira, Methylprednisolone, Prednisolone, Hydrocortisone, Medrol, Cortisone, Triamcinolone, Dexamethasone, Betamethasone, Budesonide, Entocort, Decadron, Solu-Medrol, Entocort EC, Uveitis, Cortef, MethylPREDNISolone Dose Pack, Medrol Dosepak

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, Vicoprofen, Orencia, Aggrenox, Alka-Seltzer, Fiorinal, Excedrin Migraine, Actemra, Arthritis Pain, Juvenile Rheumatoid Arthritis, Advil PM, Advil Cold and Sinus, Juvenile Idiopathic Arthritis

AbbVie's Humira (adalimumab) Receives FDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis

Posted 2 Jul 2016 by Drugs.com

NORTH CHICAGO, Ill., June 30, 2016 /PRNewswire/ – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. Humira is now the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and panuveitis. This approval marks the 10th approved indication for Humira in the United States for immune-mediated diseases. This month, the European Commission also approved Humira in the European Union for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. "We are pleased to ... Read more

Related support groups: Humira, Uveitis, Humira Pen, Adalimumab, Uveitis (Posterior), Panuveitis

FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa

Posted 11 Sep 2015 by Drugs.com

NORTH CHICAGO, Ill., Sept. 10, 2015 /PRNewswire/ – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Humira (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS). Humira is now the first and only FDA-approved therapy for adults with HS. Hidradenitis suppurativa is a chronic inflammatory skin disease characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts.1-2 Earlier this year, the FDA granted Humira orphan drug designation for the treatment of moderate to severe HS (Hurley Stage II and Hurley Stage III disease), a population of fewer than 200,000 patients. The orphan drug designation provides Humira the potential to be granted seven years of market exclusivity for the treatment of moderate to severe HS. ... Read more

Related support groups: Humira, Hidradenitis Suppurativa, Humira Pen, Adalimumab

Experimental Psoriasis Drug Shows Promise

Posted 8 Jul 2015 by Drugs.com

WEDNESDAY, July 8, 2015 – Preliminary trial results suggest that an experimental psoriasis drug may control the chronic skin disease better than the current standard treatment. The drug, guselkumab, was compared to the commonly used medication adalimumab (Humira, Enbrel) in a study involving nearly 300 patients with plaque psoriasis. Up to 86 percent of patients who received guselkumab cleared their psoriasis or had minimal psoriasis after 16 weeks of treatment, compared to 58 percent of patients taking adalimumab, the researchers reported. However, patients getting guselkumab were somewhat more prone to infections, the researchers said. "As a dermatologist, I am particularly excited about the potential of guselkumab and what this investigational therapy may mean for patients and the treatment of moderate to severe plaque psoriasis in the future," said lead researcher Dr. Kristian ... Read more

Related support groups: Humira, Psoriasis, Plaque Psoriasis, Adalimumab

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, Simponi, Rituximab, Cimzia, Arava, Leflunomide, 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, Orencia, Rituximab, Arava, Leflunomide, Azathioprine, Xeljanz, Infliximab, Adalimumab, Kineret, 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

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, Crohn's Disease, Enbrel, Remicade, Ulcerative Colitis, Inflammatory Bowel Disease, Simponi, Cimzia, Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab

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Ankylosing Spondylitis, Hidradenitis Suppurativa, Rheumatoid Arthritis, Crohn's Disease - Maintenance, Crohn's Disease - Acute, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Psoriasis, Behcet's Disease, Spondyloarthritis, Juvenile Idiopathic Arthritis, Plaque Psoriasis, Reiter's Syndrome

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Humira, Cyltezo, Amjevita

Adalimumab Patient Information at Drugs.com