The FDA approved secukinumab (Cosentyx) this past week for the treatment of adults with active ankylosing spondylitis and active psoriatic arthritis. These two new approvals are based on the safety and efficacy outcomes from four placebo-controlled Phase 3 trials in more than 1,500 adults with AS or PsA…
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FDA Approves New Drugs for Pain
FDA Updates Belbuca, buccal-administered buprenorphine, has received U.S. Food and Drug Administration (FDA) approval for treating severe chronic pain.1 The dosage form is a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. It’s expected to be commercially available in the first quarter of 2016. Seven dosage strengths…
Biosimilars Seek Regulatory Approval in the U.S. & Europe; Plus MTX Underused in the U.S.
In Europe, an etanercept biosimilar is getting closer to being approved to treat RA and more, and in the U.S., an application for an adalimumab biosimilar has been submitted for FDA approval. Also, an analysis of methotrexate use in the U.S. shows that therapy may actually be underused for RA…
Case Report: Sternoclavicular Erosions in a Patient with Uncontrolled RA
Sternoclavicular joint involvement has rarely been reported in the context of active rheumatoid arthritis (RA).1 Traditionally, rheumatologists use serial radiographs of hands and feet to diagnose, monitor for progression or evaluate the response to treatment. The sternoclavicular (SC) joint is not a typical joint assessed for RA. However, the fact that it is a diarthrodial…
New SLE Drug May Allow Patients to Reduce Steroid Use
In a recent study, the use of anifrolumab in SLE patients was shown to be safe and effective, enabling some patients to decrease their oral steroids. Also, secukinumab has been approved in Europe to treat ankylosing spondylitis and psoriatic arthritis…
The ACR/ARHP Awards Members for Contributions to Rheumatology
San Francisco is known for the Gold Rush, so it’s a particularly fitting place to collect a gold nugget. And so at the 2015 ACR/ARHP Annual Meeting in the Golden Gate City in November, the ACR and the ARHP honored a group of distinguished individuals who have made significant contributions to rheumatology research, education and…
Anti-TNF-Associated Skin Lesions Common in Inflammatory Bowel Disease
NEW YORK (Reuters Health)—Patients with inflammatory bowel disease (IBD) commonly develop skin lesions related to anti-tumor necrosis factor (anti-TNF) medications, according to a retrospective study. “We were most surprised by the relatively high percentage (30%) of patients developing skin problems while being treated with anti-TNF agents,” Dr. Isabelle Cleynen from KU Leuven, Belgium, tells Reuters…
Etanercept Biosimilars Promising in Clinical Studies
In multiple clinical studies, investigational biosimilars for etanercept were shown to be safe and effective for treating rheumatoid arthritis and moderate to severe plaque psoriasis…
Amgen Files for U.S. Approval of Biosimilar
(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…
Rheumatology Drug Updates on Brentuximab Vedotin, Tofacitinib Citrate
Brentuximab Vedotin Enters Phase 2 Trials Brentuximab vedotin (Adcetris), an antibody-drug conjugate (ADC) directed at CD30, is currently entering Phase 2 clinical trials for treating systemic lupus erythematosus (SLE).1 The ADC encompasses an anti-CD30 monoclonal antibody, which is attached by a protease-cleavable linker to a microtubule-disrupting agent, known as monomethyl auristatin E (MMAE). The ADC…
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