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Search results for: tofacitinib

FDA Declines to Expand Approval of Pfizer Arthritis Drug Xeljanz

Reuters Staff  |  

(Reuters)—U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz (tofacitinib) to treat moderate to severe cases of plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must be addressed in order…

FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning

Michele B. Kaufman, PharmD, CGP, RPh  |  

The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due to a continual review of these products, FDA is requiring label updates for all prescription NSAIDs. Over-the-counter (OTC) NSAIDs already list the increased risk of MI and…

Engaging Patients to Enhance Rheumatology Research

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It takes a great deal of time and money to produce clinical practice guidelines for rheumatic diseases. No matter how well a treatment inhibits inflammatory cytokines, it won’t lower disease activity without one essential factor: patient compliance. “You can’t propose a treatment algorithm in your research that no patient would actually use,” says Veena Ranganath,…

EULAR 2015: Biology of Fatigue Rooted in Genes, Cytokines, Free Radicals

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ROME, Italy—Fatigue, a problem experienced frequently by patients with rheumatic diseases, is best thought of as a survival mechanism and as a single phenomenon, not a condition that comes in a variety of forms, an expert said in a session at EULAR 2015, the annual congress of the European League Against Rheumatism (EULAR). Gene Regulated…

The ACR’s State-of-the-Art Clinical Symposium: Patients with Scleroderma, Lung Disease May Benefit from Aggressive Therapy

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CHICAGO—Scleroderma patients with pulmonary arterial hypertension (PAH) might benefit from more aggressive therapy, an expert in the field said in a session on lung involvement in rheumatic diseases at the American College of Rheumatology’s 2015 State-of-the-Art Clinical Symposium in May. Newer trials—the SERAPHIN trial on macitentan, GRIPHON on selexipag, and AMBITION on an ambrisentan/tadalafil combination—show…

The ACR’s State-of-the-Art Clinical Symposium: Rheumatologists Weigh in on Tough-to-Treat Cases, Paget’s Disease, Imaging

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CHICAGO—A 49-year-old woman has had RA for eight years. She has a rheumatoid factor reading of 35, an aCCP reading of 160, erythrocyte sedimentation rate of 42, plus erosions. She has been on methotrexate. She tried etanercept for six months, but then it stopped working. She was on 40 mg of adalimumab weekly, but it…

The ACR’s State-of-the-Art Clinical Symposium: Experts Discuss Jakinibs, Osteoarthritis, Membranous Lupus Nephritis

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CHICAGO—With the approval of the Jak inhibitors (i.e., jakinibs) tofacitinib and ruxolitinib—and others being investigated—rheumatologists need to arm themselves with an understanding of these drugs so they can think critically when evaluating them and deciding how to use them, said John O’Shea, MD, chief of the Molecular Immunology and Inflammation Branch of and scientific director…