EULAR has updated its recommendations for the management of early arthritis, outlining aspects of diagnosis and drug treatments…
Rheumatology Drug Updates: Giant Cell Arteritis Relapse Possible if Tocilizumab Discontinued; Plus Updates on Rituximab, Etanercept
GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab…
FDA Releases Biosimilar Guidance, Medicare Will Cover Infliximab-dyyb & More
The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…
FDA Update: FX006 Promising for Knee OA; Pioglitazone Linked to Bladder Cancer Risk; & HIV Drug Gets New Labeling
The makers of FX006, a steroid injection for treating pain in patients with knee osteoarthritis, have submitted a new drug application to the FDA…
Rheumatology Drug Updates: Celecoxib and Cardiovascular Safety Trial Results Reviewed
Nonsteroidal anti-inflammatory drugs (NSAIDs) have been used therapeutically since the 1960s.1 Evidence of adverse cardiovascular outcomes led to the withdrawal of the selective COX-2 inhibitor rofecoxib in September 2004, when the question of cardiovascular safety of NSAIDs first came into the limelight.2 Valdecoxib (Bextra) was subsequently withdrawn from the market in April 2005 due to…
Trump Considering Dr. Scott Gottlieb to Head U.S. FDA
(Reuters)—Dr. Scott Gottlieb, a partner at one of the world’s largest venture capital funds and a former deputy commissioner at the U.S. Food and Drug Administration, is being considered by President-Elect Donald Trump to run the agency, according to sources close to the transition team. Gottlieb, 44, a venture partner at New Enterprise Associates and…
Celecoxib & Cardiovascular Death: NSAID Safety Under Review
A recent study showed that at moderate doses celecoxib may be noninferior with respect to cardiovascular safety compared with ibuprofen or naproxen…
FDA Update on Rituximab & Etanercept; Plus New ACP Gout Guideline
The FDA is considering an application for subcutaneous rituximab and has approved an application for etanercept to treat pediatric patients with plaque psoriasis…
Second Biosimilar Equivalent to Adalimumab
A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…
Many Patients Discontinue Tofacitinib by Year 1; Fasinumab Promising for Pain
A recent analysis found that about 10% of RA patients taking tofacitinib do not follow recommended guidelines and more than half stop treatment by one year…
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