Here’s a brief overview of agents for rheumatology that have been newly approved or that were granted a new indication.
The FDA has approved Xeljanz and Xeljanz XR (tofacitinib) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs. Xeljanz/Xeljanz XR is the first and only Janus kinase inhibitor with approved indications for both moderate to severe rheumatoid arthritis and active PsA. The FDA approval of tofacitinib for the treatment of adults with active PsA was based on data from the phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of 2 pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance. (Approved 12/14/17, Pfizer Inc.)