EMA approves Xeljanz for psoriatic arthritis.- Pfizer.

The EMA has approved Xeljanz (tofacitinib), from Pfizer, 5mg twice daily in combination with methotrexate as a treatment for active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug (DMARD) therapy. The approval is based on data from the phase III OPAL studies (OPAL BROADEN, OPAL BEYOND, and the OPAL BALANCE extension trial) which showed statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI) score.

In the OPAL Broaden study, 50 percent of patients taking Xeljanz 5mg twice daily achieved an ACR20 response compared to 33 percent of patients in the placebo arm, while in the OPAL Beyond study, 50 percent of patients achieved an ACR20 response with Xeljanz 5mg twice daily compared to 24 percent of those given a placebo. This new approval gives patients access to the first oral Janus kinase (JAK) inhibitor to be approved in EU for psoriatic arthritis.

Comment: The FDA approved Xeljanz for this indication in April 2018 and the drug was initially approved in Europe as a treatment for rheumatoid arthritis in March 2017.