European regulators are allowing use of Xeljanz (tofacitinib citrate) 5mg twice daily in combination with methotrexate for to treat active 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 decision gives patients the opportunity to access a new treatment approach, as the drug is the first and only oral Janus kinase (JAK) inhibitor to be approved in EU for the condition, which affects between 1.5 and 3 million people in the region.
Approval came on the back of data from the Phase III Oral Psoriatic Arthritis TriaLs (OPAL) clinical development programme, which demonstrated 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 OPAL Broaden, 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 OPAL Beyond, 50 percent of patients achieved an ACR20 response with Xeljanz 5mg twice daily compared to 24 percent of those given a placebo.
Pfizer also noted that in both studies, statistically significant improvements in ACR20 response were recorded in the treatment arm versus placebo at week two, thereby meeting a secondary endpoint.
"This approval for Xelzanz is an important milestone for the psoriatic arthritis community, who are in need of an additional oral treatment option to help manage their condition," commented Frank Behrens, Rheumatology at Goethe University and Fraunhofer IME-Translational Medicine & Pharmacology, Frankfurt, Germany.
Xeljanz was initially approved in Europe as a treatment for rheumatoid arthritis in March last year.