EC moves forward with new PsA treatment

Aug 08, 2018, 3:56pm

In June, the European Commission approved tofacitinib citrate (Xeljanz/Pfizer) 5 mg twice daily in combination with methotrexate for adults with psoriatic arthritis. Learn about the parameters here.

In June, the European Commission approved tofacitinib citrate (Xeljanz/Pfizer) 5 mg twice daily in combination with methotrexate for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

Tofacitinib citrate is the first and only oral Janus kinase (JAK) inhibitor to be approved in the European Union for adults with active PsA.

The approval was based on the results of a phase three trial called the "Oral Psoriatic Arthritis Trials (OPAL)" which included two trials:  OPAL Broaden and OPAL Beyond. Results from the long-term extension trial OPAL Balance were also considered.