Recently, The US Food and Drug Administration (FDA) has approved tofacitinib for the management of adults with active psoriatic arthritis (PsA) who have failed to respond adequately or are intolerant to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). Tofacitinib is a selective oral Janus kinase (JAK) inhibitor which alters signalling of several cytokines involved in immune response. In 2012, it was first approved by the FDA for adults with moderately to severely active rheumatoid arthritis (RA) who have not responded adequately to, or are intolerant of, methotrexate.
Approval study details The FDA approval was based on data collected from the phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which mainly consisted of two studies, OPAL Broaden and OPAL Beyond. The results of both the studies demonstrated statistically significant…
