Positive topline data were announced from the phase 3 SELECT-PsA 1 study of upadacitinib, a Janus Kinase (JAK) inhibitor, in adult patients with active psoriatic arthritis who have had an inadequate response to at least 1 nonbiologic disease modifying antirheumatic drug (DMARD).
The phase 3, multicenter, double-blind study compared the efficacy and safety of upadacitinib with placebo and adalimumab. Patients were randomized to receive upadacitinib 15mg or 30mg once daily, adalimumab 40mg every 2 weeks, or placebo followed by either upadacitinib 15mg or 30mg at week 24. The primary end point was the proportion of patients who achieved an American College of Rheumatology (ACR) 20 response at week 12.
Results showed that both doses of upadacitinib achieved noninferiority at week 12 compared with adalimumab, with the 30mg dose showing superiority. Patients treated with upadacitinib 15mg and 30mg achieved the following statistically significant ACR responses at week 12 vs placebo:
Additionally, upadacitinib 15mg and 30mg were associated with statistically significant improvements for key secondary end points including:
Both doses of upadacitinib also showed significant inhibition of radiographic progression, as measured by the change from baseline in modified PsA Sharp/van der Heijde Score, compared with placebo (P