Phase 3 Trial Results of Deucravacitinib in Psoriatic Arthritis Save

Bristol Myers Squibb announced recently the results from POETYK PsA-1 and POETYK PsA-2, Phase 3 trials pivotal trials of deucravacitinib (DEUC) in adults with active psoriatic arthritis (PsA). Both trials met their primary endpoint, demonstrating ACR20 efficacy after 16 weeks of treatment with DEUC compared with placebo.

Deucravacitinib (Sotyktu) was FDA approved in September 2022 for use in moderate-to-severe plaque psoriasis in adults: While phase 2 studies have been done in PsA, DEUC is not currently FDA approved for use in PsA. DEUC is a selective, tyrosine kinase 2 (TYK2) inhibitor.

The reported Phase 3 trials in active PsA patients were multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults with active PsA.  The POETYK PsA-1 enrolled 670 PsA patients not previously treated with a biologic DMARD (bDMARD naïve). By contrast the POETYK PsA-2 study enrolled 730 PsA patients either bDMARD naïve or had previously received TNFα inhibitor. Both 52-week trials were placebo-controlled through Week 16, followed by a reallocation and continued active treatment to Week 52. POETYK PsA-2 also included an apremilast safety reference arm.

The primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Important secondary endpoints were also assessed at Week 16 across measures of PsA disease activity.

Both POETYK PsA-1 and POETYK PsA-2 trials met primary and secondary at Week 16. 

The overall safety signals observed through 16 weeks were consistent with the established safety profile of DEUC in previous clinical trials.

Full results of these trials will be reported at upcoming medical congresses.