Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial.

BACKGROUND: Effective, well-tolerated oral psoriasis treatments are needed.

OBJECTIVE: To compare the efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor (TYK2), versus placebo and apremilast in adults with moderate to severe plaque psoriasis.

METHODS: Participants were randomized 2:1:1 to deucravacitinib 6 mg QD (n=332), placebo (n=166), or apremilast 30 mg BID (n=168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). Coprimary endpoints included response rates for ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) with deucravacitinib versus placebo at Week 16.

RESULTS: At Week 16, response rates were significantly higher with deucravacitinib versus placebo or apremilast for PASI 75 (194 [58.4%] vs 21 [12.7%] vs 59 [35.1%]; P < 0.0001) and sPGA 0/1 (178 [53.6%] vs 12 [7.2%] vs 54 [32.1%]; P < 0.0001). Efficacy improved beyond Week 16 and was maintained through Week 52. Adverse event rates with deucravacitinib were similar to those with placebo and apremilast.

LIMITATIONS: One-year duration, limited racial diversity.

CONCLUSION: Deucravacitinib was superior to placebo and apremilast across multiple efficacy endpoints and was well tolerated in moderate to severe psoriasis.