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psoriasis, deucravacitinib, tyrosine kinase 2, phase 3 clinical trial, efficacy
Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved by the US FDA for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Deucravacitinib was significantly more efficacious than placebo or apremilast and was well tolerated in previous reports from the phase 3 POETYK PSO-1 trial. Here, we examined response rates through Week 52 from this trial in subgroups defined by previous biologic, systemic (biologic/nonbiologic), and/or oral systemic treatment.
Methods: PSO-1, a multicenter, double-blind trial, enrolled adults with moderate to severe plaque psoriasis. Patients with previous phototherapy, systemic treatment, and/or biologic treatment completed washout periods (4 weeks–6 months) before study entry, depending on treatment. Patients were randomized 2:1:1 to deucravacitinib 6 mg QD, placebo, or apremilast 30 mg BID; this analysis focused on deucravacitinib and placebo patients. Placebo patients switched to deucravacitinib at Week 16. PASI 75 and sPGA 0/1 were evaluated through Week 52 by prior treatment (biologic, systemic [biologic/nonbiologic], oral systemic) and by biologic- and systemic-naive patients. Nonresponder imputation was used for all reported endpoints.
Results: 332 patients were randomized to deucravacitinib and 166 to placebo. At baseline, 34.3% of deucravacitinib patients and 44.0% of placebo patients received prior oral systemic treatment, 60.2% and 65.7% received prior systemic (biologic/nonbiologic) treatment, and 39.2% and 38.0% received prior biologic treatment, respectively. Week 52 PASI 75 response rates were similar in patients receiving deucravacitinib from baseline (65.1%) and placebo patients switching to deucravacitinib at Week 16 (68.3%). Findings with deucravacitinib were similar to those in placebo patients switching to deucravacitinib regardless of prior systemic (65.5%/68.1%), oral (70.2%/69.2%), or biologic (61.5%/61.8%) treatment, and in patients with no prior systemic (64.4%/68.6%) or biologic (67.3%/72.2%) treatment. Similarly, sPGA 0/1 response rates were comparable in deucravacitinib versus placebo patients in the overall population (52.7%/53.8%) and in the prior systemic (53.0%/55.3%), prior oral systemic (57.0%/53.8%), prior biologic (47.7%/45.5%), systemic-naive (52.3%/51.0%), and biologic-naive (55.9%/58.9%) cohorts.
Conclusion: Deucravacitinib was effective through 52 weeks for moderate to severe plaque psoriasis regardless of previous systemic treatment. Placebo patients switching to deucravacitinib at Week 16 achieved PASI 75 and sPGA 0/1 similar to patients continuously treated with deucravacitinib.
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