Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: 52-week efficacy by prior treatment in the phase 3 POETYK PSO-1 trial

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Jerry Bagel
April W. Armstrong
Richard B. Warren
Kim A. Papp
Diamant Thaçi
Alan Menter
Jennifer Cather
Matthias Augustin
Lauren Hippeli
Carolin Daamen
Christopher EM Griffiths

Keywords

psoriasis, deucravacitinib, tyrosine kinase 2, phase 3 clinical trial, efficacy

Abstract

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.

References

1. SOTYKTU™ (deucravacitinib) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; September 2022.

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4. Armstrong AW, et al. J Am Acad Dermatol. 2023;88:29-39.

5. Warren RB, et al. Presented at the 30th EADV Congress, September 29–October 2, 2021. Late breaker.

6. Warren RB, et al. Presented at the 30th EADV Congress, September 29–October 2, 2021.

7. Warren RB, et al. Presented at the EADV Spring Symposium; May 12–14, 2022.

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