Session Type: Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for the treatment of adults with plaque psoriasis; it is currently being investigated in several immune-mediated diseases and has shown efficacy in phase 2 trials for SLE and PsA (NCT03252587 and NCT03881059, respectively). Deucravacitinib was superior to placebo and apremilast in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials in moderate to severe plaque psoriasis. Patients who completed PSO-1 and PSO-2 could enroll in the ongoing POETYK long-term extension (LTE) trial (NCT04036435). Patients treated with continuous deucravacitinib in PSO-1 maintained long-term efficacy responses through week 112. In the present analysis, we assessed the efficacy of deucravacitinib for up to 112 weeks among patients from PSO-1 who crossed over from placebo to deucravacitinib at week 16.
Methods: Patients in PSO-1 were randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD), or apremilast 30 mg twice daily. Patients randomized to placebo at baseline crossed over to deucravacitinib at week 16. At week 52, patients who completed the parent trial were able to enroll in the LTE trial and receive open-label deucravacitinib 6 mg QD. Efficacy outcomes included ≥ 75%/≥ 90% reductions from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static Physician’s Global Assessment (sPGA) score of
0 (clear) or 1 (almost clear) with a ≥ 2-point improvement from baseline. Efficacy is reported using modified nonresponder imputation; patients who had not reached the week 112 assessment or had not discontinued as of October 1, 2021, were excluded. As-observed data and results by treatment failure rule imputation were also analyzed.
Results: At week 16, PASI 75, PASI 90, and sPGA 0/1 response rates in patients treated with placebo were 12.7%, 4.2%, and 7.2%, respectively. A total of 126 patients randomized to placebo at baseline crossed over to deucravacitinib at week 16 and received open-label deucravacitinib in the LTE through week 112. At week 112, PASI 75 and PASI 90 response rates were 81.4% and 50.6%, respectively, and the sPGA 0/1 response rate was 58.2%. These results were similar to those at week 112 in patients who were treated with deucravacitinib from day 1.
Conclusion: Deucravacitinib treatment is associated with long-term efficacy in patients who originally received placebo and crossed over to deucravacitinib after 16 weeks in PSO-1, with results replicating those with continuous deucravacitinib treatment from day 1. These findings further indicate that the once-daily, oral treatment of deucravacitinib is an effective long-term therapy for moderate to severe plaque psoriasis.
To cite this abstract in AMA style:Warren R, Lebwohl M, Imafuku S, Bagel J, Armstrong A, Passeron T, Linaberry M, Hoyt K, Napoli A, Kisa R, Thaçi D, Blauvelt A. Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Patients with Moderate to Severe Psoriasis: Long-Term Efficacy in Placebo Crossovers [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/deucravacitinib-an-oral-selective-allosteric-tyrosine-kinase-2-inhibitor-in-patients-with-moderate-to-severe-psoriasis-long-term-efficacy-in-placebo-crossovers/. Accessed .
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/deucravacitinib-an-oral-selective-allosteric-tyrosine-kinase-2-inhibitor-in-patients-with-moderate-to-severe-psoriasis-long-term-efficacy-in-placebo-crossovers/