Bristol Myers Squibb has presented three-year results from the POETYK PSO long-term extension trial (NCT04036435) of Sotyktu (deucravacitinib) for the treatment of moderate-to-severe plaque psoriasis.
Deucravacitinib is an orally administered drug designed to selectively target tyrosine kinase 2 (TYK2) and inhibit key cytokines involved in biological pathways leading to immune-mediated diseases such as psoriasis.
Sotyktu currently has United States Food and Drug Administration (FDA) and European Commission (EC) approval as a treatment for moderate-to-severe plaque psoriasis.
The primary purpose of the study is to evaluate the long-term efficacy and safety of Sotyktu in patients who were previously enrolled in the 52-week global Phase III POETYK PSO-1 (NCT03624127) and POETYK-2 (NCT03611751) psoriasis trials.
In the double-blinded, multi-centre, randomised POETYK PSO trials, patients were given either 6mg once-daily Sotyktu or a combination of placebo and Amgen’s 30 mg twice-daily Otezla (apremilast) to investigate Sotyktu’s ability to produce clearer skin in people with moderate-to-severe plaque psoriasis.
Other pipeline drugs include Amgen and Janssen’s candidates for plaque psoriasis. Amgen’s Phase III trial for Stelara biosimilar, ABP 654, met its primary efficacy endpoint in April 2022. Janssen met its Phase IIb FRONTIER 1 primary endpoints for JNJ-2113 earlier this year.
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Patients could enroll in the ongoing long-term extension trial following the completion of the protocol-required treatment period of a previous deucravacitinib study.
Clinical trial data
In the open-label, multi-centre long-term extension trial, patients are provided a daily dose of Sotyktu. Of the 1,452 patients currently enrolled in the study, 1,221 have received at least one dose.
Data collected at 16, 52, and 148 weeks indicate sustained clinical response rates with continuous treatment of Sotyktu.
The study also reports that cumulative exposure-adjusted incidence rates (EAIRs) per 100 PY observed at three years were similar and lower than those observed at two years: 144.8 versus 154.4 for AEs and 5.5 versus 6.1 for serious AEs, respectively.
Sotyktu showed no increased or serious adverse events over time and no new safety concerns.
Primary completion of the study is expected in 2026.
Other trials of Sotyktu include Phase III plaque psoriasis trials POETYK PSO-3 (NCT04167462) in China, South Korea, and Taiwan, and POETYK PSO-4 (NCT03924427) conducted in Japan.