Three-Year Long-Term Extension Data Confirm Sustained Efficacy and Safety of Deucravacitinib in Adults with Moderate-to-Severe Plaque Psoriasis

ShanghaiOctober 16, 2023PR Newswire -- Bristol-Myers Squibb recently announced the latest three-year results of the POETYK PSO Long-Term Extension (LTE) trial for deucravacitinib in treating adult patients with moderate to severe plaque psoriasis. Continued treatment up to week 148 maintained stable clinical response rates, with improvements in the Psoriasis Area and Severity Index of at least 75% (PASI 75), PASI 90, and static Physician's Global Assessment (sPGA) 0/1 response rates at 73.2%, 48.1%, and 54.1%, respectively (using modified Non-Responder Imputation (mNRI)). Additionally, the safety profile of deucravacitinib remained consistent with previous findings, showing no increase in the incidence of adverse events (AE) or serious AEs over time, and no new safety signals were identified.

These data (oral presentation number #FC02.7) and 49 other abstracts will be presented at the European Academy of Dermatology and Venereology (EADV) Congress held in Berlin, Germany, from October 11-14, 2023, demonstrating Bristol-Myers Squibb's commitment to dermatology research.

"The newly announced three-year positive results further highlight deucravacitinib as the first and currently only approved TYK2 inhibitor, taken orally once daily, demonstrating its long-term efficacy and reliable safety. These results also reinforce our confidence in deucravacitinib as an oral treatment option for adults with moderate to severe plaque psoriasis," said POETYK-PSO clinical trial investigator April Armstrong, Professor and Principal Physician of Dermatology at UCLA, M.D., and Master of Public Health. "For patients, longer periods of disease remission mean they can better focus on other aspects of life, and the long-term data from POETYK-PSO further demonstrate our ability to provide a new standard of care for those seeking oral treatment options."

The safety analysis of the study evaluated 1,519 patients who had received at least one dose of deucravacitinib in POETYK PSO-1, POETYK PSO-2, and POETYK PSO-LTE. The efficacy analysis assessed 513 patients from the pivotal POETYK PSO-1 and POETYK PSO-2 studies who had continuously received deucravacitinib treatment from Day 1 and were subsequently enrolled in the LTE trial. In the safety analysis, cumulative exposure from the time of randomization in the main studies was 3,294 patient-years (PY).

Patients who continued to receive deucravacitinib treatment from baseline maintained their clinical efficacy until Week 148, with stable PASI 75 response rates (Week 16, 61.1%; Week 52, 72.6%; Week 148, 73.2%), PASI 90 response rates (Week 16, 35.2%; Week 52, 45.6%; Week 148, 48.1%), and sPGA 0/1 response rates (Week 16, 57.5%; Week 52, 58.1%; Week 148, 54.1%).

At year three, the cumulative exposure-adjusted incidence rates (EAIR) per 100 patient-years (PY) were similar to or lower than those observed at year two, respectively: AE (144.8, 154.4), serious AE (5.5, 6.1), discontinuation due to AE (2.4, 2.8), herpes zoster (0.6, 0.7), malignancy (0.9, 0.9), major adverse cardiovascular events (0.3, 0.4), venous thromboembolism (0.1, 0.1), and death (0.3, 0.4). The cumulative exposure-adjusted incidence rate per 100 patient-years (EAIR/100PY) was calculated as the ratio of the number of patients experiencing AE to the total exposure time in all patients at risk (for patients experiencing AE, the exposure time is from the start to the first occurrence of AE; for patients not experiencing AE, it is the total exposure time).)。

"As an innovative leader in the TYK2 field, Bristol-Myers Squibb will continue to advance the long-term research of deucravacitinib, the world's first oral therapy for psoriasis, and explore its full potential in various serious immune-mediated diseases," said Dr. Roland Chen, Senior Vice President and Head of Immunology, Cardiovascular, and Neuroscience Development at Bristol-Myers Squibb. "The new data announced this time strongly validates that deucravacitinib has the potential to bring long-term, clinically meaningful benefits to patients with moderate to severe plaque psoriasis."

Bristol-Myers Squibb sincerely thanks all the patients and researchers who participated in the POETYK PSO clinical research program.

Currently DeucravacitinibNot yet approved in China. The Chinese Pharmacopoeia Commission has confirmed the Chinese generic name of the preparation as Deucravacitinib Tablets, with the English name asDeucravacitinibTablets, but awaiting final approval from the National Medical Products Administration.

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