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New two-year deucravacitinib data reinforce durable efficacy and consistent safety profile in moderate to severe plaque psoriasis. - BMS

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Published:14th May 2022

Bristol Myers Squibb announced two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating durable efficacy and a consistent safety profile with deucravacitinib treatment in adult patients with moderate to severe plaque psoriasis.

Clinical efficacy was maintained through up to two years of deucravacitinib treatment, with response rates at Week 60 in the LTE of 77.7% and 58.7% for Psoriasis Area and Severity Index (PASI) 75 and static Physicians Global Assessment (sPGA) 0/1 (clear/almost clear skin), respectively.

These data (Presentation #133) are being presented at the European Academy of Dermatology and Venereology (EADV) Spring Symposium, taking place May 12-14, 2022.

The overall safety profile of deucravacitinib observed through two years spans 2,482 patient years of treatment and was consistent with that observed in the previously presented pivotal Phase III POETYK PSO-1 and POETYK PSO-2 trials. Adverse events (AEs) continued to be predominantly of mild or moderate severity, with the most common AEs continuing to be nasopharyngitis, upper respiratory tract infection and headache. Serious AEs and AEs leading to discontinuation remained low for up to two years, and no emerging safety signals were observed. With additional follow-up in the LTE trial, which coincided with the peak of the COVID-19 pandemic, there was an increased number of reported COVID-19 infections compared to the POETYK PSO-1 and POETYK PSO-2 trials; however, deucravacitinib treatment did not increase the risk or severity of COVID-19 infection. Overall incidence rates of COVID-19 infection and COVID-19-related hospitalization and death in the LTE trial were consistent with background epidemiologic rates. Through two years, no new trends or clinically meaningful changes from baseline in laboratory values, including hematology, chemistry and lipid parameters, were observed.

About the POETYK PSO Clinical Trial Program : PrOgram to Evaluate the efficacy and safety of deucravacitinib, a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) were global Phase III studies designed to evaluate the safety and efficacy of deucravacitinib compared to placebo and Otezla (apremilast) in patients with moderate to severe plaque psoriasis. Both POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020 patients, were multi-center, randomized, double-blind trials that evaluated deucravacitinib (6 mg once daily) compared with placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.

The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and those who achieved static Physician's Global Assessment (sPGA) score of 0 or 1 (clear/almost clear) at Week 16 versus placebo. Key secondary endpoints of the trials included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16 and other measures evaluating deucravacitinib versus placebo and Otezla.

Following the 52-week POETYK PSO-1 and POETYK PSO-2 trials, patients could enroll in the ongoing POETYK PSO-LTE trial (NCT04036435) and receive open-label deucravacitinib 6 mg once daily. 1,221 patients enrolled in the long-term extension trial and received at least 1 dose of deucravacitinib. Efficacy was analyzed utilizing treatment failure rules (TFR) method of imputation, along with sensitivity analyses using modified non-responder imputation and as-observed analysis, which have been used in similar analyses with other agents. In addition to POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE, Bristol Myers Squibb is also evaluating deucravacitinib in two other Phase III studies in psoriasis: POETYK PSO-3 (NCT04167462) and POETYK PSO-4 (NCT03924427).

Condition: Psoriasis
Type: drug

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