Bristol Myers Squibb Reports Positive Data on Deucravacitinib for Plaque Psoriasis
Long-term extension trial results show a consistent safety profile and durable efficacy for the treatment of adults with the skin condition.
Bristol Myers Squibb announced 2-year results from the POETYK PSO long-term extension trial, which demonstrating a consistent safety profile and durable efficacy with deucravacitinib for treatment in adults with moderate-to-severe plaque psoriasis, the company said in the statement.
Clinical efficacy was maintained through up to 2 years of deucravacitinib treatment, with response rates at week 60 of 58.7% for the static Physicians Global Assessment clear/almost clear skin and 77.7% for the Psoriasis Area and Severity Index.
“Long-term research showing durable efficacy, in addition to a well-understood safety profile, is critical for clinicians and patients making treatment decisions, and these new 2-year data underscore the potential of deucravacitinib to be an important new oral treatment option for [patients] living with moderate-to-severe plaque psoriasis who require systemic therapy,” Richard Warren, a consultant dermatologist at Salford Royal Hospital, said in the statement.
The data will be presented at the European Academy of Dermatology and Venerology Spring Symposium, which takes place May 12 to May 14, 2022.
The overall safety profile of deucravacitinib was observed through a 2-year span of treatment for 2482 individuals. The treatment was consistent with data previously observed in the phase 3 POETYK PSO-1 and POETYK PSO-2 trials.
The adverse events (AEs) were mild or moderate in severity and most commonly included headaches, nasopharyngitis, and upper-respiratory-tract infections. Serious AEs and AEs that lead to discontinuation remained low for up to 2 years, and no new safety concerns were observed.
Additional follow-up for the long-term extension trial coincided with the peak of the COVID-19 pandemic. Investigators found that there was an increased number of reported COVID-19 infections compared with the 2 previous trials. However, the treatment with deucravacitinib did not increase the risk or severity of a COVID-19 infection.
Furthermore, the overall incidence rate of COVID-19 infection and COVID-19-related hospitalization and death in the long-term extension trial were consistent with background epidemiologic rates.
There were no new clinically meaningful changes or trends from the baseline in laboratory values, including chemistry, hematology, and lipid parameters, during the 2-year period.
“These long-term follow up results add to the growing body of evidence for deucravacitinib, a first-in-class, oral, selective allosteric TYK2 inhibitor with a unique mechanism of action, reinforcing its potential to offer patients with moderate-to-severe plaque psoriasis an oral treatment option that addresses current gaps in care,” Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development at Bristol Myers Squibb, said in the statement.
POETYK PSO-1, which enrolled 666 individuals, and POETYK PSO-2, which enrolled 1020 individuals, were designed to evaluate the efficacy and safety of deucravacitinib compared with the placebo and apremilast (Otezla, Amgen) for individuals with moderate-to-severe plaque psoriasis.
Following the 52-week period, individuals enrolled in either study could enroll in the ongoing POETYK PSO-LTE trial and received open-label deucravacitinib, at the 6-mg dosage, once a day.
New two-year deucravacitinib data reinforce durable efficacy and consistent safety profile in treatment of moderate to severe plaque psoriasis. Bristol Myers Squibb. News release. May 12, 2022. Accessed May 12, 2022. https://news.bms.com/news/details/2022/New-Two-Year-Deucravacitinib-Data-Reinforce-Durable-Efficacy-and-Consistent-Safety-Profile-in-Treatment-of-Moderate-to-Severe-Plaque-Psoriasis/default.aspx