New Two-Year Data on Deucravacitinib Reinforce Efficacy and Safety Profile in Treatment of Moderate to Severe Plaque Psoriasis

Deucravacitinib is currently under regulatory review in multiple regions, including the U.S., Europe and Japan, and would be the first selective allosteric tyrosine kinase 2 (TYK2) inhibitor approved for the treatment of any disease.

Bristol Myers Squibb shared new 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 percent 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.

“Plaque psoriasis is a chronic, systemic immune-mediated disease associated with multiple serious comorbidities, and there remains a strong unmet need for new treatments, particularly oral medicines, as many patients are undertreated or are dissatisfied with current options,” says Professor Richard B. Warren, Consultant Dermatologist, Salford Royal Hospital, part of Northern Care Alliance NHS Foundation Trust and Professor at The University of Manchester, in a news release. “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 two-year data underscore the potential of deucravacitinib to be an important new oral treatment option for people living with moderate to severe plaque psoriasis who require systemic therapy.”

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 3 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.

“At Bristol Myers Squibb, our pioneering research is leading to the potential for novel, well-tolerated treatment options for individuals impacted by serious immune-mediated diseases like psoriasis. 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,” says Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb.