Bristol Myers Squibb claims deucravacitinib to be a potential oral treatment option for moderate to severe plaque psoriasis
Bristol Myers Squibb (BMS), on Thursday, announced two-year results from the POETYK PSO long-term extension (LTE) trial. The study demonstrated durable efficacy and a consistent safety profile with deucravacitinib treatment in adult patients with moderate to severe plaque psoriasis.
The pharma company says, ‘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.’
“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,”Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb
Professor added, “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.”
“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,” said Professor Richard B. Warren, Consultant Dermatologist, Salford Royal Hospital, part of Northern Care Alliance NHS Foundation Trust and Professor at The University of Manchester.
The company said, ‘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.’
The overall safety profile of ‘deucravacitinib’ observed through a two years period, with 2,482 patients, was consistent with that observed in the previously presented pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials.
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 first (previous) two trials. However, ‘deucravacitinib’ treatment did not increase the risk or severity of COVID-19 infection.
The company is presenting the data at the European Academy of Dermatology and Venereology (EADV) Spring Symposium, taking place May 12-14, 2022.