These new data come as the FDA reviews the new drug application for deucravacitinib which, if approved, would make deucravacitinib the first allosteric tyrosine kinase 2 inhibitor approved for any disease.
Bristol Myers Squibb announced 2-year data from the long-term extension trial POETYK PSO, which indicated durable efficacy and a consistent safety profile of deucravacitinib in adult patients with moderate to severe plaque psoriasis.
Clinical efficacy was maintained in those treated with the medication, with response rates of 77.7% for Psoriasis Area and Severity Index (PASI) 75 and 58.7% for static Physicians Global Assessment (sPGA) 0/1 at week 60 of the trial.
Deucravacitinib is an oral, tyrosine kinase 2 (TYK2) inhibitor, and is the first and only of its kind to be featured in clinical studies of multiple immune-mediated diseases.
The data were presented this morning at the European Academy of Dermatology Venereology (EADV) Spring Symposium taking place May 12-14.
Deucravacitinib is currently being explored as a therapeutic option for several diseases including psoriasis, psoriatic arthritis, lupus, and inflammatory bowel diseases.
For this particular study, the safety of duecravacitinib was observed for a total of 2482 patient years in adults with mild to moderate psoriasis, with results being consistent with those observed in phase 3 of the POETYK PSO-1 and POETYK PSO-2 trials.
Common adverse events were nasopharyngitis, upper respiratory tract infection, and headaches, yet they were predominantly mild or moderate in severity. Serious adverse events that led to discontinuation were low throughout the 2 years, and no new emerging safety signals were seen.
Additionally, no new trends or clinically meaningful changes in laboratory values were observed through the 2 years.
In a press release by Bristol Myers Squibb, Professor Richard B. Warren, PhD, Consultant Dermatologist at Salford Royal Hospital, part of Northern Care Alliance NHS Foundation Trust and Professor at The University of Manchester, reflected on the implications of this new data.
“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 people living with moderate to severe plaque psoriasis who require systemic therapy,” he said.
Deucravacitinib is currently under regulatory review in the US, Europe, and Japan. It would be the first selective allosteric TYK2 inhibitor approved for the treatment of any disease including psoriasis.