Bristol Myers Squibb has revealed two-year results from the POETYK PSO trial involving its psoriasis therapy, deucravacitinib.
The study demonstrated durable efficacy and a consistent safety profile among adult patients with moderate to severe plaque psoriasis, and clinical efficacy was maintained throughout two years of the treatment.
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.
At least 100 million people worldwide have some form of psoriasis, including around 14 million people in Europe and approximately 7.5 million in the US.
Overall observed safety of deucravacitinib effectively spanned 2,482 patient years of treatment and was consistent with previously presented pivotal phase 3 trials.
Adverse events continued to be predominantly mild or moderate, with the most frequent being nasopharyngitis, upper respiratory tract infections or headaches.
Professor Richard Warren, consultant dermatologist at Salford Royal Hospital, said: “Long-term research showing durable efficacy, in addition to a well-understood safety profile, is critical for clinicians and patients making treatment decisions, and the new two-year data underscores 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.”
No emerging safety signals were observed and serious adverse events causing patients to drop out of the two-year trial remained low.
Deucravacitinib treatment did not increase the risk or severity of COVID-19 infection, while overall rates of COVID-19-related hospitalisation or death during the trial were consistent with epidemiologic rates.
Jonathan Sadeh, senior vice president of immunology and fibrosis development at Bristol Myers Squibb, said: “Our pioneering research is leading to the potential for novel, well-tolerated treatment options for individuals impacted by serious immune-mediated diseases like psoriasis.
“The long-term follow-up results add to the growing body of evidence for deucravacitinib, reinforcing its potential to offer patients with moderate to severe plaque psoriasis an oral treatment option that addresses current gaps in care,” he added.