Bristol Myers Squibb (BMS) has revealed four-year data from the POETYK PSO long-term extension (LTE) trial of Sotyktu in treating moderate-to-severe plaque psoriasis.
The study followed the Phase III POETYK PSO-1 and POETYK PSO-2 trials, with patients receiving an open-label 6mg dose of Sotyktu daily.
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This LTE trial enrolled a total of 1,221 subjects.
After four years, the Psoriasis Area and Severity Index (PASI) 75 and 90 response rates were 71.7% and 47.5%, respectively.
A 57.2% rate for static Physician’s Global Assessment (sPGA) 0/1 (clear/almost clear) was also reported.
Sotyktu’s safety profile remained consistent over the four years, without any new safety concerns identified.
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By GlobalDataThe efficacy outcomes were sustained, with continuous treatment yielding stable PASI 75, PASI 90, and sPGA 0/1 response rates.
The exposure-adjusted incidence rates for adverse events did not increase over time for adverse events (AEs), serious AEs, discontinuation due to AEs, herpes zoster, malignancies, major adverse cardiovascular events, venous thromboembolism, and deaths.
Bristol Myers Squibb immunology, cardiovascular and neuroscience clinical development head and senior vice-president Alyssa Johnsen said: “The data from our robust POETYK PSO clinical programme continue to reinforce the potential of the first-in-class Sotyktu as an oral standard of care for individuals living with moderate-to-severe plaque psoriasis.
“Our leadership in TYK2 innovation highlights our transformational science that is advancing care for immune-mediated diseases.”
Recently, the company reported that its blockbuster cancer therapies, Opdivo (nivolumab) and Yervoy (ipilimumab), failed to meet the primary endpoint as a combination therapy in a Phase III trial in patients with unresectable, locally advanced stage III non-small cell lung cancer.
