New 5-year data showcase Sotyktu’s long-term efficacy, safety for plaque psoriasis
Key takeaways:
- New 5-year data on the efficacy and safety of Sotyktu show consistent results for adults with moderate to severe psoriasis.
- Rates of serious adverse events were similar to other psoriasis treatments.
Bristol Myers Squibb has released new 5-year results from the long-term trial evaluating Sotyktu for the treatment of adults with moderate to severe plaque psoriasis, according to a press release.
Approved in September 2022, Sotyktu (deucravacitinib, Bristol Myers Squibb) is a selective tyrosine kinase 2 inhibitor being evaluated in the long-term extension trial POETYK PSO.
Edgar Charles, MD, vice president and senior global program lead of early/late development immunology at Bristol Myers Squibb, said these 5-year results “continue to support the safety and efficacy profile of Sotyktu” for adults with moderate to severe plaque psoriasis who have been continuously taking the drug for 5 years.
“These data underscore the consistent long-term safety of Sotyktu with no new safety signals, as well as durable efficacy over time,” Charles told Healio. “They show the important role Sotyktu can play as a potential oral standard of care.”
Results showed 72.1% of the 513 patients receiving continuous Sotyktu treatment reached PASI 75 after 1 year, which was sustained by the fifth year at 67.3%.
Similarly, 45.9% of patients reached PASI 90 after 1 year and 46.3% reached it at 5 years. More than half of patients achieved static Physician Global Assessment 0/1 at 1 year (57.5%) and 5 years (52.6%).
The press release also reported that, based on the safety analysis comprised of 1,519 patients, Sotyktu did not present any new safety signals.
“Safety signals such as serious infections, major adverse cardiovascular events and malignancies were low and did not increase over time,” Charles told Healio. “Rates were consistent with long-term safety for long-term extensions and real-world data for other immunomodulators in psoriasis.”
The patient-years of exposure in the study amounted to 5,000, Charles added, suggesting Sotyktu is safe to use as a long-term treatment for moderate to severe plaque psoriasis.