Sotyktu maintains results, safety through 4 years of treatment for plaque psoriasis
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Key takeaways:
- 71.7% of patients treated with Sotyktu for 4 years maintained clinical responses.
- No new safety signals were observed at year 4.
Bristol Myers Squibb announced results from its long-term extension trial of Sotyktu for the treatment of adults with moderate to severe plaque psoriasis, according to a press release.
Sotyktu (deucravacitinib), taken once daily, is the first and only tyrosine kinase 2 (TYK2) inhibitor available for adults with moderate to severe plaque psoriasis. After being evaluated in the POETYK PSO long-term extension trial, results have shown that patients treated continuously for 4 years with Sotyktu maintained a consistent clinical response with no new safety signals.
“Many healthcare providers and their patients are seeking a convenient oral treatment option that is efficacious and provides sustained relief from psoriasis, a serious, chronic, immune-mediated disease,” Alyssa Johnsen, MD, PhD, senior vice president and head of clinical development, immunology, cardiovascular and neuroscience, Bristol Myers Squibb, said in the release. “These long-term results reinforce Sotyktu as a potential oral standard of care to meet providers’ and patients’ needs for treatment of moderate-to-severe plaque psoriasis.”
In the POETYK PSO program, PASI 75 and PASI 90 were achieved by 72% and 45.6% of the 513 patients, respectively, after 1 year of treatment. By year 4, rates remained consistent with 71.7% and 47.5% of patients achieving PASI 75 and PASI 90.
Additionally, a static PGA score of clear or almost clear was achieved by 57.7% of patients after 1 year of treatment and was sustained by 57.2% of patients by year 4.
A safety analysis of 1,519 patients who received at least one dose of Sotyktu across the POETYK program was also conducted. Taking into account a cumulative exposure of 4,392.8 patient-years, results showed the exposure-adjusted incidence rates per 100 patient-years at year 4 decreased or remained the same as those at year 1 for adverse events (229.2 vs. 131.7).
Similar findings in year 4 vs. year 1 were seen for serious adverse events (5.7 vs. 5), discontinuations due to adverse events (4.4 vs. 2.2), herpes zoster (0.8 vs. 0.6), malignancies (1 vs. 0.9), major adverse cardiovascular events (0.3 vs. 0.3), venous thromboembolism (0.2 vs. 0.1) and deaths (0.2 vs. 0.3).
Bristol Myers Squibb is presenting these data at the European Academy of Dermatology and Venereology Spring Symposium.