Four-Year Data from Long-Term Extension Trial Show Efficacy of Sotyktu Treating Moderate-to-Severe Plaque Psoriasis

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Four-year data from the long-term extension (LTE) of the POETYK PSO clinical trial program found that more than seven in 10 adults with moderate-to-severe plaque psoriasis administered Sotyktu (deucravacitinib; Bristol Myers Squibb) maintained a clinical response in the Psoriasis Area and Severity Index (PASI) 75.¹ Sotyktu, an oral, selective, allosteric tyrosine kinase 2 inhibitor, has been found to limit cytokine signaling in psoriasis pathogenesis, which could fill an unmet need among patients with the dermatologic condition.²

“These four-year results further validate the safety profile, efficacy and key role of once-daily Sotyktu, the first and only TYK2 inhibitor available, for adults with moderate-to-severe plaque psoriasis,” POETYK PSO clinical trial program investigator April Armstrong, MD, MPH, professor and chief of dermatology at the University of California, Los Angeles, said in a press release. “Many patients and their healthcare providers are looking for an efficacious, convenient oral treatment option that provides sustained relief from this chronic disease, allowing patients to prioritize other aspects of their daily lives. These findings further reinforce that we are able to offer a potential oral standard of care to meet patients’ needs.”¹

The global, multicenter, randomized, double-blind Phase III PrOgram to Evaluate the efficacy and safety of Sotyktu (POETYK) trials included PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751). The trials were developed to analyze the efficacy of Sotyktu in comparison with placebo and Otezla (apremilast), as well as evaluate the safety of Sotyktu in patients with moderate-to-severe plaque psoriasis. POETYK PSO-1 enrolled 666 patients, whereas POETYK PSO-2 enrolled 1,020 patients, who were administered Sotyktu at a dose of 6 mg once daily to compare the results vs. placebo and Otezla at a dose of 30 mg twice daily.

For both POETYK PSO-1 and POETYK PSO-2, the co-primary endpoints were the percentage of patients achieving a PASI 75 response and patients achieving static Physician's Global Assessment (sPGA) score of 0 or 1 (clear/almost clear) at week 16 compared with placebo. The trials’ key secondary endpoints included the percentage of patients achieving PASI 75 and sPGA 0/1 vs. Otezla at week 16.

Following four years of continuous treatment with Sotyktu, week 208 PASI 75 and 90 response scores were 71.7% and 47.5%, respectively, and 57.2% for sPGA 0/1 as per modified nonresponder imputation (mNRI). These data include 513 patients administered continuous Sotyktu from the start of the trials and who transitioned to the POETYK PSO-LTE trial. Efficacy outcomes were maintained in those continuously administered Sotyktu from baseline through four years, showing sustained response rates in PASI 75 of 71.7% at year four (year one, 72.0%; year three, 73.8%), PASI 90 of 47.5% (year one, 45.6%; year three, 49.0%), and sPGA 0/1 of 57.2% (year one, 57.7%; year three, 55.2%).

Prior 52-week data released in 2023 demonstrated the superiority of superiority of Sotyktu to Otezla and placebo.²

“In POETYK PSO-2, [Sotyktu] was superior to placebo and [Otezla] and provided clinically meaningful improvements over 52 weeks in multiple efficacy measures,” the study authors wrote. “The overall safety profile of [Sotyktu], including a slight increase in the risk of nonserious viral infections, appears to be consistent with the mechanism of selective TYK2 inhibition.”²

In terms of safety from the LTE, the profile of Sotyktu at year four was consistent with the established safety profile, and no new safety signals were identified.

“The data from our robust POETYK PSO clinical program 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,” Alyssa Johnsen, MD, PhD, senior vice president and head of clinical development, Immunology, Cardiovascular and Neuroscience, Bristol Myers Squibb, said in a press release.¹

References

1. New Four-Year Sotyktu (deucravacitinib) Data Demonstrate Durable Response Rates and Consistent Safety in Moderate-to-Severe Plaque Psoriasis. News release. Bristol Myers Squibb. May 17, 2024. Accessed May 17, 2024. https://news.bms.com/news/corporate-financial/2024/New-Four-Year-Sotyktu-deucravacitinib-Data-Demonstrate-Durable-Response-Rates-and-Consistent-Safety-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

2. Strober, B. et al. (2023) “Deucravacitinib versus Placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 program for evaluation of TYK2 inhibitor psoriasis second trial,” Journal of the American Academy of Dermatology, 88(1), pp. 40–51. Available at https://doi.org/10.1016/j.jaad.2022.08.061. Accessed May 17, 2024.