Data show Sotyktu maintains treatment outcomes for plaque psoriasis at 3 years

Key takeaways:

• 73.2% of patients with plaque psoriasis on continuous Sotyktu treatment maintained PASI 75 up to 3 years.
• Sotyktu exhibited a consistent safety profile with no increases in adverse events.

Three-year data from the POETYK PSO long-term extension trial of Sotyktu showed consistent efficacy and safety for the treatment of adults with moderate to severe plaque psoriasis, Bristol Myers Squibb announced in a press release.

The trial’s efficacy and safety data were presented at the European Academy of Dermatology and Venereology (EADV) 2023 Congress.

“These new 3-year data demonstrate that psoriasis patients treated with Sotyktu achieve durable and clinically meaningful improvements in skin clearance for up to 3 years,” Roland Chen, MD, senior vice president and head of immunology, cardiovascular and neuroscience development at Bristol Myers Squibb, told Healio. “Moreover, these data confirm Sotyktu’s well-established safety profile as seen in our pivotal POETYK PSO-1 and POETYK PSO-2 clinical trials.”

The efficacy data were taken from the PEOTYK PSO long-term extension trial, which included 513 patients who received continuous Sotyktu (deucravacitinib) treatment from the beginning of POETYK PSO 1 and 2 to the end of the extension trial.

Study abstract results based on modified nonresponder imputation responses showed that at week 148, clinical response rates were maintained with 73.2% (95% CI, 68.7%-77.8%) of patients at PASI 75, 48.1% (95% CI, 43.2%-53.1%) at PASI 90 and 54.1% (95% CI, 49.1%-59.1%) with a static PGA of 0/1. These results were similar regardless of which data imputation methodology was utilized, according to the study abstract.

For comparison, week 16 and week 52 scores were 61.1% and 72.6% for PASI 75, 35.2% and 45.6% for PASI 90 and 57.5% and 58.1% for sPGA 0/1, respectively, according to the press release.

The company also presented safety data at EADV including 1,519 patients from all three POETYK trials that received at least one dose of Sotyktu. Cumulative exposure-adjusted incidence rates per 100 person-years were similar or decreased at 3 years compared with 2 years, according to the study abstract.

The 3- and 2-year rates, respectively, for adverse events were 144.8 and 154.4. Further, rates for serious adverse events were 5.5 and 6.1, discontinuations due to adverse events were 2.4 and 2.8, herpes zoster were 0.6 and 0.7, major adverse cardiovascular events were 0.3 and 0.4 and death were 0.3 and 0.4. Rates for malignancies (0.9) and venous thromboembolism (0.1) were the same at both time points.

“These long-term analyses add to the evidence that Sotyktu has the potential to be the new standard of care for patients seeking an oral treatment option,” Chen told Healio.

Reference:

• Sotyktu (deucravacitinib) long-term data demonstrate durable efficacy and consistent safety for up to 3 years in moderate to severe plaque psoriasis. https://investors.bms.com/iframes/press-releases/press-release-details/2023/Sotyktu-deucravacitinib-Long-Term-Data-Demonstrate-Durable-Efficacy-and-Consistent-Safety-for-up-to-Three-Years-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx. Published Oct. 11, 2023. Accessed Oct. 11, 2023.