Deucravacitinib Found to Be Safe and Effective for Psoriasis Over 3 Years: JAMA
Researchers have found that deucravacitinib for long-term treatment is well tolerated and has a sustained clinical response in the management of moderate to severe plaque psoriasis. Recently a new study was published in the JAMA Dermatology journal which was conducted by April W. Armstrong and his colleagues.
Data were derived from the randomized, double-blinded POETYK PSO-1 and PSO-2 trials and the nonrandomized LTE trial. The two lead-in trials had enrolled patients in a 1:2:1 ratio to placebo, deucravacitinib (6 mg/day), or apremilast (30 mg twice daily). Patients who had participated in these studies for 52 weeks were allowed to enter this LTE study and received open-label deucravacitinib. The LTE trial started enrolling patients from August 2019 up to June 2022, and safety and efficacy outcomes were monitored.
The study included 1,519 participants who received at least one dose of deucravacitinib. Among them, 513 patients received continuous treatment from day 1 and entered the LTE trial. This analysis considered outcomes across 1-year and 3-year cumulative periods, highlighting safety and efficacy trends over time.
Key Findings
Safety Profile:
• Adverse events (AEs): EAIRs were lower at 3 years (144.8; 95% CI: 137.1-153.0) than at 1 year (229.2; 95% CI: 215.4-243.9).
• Serious AEs: EAIRs were similar between 1 and 3 years (5.7 vs. 5.5).
• Discontinuations due to AEs: Rates decreased from 4.4 per 100 person-years at 1 year to 2.4 at 3 years.
• Deaths: EAIRs were all steady, reported as 0.2 at 1 year and 0.3 at 3 years.
Common Adverse Events:
• Nasopharyngitis: EAIRs were lower at 3 years (11.4; 95% CI: 10.2-12.7) than at 1 year (26.1; 95% CI: 23.0-29.8).
• COVID-19: EAIRs increased from 0.5 at 1 year to 8.0 at 3 years. It reflects the impact of the pandemic.
• Upper respiratory tract infection: EAIRs declined from 13.4 at 1 year to 6.2 at 3 years.
Durable Clinical Response:
• Clinical efficacy was maintained for up to three years with important improvements in Psoriasis Area and Severity Index (PASI 75/90) scores and static Physician Global Assessment (sPGA 0/1) scores.
This study concluded that deucravacitinib maintains a consistent safety profile and durable clinical response over three years of continuous treatment for moderate to severe plaque psoriasis. The findings offer robust evidence to support the long-term use of this oral therapy in clinical practice.
Reference:
Armstrong, A. W., Lebwohl, M., Warren, R. B., Sofen, H., Imafuku, S., Ohtsuki, M., Spelman, L., Passeron, T., Papp, K. A., Kisa, R. M., Vaile, J., Berger, V., Vritzali, E., Hoyt, K., Colombo, M. J., Scotto, J., Banerjee, S., Strober, B., Thaçi, D., & Blauvelt, A. (2024). Safety and efficacy of deucravacitinib in moderate to severe plaque psoriasis for up to 3 years: An open-label extension of randomized clinical trials. JAMA Dermatology (Chicago, Ill.). https://doi.org/10.1001/jamadermatol.2024.4688
