Deucravacitinib in Moderate to Severe Plaque Psoriasis: 5-year, Long-term Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Main Article Content
Keywords
psoriasis
Abstract
Introduction: Oral, targeted therapies for plaque psoriasis with long-term efficacy and safety are needed. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in multiple countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was efficacious and well tolerated in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) parent trials. Here, we report deucravacitinib safety and efficacy through 5 years (Week 256; cutoff date, 9/2/2024).
Methods: Patients were randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. After Week 52, patients enrolled in the POETYK long-term extension (LTE) (NCT04036435) trial received open-label deucravacitinib 6 mg once daily. Safety was evaluated in patients (n=1519) receiving ≥1 deucravacitinib dose through 5 years in the POETYK PSO-1, PSO-2, or LTE trials. Exposure-adjusted incidence rate per 100 person-years was used to assess adverse events. Efficacy was analyzed using modified nonresponder imputation in patients who received continuous deucravacitinib from Day 1 of the parent trials and were enrolled and treated in the LTE. Outcomes included PASI 75/90 and sPGA 0/1.
Results: Deucravacitinib was well tolerated with no new safety signals. In patients receiving continuous deucravacitinib as described above (n=513), high clinical response rates were generally maintained from Year 1 (PASI 75, 72.1% [95% CI, 68.2%-76.1%]; PASI 90, 45.9% [95% CI, 41.5%-50.4%]; sPGA 0/1, 57.5% [95% CI, 53.1%-61.9%]) to Year 5 (PASI 75, 67.3% [95% CI, 62.0%-72.6%]; PASI 90, 46.3% [95% CI, 41.2%-51.5%]; sPGA 0/1, 52.6% [95% CI, 47.0%-58.1%]).
Conclusion: Deucravacitinib demonstrated a consistent safety profile through 5 years with no emergence of any new safety signals. Clinical efficacy rates were maintained through 5 years of continuous treatment with once-daily oral deucravacitinib. These data support the long-term safety and durable efficacy profile through 5 years of treatment with deucravacitinib, a first-in-class TYK2 inhibitor treatment for psoriasis.
References
2. Sotyktu [package insert]. Princeton, NJ: Bristol Myers Squibb; September 2022.
3. Sotyktu [European summary of product characteristics]. Dublin, Ireland: Bristol Myers Squibb EEIG; December 2023.
4. Sotyktu [package insert]. Tokyo, Japan: Bristol Myers Squibb K.K.; September 2022.
5. Sotyktu [product monograph]. Montreal, QC, Canada: Bristol Myers Squibb Canada Co.; November 2022.
6. Sotyktu [product information]. Mulgrave, VIC, Australia: Bristol Myers Squibb Australia Pty. Ltd.; December 2022.
7. Wrobleski ST, et al. J Med Chem. 2019;62:8973-8995.
8. Armstrong AW, et al. J Am Acad Dermatol. 2023;88:29-39.
9. Strober B, et al. J Am Acad Dermatol. 2023;88:40-51.
10. Lebwohl M, et al. Br J Dermatol. 2024;190:668-679.
11. Armstrong AW, et al. Presented at the EADV Symposium; 16-18 May 2024; St Julians, Malta.
12. Reich K, et al. Br J Dermatol. 2021;185:1146-1159.
13. Papp K, et al. Br J Dermatol. 2021;185:1135-1145.
14. Papp KA, et al. Br J Dermatol. 2013;168:844-854.
15. Blauvelt A, et al. J Am Acad Dermatol. 2022;86:827-834.
16. Papp KA, et al. J Am Acad Dermatol. 2023;89:1149-1158.
17. Deodhar A, et. Arthritis Res Ther. 2019;21:111.
18. Yiu ZZN, et al. J Invest Dermatol. 2018;138:534-541.
19. Kalb RE, et al. JAMA Dermatol. 2015;151:961-969.
20. Reich K, et al. Arch Dermatol Res. 2015;307:875-883.
21. Kimball AB, et al. Br J Dermatol. 2015;173:1183-1190.
22. Fiorentino D, et al. Arthritis Rheumatol. 2014;66:S690. Abstract 1563.
23. SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute; 2024. Available at: https://seer.cancer.gov/statisticsnetwork/explorer/.
24. Papp KA, et al. J Drugs Dermatol. 2020;19:571.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution 4.0 International License.
Creative Commons Attribution (CC BY): lets others distribute and copy the article, to create extracts, abstracts, and other revised versions, adaptations or derivative works of or from an article (such as a translation), to include in a collective work (such as an anthology), to text or data mine the article, even for commercial purposes, as long as they credit the author(s), do not represent the author as endorsing their adaptation of the article, and do not modify the article in such a way as to damage the author's honor or reputation.
Authors retain copyright in their work and license the publisher to publish the content. The publisher is the National Society for Cutaneous Medicine, with production and publishing support provided by OJS, Open Journal Systems,see https://pkp.sfu.
Prior to January 2022, authors transferred copyright to the National Society for Cutaneous Medicine. However, all articles are freely available to anyone in the world. There are no subscription fees, page charges, or article processing charges.