Deucravacitinib long-term efficacy with continuous treatment in plaque psoriasis: 2-year results from the phase 3 POETYK PSO program

Main Article Content

Mark Lebwohl
Richard B. Warren
Howard Sofen
Shinichi Imafuku
Carle Paul
Jacek C. Szepietowski
Lynda Spelman
Thierry Passeron
Elizabeth Colston
Lauren Hippeli
Andrew Napoli
Renata M. Kisa
Subhashis Banerjee
Alan Menter
Diamant Thaçi
Andrew Blauvelt

Keywords

psoriasis, deucravacitinib, tyrosine kinase 2, phase 3 clinical trial, efficacy, long-term

Abstract

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the pivotal phase 3 POETYK PSO-1 trial, deucravacitinib was superior to placebo and apremilast using multiple clinical endpoints, including PASI 75 and sPGA score of 0 or 1 (clear/almost clear skin) at Week 16. Clinical efficacy was maintained through Week 52 on continued treatment. We examined long-term clinical efficacy in patients randomized to deucravacitinib on Day 1 in PSO-1 who opted to continue treatment at Week 52 in the long-term extension (LTE) trial.


Methods: In the 52-week POETYK PSO-1 trial, adult patients were randomized 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily; upon trial completion, patients could enter the LTE and receive deucravacitinib. Efficacy endpoints included PASI 75, PASI 90, and sPGA 0/1. Maintenance of response was assessed in Week 16 PASI 75 responders continuing treatment in the LTE. Modified nonresponder imputation (mNRI) was used to impute missing data; patients discontinuing due to psoriasis worsening were imputed as nonresponders. Efficacy results used as-observed data and treatment failure rule imputation.


Results: Of 332 patients randomized to deucravacitinib in PSO-1, 265 completed the trial and entered the LTE, including 173 Week 16 PASI 75 responders. The mNRI population included 262 deucravacitinib patients entering the LTE, including 171 Week 16 PASI 75 responders; patients failing to reach the Week 112 assessment or discontinuing as of October 1, 2021, were excluded. At Week 112 (LTE Week 60), mNRI response rates among deucravacitinib patients entering the LTE were 82.4% (PASI 75), 55.2% (PASI 90), and 66.5% (sPGA 0/1). Efficacy was maintained up to 112 weeks in Week 16 PASI 75 responders continuing treatment, including PASI 75 response rates at Weeks 16, 52, and 112 (100%, 90.1%, 91.0%, respectively), PASI 90 (62.6%, 64.9%, 63.0%), and sPGA 0/1 (84.2%, 73.7%, 73.5%).


Conclusion: Clinical efficacy was maintained up to 112 weeks with continuous treatment, further supporting deucravacitinib as an effective treatment for patients with moderate to severe plaque psoriasis.

References

1. Burke JR, et al. Sci Transl Med. 2019;11:eaaw1736.

2. SOTYKTU™ (deucravacitinib) [package insert]. Princeton, NJ, USA; Bristol-Myers Squibb Company; September 2022.

3. Wrobleski ST, et al. J Med Chem. 2019;62:8973–8995.

4. Armstrong AW, et al. J Am Acad Dermatol. 2023;88:29-39.

5. Strober B, et al. J Am Acad Dermatol. 2023;88:40-51.

6. Armstrong A, et al. Presented at the Annual Meeting of the AAD; April 23–25, 2021.

7. Warren RB, et al. Presented at the 30th EADV Congress; September 29–October 2, 2021.

8. Warren RB, et al. Presented at the EADV Spring Symposium; May 12–14, 2022.

9. Reich K, et al. Br J Dermatol. 2021;185:1146–1159.

10. Papp K, et al. Br J Dermatol. 2021;185:1135–1145.

Similar Articles

1 2 3 4 5 > >> 

You may also start an advanced similarity search for this article.

Most read articles by the same author(s)

1 2 3 4 5 6 7 8 9 10 > >>