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TYK2, deucravacitinib, plaque psoriasis, long term efficacy
Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor for moderate-to-severe plaque psoriasis, was superior to placebo and apremilast in two global, 52-week, phase 3 trials and maintained long-term efficacy through 2 years with no new safety signals in an ongoing long-term extension (LTE) trial. We report clinical efficacy for up to 3 years (148 weeks) in a subset of patients from these trials.
Materials: POETYK PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD), or apremilast 30 mg twice daily. At Week 52, patients could enter the POETYK LTE and receive open-label deucravacitinib 6 mg QD. Deucravacitinib efficacy, as of June 15, 2022, was evaluated through Week 148 in patients from the pooled PSO-1/PSO-2 populations who received continuous deucravacitinib from Day 1, achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at Week 16 (primary endpoint) or at Week 24 (peak response), and entered the LTE. Maintenance of response assessments included PASI 75, PASI 90, and sPGA 0/1 (static Physician Global Assessment of 0 [clear] or 1 [almost clear] with a ≥2-point improvement from baseline), which were reported using modified nonresponder imputation.
Results: Of patients (N=513) who completed 52 weeks in the parent trials and received continuous deucravacitinib treatment from Day 1, 313 (61.4%) achieved PASI 75 at Week 16 and 336 (66.5%) achieved PASI 75 at Week 24. Among Week 16 PASI 75 responders, PASI 75, PASI 90, and sPGA 0/1 response rates were maintained from Week 52 (87.0%, 60.6%, and 70.8%, respectively) to Week 148 (84.5%, 60.0%, and 62.8%, respectively). Among Week 24 PASI 75 responders, PASI 75, PASI 90, and sPGA 0/1 response rates were maintained from Week 52 (90.2%, 61.6%, and 74.1%, respectively) to Week 148 (86.0%, 60.4%, and 64.5%, respectively).
Conclusion: Clinical efficacy was maintained with continuous deucravacitinib treatment in most Week 16 and Week 24 PASI 75 responders from the parent trials through 148 weeks, supporting long-term effectiveness of once-daily oral deucravacitinib for moderate to severe plaque psoriasis.
2. Sotyktu [package insert]. Princeton, NJ: Bristol Myers Squibb; September 2022.
3. Sotyktu [summary of product characteristics]. Dublin, Ireland: Bristol Myers Squibb Pharmaceutical Operations; March 2023.
4. Sotyktu [package insert]. Tokyo, Japan: Bristol Myers Squibb K.K.; September 2022.
5. Sotyktu [product information]. Mulgrave, VIC, Australia: Bristol Myers Squibb Australia Pty. Ltd.; December 2022.
6. Sotyktu [product monograph]. Montreal, QC, Canada: Bristol Myers Squibb Canada Co.; November 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. Warren RB, et al. Presented at the 30th EADV Congress; 29 September-2 October 2021.
11. Reich K, et al. Br J Dermatol. 2021;185:1146-1159.
12. Papp K, et al. Br J Dermatol. 2021;185:1135-1145.
13. Armstrong AW, et al. Presented at the 32nd EADV Congress; 11-14 October 2023; Berlin, Germany.