Impact of Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, Deucravacitinib, on Psoriasis in Patients with Active Psoriatic Arthritis: Results from a Phase 2 Trial

Main Article Content

Alice B. Gottlieb
April W. Armstrong
Joseph F. Merola
Andrew Napoli
Miroslawa Nowak
Subhashis Banerjee
Thomas Lehman
Philip J. Mease


plaque psoriasis, psoriatic arthritis, deucravacitinib, TYK2, Psorasis Area and Severity Index


Introduction: Deucravacitinib (DEUC), an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy. DEUC was superior to apremilast and placebo (PBO) in two phase 3 trials in patients with moderate to severe PsO. DEUC was efficacious on multiple measures of arthritis severity vs PBO in a phase 2 trial in patients with active psoriatic arthritis (PsA) who had ≥1 PsO lesion (≥2 cm). In patients with body surface area (BSA) involvement ≥3% at baseline (80% of patients in this trial), a greater proportion achieved PASI 75 with DEUC (6 mg QD: 42.4%, P=0.01; 12 mg QD: 59.6%, P<0.0001) vs PBO (20.4%) at Week 16. This analysis evaluated the impact of DEUC on PsO in patients with PsA in the phase 2 trial (NCT03881059).

Methods: The phase 2 double-blind PsA trial randomized patients (N=203) 1:1:1 to PBO, DEUC 6 mg once daily (QD), or DEUC 12 mg QD. After Week 16, patients could enroll in an optional, double-blind period until Week 52. DEUC-treated patients achieving minimal disease activity at Week 16 continued DEUC to Week 52. PsO disease activity measurements were assessed.

Results: Baseline PsO characteristics were comparable across groups. At Week 16, significant decreases from baseline in mean PASI were observed with DEUC vs PBO in patients with baseline BSA ≥3%-<10% or PASI ≤12 even with very low baseline PASI scores, and also in those with baseline BSA ≥10% and PASI >12. Significant decreases in PASI from baseline were observed with DEUC vs PBO in patients with background csDMARD use (DEUC 6 mg, -4.0 and 12 mg, -4.9 vs PBO, -2.3; both P<0.05) and those without csDMARD use (-3.7 and -4.0 vs -2.5, respectively; both P<0.001). At Week 16, greater proportions of DEUC vs PBO patients achieved PASI ≤1 with baseline BSA ≥3% (DEUC 6 mg: 32.2%; DEUC 12 mg: 44.2%; PBO: 18.5%) and in patients with baseline BSA ≥10% and PASI >12 (23.1%; 28.6%; 0.0%). In patients with baseline BSA ≥3%, decreases in mean PASI at Week 16 were maintained through Week 52 in patients continuing DEUC 6 mg (absolute PASI score, Week 16: 2.39, Week 52: 1.22) and 12 mg (Week 16: 0.64, Week 52: 0.24).

Conclusion: DEUC significantly improved PsO in patients with PsA, regardless of baseline PsO severity and background csDMARD use. Improvement was comparable to that observed in the phase 3 POETYK PSO-1 trial.












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

2. Sotyktu [package insert]. Princeton, NJ, USA: Bristol Myers Squibb; September 2022.

3. Sotyktu [summary of product characteristics]. Dublin, Ireland: Bristol Myers Squibb Pharmaceutical Operations; March 2023.

4. Sotyktu [product information]. Mulgrave, VIC, Australia: Bristol Myers Squibb Australia Pty. Ltd.; December 2022.

5. Sotyktu [product monograph]. Montreal, QC, Canada: Bristol Myers Squibb Canada Co.; November 2022.

6. Sotyktu [package insert]. Tokyo, Japan: Bristol Myers Squibb K.K.; September 2022.

7. Wrobleski ST, et al. J Med Chem. 2019;62:8973-8995.

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

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

10. Mease PJ, et al. Ann Rheum Dis. 2022;81:815-822.

Most read articles by the same author(s)

1 2 3 4 > >>