Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 (TYK2) Inhibitor, in Patients with Moderate to Severe Scalp Psoriasis: Time to Meaningful Improvement in Patient-Reported Outcomes in a Phase 3b/4, Multicenter, Randomized, Double-blinded, Placebo-Controlled Study (PSORIATYK SCALP)

Abstract

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. In the phase 3b/4 PSORIATYK SCALP trial, deucravacitinib was superior to placebo at Week 16 in patients with moderate to severe scalp psoriasis, including those with less extensive overall psoriasis (total body surface area [BSA] involvement ≥3%). This analysis evaluates the time to meaningful improvement in patient-reported outcomes (PROs) in patients treated with deucravacitinib vs placebo in the PSORIATYK SCALP trial.

Methods: Patients aged ≥18 years with moderate to severe scalp psoriasis were randomized 1:2 to once-daily placebo or deucravacitinib 6 mg. Evaluated PROs included scalp-specific itch, pain and flaking, and whole-body itch numeric rating scales (NRS), Scalpdex, and Dermatology Life Quality Index (DLQI). Times to meaningful improvement in these PROs (≥4-points reduction from baseline for NRS measures and DLQI; ≥20-point reduction for Scalpdex) were estimated using Kaplan-Meier methods. Cox regression models were used to calculate hazard ratios (HRs) and confidence intervals (CIs) for response up to 16 weeks. Results are reported for the overall population and for subgroups of patients with baseline BSA 3%–10% and BSA >10% at baseline.

Results: In the overall population (placebo: n = 51; deucravacitinib: n = 103), patients treated with deucravacitinib had a shorter median time to meaningful improvement and were significantly more likely to achieve response by Week 16 for all PROs compared with patients receiving placebo (P < 0.05). In patients treated with deucravacitinib, the median time (95% CI) to meaningful improvement was 9.0 (8.0, 16.3), 8.7 (2.6, 15.7), 8.0 (4.1, 8.1), 8.3 (4.1, 15.7), and 2.1 (1.4, 4.3) weeks for scalp-specific itch, pain, and flaking NRS, whole-body itch NRS, and DLQI, respectively. The median time to meaningful improvement was also shorter with deucravacitinib vs placebo for all PROs in both the BSA 3%–10% and BSA <10% subgroups.

Conclusion: Deucravacitinib was associated with a shorter time to meaningful improvement vs placebo across evaluated PROs in the overall population and in BSA subgroups.