Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Linase 2 (TYK2) Inhibitor, in Patients with Moderate to Severe Scalp Psoriasis: The Association Between Patient-Reported and Clinician-Reported Outcomes at Week 16 in a Phase 3b/4 Multicenter, Randomized, Double-blinded, Placebo-controlled Study (PSORIATYK SCALP)

Abstract

Introduction: In the phase 3b/4 PSORIATYK SCALP trial, deucravacitinib achieved superiority vs placebo for the primary and all key secondary endpoints at Week 16 in patients with moderate to severe scalp psoriasis. Patient-reported outcomes (PROs) provide additional information on treatment efficacy by capturing patients’ experiences and impact on their quality of life (QoL). This analysis evaluated the association between PROs and clinician-reported outcomes (CROs) in patients treated with deucravacitinib vs placebo.

Methods: This ad hoc analysis evaluated the associations between PROs (scalp-specific itch, pain, and flaking numeric rating scale [NRS], Scalpdex, and Dermatology Life Quality Index [DLQI]) and CROs (scalp-specific Physician Global Assessment [ss-PGA] and Psoriasis Scalp Severity Index [PSSI]) using Spearman’s correlation coefficients for absolute scores at baseline and Week 16. Descriptive analyses of PRO changes from baseline and response rates by CRO response groups were also calculated for deucravacitinib-treated patients.

Results: Baseline severity, scalp-specific symptoms, and QoL were similar between treatment groups, yet correlations were weak between PRO and CRO absolute values. At Week 16, correlations between PROs and CROs were stronger in deucravacitinib-treated patients vs placebo. The strongest correlations in deucravacitinib-treated patients were for itch and flaking NRS and Scalpdex symptoms (≥0.6; P<0.0001). QoL was moderately correlated with CROs (<0.6; P<0.0001) in deucravacitinib-treated patients. At Week 16, clinically meaningful improvements in scalp-specific itch, pain, and flaking and DLQI were reported by 76.2%, 89.5%, 88.4%, and 82.6% of patients who achieved ss-PGA 0/1 and by 72.7%, 66.7%, 91.7%, and 83.3% of those achieving PSSI 90, respectively. A 20-point reduction in Scalpdex total score was also reported by 75.6% and 66.7% of deucravacitinib-treated patients who achieved ss-PGA 0/1 and PSSI 90, respectively.

Conclusion: In deucravacitinib-treated patients, there was a strong correlation between patient-reported scalp symptoms and scalp-specific CROs, confirming the treatment benefit from the patient perspective. Moderate QoL/scalp-specific CRO correlations indicate that PROs provide complementary information about treatment benefits.