Impact of Deucravacitinib on Psoriasis Severity and Overall Patient-reported Outcomes in a US Prospective Cohort Study

Abstract

Background: Deucravacitinib is the first oral tyrosine kinase 2 inhibitor approved by the US Food and Drug Administration (FDA) for moderate-to-severe plaque psoriasis (PsO). Phase 2 and Phase 3 clinical trials have shown clinical efficacy across various endpoints.  Long-term clinical trial data of deucravacitinib in moderate-to-severe plaque PsO also show that treatment efficacy is durable. However, real-world evidence regarding the patient-reported outcomes (PROs) of patients treated with deucravacitinib for PsO is limited.

Objective: The goal of this PRO study is to understand the impact of deucravacitinib on improvement of PsO signs and symptoms.

Methods: Patients were recruited from U.S dermatology offices as a part of a national practice group, through a patient support program for deucravacitinib, and online from the FORWARD registry website. Patients were enrolled between August 2023 and November 2024. Inclusion criteria were adult patients initiating deucravacitinib ≤14 days of survey enrollment. We descriptively report demographics, disease characteristics, current treatments, and comorbidities for participants at enrollment as well as mean change in key PROs and patient-reported psoriasis severity at 6 months among the subset of patients who were persistent on deucravacitinib at 6 months. Psoriasis Symptoms and Signs Diary (PSSD) score was the primary outcome (range 0-100), and a meaningful change was set to be at least 15 point improvement. [Papp JAMA Dermatol 2023]

Results: Among 306 patients with PsO initiating deucravacitinib, 81 (20.9%) had completed a 6-month follow up. Among these, 51 (63.0%) were persistent on therapy. Baseline demographics for these 51 persistent patients did not differ substantially from the overall cohort of initiators. The mean baseline PSSD was 32.2 (SD: 24) and change from baseline to 6 months was -19.0, which is above the set point for meaningful change. For overall global assessment of psoriasis severity (range 0-100), baseline was 42.7 (SD: 28.7), and average change from baseline was -25.3 (SD: 27.4). Dermatology Life Quality Index (DLQI) was 8.5 (SD: 4.7) at baseline and changed -4.3 (5.4). The global assessment of itch (numeric rating score) was 4.3 (SD 3.0) at baseline and changed -2.7 (3.2). For patient global assessment of nail disease (range 0-100), baseline was 25.6 (SD: 31.9), and changed -10.2 (SD: 25.8). Body surface area of psoriasis improved as well. At baseline 5.9% had a BSA<1% whereas at 6 months, 45.1% achieved BSA <1%. Treatment satisfaction also improved with 69% indicating they were satisfied or highly satisfied at follow up on deucravacitinib, compared with 33% at baseline.

Conclusions: Deucravacitinib was associated with improvements in psoriasis severity and patient-reported outcomes in a real-world setting.