Improvements in patient-reported outcomes after treatment with deucravacitinib in patients with psoriatic arthritis: results from a randomized phase 2 trial.
Publication Title
Arthritis Care Res (Hoboken)
Document Type
Article
Publication Date
3-26-2024
Keywords
washington; swedish
Abstract
OBJECTIVE: Deucravacitinib, a TYK-2 inhibitor, was assessed in a phase 2 trial in patients with active psoriatic arthritis (PsA). Here, we report effects of deucravacitinib from the patient perspective.
METHODS: This phase 2, double-blind trial (NCT03881059) randomized patients with active PsA 1:1:1 to deucravacitinib 6 mg once daily (QD), 12 mg QD, or placebo, for 16 weeks. Key secondary endpoints were change from baseline (CFB) at Week 16 in Health Assessment Questionnaire Disability Index (HAQ-DI) and 36-item Short Form Health Survey (SF-36) physical component summary (PCS) score. Additional patient-reported outcomes (PROs) assessed disease impact, including fatigue, pain, and mental health. Mean CFB in PROs and percentages of patients reporting improvements with minimum clinically important differences (MCIDs) or scores of = normative values were also assessed.
RESULTS: This study comprised 203 patients (51.2% female; mean [SD] age, 49.8 [13.5] years). At Week 16, adjusted mean difference (95% CI) versus placebo in HAQ-DI and SF-36 PCS CFB was significant for each deucravacitinib group (HAQ-DI 6 mg: -0.26 [-0.42, -0.10], P = 0.0020; HAQ-DI 12 mg: -0.28 [-0.45, -0.12], P = 0.0008; SF-36 PCS 6 mg: 3.3 [0.9, 5.7], P = 0.0062; SF-36 PCS 12 mg: 3.5 [1.1, 5.9], P = 0.0042). MCID at Week 16 were reported for all PROs with either dose of deucravacitinib. Improvements of MCID or to normative values were reported by more patients receiving deucravacitinib than placebo.
CONCLUSION: Deucravacitinib demonstrated significant and clinically meaningful improvements in PROs versus placebo in patients with active PsA and warrants further study. This article is protected by copyright. All rights reserved.
Clinical Institute
Orthopedics & Sports Medicine
Specialty/Research Institute
Rheumatology
Specialty/Research Institute
Orthopedics
Specialty/Research Institute
Pharmacy
DOI
10.1002/acr.25333
