Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis.
Publication Title
Clinical rheumatology
Document Type
Article
Publication Date
5-1-2024
Keywords
Humans; Arthritis, Psoriatic; Antirheumatic Agents; Quality of Life; Treatment Outcome; Enthesopathy; Patient Reported Outcome Measures; Pain; Biological Products; Antibodies, Monoclonal, Humanized; Biologic; Dactylitis; Enthesitis; Guselkumab; Psoriatic arthritis.; washington; swedish
Abstract
OBJECTIVES: To evaluate the association between enthesitis resolution (ER) and dactylitis resolution (DR) and meaningful improvements in patient-reported outcomes (PROs) among biologic-naïve patients with PsA receiving guselkumab in the DISCOVER-2 study.
METHODS: Enthesitis and dactylitis, characteristic lesions of PsA, were evaluated by independent assessors using the Leeds Enthesitis Index (range, 0-6) and Dactylitis Severity Score (range, 0-60). Proportions of patients with ER or DR (score = 0) among those with score > 0 at baseline were determined at weeks 24, 52, and 100. PROs included: fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue]), pain (0-100 visual analog scale), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), and health-related quality of life (36-item Short-Form Health Survey physical/mental component summary [SF-36 PCS/MCS]). Meaningful responses were defined as: improvements of = 4 for FACIT-Fatigue, = 0.35 for HAQ-DI, and = 5 for SF-36 PCS/MCS and absolute scores of = 15 for minimal pain and = 0.5 for normalized HAQ-DI. Associations between ER/DR status and PRO response status were tested using a Chi-square test.
RESULTS: Guselkumab-treated patients with ER were more likely than those without ER to achieve minimal pain (p < 0.001), normalized HAQ-DI (p < 0.001), and PCS response (p < 0.05) at weeks 24, 52, and 100. Patients with DR were more likely than those without DR to achieve FACIT-Fatigue response at week 24 and week 52 (both p = 0.01) and minimal pain at week 24 and normalized HAQ-DI at week 52 (both p = 0.03).
CONCLUSION: In biologic-naïve patients with active PsA treated with guselkumab, achieving ER or DR was associated with durable improvements in selected PROs, including those of high importance to patients.
TRIAL REGISTRATION: ClinicalTrials.gov ( https://clinicaltrials.gov ) NCT03158285; Registered: May 16, 2017. Key Points • At week 100, 65% and 76% of guselkumab-treated patients achieved enthesitis and dactylitis resolution (ER/DR). • Achieving ER was associated with achieving DR and vice versa through the end of study. • Achieving ER or DR was associated with durable and meaningful improvements in selected patient-reported outcomes.
Clinical Institute
Orthopedics & Sports Medicine
Specialty/Research Institute
Rheumatology
Specialty/Research Institute
Orthopedics
Specialty/Research Institute
Pharmacy
DOI
10.1007/s10067-024-06921-8
