Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis.
Clin Rheumatol
; 43(5): 1591-1604, 2024 May.
Article
en En
| MEDLINE
| ID: mdl-38472528
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.Palabras clave
Texto completo:
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Base de datos:
MEDLINE
Asunto principal:
Productos Biológicos
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Artritis Psoriásica
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Antirreumáticos
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Anticuerpos Monoclonales Humanizados
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Entesopatía
Límite:
Humans
Idioma:
En
Revista:
Clin Rheumatol
Año:
2024
Tipo del documento:
Article
País de afiliación:
Canadá