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Clinical Rheumatology
Published in: Clinical Rheumatology 5/2024

Open Access 12-03-2024 | Guselkumab | ORIGINAL ARTICLE

Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis

Authors: Proton Rahman, Iain B. McInnes, Atul Deodhar, Georg Schett, Phillip J. Mease, May Shawi, Daniel J. Cua, Jonathan P. Sherlock, Alexa P. Kollmeier, Xie L. Xu, Shihong Sheng, Christopher T. Ritchlin, Dennis McGonagle

Published in: Clinical Rheumatology | Issue 5/2024

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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.
Appendix
Available only for authorised users
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Metadata
Title
Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis
Authors
Proton Rahman
Iain B. McInnes
Atul Deodhar
Georg Schett
Phillip J. Mease
May Shawi
Daniel J. Cua
Jonathan P. Sherlock
Alexa P. Kollmeier
Xie L. Xu
Shihong Sheng
Christopher T. Ritchlin
Dennis McGonagle
Publication date
12-03-2024
Publisher
Springer International Publishing
Published in
Clinical Rheumatology / Issue 5/2024
Print ISSN: 0770-3198
Electronic ISSN: 1434-9949
DOI
https://doi.org/10.1007/s10067-024-06921-8

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