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. 2024 May;43(5):1591-1604.
doi: 10.1007/s10067-024-06921-8. Epub 2024 Mar 12.

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

Proton Rahman  1 , Iain B McInnes  2 , Atul Deodhar  3 , Georg Schett  4 , Phillip J Mease  5   6 , May Shawi  7 , Daniel J Cua  8 , Jonathan P Sherlock  8   9 , Alexa P Kollmeier  10 , Xie L Xu  10 , Shihong Sheng  8 , Christopher T Ritchlin  11 , Dennis McGonagle  12
Affiliations

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

Proton Rahman et al. Clin Rheumatol. 2024 May.

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.

Keywords: Biologic; Dactylitis; Enthesitis; Guselkumab; Psoriatic arthritis.

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Conflict of interest statement

PR has received consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; meeting attendance/travel support from Janssen; and research grants from Janssen and Novartis. IBM has received consultant fees from AbbVie, Amgen, Astra Zeneca, Bristol Myers Squibb, Cabaletta, Compugen, Eli Lilly, Gilead, Glaxo Smith Kline, Janssen, Novartis, Pfizer, Roche, Sanofi, and UCB; grant/research support from Amgen, Astra Zeneca, Bristol Myers Squibb, Eli Lilly, Glaxo Smith Kline, Janssen, Novartis, Roche, and UCB; is a shareholder for Causeway Therapeutics, and Evelo Compugen; NHS GGC Board Member; Evelo Board of Directors; and Versus Arthritis Trustee. AD has received consulting fees for participation in Advisory Boards from AbbVie, Amgen, Aurinia, Bristol Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, MoonLake, Novartis, Pfizer, and UCB; Research Grant funding from AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and UCB; and Speaker fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. GS has received speaker fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, and Novartis. PJM has received research grants from AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, SUN Pharma, and UCB; consulting fees from AbbVie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Immagene, Janssen, Moonlake Pharma, Novartis, Pfizer, SUN Pharma, UCB, Ventyx, and Xinthera; and speaker fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. MS, DJC, JPS, APK, XLX, SS are all employees of Janssen (a subsidiary of Johnson & Johnson) and own Johnson & Johnson stock and/or stock options. CTR has received research support from AbbVie, Amgen, and UCB; consultant fees from AbbVie, Amgen, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB. DM has received grants/research support: AbbVie, Celgene, Janssen, Merck, Pfizer, Novartis; receipt of honoraria or consultation fees: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, UCB; participation in speaker’s bureau: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, UCB.

Figures

Fig. 1
Fig. 1
Proportion of patients achieving ER or DR among those with and without resolution of the other based on observed data at weeks 24, 52, and 100: a) DR among patients who did vs. did not achieve ER; and b) ER among patients who did vs. did not achieve DR. DR, dactylitis resolution; ER, enthesitis resolution
Fig. 2
Fig. 2
Proportion of patients achieving fatigue response and minimal pain among those with vs. without ER or DR based on observed data at weeks 24, 52, and 100: Proportion of patients achieving fatigue and minimal pain responses among those with and without ER or DR based on observed data at weeks 24, 52, and 100: a) FACIT-Fatigue response and b) minimal pain response in patients with vs. without ER; c) FACIT-Fatigue response and d) minimal pain response in patients with vs. without DR. DR, dactylitis resolution; ER, enthesitis resolution; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-Fatigue response, ≥ 4 point improvement; pain response, ≤ 15 on 100-unit visual analog scale; PRO, patient-reported outcome
Fig. 3
Fig. 3
Proportion of patients achieving physical function response among those with vs. without ER or DR based on observed data at weeks 24, 52, and 100: a) HAQ-DI response and b) normalized HAQ-DI in patients with vs. without ER; c) HAQ-DI response and d) normalized HAQ-DI in patients with vs. without DR. DR, dactylitis resolution; ER, enthesitis resolution; HAQ-DI, Health-Assessment Questionnaire-Disability Index; HAQ-DI response, ≥ 0.35 point improvement in HAQ-DI score; normalized HAQ-DI, score of ≤ 0.5; PRO, patient-reported outcome
Fig. 4
Fig. 4
Proportion of patients achieving HRQoL response among those with vs. without ER or DR based on observed data at weeks 24, 52, and 100: a) SF-36 PCS response and b) SF-36 MCS response in patients with vs. without ER; c) SF-36 PCS response and d) SF-36 MCS response in patients with vs. without DR. DR, dactylitis resolution; ER, enthesitis resolution; HRQoL, health-related quality of life; MCS, mental component summary; PCS, physical component summary; PRO, patient-reported outcome; SF-36, 36-item Short-Form Health Survey; SF-36 PCS response, ≥ 5 point improvement in SF-36 PCS; SF-36 MCS response, ≥ 5 point improvement in SF-36 MCS
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