Guselkumab, a Selective Interleukin-23 p19 Subunit Inhibitor, Resolves Dactylitis in Patients With Active Psoriatic Arthritis: Pooled Results Through Week 52 From Two Phase 3 Studies

Mcgonagle D, Mcinnes IBB, Deodhar A, Schett G, Shawi M, Chakravarty SDD, Kollmeier APP, Xu XLL, Sheng S, Xu S, Ritchlin CTT, Rahman P, Mease PJJ (2023)

Publication Type: Journal article

Publication year: 2023

Journal

ACR Open Rheumatology Wiley

DOI: 10.1002/acr2.11537

Abstract

Objective: Previous analyses of pooled DISCOVER-1 and DISCOVER-2 data through Week 24 showed significantly higher rates of dactylitis resolution in patients treated with guselkumab compared with placebo. Here, we investigate associations between dactylitis resolution and other outcomes through 1 year. Methods: Patients were randomized 1:1:1 to receive subcutaneous injections of guselkumab 100 mg at Week 0, Week 4, and then every 4 or 8 weeks, or placebo with crossover to guselkumab at Week 24. Independent assessors determined dactylitis severity score (DSS; 0-3/digit; total = 0-60). Dactylitis resolution (DSS = 0) (prespecified) and at least 20%, at least 50%, and at least 70% DSS improvement from baseline (post hoc) were determined through Week 52 (nonresponder imputation for treatment failure through Week 24 and for missing data through Week 52). ACR50, tender/swollen joints, low disease activity (LDA) as assessed by composite indices, and radiographic progression (DISCOVER-2 only) were assessed in patients with dactylitis versus without dactylitis resolution at Week 24 and Week 52. Results: Patients with dactylitis at baseline (473 of 1118) had more severe joint and skin disease than those without dactylitis (645 of 1118). At Week 52, approximately 75% of guselkumab-randomized patients with dactylitis at baseline had complete resolution; approximately 80% had at least 70% DSS improvement. Through Week 52, new-onset dactylitis (DSS ≥1) was uncommon among patients with a DSS of 0 at baseline. Guselkumab-randomized patients with dactylitis resolution were more likely to achieve ACR50, at least 50% reduction in tender and swollen joints, and LDA at Week 24 and Week 52 than those without resolution. At Week 52, patients with dactylitis resolution had numerically less radiographic progression from baseline (DISCOVER-2). Conclusion: Through 1 year, approximately 75% of guselkumab-randomized patients had complete resolution of dactylitis; patients exhibiting resolution were more likely to achieve other important clinical outcomes. Given the high burden of dactylitis, resolution may be associated with better long-term patient outcomes.

Authors with CRIS profile

Georg Schett Lehrstuhl für Innere Medizin III

Involved external institutions

Janssen Pharmaceutica NV BE Belgium (BE) Janssen Biologics BV NL Netherlands (NL) University of Leeds GB United Kingdom (GB) University of Washington US United States (USA) (US) Memorial University of Newfoundland (MUN) CA Canada (CA) Janssen Global Services, LLC US United States (USA) (US) Oregon Health and Science University (OSHU) US United States (USA) (US) University of Glasgow GB United Kingdom (GB) University of Rochester (UR) US United States (USA) (US)

How to cite

APA:

Mcgonagle, D., Mcinnes, I.B.B., Deodhar, A., Schett, G., Shawi, M., Chakravarty, S.D.D.,... Mease, P.J.J. (2023). Guselkumab, a Selective Interleukin-23 p19 Subunit Inhibitor, Resolves Dactylitis in Patients With Active Psoriatic Arthritis: Pooled Results Through Week 52 From Two Phase 3 Studies. ACR Open Rheumatology. https://dx.doi.org/10.1002/acr2.11537

MLA:

Mcgonagle, Dennis, et al. "Guselkumab, a Selective Interleukin-23 p19 Subunit Inhibitor, Resolves Dactylitis in Patients With Active Psoriatic Arthritis: Pooled Results Through Week 52 From Two Phase 3 Studies." ACR Open Rheumatology (2023).

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