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Journal article
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, v 5(4), pp 227-240
Apr 2023
PMID: 36880890
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.
Metrics
Details
- Title
- 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
- Creators
- Dennis McGonagle - NIHR Leeds Musculoskeletal Biomedical Research UnitIain B. B. McInnes - University of GlasgowAtul Deodhar - Oregon Health & Science UniversityGeorg Schett - Friedrich-Alexander-Universität Erlangen-NürnbergMay Shawi - JanssenSoumya D. D. Chakravarty - Drexel University, General Internal MedicineAlexa P. P. Kollmeier - Janssen Res & Dev LLC, San Diego, CA USAXie L. L. Xu - JanssenShihong Sheng - Janssen Res & Dev LLC, Immunol Biostat, Spring House, PA USAStephen Xu - Janssen Res & Dev LLC, Immunol Biostat, Spring House, PA USAChristopher T. T. Ritchlin - University of Rochester Medical CenterProton Rahman - Memorial University of NewfoundlandPhillip J. J. Mease - University of Washington
- Publication Details
- ACR open rheumatology, v 5(4), pp 227-240
- Publisher
- Wiley
- Number of pages
- 14
- Grant note
- Janssen Research & Development, LLC
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Rheumatology; General Internal Medicine
- Web of Science ID
- WOS:000944311000001
- Scopus ID
- 2-s2.0-85150416689
- Other Identifier
- 991021861298704721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Rheumatology