Journal article
Persistent Patient-Level Effect of Guselkumab at Consecutive 8-Week Dosing Visits and Over Time in Patients With Active Psoriatic Arthritis: Post Hoc Analysis of a 2-Year, Phase 3, Randomized, Controlled Study
ACR open rheumatology
04 Oct 2024
PMID: 39365294
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
ObjectiveGroup-level analyses from the phase 3 DISCOVER-2 trial of guselkumab demonstrated robust and durable improvements across psoriatic arthritis (PsA) domains. To specifically evaluate continuous disease control in individual patients, persistence of clinically relevant improvements was assessed, both at consecutive guselkumab dosing visits and over time.MethodsPost hoc analyses included biologic-na & iuml;ve patients randomized to 100 mg of guselkumab at week 0, week 4, and then every 8 weeks (Q8W). Improvements in joint (minimal clinically important improvement [MCII] in Disease Activity Index for PsA [DAPSA; >= 7.25], clinical DAPSA [cDAPSA; >= 5.7]), skin (Investigator's Global Assessment [IGA] 0/1), and overall disease activity (patient global assessment of arthritis and psoriasis [PtGA Arthritis+Psoriasis; MCII >= 15 mm], PsA Disease Activity Score [PASDAS; MCII >= 0.8]) were assessed. Proportions of patients with maintenance of DAPSA and cDAPSA MCII at consecutive Q8W guselkumab dosing visits (ie, at weeks 4 and 12, weeks 12 and 20, etc through week 52) and patient-level durability of response through week 100 (Kaplan-Meier) were determined.ResultsAmong 248 patients randomized to guselkumab Q8W, 93% to 99% maintained clinical improvement in joint disease at consecutive Q8W dosing visits through week 52 across time periods. Among guselkumab patients achieving MCII by week 24, estimated probabilities of maintenance of clinical improvement 100 weeks post achievement ranged from 68% (IGA 0/1) to 89% (PASDAS MCII). Median times to loss of improvement were not reached; estimated mean weeks of maintenance of improvement were 58.6, 52.4, 75.7, 83.6, and 76.7, respectively, for DAPSA, cDAPSA, IGA, PtGA Arthritis+Psoriasis, and PASDAS.ConclusionGuselkumab provided highly durable patient-level improvements, both at consecutive Q8W dosing visits for joint disease activity and over time across PsA domains according to physician- and patient-driven assessments.
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Details
- Title
- Persistent Patient-Level Effect of Guselkumab at Consecutive 8-Week Dosing Visits and Over Time in Patients With Active Psoriatic Arthritis: Post Hoc Analysis of a 2-Year, Phase 3, Randomized, Controlled Study
- Creators
- Philip J. Mease - Providence CollegeXenofon Baraliakos - Rheumazentrum RuhrgebietVinod Chandran - Arthritis SocietyEnrique R. Soriano - Hospital Italiano de Buenos AiresPeter Nash - Griffith UniversityAtul Deodhar - Oregon Health & Science UniversityEmmanouil Rampakakis - McGill UniversityNatalie J. Shiff - Johnson & JohnsonSoumya D. Chakravarty - Johnson & JohnsonMay Shawi - JanssenJoseph F. Merola - The University of Texas Southwestern Medical CenterIain B. Mcinnes - University of Glasgow
- Publication Details
- ACR open rheumatology
- Publisher
- Wiley
- Number of pages
- 11
- Grant note
- Janssen Research & Development, LLC.
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Rheumatology; General Internal Medicine
- Web of Science ID
- WOS:001325902300001
- Scopus ID
- 2-s2.0-85203601414
- Other Identifier
- 991021930322804721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Rheumatology