Journal article
Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial
Trials, v 26(1), p96
19 Mar 2025
PMID: 40102973
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Psoriatic arthritis (PsA) is a multi-domain, inflammatory disease impacting joints, soft tissues, and skin; tumor necrosis factor inhibitors (TNFi) are typically the first biologic following inadequate response (IR) to conventional therapies. Although guidance is lacking on therapy selection after initial TNFi failure, data suggest TNFi-IR PsA patients may benefit from switching to a different mechanism of action (MOA) vs. cycling to another TNFi. Guselkumab is a fully human monoclonal antibody targeting the interleukin-23p19 subunit. Emphasizing practicality and applicability to routine clinical practice, EVOLUTION will pragmatically evaluate whether switching to guselkumab is more effective than cycling to a second TNFi (subcutaneous [SC] golimumab) in TNFi-IR PsA patients.
The multicenter, longitudinal, prospective, observational Psoriatic Arthritis Research Consortium study guided eligibility criteria, outcome measures, and sample size estimates. Adults seen in clinical practice with active PsA (≥ 1 swollen joint) while receiving TNFi treatment will be eligible. Participants will be randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week 0, Week 4, and Q8W; or SC golimumab 50 mg Q4W (no washout period). The novel primary composite endpoint is achievement of clinical Disease Activity in Psoriatic Arthritis (cDAPSA) low disease activity (≤ 13) and an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 (scale: 0-4) at Month12. Secondary endpoints include cDAPSA + IGA 0/1 at Month 6; achievement of minimal disease activity, resolution of enthesitis and dactylitis (among patients affected at baseline) at Months 6/12; and mean changes at Months 6/12 in the 12-item PsA Impact of Disease, Dermatology Life Quality Index, Patient-Reported Outcomes Measurements Information System fatigue and depression questionnaires, and Bath Ankylosing Spondylitis Disease Activity Index (patients with physician-determined axial disease). The target sample size is 150 participants (50/treatment group); all analyses are considered exploratory.
EVOLUTION will employ a pragmatic approach, including a novel primary endpoint relevant to clinical practice, to assess whether switching to an alternate MOA biologic with guselkumab is more effective than cycling to a second TNFi among TNFi-IR PsA patients.
This trial was registered at ClinicalTrials.gov, NCT05669833, on 3 January 2023, https://www.
gov/study/NCT05669833?term=%20NCT05669833&rank=1.
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Details
- Title
- Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial
- Creators
- Alexis Ogdie - University of PennsylvaniaSoumya M Reddy - New York UniversitySarah H Gillespie - University of PennsylvaniaM Elaine Husni - Cleveland ClinicJose U Scher - New York UniversityKaren Salomon-Escoto - University of Massachusetts Chan Medical SchoolJonathan Kay - University of Massachusetts Chan Medical SchoolBrent A Luedders - University of Nebraska Medical CenterJeffrey R Curtis - University of Alabama at BirminghamAlisa J Stephens Shields - University of PennsylvaniaSoumya D Chakravarty - Johnson & JohnsonCinty Gong - Johnson & JohnsonJessica A Walsh - University of Utah
- Publication Details
- Trials, v 26(1), p96
- Publisher
- BMC; LONDON
- Number of pages
- 15
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Rheumatology; General Internal Medicine
- Web of Science ID
- WOS:001451210600001
- Scopus ID
- 2-s2.0-105000819708
- Other Identifier
- 991022041489804721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Medicine, Research & Experimental