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Journal article
Efficacy of guselkumab, a selective IL-23 inhibitor, in Preventing Arthritis in a Multicentre Psoriasis At-Risk cohort (PAMPA): protocol of a randomised, double-blind, placebo controlled multicentre trial
BMJ open, v 12(12), e063650
23 Dec 2022
PMID: 36564123
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Introduction
Psoriatic arthritis (PsA) is a complex, immune-mediated disease associated with skin psoriasis that, if left untreated, can lead to joint destruction. Up to 30% of patients with psoriasis progress to PsA. In most cases, psoriasis precedes synovio-entheseal inflammation by an average of 5–7 years, providing a unique opportunity for early and potentially preventive intervention in a susceptible and identifiable population. Guselkumab is an effective IL-23p19 inhibitor Food and Drug Administration (FDA)-approved for treatment of moderate-to-severe psoriasis and PsA. The Preventing Arthritis in a Multicentre Psoriasis At-Risk cohort (PAMPA) study aims to evaluate the efficacy of guselkumab in preventing PsA and decreasing musculoskeletal power Doppler ultrasound (PDUS) abnormalities in a population of patients with psoriasis who are at-increased risk for PsA progression.
Methods and analysis
The PAMPA study is a multicentre, randomised, double-blind, placebo-controlled, interventional, preventive trial comparing PDUS involvement and conversion to PsA in patients with psoriasis at-increased risk for progression treated with guselkumab compared with non-biological standard of care. The study includes a screening period, a double-blind treatment period (24 weeks) and an open-label follow-up period (72 weeks). At baseline, 200 subjects will be randomised (1:1) to receive either guselkumab 100 mg (arm 1) or placebo switching to guselkumab 100 mg starting at week 24 (arm 2). Arm 3 will follow 150 at-risk psoriasis patients who decline biological therapy and randomisation. Changes from baseline in the PDUS score at week 24 and the difference in proportion of patients transitioning to PsA at 96 weeks will be examined as the coprimary endpoints.
Ethics and dissemination
Ethics approval for this study was granted by the coordinating centre’s (NYU School of Medicine) Institutional Review Board (IRB). Each participating site received approval through their own IRBs. The findings will be shared in peer-reviewed articles and scientific conference presentations.
Trial registration number NCT05004727.
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Details
- Title
- Efficacy of guselkumab, a selective IL-23 inhibitor, in Preventing Arthritis in a Multicentre Psoriasis At-Risk cohort (PAMPA): protocol of a randomised, double-blind, placebo controlled multicentre trial
- Creators
- Rebecca H Haberman - New York UniversityKatrina A MacFarlane - New York UniversitySydney Catron - New York UniversityJonathan Samuels - New York UniversityRebecca B Blank - New York UniversityMichael Toprover - New York UniversityZakwan Uddin - New York UniversityJiyuan Hu - New York UniversityRochelle Castillo - New York UniversityCinty Gong - JanssenKun Qian - New York UniversityVincent Piguet - University of TorontoFrancisco Tausk - University of Rochester Medical CenterJensen Yeung - Women's College HospitalAndrea L Neimann - New York UniversityWayne Gulliver - Memorial University of NewfoundlandRalf G Thiele - University of Rochester Medical CenterJoseph F Merola - The University of Texas Southwestern Medical CenterAlexis Ogdie - University of PennsylvaniaProton Rahman - Memorial University of NewfoundlandSoumya D Chakravarty - Drexel University, General Internal MedicineLihi Eder - University of TorontoC T Ritchlin - University of Rochester Medical CenterJose U Scher - New York University
- Publication Details
- BMJ open, v 12(12), e063650
- Publisher
- British Medical Journal Publishing Group
- Grant note
- NA / Janssen Pharmaceuticals (http://dx.doi.org/10.13039/100008897)
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- College of Medicine; Rheumatology; General Internal Medicine
- Web of Science ID
- WOS:000933591600034
- Scopus ID
- 2-s2.0-85144638210
- Other Identifier
- 991021861214404721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Rheumatology