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
Joseph F Merola,
Lihi Eder,
Proton Rahman,
Soumya D Chakravarty,
Jose U Scher,
Alexis Ogdie,
Rebecca B Blank,
Vincent Piguet,
C T Ritchlin,
Jonathan Samuels,
Kun Qian,
Wayne Gulliver,
Ralf G Thiele,
Rebecca H Haberman,
Rochelle Castillo,
Cinty Gong,
Andrea L Neimann,
Katrina A MacFarlane,
Sydney Catron,
Michael Toprover,
Zakwan Uddin,
Jiyuan Hu,
Francisco Tausk,
Jensen Yeung
Affiliations
Joseph F Merola
Dermatology, Brigham and Women`s Hospital, Boston, Massachusetts, USA
Lihi Eder
Women`s College Research Institute, University of Toronto, Toronto, Ontario, Canada
Proton Rahman
Rheumatology, Memorial University, St John`s, Newfoundland, Canada
Soumya D Chakravarty
Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA
Jose U Scher
3 Division of Rheumatology, Department of Medicine and Psoriatic Arthritis Center, New York University Grossman School of Medicine, New York, New York, USA
Alexis Ogdie
Departments of Medicine/Rheumatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
Rebecca B Blank
3 Division of Rheumatology, Department of Medicine and Psoriatic Arthritis Center, New York University Grossman School of Medicine, New York, New York, USA
Vincent Piguet
University of Toronto, Toronto, Ontario, Canada
C T Ritchlin
9 Rheumatology, University of Rochester Medical Center, Rochester, New York, USA
Jonathan Samuels
1 Division of Rheumatology, Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA
Kun Qian
1 School of Medicine, Shanghai Jiaotong University, Shanghai, China
Wayne Gulliver
9Faculty of Medicine, Memorial University of Newfoundland, St. John`s, Newfoundland, Canada
Ralf G Thiele
Department of Medicine, Division of Allergy, Immunology, and Rheumatology, University of Rochester Medical Center, Rochester, NY, USA
Rebecca H Haberman
3 Division of Rheumatology, Department of Medicine and Psoriatic Arthritis Center, New York University Grossman School of Medicine, New York, New York, USA
Rochelle Castillo
1 Division of Rheumatology, Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA
Cinty Gong
Immunology, Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA
Andrea L Neimann
4 Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York, USA
Katrina A MacFarlane
Department of Medicine, Division of Rheumatology, New York University Grossman School of Medicine and Psoriatic Arthritis Center, NYU Langone Health, New York, New York, USA
Sydney Catron
Department of Medicine, Division of Rheumatology, New York University Grossman School of Medicine and Psoriatic Arthritis Center, NYU Langone Health, New York, New York, USA
Michael Toprover
Department of Medicine, Division of Rheumatology, New York University Grossman School of Medicine and Psoriatic Arthritis Center, NYU Langone Health, New York, New York, USA
Zakwan Uddin
Department of Medicine, Division of Rheumatology, New York University Grossman School of Medicine and Psoriatic Arthritis Center, NYU Langone Health, New York, New York, USA
Jiyuan Hu
Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA
Francisco Tausk
Department of Dermatology, University of Rochester Medical Center, Rochester, New York, USA
Jensen Yeung
Division of Dermatology, Department of Medicine, Women`s College Hospital, Toronto, Ontario, Canada
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.
