Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis.


Journal

Rheumatology (Oxford, England)
ISSN: 1462-0332
Titre abrégé: Rheumatology (Oxford)
Pays: England
ID NLM: 100883501

Informations de publication

Date de publication:
01 02 2023
Historique:
received: 04 03 2022
accepted: 18 06 2022
pubmed: 30 6 2022
medline: 4 2 2023
entrez: 29 6 2022
Statut: ppublish

Résumé

To evaluate the efficacy of guselkumab for the treatment of active PsA utilizing composite indices. Data were pooled from the phase 3 DISCOVER-1 (n = 381) and DISCOVER-2 (n = 739) studies. In both studies, patients were randomized 1:1:1 to subcutaneous guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, then Q8W; or placebo Q4W with crossover to guselkumab 100 mg Q4W at week 24. Composite indices used to assess efficacy through week 52 included Disease Activity Index for Psoriatic Arthritis (DAPSA), Psoriatic Arthritis Disease Activity Score (PASDAS), minimal disease activity (MDA), and very low disease activity (VLDA). Through week 24, treatment failure rules were applied. Through week 52, non-responder imputation was used for missing data. Greater proportions of guselkumab- than placebo-treated patients achieved DAPSA low disease activity (LDA) and remission, PASDAS LDA and VLDA, MDA, and VLDA at week 24 vs placebo (all unadjusted P < 0.05). At week 52, in the guselkumab Q4W and Q8W groups, respectively, response rates were as follows: DAPSA LDA, 54.2% and 52.5%; DAPSA remission, 18.2% and 17.6%; PASDAS LDA, 45.3% and 41.9%; PASDAS VLDA, 16.9% and 19.5%; MDA, 35.9% and 30.7%; and VLDA, 13.1% and 14.4%. In the placebo-crossover-to-guselkumab group, response rates for all composite indices increased after patients switched to guselkumab, from week 24 through week 52. Treatment with guselkumab provided robust and sustained benefits across multiple PsA domains through 1 year, indicating that guselkumab is an effective therapy for the diverse manifestations of PsA. NCT03162796; NCT03158285.

Identifiants

pubmed: 35766811
pii: 6619576
doi: 10.1093/rheumatology/keac375
pmc: PMC9891416
doi:

Substances chimiques

guselkumab 089658A12D
Antirheumatic Agents 0
Antibodies, Monoclonal, Humanized 0

Banques de données

ClinicalTrials.gov
['NCT03162796', 'NCT03158285']

Types de publication

Randomized Controlled Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

606-616

Subventions

Organisme : Department of Health
Pays : United Kingdom

Informations de copyright

© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.

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Auteurs

Laura C Coates (LC)

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Christopher T Ritchlin (CT)

Department of Medicine, Allergy/Immunology and Rheumatology, University of Rochester Medical Center, Rochester, NY, USA.

Laure Gossec (L)

Department of Rheumatology, Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Sorbonne Université, Paris.
Rheumatology Department, Pitié-Salpêtrière Hospital, AP-HP, Paris, France.

Philip S Helliwell (PS)

Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.

Proton Rahman (P)

Discipline of Medicine, Division of Rheumatology, Craig L Dobbin Genetics Research Centre, Memorial University of Newfoundland, St Johns, NL, Canada.

Alexa P Kollmeier (AP)

Department of Immunology, Janssen Research & Development, LLC, San Diego, CA.

Xie L Xu (XL)

Department of Immunology, Janssen Research & Development, LLC, San Diego, CA.

May Shawi (M)

Immunology, Rheumatology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham.

Chetan S Karyekar (CS)

Department of Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.

Christine Contré (C)

Janssen Cilag, Issy-les-Moulineaux, Île-de-France, France.

Wim Noël (W)

Department of Immunology, Janssen Scientific Affairs, LLC, Brussels, Belgium.

Shihong Sheng (S)

Department of Statistics and Decision Sciences, Immunology, Janssen Research & Development, LLC, Spring House, PA.

Yanli Wang (Y)

Department of Statistics and Decision Sciences, Immunology, Janssen Research & Development, LLC, Spring House, PA.

Stephen Xu (S)

Department of Statistics and Decision Sciences, Immunology, Janssen Research & Development, LLC, Spring House, PA.

Philip J Mease (PJ)

Department of Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health.
University of Washington, Rheumatology Research, Seattle, WA, USA.

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