Long-Term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin-23, Through Two Years: Results From a Phase III, Randomized, Double-Blind, Placebo-Controlled Study Conducted in Biologic-Naive Patients With Active Psoriatic Arthritis

Iain B McInnes; Proton Rahman; Alice B Gottlieb; Elizabeth C Hsia; Alexa P Kollmeier; Xie L Xu; Yusang Jiang; Shihong Sheng; May Shawi; Soumya D Chakravarty; Désirée van der Heijde; Philip J Mease

doi:10.1002/art.42010

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Long-Term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin-23, Through Two Years: Results From a Phase III, Randomized, Double-Blind, Placebo-Controlled Study Conducted in Biologic-Naive Patients With Active Psoriatic Arthritis

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Long-Term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin-23, Through Two Years: Results From a Phase III, Randomized, Double-Blind, Placebo-Controlled Study Conducted in Biologic-Naive Patients With Active Psoriatic Arthritis

Iain B McInnes, Proton Rahman, Alice B Gottlieb, Elizabeth C Hsia, Alexa P Kollmeier, Xie L Xu, Yusang Jiang, Shihong Sheng, May Shawi, Soumya D Chakravarty, …

Arthritis & rheumatology (Hoboken, N.J.), v 74(3), pp 475-485

Mar 2022

DOI: https://doi.org/10.1002/art.42010

PMID: 34719872

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Abstract

Adult; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis, Psoriatic - diagnosis; Arthritis, Psoriatic - drug therapy; Arthritis, Psoriatic - immunology; Double-Blind Method; Female; Humans; Interleukin-23 Subunit p19 - immunology; Male; Middle Aged; Severity of Illness Index; Treatment Outcome

To assess long-term efficacy and safety of guselkumab, an interleukin-23 p19 subunit (IL-23p19) inhibitor, in patients with active psoriatic arthritis (PsA) from the phase III DISCOVER-2 trial. In the DISCOVER-2 trial, patients with active PsA (≥5 swollen joints and ≥5 tender joints; C-reactive protein level ≥0.6 mg/dl) despite prior nonbiologic therapy were randomized to receive the following: guselkumab 100 mg every 4 weeks; guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks; or placebo with crossover to guselkumab 100 mg every 4 weeks, beginning at week 24. Efficacy assessments included American College of Rheumatology ≥20%/50%/70% improvement criteria (ACR20/50/70), Investigator's Global Assessment (IGA) of psoriasis score of 0 (indicating complete skin clearance), resolution of enthesitis (Leeds Enthesitis Index) and dactylitis (Dactylitis Severity Score), and changes in the Sharp/van der Heijde modified radiographic scores for PsA. Clinical data (imputed as no response/no change from baseline if missing) and observed radiographic data were summarized through week 100; safety assessments continued through week 112. Of the 739 randomized and treated patients, 652 (88%) completed treatment through week 100. Across groups of guselkumab-treated patients (including those in the placebo-guselkumab crossover group), the following findings at week 100 indicated that amelioration of arthritis signs/symptoms and extraarticular manifestations was durable through 2 years: ACR20 response (68-76%), ACR50 response (48-56%), ACR70 response (30-36%), IGA score of 0 (55-67%), enthesitis resolution (62-70%), and dactylitis resolution (72-83%). Mean changes in the Sharp/van der Heijde modified score for PsA from weeks 52 to week 100 (range 0.13-0.75) indicated that the low rates of radiographic progression observed among guselkumab-treated patients at earlier time points extended through week 100. Through week 112, 8% (5.8 per 100 patient-years) and 3% (1.9 per 100 patient-years) of the 731 guselkumab-treated patients had a serious adverse event or serious infection, respectively; 1 death occurred (road traffic accident). In biologic-naive PsA patients, guselkumab provided durable improvements in multiple disease domains with no unexpected safety findings through 2 years.

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Title: Long-Term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin-23, Through Two Years: Results From a Phase III, Randomized, Double-Blind, Placebo-Controlled Study Conducted in Biologic-Naive Patients With Active Psoriatic Arthritis
Creators: Iain B McInnes - University of Glasgow
Proton Rahman - Memorial University of Newfoundland
Alice B Gottlieb - Icahn School of Medicine at Mount Sinai
Elizabeth C Hsia - Janssen Research & Development, LLC, Spring House PA USA
Alexa P Kollmeier - Janssen Research & Development LLC, Spring House, PA, USA
Xie L Xu - Janssen Research & Development LLC, Spring House, PA, USA
Yusang Jiang - Janssen Research & Development LLC, Spring House, PA, USA
Shihong Sheng - Janssen Research & Development LLC, Spring House, PA, USA
May Shawi - Johnson & Johnson
Soumya D Chakravarty - Drexel University
Désirée van der Heijde - Leiden University Medical Center
Philip J Mease - Swedish Medical Center/Providence St. Joseph Health University of Washington Seattle WA USA
Publication Details: Arthritis & rheumatology (Hoboken, N.J.), v 74(3), pp 475-485
Publisher: Wiley
Resource Type: Journal article
Language: English
Academic Unit: Rheumatology
Web of Science ID: WOS:000752004800001
Scopus ID: 2-s2.0-85120694804
Other Identifier: 991019167461204721

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Collaboration types: Industry collaboration; Domestic collaboration; International collaboration
Web of Science research areas: Rheumatology