en
Scientific article
Open access
English

Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced

Published inRMD open, vol. 7, no. 1, e001457
Publication date2021-02
Abstract

Objective: Evaluation of the efficacy and safety of guselkumab, a human monoclonal antibody targeting the interleukin-23p19 subunit, in patients with psoriatic arthritis (PsA) through 1 year.

Methods: Adults who met ClASsification criteria for Psoriatic ARthritis, with active disease (≥3 swollen and ≥3 tender joints; C reactive protein ≥0.3 mg/dL) despite standard treatment (31% previously received ≤2 tumour necrosis factor inhibitors (TNFi)), were randomised (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week0, Week4, then Q8W; or placebo with cross-over to guselkumab 100 mg Q4W at Week24 (PBO→Q4W) through Week48. Clinical efficacy through Week52 (employing non-responder imputation) and adverse events (AEs) through Week60 were evaluated.

Results: Of 381 treated patients, 90% completed the study. Numerical increases in the proportions of patients achieving ≥20% improvement in ACR criteria (ACR20) were observed post-Week24, reaching 73% (94/128) and 60% (76/127) for Q4W-randomised and Q8W-randomised patients, respectively, by Week52. Proportions of patients achieving ACR50/ACR70/skin responses and minimal/very low disease activity were maintained, as were improvements in physical function and health-related quality of life, through Week52 in guselkumab-randomised patients. Response to guselkumab was maintained in both TNFi-naïve and TNFi-experienced patients. Serious AEs and serious infections occurred in similar proportions of guselkumab Q4W-randomised (3% and 0%) and Q8W-randomised (6% and 2%) patients through Week60, with no new safety concerns versus observations through Week24. No guselkumab-treated patient and two patients receiving placebo died; no study participant developed opportunistic infection or inflammatory bowel disease.

Conclusion: Guselkumab provided sustained improvement across multiple clinical manifestations of PsA, maintaining a favourable benefit-risk profile, through 1 year regardless of prior TNFi exposure.

eng
Keywords
  • Arthritis
  • Biological therapy
  • Cytokines
  • Psoriatic
  • Tumor necrosis factor inhibitors
  • Adult
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents / adverse effects
  • Arthritis, Psoriatic / drug therapy
  • Biological Products / therapeutic use
  • Humans
  • Interleukin-23 Subunit p19
  • Quality of Life
Funding
  • Janssen Research and Development -
Citation (ISO format)
RITCHLIN, Christopher T et al. Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced. In: RMD open, 2021, vol. 7, n° 1, p. e001457. doi: 10.1136/rmdopen-2020-001457
Main files (1)
Article (Published version)
Secondary files (3)
Identifiers
ISSN of the journal2056-5933
121views
49downloads

Technical informations

Creation03/11/2022 12:15:00 PM
First validation03/11/2022 12:15:00 PM
Update time03/16/2023 2:57:02 AM
Status update03/16/2023 2:56:59 AM
Last indexation05/06/2024 10:30:35 AM
All rights reserved by Archive ouverte UNIGE and the University of GenevaunigeBlack