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

Christopher T. Ritchlin, Philip S. Helliwell, Wolf Henning Boehncke, Enrique R. Soriano, Elizabeth C. Hsia, Alexa P. Kollmeier, Soumya D. Chakravarty, Federico Zazzetti, Ramanand A. Subramanian, Xie L. Xu, Qing C. Zuraw, Shihong Sheng, Yusang Jiang, Prasheen Agarwal, Bei Zhou, Yanli Zhuang, May Shawi, Chetan S. Karyekar, Atul Deodhar

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article number001457
JournalRMD open
Volume7
Issue number1
DOIs
StatePublished - Feb 10 2021

Keywords

  • arthritis
  • biological therapy
  • cytokines
  • psoriatic
  • tumor necrosis factor inhibitors

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

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