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Janssen Announces Positive Results From Guselkumab Psoriatic Arthritis Trial

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The phase 3b trial showed improvements to minimal disease activity in adults with the condition.

In adults with active psoriatic arthritis (PsA) and prior inadequate responses to tumor necrosis factor inhibitors (TNFi-IR), guselkumab (Tremfya; Janssen) provided consistent and sustained improvements to minimal disease activity domains.

and.one/AdobeStock
and.one/AdobeStock

Janssen announced the results of its phase 3b COSMOS clinical trial evaluating the drug’s safety and efficacy in a press release1. The study is 1 of several abstracts the company will be presenting at the 2023 Annual European Congress of Rheumatology (EULAR) meeting in Milan, Italy, this week.

“Our continued research underscores Janssen’s commitment to not only provide therapeutic options for psoriatic disease, but also to better understand and support the pressing needs of the patients we serve,” said Terence Rooney, MD, PhD, in the press release. Rooney is vice president, Rheumatology and Maternal-Fetal Immunology Disease area leader for Janssen Research & Development, LLC. “Active psoriatic arthritis is a challenging, chronic disease, so these findings have important implications for patients and their providers as they work together to address the full spectrum of disease symptoms, including patient-reported outcomes, with the goal of achieving long-term relief.”

Adults who had been diagnosed with active PsA and had a history of inadequate responses to 1 or 2 TNFi-IR (n=189) were eligible for participation in the trial. Researchers measured the efficacy of guselkumab in achieving sustained improvements across all MDA domains for a 48-week period.

Throughout the trial, researchers evaluated disease-specific, physician-reported domains and patient-driven domains, particularly at weeks 24 and 48. These included Health Assessment Questionnaire – Disability Index (HAQ-DI), Leeds Enthesitis Index (LEI), patient global assessment (GA), patient pain, Psoriasis Areaand Severity Index (PASI), swollen joint count (SJC), and tender joint count (TJC).

Between week 24 and 48, all domains experienced improvement.

Week 24 Domains:

  • HAQ-DI: 26.1%
  • LEI: 74.5%
  • Patient GA: 24.5%
  • Patient pain: 14.7%
  • PASI: 66.8%
  • SJC: 46.2%
  • TJC: 14.7%

Week 48 Domains:

  • HAQ-DI: 37.0%
  • LEI: 79.8%
  • Patient GA: 39.9%
  • Patient pain: 30.6%
  • PASI: 81.5%
  • SJC: 63.0%
  • TJC: 28.3%

These results contradict those of a prior trial stating that a minority of patients with active PsA receiving biologic therapy are able to achieve sustained MDA, according to the press release.

“Assessing patient-reported symptoms is a vital part of our research that helps us to address unmet needs and provide treatments that can improve outcomes,” said Laura Coates, MD, PhD, in the press release. Coates is a senior clinical research fellow at the University of Oxford. “These results advance our understanding of the psoriatic arthritis patient experience and will help healthcare professionals develop individualized treatment plans that can target debilitating symptoms and, ultimately, aim to improve quality of life for people living with psoriatic arthritis.”

Reference

  1. Tremfya (guselkumab) provides sustained improvements across all minimal disease activity domains for adults living with active psoriatic arthritis in phase 3B trial. Janssen. May 31, 2023. Accessed May 31, 2023. https://www.janssen.com/tremfyar-guselkumab-provides-sustained-improvements-across-all-minimal-disease-activity-domains.
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