Janssen Reveals Positive Results from Phase 3 Trial of Guselkumab in Psoriatic Arthritis Treatment

Results of a Phase 3 clinical trial of TREMFYA® (guselkumab) have been shown to provide sustainable improvements in all minimal disease activity (MDA) in adults living with active psoriatic arthritis (PsA) who previously had an inadequate response to one to two tumor necrosis factor inhibitors (TNFi-IR).

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the results of their COSMOS study which included adults who had been diagnosed with active PsA and had a history of inadequate responses to 1 or 2 TNFi-IR.

guselkumab

The study measured the safety and efficacy of guselkumab in achieving sustained improvements across all MDA domains for a 48-week period.

Researchers evaluated disease-specific, physician-reported domains as well as patient-driven domains 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 Area and Severity Index (PASI), swollen joint count (SJC), and tender joint count (TJC).

The following results were recorded at weeks 24 and 48 respectively:

PASI – 66.8% and 81.5%

LEI – 74.5% and 79.8%

SJC – 46.2% and 63.0%

Patient GA – 24.5% and 39.9%

HAQ-DI – 26.1% and 37.0%

TJC – 14.7% and 28.3%

The results of this latest study contradict a prior one which revealed a minority of patients with active PsA receiving biologic therapy are able to achieve sustained MDA.

“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. 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.”

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