Guselkumab (Tremfya, Johnson & Johnson Innovative Medicine) achieved its primary endpoint of reducing signs and symptoms of active psoriatic arthritis (PsA), compared to placebo in the Phase 3b APEX study.
The study’s primary endpoint was an American College of Rheumatology (ACR20), a measure of treatment response, defined as a 20% improvement in both tender joint count and swollen joint count, along with a 20% improvement in other core measures.
In the study, guselkumab-treated patients also exhibited significantly less progression of structural damage versus patients receiving placebo at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score, which includes joint space narrowing and erosion subscores. Data were consistent with the safety profile of guselkumab with no new safety signals identified.
APEX is a Phase 3b study with long-term extension data through three years that will further assess the sustained efficacy of interleukin-23 (IL23)-inhibition with guselkumab on structural damage in patients with active PsA. Results from the APEX study are being prepared for presentation at upcoming medical congresses.
