United States-based pharmaceutical, biotechnology and medical technologies corporation Johnson & Johnson (NYSE: JNJ) announced on Friday that it has achieved its primary endpoint in the Phase 3b APEX study of TREMFYA (guselkumab).
The product achieved both its primary endpoint (ACR20a) of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis (PsA), compared to placebo.
TREMFYA, claimed to be the first and only fully-human, dual-acting monoclonal antibody, is approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23.
In the Phase 3b APEX study, TREMFYA-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 sub-scores. Data were consistent with the well-established safety profile of TREMFYA with no new safety signals identified.
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