Johnson & Johnson has reported positive topline results from its Phase IIIb APEX trial evaluating Tremfya (guselkumab) in adults with active psoriatic arthritis (PsA) who had not responded adequately to standard therapies and were biologic-naïve. At 24 weeks, the fully-human monoclonal antibody met both its primary and major secondary endpoints, significantly reducing PsA signs and symptoms compared to placebo. Tremfya also showed efficacy in slowing structural joint damage, measured by the PsA-modified van der Heijde-Sharp (vdH-S) score, including joint space narrowing and erosion. The double-blind, multicentre trial includes a 24-week placebo-controlled phase, a 24-week active treatment phase, and a 12-week safety follow-up, with an optional two-year extension. Tremfya, which targets interleukin-23 (IL-23) and binds to CD64, demonstrated a safety profile consistent with prior data. These results emphasize the importance of early intervention to prevent long-term joint damage. Tremfya is the only IL-23 inhibitor to demonstrate significant structural damage inhibition in PsA.
07-04-2025