Johnson & Johnson Announces TREMFYA® Achieves Key Phase 3b Milestones in Psoriatic Arthritis Treatment

Johnson & Johnson announced on April 4, 2025, that TREMFYA (guselkumab) met key clinical endpoints in its Phase 3b APEX study for adults with active psoriatic arthritis (PsA). At week 24, the treatment showed significant reductions in both the signs and symptoms of PsA, as well as in the progression of structural joint damage, compared to placebo.

TREMFYA is the first and only IL-23 inhibitor to demonstrate this dual benefit. It is a fully-human monoclonal antibody that not only blocks IL-23 but also binds to CD64, a receptor on immune cells that produce IL-23—a key driver of immune-mediated diseases like PsA.

In the APEX study, patients treated with TREMFYA showed significantly less radiographic progression, as measured by the PsA modified van der Heijde-Sharp (vdH-S) score, which evaluates joint space narrowing and erosions. The safety profile remained consistent with previous data, with no new safety signals identified.

According to Terence Rooney, Vice President and Rheumatology Disease Area Leader at Johnson & Johnson Innovative Medicine, these findings highlight the importance of addressing both inflammation and structural damage early in treatment to preserve long-term joint health.

The APEX study includes a long-term extension to assess sustained outcomes over three years. Full results are being prepared for presentation at upcoming medical congresses.