FDA OKs Tremfya label update highlighting joint protection in psoriatic arthritis

Joint damage in psoriatic arthritis can occur early in the disease course and may lead to irreversible disability if not adequately controlled. On May 28, FDA approved a label update for Tremfya (guselkumab) to include inhibition of progression of structural joint damage in adults with active psoriatic arthritis, adding evidence that the therapy can help preserve joint integrity in addition to improving symptoms.

The update was supported by results from the phase 3b APEX trial in biologic-naïve patients with active psoriatic arthritis who had an inadequate response to standard therapies. In addition to meeting its primary endpoint of improving joint symptoms, Tremfya significantly reduced radiographic progression of structural damage compared with placebo at 24 weeks.

Patients who initially received placebo and switched to Tremfya at week 24 experienced a 57% reduction in the rate of radiographic progression through week 48, suggesting benefit even after early disease progression.

The new label includes evidence that Tremfya not only improves signs and symptoms of active psoriatic arthritis but also inhibits progression of structural joint damage, an outcome that may help inform treatment selection for patients at risk of irreversible joint deterioration.

The safety findings were consistent with the established profile, with no new safety signals identified in the APEX study.

“Joint damage associated with active psoriatic arthritis can happen as soon as six months after onset of disease, so it’s important to have treatment solutions that can help provide daily symptom relief while also protecting joints from long-term structural damage,” said Philip J. Mease, MD, director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and clinical professor at the University of Washington School of Medicine. “With the inclusion of these findings in the label, we now have stronger clinical evidence that sets Tremfya apart as a treatment option for patients with active psoriatic arthritis at risk for joint damage.”

Source: Johnson & Johnson. (2026, May 28). Press release. FDA approves label expansion, cementing Tremfya as the only IL-23 inhibitor proven to help stop further joint damage