Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for TREMFYA (guselkumab), allowing the inclusion of data demonstrating inhibition of structural joint damage progression in adults with active psoriatic arthritis (PsA).

With the approval, TREMFYA becomes the only interleukin-23 (IL-23) inhibitor with label evidence supporting its ability to help prevent further structural joint damage while delivering effective symptom control. The update provides physicians and patients with an additional treatment option aimed at addressing both the symptoms and long-term progression of the disease.

The label expansion is supported by findings from the Phase 3b APEX clinical trial. The study achieved its primary endpoint of improving joint symptoms, measured by the American College of Rheumatology 20 percent improvement criteria (ACR20), and its major secondary endpoint of significantly inhibiting structural joint damage progression compared with placebo in biologic-naïve patients.

Results from the study also showed that patients who initially received placebo and later switched to TREMFYA at Week 24 experienced a 57 percent reduction in the rate of radiographic disease progression through Week 48. The safety findings remained consistent with the established safety profile of TREMFYA, with no new safety concerns identified during the study.

Philip J. Mease, MD, Director of Rheumatology Research at Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine, noted that joint damage in psoriatic arthritis can occur within months of disease onset, making early intervention critical. He said the updated label strengthens clinical evidence supporting TREMFYA as a treatment option for patients at risk of irreversible joint damage.

According to Johnson & Johnson, up to half of patients with active psoriatic arthritis may develop permanent joint damage early in the disease course, potentially affecting mobility, daily activities and quality of life. The company believes the label update further differentiates TREMFYA by offering both symptom relief and protection against long-term structural deterioration.

TREMFYA is a fully human, dual-acting monoclonal antibody approved for the treatment of psoriatic arthritis. The therapy works by blocking IL-23, a cytokine involved in immune-mediated inflammatory diseases, while also binding to CD64 receptors found on cells that produce IL-23. The treatment is also approved for several other immune-mediated conditions, including moderate-to-severe plaque psoriasis, ulcerative colitis and Crohn’s disease.

Johnson & Johnson stated that the approval reinforces its commitment to advancing innovative therapies that address unmet needs in chronic inflammatory diseases and improve long-term outcomes for patients living with psoriatic arthritis.