The US Food and Drug Administration has approved a supplemental Biologics License Application for guselkumab (TREMFYA) to include evidence in the prescribing information for inhibition of structural joint damage progression in adults with active psoriatic arthritis (PsA), according to a press release from Johnson & Johnson.

"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," said Philip J. Mease, MD, of the Swedish Medical Center/Providence St. Joseph Health and the University of Washington School of Medicine.

The approval was supported by results from the phase 3b APEX trial, a randomized, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis (PsA) who had an inadequate response to standard therapies. The company reported that guselkumab met the primary endpoint of reducing joint symptoms and a major secondary endpoint of inhibiting progression of structural damage compared with placebo, as measured by the PsA-modified van der Heijde-Sharp score.

According to Johnson & Johnson, patients who switched from placebo to guselkumab at week 24 had a 57% reduction in radiographic progression from weeks 24 to 48. The company also reported that no new safety signals were identified and that the findings were consistent with the established safety profile of guselkumab.

PsA is a chronic immune-mediated inflammatory disease characterized by joint inflammation, enthesitis, dactylitis, axial disease, and skin manifestations associated with plaque psoriasis. The condition can lead to irreversible joint damage.

Johnson & Johnson stated that the label update makes guselkumab the only interleukin-23 inhibitor with structural inhibition included in its US prescribing information.

Source: Johnson & Johnson