FDA adds structural joint damage data to TREMFYA psoriatic arthritis label

The FDA approved a supplemental BLA that adds evidence to TREMFYA (guselkumab) for slowing structural joint damage in adults with active psoriatic arthritis. The data come from the Phase 3b APEX study in biologic-naive patients, which met its major secondary endpoint on structural progression versus placebo. The release reports only one number, a 57% reduction in radiographic progression for placebo patients who switched to TREMFYA between weeks 24 and 48.

• Label addition: inhibition of structural joint damage progression in active psoriatic arthritis
• Basis: Phase 3b APEX study (placebo-controlled for 24 weeks) in biologic-naive adults
• Structural progression endpoint met versus placebo; detailed scores not disclosed in the release
• Radiographic progression reduced 57% from week 24 through week 48 in patients who switched to TREMFYA