FDA Expands Guselkumab Label in PsA
Phase 3b APEX findings support the addition of structural joint damage inhibition data to the prescribing information.
By
Kathryn Wighton
May 29, 2026
Objective: To inform about the FDA's approval of guselkumab for inhibiting structural joint damage in adults with active psoriatic arthritis.
Key Findings: Guselkumab met the primary endpoint of reducing joint symptoms. It also met a major secondary endpoint of inhibiting progression of structural damage compared with placebo. Patients switching from placebo to guselkumab at week 24 had a 57% reduction in radiographic progression from weeks 24 to 48. No new safety signals were identified, consistent with the established safety profile of guselkumab. Interpretation:
Limitations: Conclusion:
