FDA Expands Guselkumab Label in PsA - Summary - MDSpire

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

  • 2 min

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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:

Original Source(s)

FDA Expands Guselkumab Label in PsA

  • by Kathryn Wighton

  • May 29, 2026

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