FDA Expands Guselkumab Label in PsA - Summary - MDSpire
Coming Soon: Introducing MDSpire News. Learn more
Conexiant’s news site is now MDSpire News. Learn more

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

Share

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

Related Content

Obesity Not Associated With Worse Long-Term TAR Outcomes

A long-term cohort study found that obesity was not associated with worse patient-reported outcomes or higher reoperation rates following total ankle replacement in optimized surgical candidates.

Infections Lead Thoracic CT Findings in SLE

Researchers characterize spectrum of pulmonary and extrathoracic involvement in systemic lupus erythematosus.

PRP Linked to Better Outcomes in Advanced Knee OA

In a small open-label randomized trial, 2 platelet-rich plasma injections were associated with greater 6-month improvements in pain and function than corticosteroid injection or oral aceclofenac among patients awaiting knee arthroplasty.