FDA Expands Guselkumab Label in PsA - Summary - MDSpire

FDA Expands Guselkumab Label in PsA

  • By

  • Kathryn Wighton

  • May 29, 2026

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

RA Outcomes Improved in KURAMA Cohort

Ten-year observational data showed lower disease activity and functional disability coinciding with broader use of biologic and targeted synthetic therapies.

JAK Monotherapy Shows Efficacy in RA Review

A systematic review found Janus kinase inhibitor monotherapy improved outcomes vs methotrexate or placebo, but direct comparisons with combination therapy were limited.

FDA Clears Golimumab Biosimilars

New biosimilars enter the market with pharmacy-level substitution eligibility for rheumatology and gastroenterology indications.