FDA Expands Guselkumab Label in PsA

Phase 3b APEX findings support the addition of structural joint damage inhibition data to the prescribing information.

Category	Detail
Condition	Active Psoriatic Arthritis (PsA)
Key Mechanisms	Inhibition of structural joint damage progression
Target Population	Adults with active psoriatic arthritis at risk for joint damage
Care Setting	Outpatient care for biologic-naïve patients

Guselkumab approved for inhibition of structural joint damage in PsA
Supported by phase 3b APEX trial results
57% reduction in radiographic progression from weeks 24 to 48 for patients switching from placebo
No new safety signals identified
Only interleukin-23 inhibitor with structural inhibition in US prescribing information

Guselkumab as a treatment option for patients with inadequate response to standard therapies

Biologic-naïve adults with active PsA

Guselkumab shows significant efficacy in reducing joint symptoms and structural damage

Clinical Scorecard: FDA Expands Guselkumab Label in PsA