Spondyloarthritis & psoriatic arthritis
Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active psoriatic arthritis (PsA): results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study
Authors' conclusion
Guselkumab, a fully human monoclonal antibody able to bind CD64 and simultaneously inhibit the IL-23p19 subunit, provided significantly higher rates of clinical improvement and significant inhibition of structural damage progression versus placebo, with no new safety signals, at week 24 in biologic-naïve participants with active and erosive PsA.
Study context
- Population
- Biologic-naïve adults with active PsA (≥3 tender, ≥3 swollen joints; CRP ≥0.3 mg/dL; ≥2 erosive joints)
- Participants
- 1,020 adults
- Comparison
- Subcutaneous guselkumab 100 mg Q4W or Q8W vs placebo
- Q4Wn = 273
- Q8Wn = 371
- Placebon = 376reference
- Primary endpoint
- Proportion achieving ACR20
- Follow-up
- Week 24
Methodological detailsphase 3b, double-blind, placebo-controlled, ongoing, multiplicity-controlled
- Phase 3b
- Double-blind
- Placebo-controlled
- Ongoing
- Multiplicity-controlled
Primary result
As reported in the abstract
ACR20
Q4W vs Placebo: P < 0.001 · Q8W vs Placebo: P < 0.001
Further findings
LSM change
| Outcome | Q4W | Q8W | Placebo | P value |
|---|---|---|---|---|
| Major secondary: total vdH-S score LSM change from baseline (radiographic progression) · week 24Q4W vs Placebo | 0.55 | 0.54 | 1.35 | P = 0.002 |
| Major secondary: total vdH-S score LSM change from baseline (radiographic progression) · week 24Q8W vs Placebo | P < 0.001 |
- Major secondary: total vdH-S score LSM change from baseline (radiographic progression): Baseline mean total vdH-S scores 26.7 to 27.7 across groups
Safety
≥1 adverse event · through week 24 · no new safety signals
Original publication
Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study. Ann Rheum Dis. Published 17 September 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →