Spondyloarthritis & psoriatic arthritis
Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis
Authors' conclusion
In these post hoc analyses, the achievement of low levels of disease activity, including MDA, was associated with diminished rates of radiographic progression observed in patients receiving up to 2 years of guselkumab.
Study context
- Population
- Biologic-naïve adults with active PsA (≥5 swollen joints /≥5 tender joints; CRP ≥0.6 mg/dL)of 739 treated patients
- Participants
- 664 adults
- Comparison
- Radiographic progression (change in van der Heijde-Sharp (vdH-S) score) by achievement vs non-achievement of clinical response (ACR20/50/70, Disease Activity in Psoriatic Arthritis (DAPSA) low disease activity (LDA), Psoriatic ArthritiS Disease Activity Score (PASDAS) LDA, MDA, VLDA, Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤0.5) with guselkumab
- Primary endpoint
- Mean changes in vdH-S scores according to achievement of clinical response (ACR20/50/70, LDA by DAPSA ≤14 or PASDAS ≤3.2, MDA/VLDA, HAQ-DI ≤0.5)
- Follow-up
- Week 52 and week 100
Methodological detailsphase 3, double-blind, placebo-controlled, no formal hypothesis testing
- Phase 3
- Double-blind
- Placebo-controlled
- No formal hypothesis testing
Primary result
As reported in the abstract
Mean change in vdH-S score, responders vs non-responders (guselkumab-randomised)
Responders vs non-responders at week 52: smaller mean changes in vdH-S
0.2-1.2 vs 1.7-4.1
Responders vs non-responders at week 100: smaller mean changes in vdH-S
0.3-1.2 vs 2.0-4.6
Further findings
Mean
| Outcome | Q4W | Q8W |
|---|---|---|
| Mean change in vdH-S score, all patients · weeks 0 to 100 | 1.7 | 1.5 |
MDA components by radiographic progression (change in total vdH-S >0.5) · through week 100
- Non-progressors more likely to achieve MDA criteria for swollen and tender joint counts, patient-reported pain and global assessment, and normalised physical function
Original publication
Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis. RMD Open. Published 24 February 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →