Spondyloarthritis & psoriatic arthritis
Sustained response to guselkumab regardless of baseline characteristics in patients with active psoriatic arthritis and inadequate response to TNF inhibitors: results from the phase 3b COSMOS clinical trial
Authors' conclusion
Guselkumab every 8 weeks led to consistent improvements through week 24 in joint, skin, PRO and composite outcomes versus placebo across diverse baseline-defined subgroups of TNFi-IR patients with PsA. Response rates increased or were durable through week 48 within most subgroups.
Study context
- Population
- Patients with active PsA (tender joint count (TJC) and swollen joint count (SJC) both ≥3) and inadequate response to TNFi (TNFi-IR)
- Participants
- 189 vs 96
- Comparison
- Guselkumab 100 mg at week 0, week 4, then every 8 weeks vs placebo
- Guselkumabn = 189
- Placebon = 96reference
- Primary endpoint
- ACR20 response
- Follow-up
- Week 24
Methodological detailsplacebo-controlled, placebo cross-over to guselkumab at week 16 (early escape) or week 24 (planned), descriptive subgroup analysis
- Placebo-controlled
- Placebo cross-over to guselkumab at week 16 (early escape) or week 24 (planned)
- Descriptive subgroup analysis
Primary result
As reported in the abstract
ACR20 response (primary endpoint) across subgroups
Further findings
ACR50 response across subgroups · week 24
ACR50 response across subgroups · week 24
- Benefit of guselkumab over placebo observed within all subgroups
Response rates in guselkumab group, week 24 to week 48
- Response rates increased within almost all subgroups
- Similar response patterns at week 24 and through week 48 across various clinical outcomes
Original publication
Sustained response to guselkumab regardless of baseline characteristics in patients with active psoriatic arthritis and inadequate response to TNF inhibitors: results from the phase 3b COSMOS clinical trial. RMD Open. Published 12 December 2024. doi:10.
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