Stratification of biological therapies by pathobiology in biologic-naive patients with rheumatoid arthritis (STRAP and STRAP-EU): two parallel, open-label, biopsy-driven, randomised trials
Primary result · ACR20 response, B cell-poor populationResult — go to the resultOdds ratio 1.02 95% CI 0.47–2.17Authors' conclusion
In this biologic-naive population of patients with rheumatoid arthrtitis, the dichotomic classification into synovial B cell poor versus rich did not predict treatment response to B cell depletion with rituximab compared with alternative treatment strategies.
Study context
- Population
- Biologic-naive adults (≥18 years) with RA (ACR-EULAR criteria) and inadequate response to csDMARDs, classified B cell poor or rich by synovial biopsy; 26 university centres in the UK and Europe223 in ITT population
- Participants
- 226 adults
- Comparison
- Etanercept and tocilizumab (grouped) vs rituximab in biologic-naive RA stratified by synovial B cell status
- Etanerceptn = 73
- Tocilizumabn = 74
- Rituximabn = 79reference
- Primary endpoint
- ACR20 response in the B cell-poor ITT population, pooled from both trials, etanercept and tocilizumab (grouped) vs rituximab
- Follow-up
- 16 weeks
Methodological detailstwo parallel trials, open-label, biopsy-driven, stratified, phase 3, multicentre (26 university centres)
- Two parallel trials
- Open-label
- Biopsy-driven
- Stratified
- Phase 3
- Multicentre (26 university centres)
Primary result
ACR20 response, B cell-poor population
Odds ratio
1.02
95% CI 0.47–2.17
P = 0.97
Events by treatment group
Etanercept + Tocilizumabvs Rituximab
OR 1.02 (95% CI 0.47–2.17); P = 0.97
As reported in the abstract
Safety
Serious adverse events — Rituximab vs Etanercept · across the three groups
P = 0.53
- Serious adverse events: denominators: 102 rituximab, 108 etanercept, 73 tocilizumab (safety population)
Serious adverse events
- No differences observed for adverse events, including serious adverse events
Original publication
Stratification of biological therapies by pathobiology in biologic-naive patients with rheumatoid arthritis (STRAP and STRAP-EU): two parallel, open-label, biopsy-driven, randomised trials. Lancet Rheumatol. Published November 2023. doi:10.
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