Can efficacy and safety data from clinical trials of rituximab in RA be extrapolated? Insights from 1984 patients from the AIR-PR Registry
Authors' conclusion
Few real-life RA patients were eligible for the drug-registration trials. Non-eligible patients had lower chance of response, and higher risk of serious AEs.
Study context
- Population
- RA patients treated with RTX in a real-life setting, French AIR-PR registry9–12% fulfilled all eligibility criteria
- Participants
- 1,984 patients
- Exposure
- Patients non-eligible vs eligible for the three RTX-registration trials
- Outcome
- EULAR response
- Follow-up
- 12 months
Methodological detailsmulticentre, registry, real-life setting
- Multicentre
- Registry
- Real-life setting
Main finding
As reported in the abstract
P = 0.044
Observational data: associations, not effects.
Further findings
Fulfilment of critical eligibility criteria
- Fulfilled critical eligibility criteria
- 20.8%
Incremental risk-benefit ratio
- Decreased with the number of unmet critical inclusion criteria and of fulfilled exclusion criteria
Safety
| Outcome | HR (95% CI) | |
|---|---|---|
| Serious AEs by critical exclusion criteria · first year≥3 critical exclusion criteriavs 0 critical exclusion criteria | 3.03 (2.25–4.06) | |
| 0.20.5125Hazard ratio (log scale) |
Serious adverse events (AEs) during the first year
- Patients with serious AEs
- 182 (9.2%)
- Serious infections among serious AEs
- 70.3%
Original publication
Can efficacy and safety data from clinical trials of rituximab in RA be extrapolated? Insights from 1984 patients from the AIR-PR Registry. Rheumatology (Oxford). Published 19 September 2023. doi:10.
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