Long-term clinical and radiological effectiveness and safety of ultralow doses of rituximab in rheumatoid arthritis: observational extension of the REDO trial
Primary result · DAS28-CRP by original randomisation groupResult — go to the resultDifference in DAS28-CRP (time-varying RTX dose) 0.22 95% CI 0.05–0.40Authors' conclusion
Long-term use of ultralow doses of RTX is effective in patients with rheumatoid arthritis responding to standard dose RTX.
Study context
- Population
- Patients with RA from the REDO trial, followed from trial start to April 2021; Rituximab (RTX) use at discretion of patient and rheumatologist using treat to targetof 142 REDO patients
- Participants
- 126 patients
- Comparison
- Ultralow-dose RTX (200 mg or 500 mg per 6 months) vs standard low-dose RTX (1000 mg per 6 months), by original randomisation and time-varying dose
- Primary endpoint
- Disease activity (DAS28-CRP), longitudinal mixed model by original randomisation and time-varying RTX dose
Methodological detailslongitudinal mixed model, non-inferiority margin 0.6 (DAS28-CRP), Drop-outs continued treatment elsewhere (n=3) or did not consent (n=13)
- Longitudinal mixed model
- Non-inferiority margin 0.6 (DAS28-CRP)
- Drop-outs continued treatment elsewhere (n=3) or did not consent (n=13)
Primary result
DAS28-CRP by original randomisation group
Difference in DAS28-CRP (time-varying RTX dose)
0.22
95% CI 0.05–0.40
By group
1000 mg
2.2
mean · 95% CI 2.0–2.5
500 mg
2.3
mean · 95% CI 2.1–2.4
200 mg
2.4
mean · 95% CI 2.2–2.5
200 mgvs 1000 mg
difference in DAS28-CRP (time-varying RTX dose) 0.22 (95% CI 0.05–0.40)
As reported in the abstract
Further findings
RTX persistence
- RTX persistence
- 93%
RTX dose per year
- Median RTX dose 978 mg (IQR 684-1413) per year
Radiological damage
- No association between RTX dose and radiological damage
Safety
- No association between RTX dose and adverse events
Original publication
Long-term clinical and radiological effectiveness and safety of ultralow doses of rituximab in rheumatoid arthritis: observational extension of the REDO trial. RMD Open. Published 9 April 2024. doi:10.
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