Vasculitis & polymyalgia rheumatica
Association Between Plasma Rituximab Concentration and the Risk of Major Relapse in Antineutrophil Cytoplasmic Antibody–Associated Vasculitides During Rituximab Maintenance Therapy
Primary result · Major relapseResult — go to the resultOdds ratio 6.56 95% CI 1.26–34.09Study context
- Population
- Patients with AAV on rituximab maintenance therapy in the MAINRITSAN2 trialDNA samples n = 53
- Participants
- 135 patients
- Comparison
- Low (<4 μg/ml) vs higher plasma rituximab concentration at month 3 (CM3); fixed-schedule vs individually tailored rituximab maintenance
- Primary endpoint
- Major relapse by rituximab plasma concentration at month 3 (CM3)
- Follow-up
- Month 28
Methodological detailspharmacokinetic/pharmacodynamic analysis, pharmacogenetic analysis, logistic regression, sensitivity survival analysis
- Pharmacokinetic/pharmacodynamic analysis
- Pharmacogenetic analysis
- Logistic regression
- Sensitivity survival analysis
Primary result
Major relapse
Odds ratio
6.56
95% CI 1.26–34.09
P = 0.025
CM3 <4 μg/mlvs Fixed-schedule
OR 6.56 (95% CI 1.26–34.09); P = 0.025
As reported in the abstract
Further findings
| Outcome | Estimate | P value | |
|---|---|---|---|
| Major relapse by CM3 <4 μg/ml, sensitivity survival analysisCM3 <4 μg/mlvs Fixed-scheduleIndependent risk factor · sensitivity survival analysis | HR for major relapse 4.81 (95% CI 1.56–14.82) | P = 0.006 | |
| Relapse by CM3 <4 μg/ml, sensitivity survival analysisCM3 <4 μg/mlvs Fixed-scheduleIndependent risk factor · sensitivity survival analysis | HR for relapse 2.70 (95% CI 1.02–7.15) | P = 0.046 | |
| 0.050.21520Ratio (log scale) |
| Outcome | Fixed-schedule | P value |
|---|---|---|
| Underexposure (CM3 <4 μg/ml) · month 3Fixed schedule vs Tailored | 2.0% | P = 0.02 |
- Underexposure (CM3 <4 μg/ml): Tailored 18.0%
Genetic polymorphisms · M28
- STAT4 rs2278940 and PRKCA rs8076312 significantly associated with CM3 but not with major relapse onset at M28
Original publication
Association Between Plasma Rituximab Concentration and the Risk of Major Relapse in Antineutrophil Cytoplasmic Antibody–Associated Vasculitides During Rituximab Maintenance Therapy. Arthritis Rheumatol. Published 13 August 2023. doi:10.
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