Subcutaneous versus intravenous ultra-low-dose rituximab in rheumatoid arthritis: a randomized controlled PK-PD non-inferiority trial
Primary result · Rituximab serum AUC0-6mResult — go to the resultGeometric mean ratio 0.99 90% CI 0.82–1.20Authors' conclusion
Our data suggest non-inferior pharmacokinetics for s.c. rituximab; however, this cannot be definitively concluded due to uncertainty of the AUC estimates.
Study context
- Population
- RA patients with stable low disease activity on ultra-low-dose rituximab (500 mg or 200 mg every 6 months)randomized
- Participants
- 35 patients
- Comparison
- Rituximab 336 mg s.c. vs 200 mg i.v.
- s.c.n = 18
- i.v.n = 17reference
- Primary endpoint
- Non-inferiority of s.c. to i.v. rituximab based on estimated rituximab serum concentration AUC during the first 6 months (AUC0-6m), estimated by PK modelling; non-inferiority margin 0.8
- Follow-up
- 6 months
Methodological detailsopen-label, non-inferiority, PK-PD, stratified by previous rituximab dose
- Open-label
- Non-inferiority
- PK-PD
- Stratified by previous rituximab dose
Primary result
Rituximab serum AUC0-6m
Geometric mean ratio
0.99
90% CI 0.82–1.20
s.c.vs i.v.
geometric mean ratio 0.99 (90% CI 0.82–1.20)
As reported in the abstract
- Mean prediction error (bias) of AUC estimates, i.v.
- 13.1 (1.86%)
- Mean prediction error (bias) of AUC estimates, s.c.
- −3.40 (−0.47%)
- Root mean square error of AUC estimates, i.v.
- 140 (19.8%)
- Root mean square error of AUC estimates, s.c.
- 142 (19.5%)
Secondary outcomes
| Outcome | Mean change (95% CI) | |
|---|---|---|
| Mean change in DAS28-CRPNon-inferior; margin 0.6 · non-inferior for s.c. rituximab | −0.39 (−0.77 to −0.004) | |
| −1−0.500.5Difference (linear scale) |
- Mean change in DAS28-CRP: non-inferiority margin of 0.6
Original publication
Subcutaneous versus intravenous ultra-low-dose rituximab in rheumatoid arthritis: a randomized controlled PK-PD non-inferiority trial. Rheumatology (Oxford). Published 18 August 2026. doi:10.
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