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Safety of Obinutuzumab in Children With Autoimmune Encephalitis and Early B-Cell Repopulation on Rituximab
Ai-Tien Nguyen1, Camille Cotteret2, Clarisse Gins1
1Department of Pediatric Neurology, Necker-Enfants Malades Hospital, University of Paris Cité, AP-HP, Paris, France.
Insights
Obinutuzumab shows improved B-cell depletion compared to Rituximab in pediatric neurological diseases. This anti-CD20 antibody demonstrated longer B-cell repopulation times and favorable outcomes in children.
Area of Science:
- Pediatric Neurology
- Immunotherapy
- B-cell depletion therapy
Background:
- Rituximab (RTX) resistance and early B-cell repopulation are concerns in pediatric autoimmune neurological diseases.
- Limited data exists on Obinutuzumab use and optimal dosing in children.
Purpose of the Study:
- To evaluate the efficacy and safety of Obinutuzumab in pediatric patients with neurological inflammatory diseases.
- To compare B-cell repopulation kinetics between Obinutuzumab and Rituximab.
Main Methods:
- Retrospective cohort study of 8 pediatric patients treated with Obinutuzumab (Nov 2019 - Nov 2021).
- Patients received Obinutuzumab (1000 mg/1.73 m²) after RTX or due to resistance.
- Data collected on B-cell repopulation, clinical outcomes, and adverse events.
Main Results:
- Obinutuzumab treatment resulted in a significantly longer median B-cell repopulation delay (230 days) compared to RTX (87 days).
- All patients showed favorable clinical evolution with no reported side effects.
- The study extrapolated adult dosage for Obinutuzumab in the pediatric cohort.
Conclusions:
- Obinutuzumab is a viable therapeutic option for pediatric neurological inflammatory diseases.
- Obinutuzumab demonstrates superior biological efficacy over Rituximab, indicated by prolonged B-cell depletion.
- Further research is warranted to establish definitive pediatric dosing guidelines for Obinutuzumab.
Background:
Rituximab (RTX) resistance or early B-cells repopulation were observed in children but only few publications reported the use of Obinutuzumab and no recommendations were made concerning the dosage for children.
Methods:
This study was a single-center retrospective cohort study of all the children followed-up in the Pediatric Neurology Department of Necker-Enfants malades Hospital in Paris, France, and treated with obinutuzumab, between November 1, 2019, and November 1, 2021.
Results:
A total of eight children (three females, median age 4.5 years) were treated. Seven patients presented with autoimmune encephalitis and one with myeloradiculitis. The median delay of B-cell repopulation after a course of RTX was 87 days (range 41 to 160). A switch to obinutuzumab (anti-CD20) was performed for eight children. The median duration between the first RTX infusion and obinutuzumab administration was 6.6 months. The dosage regimen for obinutuzumab was one infusion of 1000 mg/1.73 m2, that is to say 580 mg/m2 (maximum 1000 mg/infusion), by extrapolation from the adult dosage. The median delay of B-cell repopulation after one course of obinutuzumab was 230 days (range 66 to 303 days) vs 87 days after one course of RTX (P < 0.01). None of the patients presented side effects with obinutuzumab treatment. All patients had a favorable evolution at the last-follow up. Median follow-up was 1.6 years.
Conclusions:
This study reports the use of obinutuzumab in neurological inflammatory diseases in a pediatric population. Obinutuzumab seems to have a better biological efficacy than RTX with a longer time of B-cell repopulation.
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