Trial reportBritish journal of clinical pharmacology2021
Ocrelizumab in relapsing and primary progressive multiple sclerosis: Pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO.
Trial report in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
48 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Disease-modifying therapies and hematological disorders: a systematic review of case reports and case series.Frontiers in neurology · 2024Pooled it
- Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis: Results of the Phase 3 OCARINA II Study.Neurology · 2025Trial
- Ocrelizumab dose selection for treatment of pediatric relapsing-remitting multiple sclerosis: results of the OPERETTA I study.Journal of neurology · 2025Trial
- Subcutaneous ocrelizumab in multiple sclerosis: Results of the Phase 1b OCARINA I study.Annals of clinical and translational neurology · 2024Trial
- Effect of Ocrelizumab on B- and T-Cell Receptor Repertoire Diversity in Patients With Relapsing Multiple Sclerosis From the Randomized Phase III OPERA Trial.Neurology(R) neuroimmunology & neuroinflammation · 2023Trial
- Association of Higher Ocrelizumab Exposure With Reduced Disability Progression in Multiple Sclerosis.Neurology(R) neuroimmunology & neuroinflammation · 2023Trial
- Ocrelizumab in relapsing and primary progressive multiple sclerosis: Pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO.British journal of clinical pharmacology · 2021Trial
- Pharmacokinetic-Pharmacodynamic Modelling of Repeated Ocrelizumab Dosing in Relapsing-Remitting Multiple Sclerosis.Clinical pharmacokinetics · 2026Observational
- Ocrelizumab versus ofatumumab efficacy and safety after natalizumab discontinuation in multiple sclerosis: a retrospective real-world comparison.Journal of neurology · 2026Article
- Predictors of B-cell repopulation in people with multiple sclerosis treated with ocrelizumab: insights from two large cohorts.Journal of neurology, neurosurgery, and psychiatry · 2026Article
- Real World Data of Laboratory Changes and Immunophenotyping in Patients with Multiple Sclerosis Treated with Ofatumumab-Single Center Experience.Biomedicines · 2026Article
- Multiple Sclerosis in Women: Impact of Different Life Stages on Treatment Decisions.CNS drugs · 2026Review
- Pharmacodynamics and Pharmacokinetics of Ublituximab Compared with Other Anti-CD20 Monoclonal Antibodies for Multiple Sclerosis Treatment.Current neuropharmacology · 2026Review
- Serum neurofilament light chain as a biomarker of disease control in multiple sclerosis: a real-world cross-sectional analysis of therapeutic regimens.Journal of neurology · 2025Article
- Article
- Immunological Monitoring During Anti-CD20 Therapies to Predict Infection Risk and Treatment Response in Multiple Sclerosis Patients.Diseases (Basel, Switzerland) · 2025Article
- Neurofilament Biomarkers in Neurology: From Neuroinflammation to Neurodegeneration, Bridging Established and Novel Analytical Advances with Clinical Practice.International journal of molecular sciences · 2025Review
- Impact of Age on Switching or Stopping Disease Modifying Therapies in Multiple Sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025Review
- The Evolution of Anti-CD20 Treatment for Multiple Sclerosis: Optimization of Antibody Characteristics and Function.CNS drugs · 2025Review
- Balo Concentric Sclerosis: A Rare Variant of Multiple Sclerosis With Excellent Response to Early Steroid Treatment.Cureus · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsOcrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells and is indicated for treatment of patients with relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The pharmacokinetics and pharmacodynamics of ocrelizumab in patients with RMS or PPMS were assessed.
methodsA population pharmacokinetic model was developed based on data from the Phase II study and the Phase III studies OPERA I and OPERA II in patients with RMS. Data from the ORATORIO Phase III study in patients with PPMS became available after model finalization and was used for external model evaluation.
resultsThe ocrelizumab serum concentration vs time course was accurately described by a 2-compartment model with time-dependent clearance. Body weight was found to be the main covariate. The area under the concentration-time curve over the dosing interval was estimated to be 26% higher for patients with RMS weighing <60 kg and 21% lower for patients weighing >90 kg when compared with the 60-90 kg group. The terminal half-life of ocrelizumab was estimated as 26 days. The extent of B-cell depletion in blood, as the pharmacodynamic marker, was greater with increasing ocrelizumab exposure.
conclusionThe pharmacokinetics of ocrelizumab was described with pharmacokinetic parameters typical for an immunoglobulin G1 monoclonal antibody, with body weight as the main covariate. The pharmacokinetics and B-cell depletion in blood were comparable across the RMS and PPMS trials, and the extent of blood B-cell depletion was greater with higher exposure.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.