Evidence map›Paper›PMID 26589235›Full record

Observational studyJournal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology2016

Safety and Clinical Outcomes of Rituximab Treatment in Patients with Multiple Sclerosis and Neuromyelitis Optica: Experience from a National Online Registry (GRAID).

P S Rommer, T Dörner, K Freivogel, J Haas, B C Kieseier, T Kümpfel, F Paul, F Proft, H Schulze-Koops, E Schmidt and 4 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04466150 (Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 9% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT04466150 phase4active not recruitingnot on this mapstarted 2020, after this paper: background citation

Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset

TypeinterventionalSponsorUniversity of California, San FranciscoRan2020 to 2027Enrolled30ConditionsRelapsing Multiple Sclerosis, Clinically Isolated SyndromeArmsOcrelizumab
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Efficacy of rituximab in secondary progressive multiple sclerosis: Insights from magnetic resonance imaging and disability assessments.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2025
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  15. Ocrelizumab and Other CD20Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 2 countries.

P S RommerDepartment of Neurology, Neuroimmunological Section, University of Rostock, Rostock, Germany. paulus.rommer@meduniwien.ac.at.
T DörnerDepartment of Medicine/Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
K FreivogelAnalytica GmbH, Lörrach, Germany.
J HaasDepartment of Neurology, Jewish Hospital Berlin, Berlin, Germany.
B C KieseierDepartment of Neurology, Medical Faculty, Heinrich Heine-University, Düsseldorf, Germany.
T KümpfelInstitute of Clinical Neuroimmunology, Ludwig-Maximilians-University, Munich, Germany.
F PaulNeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, Berlin, Germany.
F ProftDivision of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany.
H Schulze-KoopsDivision of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany.
E SchmidtAnalytica GmbH, Lörrach, Germany.
H WiendlDepartment of Neurology, University of Muenster, Muenster, Germany.
U ZiemannDepartment of Neurology & Stroke, Hertie Institute for Clinical Brain Research, Eberhard-Karls-University, Tübingen, Germany.
U K ZettlDepartment of Neurology, Neuroimmunological Section, University of Rostock, Rostock, Germany.
GRAID investigators
Charité - Universitätsmedizin Berlin · DEUniversity of Rostock · DEHeinrich Heine University Düsseldorf · DELudwig-Maximilians-Universität München · DEUniversity of Münster · DEGoethe University Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMultiple sclerosis (MS) is an immune-mediated disease. Over the last decades therapeutic options have broadened tremendously. Nevertheless, various therapeutic agents, e.g., rituximab, are currently used in the treatment of MS off label. Disease or health registries are useful methods to collect information about off-label treatments. The German registry for autoimmune disease (GRAID) is a multicenter, retrospective, non-interventional database of patients with various autoimmune diseases. AIM/

methodsThe aim of this observational analysis is to present safety data of rituximab in the treatment of MS and neuromyelitis optica (NMO) in a real life clinical setting based on the available registry data.

resultsData were collected nationwide in patients who received rituximab. 56 patients were treated with rituximab for MS or NMO. Average observation period was 9.6 months (SD 7.6, ranging from 6 to 29.7 months). Interval between treatments cycles differed tremendously (ranging from 0 to 21 months, median 10 months). Number of infusions ranged from 1 up to more than 8. The analysis provides experience on almost 50 patient years. Infusion related reactions were most common and reported in four patients; infections were seen in three patients (two of them were hospitalized for urinary tract infection and urosepsis). All patients recovered from infection. Full treatment response was attested in a quarter of the patients; two thirds benefited partially from treatment. DISCUSSION: Safety data of almost 50 patient years of treatment with rituximab show that rituximab is tolerated well in MS/NMO patients. Infections and infusion reactions are the most common adverse events. Our data may help the individual physician to balance efficacy of rituximab against the risk. • Data on rituximab in MS and NMO are provided for almost 50 patientyears • Rituximab was tolerated well • No unexpected side effects were seen • Almost 80% of the patients benefited at least partially from treatment.

Indexed as

AdultFemaleGermanyHumansImmunologic FactorsMaleMiddle AgedMultiple SclerosisNeuromyelitis OpticaRegistriesRetrospective StudiesRituximabTreatment OutcomeImmunologic FactorsRituximabMultiple sclerosisNeuromyelitis opticaRituximabTreatment

Identifiers

PMID26589235
OpenAlexW2175591334

What OpenQuestion holds

Textmetadata
Read underepoch 390

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 OpenQuestion graph.