Evidence map›Paper›PMID 35614917›Full record

ArticleFrontiers in neurology2022

Safety, Adherence and Persistence in a Real-World Cohort of German MS Patients Newly Treated With Ocrelizumab: First Insights From the CONFIDENCE Study.

Martin S Weber, Mathias Buttmann, Sven G Meuth, Petra Dirks, Erwan Muros-Le Rouzic, Julius C Eggebrecht, Stefanie Hieke-Schulz, Jost Leemhuis, Tjalf Ziemssen

Open access · goldAbstract read
In one paragraph

Article in Frontiers in neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.3field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 16 citations in OpenAlex.

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  4. Treatment Adherence in a Large Cohort of Turkish Multiple Sclerosis Population.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
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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

9 authors at 6 institutions in 2 countries.

Martin S WeberDepartment of Neurology, Institute of Neuropathology, University Medicine Göttingen, Göttingen, Germany.
Mathias ButtmannCaritas-Hospital, Bad Mergentheim, Germany.
Sven G MeuthClinic of Neurology, Heinrich-Heine University, Düsseldorf, Germany.
Petra DirksF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Erwan Muros-Le RouzicF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Julius C EggebrechtRoche Pharma AG, Grenzach-Wyhlen, Germany.
Stefanie Hieke-SchulzRoche Pharma AG, Grenzach-Wyhlen, Germany.
Jost LeemhuisRoche Pharma AG, Grenzach-Wyhlen, Germany.
Tjalf ZiemssenCenter of Clinical Neuroscience, Neurological Clinic, Carl Gustav Carus University Clinic, University of Technology, Dresden, Germany.
Roche Pharma AG (Germany) · DERoche (Switzerland) · CHCaritas-Krankenhaus Bad Mergentheim · DEFraunhofer Institute for Translational Medicine and Pharmacology · DEHeinrich Heine University Düsseldorf · DEUniversity Hospital Carl Gustav Carus · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Real-world relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS) populations may be more diverse than in clinical trials. Here, we present a first analysis of safety, adherence and persistence data from a real-world cohort of patients newly treated with ocrelizumab. Methods: CONFIDENCE (ML39632, EUPAS22951) is an ongoing multicenter, non-interventional post authorization safety study assessing patients with RMS or PPMS newly treated with ocrelizumab or other disease-modifying therapies for up to 10 years. For this analysis, patients newly treated with ocrelizumab were analyzed in subgroups by MS phenotype and age over a mean ~1 year of exposure totaling 2,329 patient years [PY]). Results: At data cutoff (14 October 2020), 1,702 patients with RMS and 398 patients with PPMS were treated with ≥1 dose of ocrelizumab. At baseline, the mean ages (SD) of patients with RMS and PPMS were 41.59 (11.24) and 50.95 (9.88) years and the mean EDSS (Expanded Disability Status Scale) was 3.18 (1.87) and 4.41 (1.59), respectively. The most common adverse events (AEs) and serious AEs across both phenotypes were infections and infestations, with infection SAE rates of 2.8 events/100 PY and 1.5 events/100 PY in patients with RMS and PPMS, respectively. Across all phenotypes, ocrelizumab persistence was 92% at 24 months; median time between doses was ~6 months. Conclusions: The ocrelizumab safety profile observed in the CONFIDENCE real-world MS population was consistent to the one observed in pivotal clinical trials. High treatment persistence and adherence were observed. Trial Registration: ML39632, EUPAS22951.

Indexed as

drug (or treatment) persistencehumanized monoclonal antibody anti-CD20multiple sclerosisneurodegenerative diseasesnon-interventional study (NIS)ocrelizumabreal-world cohortsafety

Identifiers

PMID35614917
PMCPMC9126090
OpenAlexW4229458352

What OpenQuestion holds

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Registered trials

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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.