Evidence map›Paper›PMID 33975489›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2022

Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres.

Steffen Pfeuffer, Leoni Rolfes, Jana Hackert, Konstanze Kleinschnitz, Tobias Ruck, Heinz Wiendl, Luisa Klotz, Christoph Kleinschnitz, Sven G Meuth, Refik Pul

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
8.4field-weighted citation impact, top 1% 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

33 citing papers in PubMed, 74 citations in OpenAlex.

  1. The Art of Sequencing Disease-Modifying Therapies in Multiple Sclerosis.Neurology(R) neuroimmunology & neuroinflammation · 2026
    Review
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  11. Cladribine tablets in the new multiple sclerosis era.Therapeutic advances in neurological disorders · 2025
    Review
  12. Cladribine use trend in Latin America: the changes in patient profile impact in the drug effectiveness.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
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  15. Review
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  20. Observational
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

10 authors at 2 institutions in 1 country.

Steffen PfeufferDepartment of Neurology with Institute of Translational Neurology, University Hospital Münster, Münster, Germany.ORCID 0000-0001-5171-4845
Leoni RolfesDepartment of Neurology with Institute of Translational Neurology, University Hospital Münster, Münster, Germany.
Jana HackertDepartment of Neurology and Center for Translational and Behavioral Neurosciences (C-TNBS), University Medicine Essen, Essen, Germany.
Konstanze KleinschnitzDepartment of Neurology and Center for Translational and Behavioral Neurosciences (C-TNBS), University Medicine Essen, Essen, Germany.
Tobias RuckDepartment of Neurology with Institute of Translational Neurology, University Hospital Münster, Münster, Germany/Department of Neurology, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Heinz WiendlDepartment of Neurology with Institute of Translational Neurology, University Hospital Münster, Münster, Germany.ORCID 0000-0003-4310-3432
Luisa KlotzDepartment of Neurology with Institute of Translational Neurology, University Hospital Münster, Münster, Germany.
Christoph KleinschnitzDepartment of Neurology and Center for Translational and Behavioral Neurosciences (C-TNBS), University Medicine Essen, Essen, Germany.
Sven G MeuthDepartment of Neurology with Institute of Translational Neurology, University Hospital Münster, Münster, Germany/Department of Neurology, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Refik PulDepartment of Neurology and Center for Translational and Behavioral Neurosciences (C-TNBS), University Medicine Essen, Essen, Germany.
University Hospital Münster · DEDüsseldorf University Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral cladribine has been approved for the treatment of relapsing multiple sclerosis (MS) yet real-world evidence regarding its effectiveness and safety remains scarce.

objectiveTo evaluate efficacy and safety outcomes of MS patients following induction of cladribine.

methodsWe evaluated our prospective cohort of cladribine-treated MS patients from two tertiary centres in Germany. Relapses, disability worsening and occurrence of new or enlarging T2-hyperintense magnetic resonance imaging (MRI) lesions were assessed as well as lymphocyte counts and herpes virus infections.

resultsAmong 270 patients treated with cladribine, we observed a profound reduction of both relapses and new or enlarging MRI lesions. Treatment appeared more efficacious, especially in patients without previous therapy or following platform substances. Patients switching from natalizumab were prone to re-emerging disease activity. Among patients following dimethyl fumarate pre-treatment, severe lymphopenia was common and associated with increased rates of herpes virus manifestations.

conclusionOverall, we observed an efficacy and safety profile of cladribine consistent with data from the phase 3 clinical trial. However, patients switching from natalizumab experienced suboptimal disease control beyond rebound activity following cessation of natalizumab. Furthermore, dimethyl fumarate pre-treatment was associated with a profound risk of developing severe lymphopenia and subsequent herpes virus infections.

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingCladribineHumansImmunosuppressive AgentsNatalizumabProspective StudiesCladribineImmunosuppressive AgentsNatalizumabCladribinereal-world evidencetreatment response

Identifiers

PMID33975489
PMCPMC8795224
OpenAlexW3160836548

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.