Evidence map›Paper›PMID 29696498›Full record

Observational studyJournal of neurology2018

Alemtuzumab as rescue therapy in a cohort of 50 relapsing-remitting MS patients with breakthrough disease on fingolimod: a multi-center observational study.

Konstantin Huhn, Antonios Bayas, Sebastian Doerck, Benedikt Frank, Kathrin Gerbershagen, Kerstin Hellwig, Boris Kallmann, Christoph Kleinschnitz, Ingo Kleiter, De-Hyung Lee and 7 more

Abstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

21 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  12. Effectiveness and safety of alemtuzumab in the treatment of active relapsing-remitting multiple sclerosis: a multicenter, observational study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
    Observational
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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

17 authors.

Konstantin HuhnDepartment of Neurology, University Hospital Erlangen, Friedrich-Alexander-University, Erlangen-Nürnberg, Germany. Konstantin.Huhn@uk-erlangen.de.ORCID http://orcid.org/0000-0002-6965-2117
Antonios BayasDepartment of Neurology, Klinikum Augsburg, Augsburg, Germany.
Sebastian DoerckDepartment of Neurology, Julius-Maximilians-University Würzburg, Würzburg, Germany.
Benedikt FrankDepartment of Neurology, University Hospital Essen, Essen, Germany.
Kathrin GerbershagenDepartment of Neurology, Klinikum Köln-Merheim, Cologne, Germany.
Kerstin HellwigDepartment of Neurology, St. Josef-Hospital/Ruhr-University Bochum, Bochum, Germany.
Boris KallmannMS Center Bamberg, Bamberg, Germany.
Christoph KleinschnitzDepartment of Neurology, Julius-Maximilians-University Würzburg, Würzburg, Germany.
Ingo KleiterDepartment of Neurology, St. Josef-Hospital/Ruhr-University Bochum, Bochum, Germany.
De-Hyung LeeDepartment of Neurology, University Hospital Erlangen, Friedrich-Alexander-University, Erlangen-Nürnberg, Germany.
Volker LimmrothDepartment of Neurology, Klinikum Köln-Merheim, Cologne, Germany.
Mathias MäurerDepartment of Neurology, Caritas Krankenhaus Bad Mergentheim, Bad Mergentheim, Germany.
Sven MeuthDepartment of Translational Neurology, University Hospital Münster, Münster, Germany.
Peter RieckmannMS Center Bamberg, Bamberg, Germany.
Tobias RuckDepartment of Translational Neurology, University Hospital Münster, Münster, Germany.
Ralf GoldDepartment of Neurology, St. Josef-Hospital/Ruhr-University Bochum, Bochum, Germany.
Ralf A LinkerDepartment of Neurology, University Hospital Erlangen, Friedrich-Alexander-University, Erlangen-Nürnberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRelapsing-remitting multiple sclerosis (RRMS) requires efficient immunomodulatory treatment to reach "no evidence of disease activity" status at best. Alemtuzumab and fingolimod have proved to be efficient options in RRMS with active disease course. Yet, side effects and break-through disease may limit long-time treatment and necessitate switch of medication. Data on efficacy and safety of alemtuzumab following fingolimod treatment are limited, but useful for clinical practice.

methodsClinical and MRI data of 50 RRMS patients with a history of therapy switch from fingolimod to alemtuzumab were retrospectively analyzed. Data were acquired from nine large German MS Centers from 2013 to 2016 and analyzed using descriptive statistics.

resultsOn average, patients with disease duration of 12.9 years and median EDSS of 3.0 at baseline switched to alemtuzumab after 68 weeks of fingolimod treatment. Thereafter, patients on alemtuzumab were followed for a mean of 64 weeks. The annualized relapse rate decreased from 2.2 in the year prior to 0.34 in the following year after switching to alemtuzumab and EDSS stabilized. In a subgroup of patients (n = 23), MRI data point to a reduction in enhancing (4.47 vs. 0.26) and new/enlarging T2 lesions (5.8 vs. 0.27) after treatment adjustment. Side effects were generally as expected from published data for alemtuzumab (autoimmunity 2/50, severe infections 1/50). One patient suffered combined lethal necrotizing leukoencephalopathy and hemolytic anemia. DISCUSSION: Therapy switch was highly effective in reducing clinical and MRI surrogates of disease activity and was mainly well tolerated within one year of follow-up. Hence, alemtuzumab constitutes a promising therapy in RRMS with refractory disease activity despite fingolimod treatment. Further studies are warranted to confirm these beneficial findings and to reveal safety concerns in the longer-term follow-up.

Indexed as

AdultAlemtuzumabAntineoplastic Agents, ImmunologicalCohort StudiesDisability EvaluationFemaleFingolimod HydrochlorideHumansImmunosuppressive AgentsLymphocytesMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingYoung AdultAlemtuzumabAntineoplastic Agents, ImmunologicalFingolimod HydrochlorideImmunosuppressive AgentsAlemtuzumabDisease-modifying treatmentFingolimodMultiple sclerosis

Identifiers

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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.