Evidence map›Paper›PMID 30289355›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2019

Infection risk with alemtuzumab decreases over time: pooled analysis of 6-year data from the CAMMS223, CARE-MS I, and CARE-MS II studies and the CAMMS03409 extension study.

Sibyl Wray, Eva Havrdova, David R Snydman, Douglas L Arnold, Jeffrey A Cohen, Alasdair J Coles, Hans-Peter Hartung, Krzysztof W Selmaj, Howard L Weiner, Nadia Daizadeh and 3 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
7.8field-weighted citation impact, top 2% 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

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

  1. Pooled it
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  11. Atypical imaging patterns during lung invasive mould diseases: lessons for clinicians.European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
  12. Review
  13. Monoclonal Antibodies in the Treatment of Relapsing Multiple Sclerosis: an Overview with Emphasis on Pregnancy, Vaccination, and Risk Management.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  14. Article
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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

13 authors at 9 institutions in 6 countries.

Sibyl WrayHope Neurology MS Center, Knoxville, TN, USA.
Eva HavrdovaMS Center, Department of Neurology, First Medical Faculty, Charles University, Prague, Czech Republic.
David R SnydmanDivision of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, MA, USA.
Douglas L ArnoldMontréal Neurological Institute, McGill University, Montréal, QC, Canada.
Jeffrey A CohenNeurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Alasdair J ColesUniversity of Cambridge School of Clinical Medicine, Cambridge, UK.
Hans-Peter HartungDepartment of Neurology, Medical Faculty, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.
Krzysztof W SelmajMedical University of Łódź, Łódź, Poland.
Howard L WeinerThe Ann Romney Center for Neurologic Diseases, Brigham and Women's Hospital, Boston, MA, USA.
Nadia DaizadehSanofi, Cambridge, MA, USA.
David H MargolinSanofi, Cambridge, MA, USA.
Madalina C ChirieacSanofi, Cambridge, MA, USA.
D Alastair S CompstonUniversity of Cambridge School of Clinical Medicine, Cambridge, UK.
Sanofi (United States) · USUniversity of Cambridge · GBBrigham and Women's Hospital · USCharles University · CZCleveland Clinic · USHeinrich Heine University Düsseldorf · DEMedical University of Lodz · PLMontreal Neurological Institute and Hospital · CATufts Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReduced MS disease activity with alemtuzumab versus subcutaneous interferon beta-1a (SC IFNB-1a) in core phase 2/3 studies was accompanied by increased incidence of infections that were mainly nonserious and responsive to treatment. Alemtuzumab efficacy was durable over 6 years.

objectiveTo evaluate infections over 6 years in alemtuzumab-treated patients.

methodsThree randomized trials (CAMMS223, Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) I, and CARE-MS II) compared two courses of alemtuzumab 12 mg with SC IFNB-1a 44 μg in patients with active relapsing-remitting MS. An extension study (CAMMS03409) provided further evaluation and as-needed alemtuzumab retreatment.

resultsInfections occurred more frequently with alemtuzumab 12 mg than SC IFNB-1a during Years 1 (58.7% vs 41.3%) and 2 (52.6% vs 37.7%), but declined for alemtuzumab-treated patients in Years 3 (46.6%), 4 (42.8%), 5 (40.9%), and 6 (38.1%). Serious infections were uncommon (1.0%-1.9% per year). Infections were predominantly (>95%) mild to moderate and included upper respiratory tract infections, urinary tract infections, and mucocutaneous herpetic infections. Prophylactic acyclovir reduced herpetic infections. Lymphocyte counts after alemtuzumab therapy did not predict infection risk.

conclusionInfections with alemtuzumab were mostly mild to moderate and decreased over time, consistent with preservation of components of protective immunity.

Indexed as

AdultAlemtuzumabAntibodies, Monoclonal, HumanizedDisease SusceptibilityFemaleHumansInfectionsInterferon beta-1aMaleMultiple SclerosisRecurrenceRisk FactorsTime FactorsAlemtuzumabAntibodies, Monoclonal, HumanizedInterferon beta-1aAlemtuzumabdisease-modifying therapyinfectionrelapsing-remitting multiple sclerosissafety

Identifiers

PMID30289355
PMCPMC6764150
OpenAlexW2894814928

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.