Evidence map›Paper›PMID 31675266›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2020

Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies.

Bart Van Wijmeersch, Barry A Singer, Aaron Boster, Simon Broadley, Óscar Fernández, Mark S Freedman, Guillermo Izquierdo, Jan Lycke, Carlo Pozzilli, Basil Sharrack and 8 more

3 registry-linked trialsOpen access · greenAbstract read
In one paragraph

Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.5field-weighted citation impact, top 17% 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.

NCT00530348 phase3completednot on this map

A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2007 to 2011Enrolled581ConditionsMultiple Sclerosis, Relapsing-RemittingArmsAlemtuzumab, Interferon beta-1a
NCT00548405 phase3completednot on this map

A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2007 to 2011Enrolled840ConditionsMultiple Sclerosis, Relapsing-RemittingArmsAlemtuzumab 12 mg, Alemtuzumab 24 mg, Interferon beta-1a
NCT00930553 phase3completednot on this map

An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2009 to 2016Enrolled1,314ConditionsMultiple Sclerosis, Relapsing-RemittingArmsalemtuzumab
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 19 citations in OpenAlex.

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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

18 authors at 14 institutions in 10 countries.

Bart Van WijmeerschRehabilitation and MS Center Overpelt; BIOMED, Hasselt University, Hasselt, Belgium.
Barry A SingerThe MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA.
Aaron BosterOhioHealth Neurological Physicians, Columbus, OH, USA.
Simon BroadleySchool of Medicine, Griffith University, Southport, QLD, Australia.ORCID 0000-0002-9429-4307
Óscar FernándezFundación IMABIS, Hospital Universitario Carlos Haya, Málaga, Spain.
Mark S FreedmanUniversity of Ottawa and The Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Guillermo IzquierdoVirgen Macarena University Hospital, Seville, Spain.
Jan LyckeInstitution of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Carlo PozzilliSapienza University of Rome, Rome, Italy.
Basil SharrackNIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals, University of Sheffield, Sheffield, UK.
Brian SteingoFort Lauderdale Multiple Sclerosis Center, Fort Lauderdale, FL, USA.
Heinz WiendlUniversity of Münster, Münster, Germany.
Sibyl WrayHope Neurology PLLC, Knoxville, TN, USA.
Tjalf ZiemssenCenter of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.ORCID 0000-0001-8799-8202
Luke ChungSanofi, Cambridge, MA, USA.
David H MargolinSanofi, Cambridge, MA, USA; Cerevance, Boston, MA, USA.
Karthinathan ThangaveluSanofi, Cambridge, MA, USA; EMD Serono, Billerica, MA, USA.
Patrick VermerschUniversity of Lille, INSERM U995, CHU Lille, FHU Imminent, Lille, France.
Sanofi (United States) · USGriffith University · AUHasselt University · BEHospital Universitario Virgen Macarena · ESInserm · FRMissouri Baptist Medical Center · USMultiple Sclerosis Foundation · USOhioHealth · USSapienza University of Rome · ITUniversity Hospital Carl Gustav Carus · DEUniversity of Gothenburg · SEUniversity of Münster · DEUniversity of Ottawa · CAUniversity of Sheffield · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlemtuzumab is administered as two annual courses for relapsing-remitting multiple sclerosis (MS). Patients may relapse before completing the two-course regimen.

objectiveThe objective was to evaluate 6-year outcomes in patients who relapsed between alemtuzumab Courses 1 and 2 (early relapsers).

methodsPost hoc analysis of patients from the Comparison of Alemtuzumab and Rebif

resultsEarly relapsers (CARE-MS I: 15%; CARE-MS II: 24%) had more relapses in 1-2 years pre-alemtuzumab and higher mean baseline Expanded Disability Status Scale score than patients without relapse. Their annualized relapse rate declined from Year 1 (CARE-MS I: 1.3; CARE-MS II: 1.2) to Year 2 following Course 2 (0.3; 0.5) and remained low thereafter. Over 6 years, 60% remained free of 6-month confirmed disability worsening; 24% (CARE-MS I) and 34% (CARE-MS II) achieved 6-month confirmed disability improvement. During Year 6, 69% (CARE-MS I) and 68% (CARE-MS II) were free of magnetic resonance imaging (MRI) disease activity. Median percent yearly brain volume loss (Year 1: -0.67% (CARE-MS I); -0.47% (CARE-MS II)) declined after Course 2 (Year 6: -0.24%; -0.13%).

conclusionEarly relapsers' outcomes improved after completing the second alemtuzumab course. These findings support administering the approved two-course regimen to maximize clinical benefit. CLINICALTRIALS.GOV REGISTRATION NUMBERS: CARE-MS I, II, extension: NCT00530348, NCT00548405, NCT00930553.

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingAlemtuzumabAntibodies, Monoclonal, HumanizedHumansInterferon beta-1aAlemtuzumabAntibodies, Monoclonal, HumanizedInterferon beta-1aAlemtuzumabdisabilitydisease-modifying therapyefficacymagnetic resonance imaging (MRI)relapsing–remitting multiple sclerosis (MS)

Identifiers

PMID31675266
PMCPMC7604550
OpenAlexW2983891338

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.