Evidence map›Paper›PMID 32583052›Full record

ArticleJournal of neurology2020

Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223.

Brian Steingo, Yaser Al Malik, Ann D Bass, Regina Berkovich, Matthew Carraro, Óscar Fernández, Carolina Ionete, Luca Massacesi, Sven G Meuth, Dimos D Mitsikostas and 7 more

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

Article in Journal of neurology, 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 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
4.3field-weighted citation impact, top 4% 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.

NCT00050778 phase2completednot on this map

A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2002 to 2010Enrolled334ConditionsMultiple Sclerosis, Relapsing-RemittingArmsInterferon beta-1a, Alemtuzumab 12 mg, Alemtuzumab 24 mg
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
NCT02255656 phase4completednot on this map

A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2015 to 2020Enrolled1,062ConditionsRelapsing Remitting Multiple SclerosisArmsalemtuzumab GZ402673
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 52 citations in OpenAlex.

  1. Towards primary prevention of multiple sclerosis.Nature reviews. Neurology · 2026
    Review
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  6. The epidemiology, pathology and pathogenesis of MS: Therapeutic implications.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
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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 at 14 institutions in 8 countries.

Brian SteingoInfinity Clinical Research, Sunrise, FL, USA. ogniets@yahoo.com.
Yaser Al MalikKing Saud Bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
Ann D BassNeurology Center of San Antonio, San Antonio, TX, USA.
Regina BerkovichKeck School of Medicine of University of Southern California, Los Angeles, CA, USA.
Matthew CarraroNovant Health, Charlotte, NC, USA.
Óscar FernándezFundación IMABIS, Hospital Universitario Carlos Haya, Málaga, Spain.
Carolina IoneteUniversity of Massachusetts Memorial Medical Center, Worcester, MA, USA.
Luca MassacesiDepartment of Neurosciences, Drugs and Child Health, University of Florence, Florence, Italy.
Sven G MeuthClinic of Neurology with Institute of Translational Neurology, University Clinic Münster, Münster, Germany.
Dimos D MitsikostasFirst Neurology Department, Aeginition Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Gabriel PardoOklahoma Medical Research Foundation, Oklahoma City, OK, USA.
Renata Faria SimmUniversidade de São Paulo, São Paulo, Brazil.
Anthony TraboulseeUniversity of British Columbia, Vancouver, BC, Canada.
Zia ChoudhrySanofi, Cambridge, MA, USA.
Nadia DaizadehSanofi, Cambridge, MA, USA.
D Alastair S CompstonUniversity of Cambridge, Cambridge, UK.
CAMMS223, CAMMS03409, and TOPAZ Investigators
Sanofi (United States) · USEginition Hospital · GRInfinity HealthCare (United States) · USKing Saud bin Abdulaziz University for Health Sciences · SANovant Health · USOklahoma Medical Research Foundation · USSynergy Health · USUMass Memorial Medical Center · USUniversidade de São Paulo · BRUniversity Hospital Münster · DEUniversity of British Columbia · CAUniversity of Cambridge · GBUniversity of Florence · ITUrology San Antonio · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing-remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656).

methodsIn CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies.

resultsOf 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients had stable or improved Expanded Disability Status Scale scores, and 69% were free of 6-month confirmed disability worsening. In Year 12, 73% of patients were free of MRI disease activity. Cumulatively throughout the extensions (Years 7-12), 34% of patients had no evidence of disease activity. Adverse event (AE) incidence declined through Year 12. Infusion-associated reactions peaked at first course and declined thereafter. Cumulative thyroid AE incidence was 50%; one immune thrombocytopenia event occurred, and there were no autoimmune nephropathy cases.

conclusionsAlemtuzumab efficacy was maintained over 12 years in CAMMS223 patients, with 73% receiving no more than three courses. The safety profile in this cohort was consistent with other alemtuzumab clinical trials.

Indexed as

Multiple Sclerosis, Relapsing-RemittingAlemtuzumabAntibodies, Monoclonal, HumanizedFollow-Up StudiesHumansInterferon beta-1aAlemtuzumabAntibodies, Monoclonal, HumanizedInterferon beta-1aAlemtuzumabDisease-modifying therapyEfficacyLong-termMultiple sclerosisSafety

Identifiers

PMID32583052
PMCPMC7578137
OpenAlexW3037496544

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.