Evidence map›Paper›PMID 34378446›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2022

Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS.

Jens Kuhle, Nadia Daizadeh, Pascal Benkert, Aleksandra Maceski, Christian Barro, Zuzanna Michalak, Maria Pia Sormani, Jean Godin, Srinivas Shankara, Tarek A Samad and 8 more

3 registry-linked trialsOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article 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. It is linked to 3 registered trials, which are not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 7% 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
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

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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  16. Protein biomarkers in multiple sclerosis.Encephalitis (Seoul, Korea) · 2023
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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 7 institutions in 3 countries.

Jens KuhleNeurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Nadia DaizadehSanofi, Cambridge, MA, USA.
Pascal BenkertClinical Trial Unit Basel, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.ORCID 0000-0001-6525-8174
Aleksandra MaceskiNeurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Christian BarroNeurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland Current affiliation: Ann Romney Center for Neurologic Diseases, Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.
Zuzanna MichalakNeurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland Current affiliation: F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Maria Pia SormaniDepartment of Health Sciences, University of Genoa and IRCCS Ospedale Policlinico San Martino, Genoa, Italy.ORCID 0000-0001-6892-104X
Jean GodinSanofi, Cambridge, MA, USA.
Srinivas ShankaraSanofi, Framingham, MA, USA.
Tarek A SamadSanofi, Framingham, MA, USA.
Alan JacobsSanofi, Cambridge, MA, USA.
Luke ChungSanofi, Cambridge, MA, USA.
Nora RӧschSanofi, Cambridge, MA, USA.
Carina KaiserSanofi, Baar, Switzerland.
Colin P MitchellSanofi, Cambridge, MA, USA.
David LeppertNeurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Evis HavariSanofi, Framingham, MA, USA.
Ludwig KapposNeurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.ORCID 0000-0003-4175-5509
Sanofi (United States) · USUniversity of Basel · CHBrigham and Women's Hospital · USImmunitas Therapeutics (United States) · USOspedale Policlinico San Martino · ITRoche (Switzerland) · CHSanofi (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlemtuzumab efficacy and safety was demonstrated in CARE-MS I and extension studies (CAMMS03409; TOPAZ).

objectiveEvaluate serum neurofilament light chain (sNfL) in CARE-MS I patients and highly active disease (HAD) subgroup, over 7 and 2 years for alemtuzumab and subcutaneous interferon beta-1a (SC IFNB-1a), respectively.

methodsPatients received SC IFNB-1a 44 µg 3×/week or alemtuzumab 12 mg/day at baseline and month 12, with further as-needed 3-day courses. sNfL was measured using single-molecule array (Simoa™). HAD definition was ⩾2 relapses in year before randomization and ⩾1 baseline gadolinium-enhancing lesion.

resultsBaseline median sNfL levels were similar in alemtuzumab (

conclusionAlemtuzumab was superior to SC IFNB-1a in reducing sNfL, with levels in alemtuzumab patients remaining stable through Y7. CLINICALTRIALS.GOV IDENTIFIER: NCT00530348, NCT00930553, NCT02255656.

Indexed as

Intermediate FilamentsMultiple Sclerosis, Relapsing-RemittingAlemtuzumabHumansInterferon beta-1aNeurofilament ProteinsAlemtuzumabInterferon beta-1aNeurofilament ProteinsAlemtuzumabbiomarkersclinical trials randomized controlledhighly active diseasemultiple sclerosisNfL/neurofilament light chain

Identifiers

PMID34378446
PMCPMC8958562
OpenAlexW3188156200

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.