Evidence map›Paper›PMID 31144568›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2020

Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis.

Rafael Arroyo, Denise P Bury, Jennifer D Guo, David H Margolin, Maria Melanson, Nadia Daizadeh, David Cella

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report 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. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
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

7 authors at 3 institutions in 2 countries.

Rafael ArroyoDepartment of Neurology, Hospital Universitario Quirónsalud, Madrid, Spain.
Denise P BuryContractor to Sanofi Genzyme, Cambridge, MA, USA.
Jennifer D GuoSanofi, Cambridge, MA, USA; Bristol-Myers Squibb, Lawrence Township, NJ, USA.
David H MargolinSanofi, Cambridge, MA, USA; Cerevance, Inc., Boston, MA, USA.
Maria MelansonSanofi, Cambridge, MA, USA.
Nadia DaizadehSanofi, Cambridge, MA, USA.
David CellaDepartment of Medical Social Sciences, Center for Patient-Centered Outcomes, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Sanofi (United States) · USHospital Universitario Quirónsalud Madrid · ESNorthwestern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn CARE-MS II (Comparison of Alemtuzumab and Rebif

objectiveThe aim of this study is to assess 6-year HRQL outcomes in alemtuzumab-treated CARE-MS II patients, including those with highly active disease (HAD).

methodsDuring extension, patients could receive additional alemtuzumab for clinical/magnetic resonance imaging (MRI) activity or other disease-modifying therapies per investigator's discretion. Assessments include Functional Assessment of Multiple Sclerosis (FAMS), 36-Item Short-Form Health Survey (SF-36), and EQ-5D visual analog scale (EQ-VAS).

resultsAlemtuzumab-treated patients improved or stabilized all HRQL measures over 6 years with significant improvements from baseline at all time points on EQ-VAS and for up to 5 years on FAMS, SF-36 MCS, and SF-36 PCS. Alemtuzumab-treated patients with HAD showed significant improvements versus baseline at Year 2 on all HRQL measures, and significant improvements versus SC IFNB-1a on SF-36 PCS and EQ-VAS; however, the improvements did not reach the threshold for clinical relevance.

conclusionAlemtuzumab-treated CARE-MS II patients improved or stabilized HRQL versus baseline over 6 years. This is the first study to show long-term HRQL benefits in patients with HAD.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeAdolescentAdultAlemtuzumabFollow-Up StudiesHumansImmunologic FactorsInterferon beta-1aMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingYoung AdultAlemtuzumabImmunologic FactorsInterferon beta-1aAlemtuzumabEQ-VASFAMShealth-related quality of lifepatient-reported outcomesrelapsing-remitting multiple sclerosisSF-36

Identifiers

PMID31144568
PMCPMC7350196
OpenAlexW2947647736

What OpenQuestion holds

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LicenceCC BY-NC
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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.