Evidence map›Paper›PMID 28817997›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2018

Positive impact of cladribine on quality of life in people with relapsing multiple sclerosis.

Dayo Afolabi, Christo Albor, Lukasz Zalewski, Dan R Altmann, David Baker, Klaus Schmierer

Registry-linked trialAbstract read
In one paragraph

Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00213135 (A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT00213135 phase3completednot on this map

A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

TypeinterventionalSponsorEMD SeronoRan2005 to 2008Enrolled1,326ConditionsMultiple Sclerosis, Relapsing-RemittingArmsCladribine 5.25 mg/kg, Cladribine 3.5 mg/kg, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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  5. Review
  6. Article
  7. Cladribine tablets in the new multiple sclerosis era.Therapeutic advances in neurological disorders · 2025
    Review
  8. Review
  9. Article
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  11. Review
  12. Article
  13. Article
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  15. Article
  16. Subcutaneous cladribine to treat multiple sclerosis: experience in 208 patients.Therapeutic advances in neurological disorders · 2021
    Article
  17. Review
  18. 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

6 authors.

Dayo AfolabiBlizard Institute (Neuroscience), Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Christo AlborBlizard Institute (Neuroscience), Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Lukasz ZalewskiITS Research, Queen Mary University of London, London, UK.
Dan R AltmannBlizard Institute (Neuroscience), Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK/London School of Hygiene & Tropical Medicine, London, UK.
David BakerBlizard Institute (Neuroscience), Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Klaus SchmiererBlizard Institute (Neuroscience), Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK/Emergency Care and Acute Medicine Clinical Academic Group Neurosciences, The Royal London Hospital, Barts Health NHS Trust, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA number of elements of the pivotal 'cladribine tablets treating multiple sclerosis orally' (CLARITY) trial have remained unpublished.

objectiveTo report the impact of cladribine on health-related quality of life (QoL) in people with relapsing multiple sclerosis (pwRMS).

methodsQoL data from the phase III trial of two different doses (3.5 and 5.25 mg/kg) of oral cladribine in pwRMS were acquired from the European Medicines Agency through Freedom of Information. Spearman's rank correlation was used to analyse the relationship between baseline QoL scores and baseline Expanded Disability Status Scale (EDSS) scores. Responses of the Euro Quality of Life 5 Dimensions (EQ-5D) and Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaires were compared between treatment and control groups using univariate analyses of covariance.

resultsIn total, n = 5148 EQ-5D responses and n = 894 MSQOL-54 physical, mental health and dimension scores were extracted. Baseline EQ-5D indices correlated with EDSS scores. After 2 years, pwRMS taking 3.5 ( p = .001) and 5.25 mg/kg ( p = .022) reported significantly improved EQ-5D index scores compared with placebo. Positive, yet non-significant, differences were detected in MSQOL-54 scores between cladribine and placebo.

conclusionAnalysis of the CLARITY dataset suggests that, over and above its established clinical efficacy, cladribine leads to improved QoL over 96 weeks. ClinicalTrials.gov identifier: NCT00213135.

Indexed as

Quality of LifeAdultCladribineClinical Trials, Phase III as TopicFemaleHumansImmunosuppressive AgentsMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingCladribineImmunosuppressive AgentsCladribineEQ-5Dmultiple sclerosisquality of life

Identifiers

PMID28817997
PMCPMC6174629

What OpenQuestion holds

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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.