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

Abstract

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number of elements of the pivotal 'cladribine tablets treating multiple sclerosis orally' (CLARITY) trial have remained unpublished.

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

Methods: QoL 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.

Results: In 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.

Conclusion: Analysis 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.

Keywords: Cladribine; EQ-5D; multiple sclerosis; quality of life.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: None considered relevant. D.A. has nothing to declare, C.A. has nothing to declare, L.Z. has nothing to declare, D.R.A. has nothing to declare. D.B. has nothing relevant to declare. K.S. has been a PI of trials sponsored by Novartis, Roche, Teva, Medday, involved in trials sponsored by Biogen, Sanofi-Genzyme, BIAL, Cytokinetics and Canbex and has received speaking honoraria for lecturing and advisory activity and meeting support from Biogen, Merck Inc., Merck Serono, Novartis, Roche, Sanofi-Genzyme and Teva.

Figures

Figure 1.
Figure 1.
The impact of cladribine on EQ-5D. People with relapsing MS were treated with either placebo (circle;n = 281–310) or 3.5-mg/kg cladribine (diamond;n = 306–319) on weeks 0, 5, 48 and 52 or treated with 5.25 mg/kg (hexagon; n = 320–329) by receiving additional oral doses in weeks 9 and 13. The results represent the mean ± standard error of the mean. *p < .05, **p < .01 compared to placebo. Inverse triangles indicate time points of drug administration.

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Source: PubMed

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