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
and Klaus Schmierer. Mult Scler J, August 17, 2017
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number of elements of the pivotal ‘cladribine tablets treating multiple sclerosis orally’ (CLARITY) trial have remained unpublished.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.
We maintained our interest in cladribine even after it had been rejected by the EMA in 2011, because its efficacy was impressive, and its adverse effects comparatively minor. We revealed important pathophysiological insights from the cell count data collected during CLARITY, confirmed that the cancer risk of cladribine in pwMS is no different when compared to licensed DMT, and subsequently started using the drug in a select group of pwMS.
Here's further output from our work on cladribine, an analysis of the quality of life data collected during the largest ever trial of the compound in pwMS. Though the data was available since 2010 nobody cared to analyse and publish them, so we did it after receiving the CLARITY dataset from the EMA through freedom of information, and with zero industry support.
Congratulations to Dayo Afolabi BSc, medical student at Cambridge University and Christo Albor PhD, epidemiologist and currently junior doctor at Barts Health NHS Trust for their excellent work, supported by QMUL IT (Lukasz Zalewski) and Dan Altmann, statistician at QMUL, UCL and The London School for Hygiene & Tropical Medicine.
The abstract summarises the results well, however reading the paper you will learn more about various aspects of this project and the potential of the drug.
CoI: Multiple, however none related to this paper.