BACKGROUND: Multiple sclerosis (MS) negatively affects health-related quality of life (HRQoL). OBJECTIVE: To evaluate HRQoL in people with highly active relapsing MS treated with cladribine tablets (CladT; 3.5 mg/kg cumulative dose over 2 years) in CLARIFY-MS. METHODS: Changes in the MS quality of life (MSQoL)-54 scores were analysed using a repeated mixed-effects linear model. Subgroup analyses were performed for participants who were pretreatment-naïve and those pretreated with disease-modifying therapies (DMTs) before initiating CladT. Safety and tolerability of CladT were also assessed. RESULTS: MSQoL-54 physical (mean change = 4.86; 95% confidence interval (CI) = 3.18, 6.53) and mental health (4.80; 95% CI = 3.13, 6.46) composite scores (primary endpoints) showed significant improvement at Month 24 versus Baseline (p < 0.0001). Changes in the MSQoL-54 scores were consistent across the pretreatment-naïve and DMT-pretreated subgroups. No new severe or opportunistic infections occurred. Most post-baseline lymphopenia events were Grade 1-2 in severity. Transient Grade-3 lymphopenia was observed in 19.7% (95/482) of participants. Grade-4 lymphopenia was not observed. CONCLUSIONS: CladT treatment significantly improved the mean MSQoL-54 physical and mental health composite scores over 2 years. CladT efficacy in HRQoL, relapse rates and Expanded Disability Status Scale scores demonstrates its multidimensional effects in MS treatment.

Center for Neurology Lodz Poland

Department of Clinical Neuroscience Karolinska Institutet Stockholm Sweden

Department of Medical and Surgical Sciences and Advanced Technologies GF Ingrassia University of Catania and Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco University of Catania Italy

Department of Neurology and Center for Clinical Neuroscience 1st Medical Faculty Charles University Prague Czech Republic

Department of Neurology Neuroimmunology Centre of Multiple Sclerosis of Catalonia University Hospital Vall d'Hebron Barcelona Spain

Department of Psychology Royal Holloway University of London Egham UK

INSERM U 1215 University of Bordeaux Bordeaux France

IRBlLeida Hospital Arnau de Vilanova Lérida Spain

Merck Healthcare KGaA Darmstadt Germany

Multiple Sclerosis Center Vienna Austria

Unit of Neuroepidemiology Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy

University of Newcastle Newcastle NSW Australia Division of Neurology John Hunter Hospital Newcastle NSW Australia

Zuyderland Medisch Centrum Sittard Maastricht University Medical Center Maastricht The Netherlands

Nat Rev Neurol. 2024 Jan;20(1):1. doi: 10.1038/s41582-023-00913-z. PubMed

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