Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study

Bruno Brochet, Alessandra Solari, Jeanette Lechner-Scott, Fredrik Piehl, Dawn Langdon, Raymond Hupperts, Krzysztof Selmaj, Francesco Patti, Luis Brieva, Eva Maida, Nektaria Alexandri, Andrzej Smyk, Axel Nolting, Birgit Keller, Xavier Montalban, Eva Havrdová

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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.
Original languageEnglish
JournalMultiple Sclerosis Journal
Early online date18 Nov 2023
Publication statusE-pub ahead of print - 18 Nov 2023

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