- Title
- Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study
- Creator
- Brochet, Bruno; Solari, Alessandra; Alexandri, Nektaria; Smyk, Andrzej; Nolting, Axel; Keller, Birgit; Montalban, Xavier; Kubala Havrdova, Eva; Lechner-Scott, Jeannette; Piehl, Fredrik; Langdon, Dawn; Hupperts, Raymond; Selmaj, Krzysztof; Patti, Francesco; Brieva, Luis; Maida, Eva Maria
- Relation
- Multiple Sclerosis Journal Vol. 29, Issue 14, p. 1808-1818
- Publisher Link
- http://dx.doi.org/10.1177/13524585231205962
- Publisher
- Sage
- Resource Type
- journal article
- Date
- 2023
- Description
- 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.
- Subject
- cladribine tablets; CLARIFY-MS; quality of life; disease-modifying therapies; multiple sclerosis
- Identifier
- http://hdl.handle.net/1959.13/1495747
- Identifier
- uon:54058
- Identifier
- ISSN:1352-4585
- Rights
- x
- Language
- eng
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