ArticleAnnals of Indian Academy of Neurology2026
Effectiveness and Safety of Cladribine in Relapsing-Remitting Multiple Sclerosis in Clinical Practice: A 2-Year Multicenter Retrospective Open-Label Study.
Article in Annals of Indian Academy of Neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND AND
objectivesCladribine is an oral immunomodulatory drug approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). The study aimed to evaluate the effectiveness and safety of cladribine in real-world RRMS patients.
methodsA retrospective multicenter study was conducted, including RRMS patients treated with cladribine during a 2-year follow-up period. The endpoints were: Annual relapse rate (ARR), disability progression (according to the Expanded Disability Status Scale, EDSS), absence of new lesions and/or gadolinium enhancement on magnetic resonance imaging, and incidence of adverse events (AEs).
resultsA total of 210 patients (74.3% women) were included, with a mean age of 41.96 ± 10.42 years, and 77.6% had received prior treatments. The ARR significantly decreased to 0.16 and 0.16 in the first and second year, respectively ( P < 0.05). Disability, as measured by EDSS, improved during the first year (1.89, P < 0.05) and remained stable in the second year (1.92, P = 0.73). Gadolinium-enhancing lesions improved to 0.14 and 0.26 ( P < 0.05). Mild to moderate AEs were reported in 29% (year 1) and 15% (year 2). One case of prostate cancer and one case of urinary sepsis with a fatal outcome were reported.
conclusionsCladribine demonstrated clinical and radiological effectiveness in a real-world setting over 2 years, with an acceptable safety profile.
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