Multicenter study of cladribine in relapsing-remitting multiple sclerosis in patients over 50 years.

OBJECTIVE: Cladribine is an oral immunomodulatory drug approved for the treatment of relapsing-remitting multiple sclerosis. However, evidence regarding its use in patients over 50 years is limited. The aim of the study was to evaluate the effectiveness and safety of cladribine in patients with relapsing-remitting multiple sclerosis over 50 years in real-world clinical practice. METHODS: A retrospective, multicenter open study conducted in eight hospitals in Galicia. Inclusion criteria were: age ≥ 50 years, relapsing-remitting multiple sclerosis who received treatment with cladribine oral and completed a two-year follow-up. The annualized relapse rate, disability progression, magnetic resonance imaging activity (gadolinium-enhancing lesions) and the incidence of adverse events were assessed. RESULTS: 48 patients (66.7% female with a mean age of 56.8 ± 5.7 years) were included. 79.2% of patients had received prior therapy. The annualized relapse rate significantly decreased to 0.13 and 0.14 in the first and second year, respectively (p < 0.05). Gadolinium-enhancing lesions decreased to 0.05 and 0.00 (p < 0.05). No significant disability progression was observed. Mild-to-moderate adverse events were reported in 20.8% (year 1) and 8.3% (year 2) of patients. One case of prostate cancer and one fatal sepsis were reported. CONCLUSIONS: Cladribine has demonstrated both clinical and radiological effectiveness in relapsing-remitting multiple sclerosis patients over 50 years of age, with an acceptable safety profile.