Monitoring of safety and effectiveness of cladribine in multiple sclerosis patients over 50 years.

Clinical trial data regarding efficacy and safety of cladribine in MS are limited to young individuals, and the overall risk-benefit profile does not necessarily applies to elderly patients. We investigated effectiveness and safety outcomes in MS patients initiating cladribine at ≥50 years (n=35) and <50 years (n=62), over a median follow-up of 12.4 months. There were no differences in time to evidence of disease activity (HR=0.73, 95%CI=0.18-2.91, p=0.657), post-treatment lymphocyte counts (β=0.24, p=0.825) or occurrence of adverse events (OR=0.84, 95%CI=0.24-2.93, p=0.791) between age groups. Female sex and greater disability were associated with higher risk of adverse events (especially infections). These limited data do not suggest safety concerns regarding use of cladribine in elderly MS.