Objective: The objective of this study was to evaluate the efficacy and safety of rituximab (RTX) treatment given off-label to Cypriot patients with multiple sclerosis (MS). Methods: Clinical data from 30 MS patients ever treated with off-label RTX until mid-2018 at the Cyprus Institute of Neurology and Genetics were retrospectively collected and reviewed. The heterogeneous patient cohort included patients with relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS). Outcome data (relapse rate and EDSS progression) as well as adverse effects for patients with a follow-up period of >12 months (n = 13) were recorded. Results: Following RTX administration, all patients with RRMS remained relapse free and had a stable or slightly improved EDSS score (mean EDSS before treatment = 6, mean EDSS at 12 months = 4.75). Patients with SPMS had a significant reduction in their relapse rate and a stabilization or slight improvement of their EDSS scores (mean EDSS before treatment = 6.25, mean EDSS at 12 months = 5.5). Only one of the patients with PPMS had a follow-up period of >12 months and his EDSS score remained unchanged. Rituximab infusions were generally well tolerated; there were only seven grade 3 or 4 adverse events recorded. Conclusion: Our results are in agreement with larger retrospective studies in which it was demonstrated that RTX was well tolerated and effective in treating RRMS and SPMS patients by reducing relapse rate and stabilizing disease.
Keywords: Cyprus; Multiple sclerosis; RRMS; SPMS; efficacy; rituximab; safety.