Safety of high efficacy therapies in older people with Multiple Sclerosis: A real-world evidence study

Introduction: the increase of older adults living with Multiple Sclerosis (MS) is associated with higher use of high efficacy therapies (HETs) in a clinical practice. The are no data regarding the safety of HET in this patient group. Objective: to analyze the safety of HETs in older people with MS (pwMS) in a real-life cohort. Methods: retrospective cohort study including pwMS under HETs (cladribine and monoclonal antibodies) treated in two specialized MS centers in Latin America. We compare: pwMS >= 50 years old (G1) and < 50 years old (G2). In all pwMS, presence and type of adverse events, and comorbidities were recorded. Results: 882 pwMS were included, 141 (15.9 %) had >= 50 years old, 47 (33.3 %) werunde HETs (G1). The most used DMT in G1 was ocrelizumab (48.9 %), mean time under HETs: 2.06 +/- 0.8 years. The most frequent adverse event in G1 was urinary tract infection (UTI) (21.3 %). We did not find significant differences between G1 and G2 in infusion reactions, lymphopenia, neoplasms, respiratory infections, and liver disease. We found differences in the frequency of urinary tract infections (p = 0.004). No cases of VZV reactivation, tuberculosis or progressive multifocal leukoencephalopathy were registered. In a regression model adjusted for MS evolution, time under HET, EDSS, Charlson comorbidity index and phenotype, patients 50 >= under HETs did not have a higher incidence of adverse events compared to < 50 (Adjusted OR 0.72; CI95 % 0.143 -3.43, p = 0.67)} Conclusion: the short term use of HETs in pwMS older than 50 years old seems to be safe.