Ocrelizumab treatment in Multiple Sclerosis: A Danish population-based cohort study.

Abstract

BACKGROUND\nReal-world evidence regarding effectiveness and safety of ocrelizumab for treatment of multiple sclerosis (MS) are limited. We aimed to evaluate the effectiveness and safety of ocrelizumab treatment for MS in a real-world setting.\n\n\nMETHODS\nWe conducted a nationwide population-based cohort study where we analyzed clinical and MRI data of MS patients enrolled prospectively in the Danish Multiple Sclerosis Registry (DMSR) who initiated ocrelizumab treatment between January 2018 and November 2020.\n\n\nRESULTS\nA total of 1104 patients (85.7% relapsing-remitting MS [RRMS], 8.8% secondary progressive MS [SPMS], 5.5% primary progressive MS [PPMS]) were included, with a median follow-up period of 1.3 years. At baseline, the mean age was 41.4 years in the RRMS group, 44.5 years in the PPMS group and 50.3 years in the SPMS group. Median Expanded Disability Status Scale (EDSS) score was 2.5, 3.5 and 5.5, respectively. Most RRMS and SPMS patients had received previous disease-modifying therapies (87.5% and 91.8%, respectively), whereas PPMS patients were mostly treatment naïve (78.7%). After ocrelizumab initiation, 9.3% of the patients experienced a relapse and 8.7% a 24-week confirmed disability worsening. Conversely, 16.7% showed a 24-week confirmed disability improvement. After ~1 year of treatment, most patients (94.5%) were free of MRI activity. Ocrelizumab was generally well tolerated, as side effects were only reported for 10% of patients and mostly consisting of infusion-related reactions and infections.\n\n\nCONCLUSIONS\nWe show that most MS patients treated with ocrelizumab are clinically stabilized and with an adverse event profile consistent with the experience from the pivotal clinical trials.