Real-world experience with Ocrelizumab in the MSBase registry. [Multiple Sclerosis Journal. 25 (2 Suppl)]

Abstract

Introduction: Ocrelizumab (OCR) is a humanised anti-CD20+ monoclonal antibody approved for the treatment of primary progressive multiple sclerosis (PPMS), and relapsing forms of MS, including both relapsing-remitting (RRMS) and secondary progressive (SPMS). Objective(s): In a real-world setting, to describe 1) baseline characteristics of patients with MS treated with OCR, 2) treatment pathway across lines of therapy up to initiation of OCR, and 3) initial clinical experience in patients with >=6 months follow-up data from OCR initiation Methods: Secondary data analysis using MSBase Registry data including patients with a confirmed diagnosis of MS and newly treated with OCR after regulatory approval. Descriptive statistics were used to analyze baseline patients' characteristics recorded within 3 months prior to or at time of OCR initiation, including demographics, disease course and duration, prior disease modifying therapies (DMT), and EDSS. Occurrence of relapse was analyzed in patients with >=6 months follow-up data since OCR initiation. Result(s): As of 6th March 2019, MSBase included 1216 patients newly treated with OCR (15 countries, mainly from across Europe and Australia), 882 patients with RRMS, 160 with SPMS, and 174 with PPMS. Median age at OCR initiation varied from 42.8 years, 49.2 years, to 52.4 years in patients with RRMS, SPMS, and PPMS, respectively. Most RRMS and SPMS patients were female (69.6% and 64.4%) by contrast to PPMS patients (43.1% females). Median disease duration from symptom onset up to OCR initiation was longer in SPMS (19.7 years) than in RRMS (9.7 years) and PPMS (8.7 years). Median EDSS at OCR start was 3.0, 6.5, and 6.0 in RRMS, SPMS, and PPMS, respectively. OCR was initiated as first line therapy in 11.2%, 3.1%, and 58.1% of RRMS, SPMS, and PPMS patients respectively. 583 RRMS patients initiated OCR switching from another DMT, primarily natalizumab (37.9%) and fingolimod (34.1%). 234 patients with RRMS had >=6 months follow-up during OCR exposure. Of these, 214 remained relapse free (91.5%; 95% CI 87.1, 94.4). Conclusion(s): This study characterizes a broad and international population of patients with RRMS, PPMS, and SPMS newly-treated with OCR in real-world clinical settings. This cohort includes mostly middle-aged female adults with long disease duration, and with high disability status in the case of progressive MS. Most RRMS and SPMS patients were treatment-experienced at OCR initiation.