Real-world experience with Cladribine in the MSBase Registry.

Introduction: Cladribine tablets were recently approved for treatment of Multiple Sclerosis in many jurisdictions. We characterised the profiles of patients initiated on cladribine in the global MSBase registry. Objective(s): In a real-world setting, to describe 1) baseline characteristics of patients with MS treated with cladribine, 2) treatment pathway across lines of therapy up to initiation of cladribine, and 3) initial clinical experience in patients with >=6 months follow-up data from cladribine initiation Methods: Secondary data analysis using MSBase Registry data including patients with a confirmed diagnosis of MS and newly treated with cladribine after regulatory approval. Descriptive statistics were used to analyze baseline patient characteristics recorded within 3 months prior to or at time of cladribine 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 from cladribine initiation. Result(s): As of the 5th April 2019, MSBase included 337 patients newly treated with cladribine from 9 countries, mainly across Australian and Europe, including 258 RRMS patients and 51 with SPMS. Median age at cladribine initiation was 44.4 years in RRMS and 56.2 years in SPMS. Median time from diagnosis to cladribine initiation was longer in SPMS (median 19.4 years) than in RRMS (median 6.6 years). Median EDSS at cladribine start was 3 and 6.5 in RRMS and SPMS, respectively. 32.6% and 7.8% of all RRMS and SPMS, respectively, initiated cladribine as the first line therapy. 150 patients switched from an active DMT to cladribine. Of these, patients switched primarily from fingolimod (25.3%) or natalizumab (16.7%). 62 patients with RRMS had >=6 months follow-up after cladribine exposure. Of these, 8 (12.9%) experienced >=1 clinical relapse within the first 6 months on cladribine. Conclusion(s): This study characterizes patients with MS new