OBJECTIVES: To present the RWE information available from a patient support program registry of patients with multiple sclerosis treated with cladribine tablets in Portugal.

METHODS: Properly anonymized data was retrieved from a patient support program database of multiple sclerosis patients being currently treated with cladribine tablets in Portugal. Data was checked for missing values and descriptive analysis was run for the available information using STATA16. For all parameters missing data was censured from the analysis with number of samples being mentioned. Information was available from a total of 22 hospitals and a total of 31 prescribing physicians. Cut-off date for the analysis was May 15^th, 2020.

RESULTS: Out of a total of 88 patients, 71,6% were female. Age was available for 87 patients with an average of 40,7 ± 11,26 years, a median of 41 years, with a minimum of 20 and a maximum of 63 years. Data on diagnosis was reported for 74 patients, with 6,8% being patients with relapsing SPMS and the remaining being RRMS. The average time on treatment with cladribine tablets for the whole population was 299,77 ± 181,48 days, with a median of 222,5 days, and a minimum of 4 days and a maximum of 716 days. Information regarding previous treatments was available for 68 patients: fingolimod 35,3%, dimethyl fumarate 20,6%, teriflunomide 11,7%, interferon beta-1a 11,7%, glatiramer acetate 5,9%, peginterferon beta-1a 4,4%, natalizumab 4,4%, interferon beta-1b 2,9%, and 1,5% of patients were naïve.

CONCLUSIONS: Characterization of RWE data is possible and should be pursued in order to properly verify real world outcomes. Further analysis should be carried-out over time to properly characterize this patient population and the long-term outcomes resulting from this specific treatment option, such as the time on treatment.