Real-world persistence and benefit–risk profile of fingolimod over 36 months in Germany

(A) Mean change in the EDSS score during each 12-month follow-up period and in the overall 36-month follow-up period following fingolimod initiation. (B) Mean proportion of patients with 6-month confirmed disability improvement or 6-month confirmed disability worsening during each 12-month follow-up period and in the overall 36-month follow-up period following fingolimod initiation. ^aConfirmed disability improvement was assessed in accordance with the decreases in the EDSS score from baseline, with confirmation of the decrease in disability made at a visit in the absence of a relapse: a decrease of at least 1 point regardless of baseline EDSS scores. ^bConfirmed disability worsening was assessed in accordance with the increases in EDSS score from baseline, with confirmation of the increase in disability made at a visit in the absence of a relapse: a 1.5-point increase from a baseline EDSS score of 0; a 1-point increase from baseline EDSS scores of 1–5.0; and a 0.5-point increase in baseline EDSS scores of 5.5 or more. Patients for whom MS was a cause of death were considered to have confirmed disability worsening irrespective of baseline EDSS score or change in the EDSS score. Error bars show 95% CI. EDSS = Expanded Disability Status Scale; n = number of patients. Data for the 0–12-month change in the EDSS score were taken from Ziemssen T, Lang M, Tackenberg B et al. Clinical and demographic profile of patients receiving fingolimod in clinical practice in Germany and the benefit–risk profile of fingolimod after 1 year of treatment: initial results from the observational, noninterventional study PANGAEA. Neurotherapeutics 2018;15:190–199, with the permission of the copyright holders (authors).