Second line use of Fingolimod is as effective as Natalizumab in a German out-patient RRMS-cohort

• Published in: Journal of neurology Vol. 260; no. 12; pp. 2981 - 2985
• Main Authors: Braune, Stefan, Lang, M., Bergmann, A.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-12-2013; Springer Nature B.V
• Subjects: Adult; Antibodies, Monoclonal, Humanized - therapeutic use; Cohort Studies; Demographics; Disease Progression; Female; Fingolimod Hydrochloride; Germany; Humans; Immunosuppressive Agents - therapeutic use; Male; Medicine; Medicine & Public Health; Multiple sclerosis; Multiple Sclerosis, Relapsing-Remitting - drug therapy; Natalizumab; Neurology; Neuroradiology; Neurosciences; Original Communication; Outpatients; Patients; Propylene Glycols - therapeutic use; Recurrence; Regression analysis; Sphingosine - analogs & derivatives; Sphingosine - therapeutic use; Germany; Europe; RRMS; Efficacy; Fingolimod; Natalizumab
• ISSN: 0340-5354; 1432-1459
• DOI: 10.1007/s00415-013-7082-0

Although Fingolimod is registered as a second-line drug in relapsing-remittend multiple sclerosis (RRMS) in Europe there are no clinical studies available comparing Fingolimod (FTY) and Natalizumab (N). This observational cohort-study used health data routinely collected in outpatient neurology practices throughout Germany completing a treatment period of 12 months included 237 patients starting on N and 190 patients on FTY because of failure of the first-line treatment. Mean relapse rate drastically decreased in both treatment groups within three months of therapy in a similar degree and remained on a low level. Both treatment groups saw a similar proportion of patients with unchanged and improved EDSS (80.53 % in FTY, 79.32 % in N). There was no statistically significant difference between the proportion of patients being relapse free (75.79 % in FTY, 71.73 % in N), progression free (87.39 % in FTY, 82.70 % in N) or relapse and progression free (71.05 % in FTY, 62.03 % in N) at 12 months in both strata. Clinical efficacy of FTY and N in RRMS second-line-therapy was similar during the first 12 months of treatment.