title: Second line use of Fingolimod is as effective as Natalizumab in a German out-patient RRMS-cohort.
abstract: 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.
authors.affiliation: NeuroTrans Concept, Bahnhofstr. 103b, 86633, Neuburg, Germany, braune@neurozentrum-prien.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Braune
authors.forename: M
authors.initials: M
authors.lastname: Lang
authors.forename: A
authors.initials: A
authors.lastname: Bergmann
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D015331:Cohort Studies; D018450:Disease Progression; D005260:Female; D000068876:Fingolimod Hydrochloride; D005858:Germany; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D000069442:Natalizumab; D010045:Outpatients; D011409:Propylene Glycols / Q000627:therapeutic use*; D012008:Recurrence; D013110:Sphingosine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000069442:Natalizumab; D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine