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

J Neurol. 2013 Dec;260(12):2981-5. doi: 10.1007/s00415-013-7082-0. Epub 2013 Sep 6.


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.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Cohort Studies
  • Disease Progression
  • Female
  • Fingolimod Hydrochloride
  • Germany
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Natalizumab
  • Outpatients
  • Propylene Glycols / therapeutic use*
  • Recurrence
  • Sphingosine / analogs & derivatives*
  • Sphingosine / therapeutic use


  • Antibodies, Monoclonal, Humanized
  • Immunosuppressive Agents
  • Natalizumab
  • Propylene Glycols
  • Fingolimod Hydrochloride
  • Sphingosine