Previous treatment influences fingolimod efficacy in relapsing-remitting multiple sclerosis: results from an observational study.
OBJECTIVE
Fingolimod (FTY) is licensed as a disease-modifying treatment in highly active relapsing-remitting multiple sclerosis. The aim of the study was to evaluate the efficacy and safety of FTY in a real-life setting and to explore the possible role of clinical and MRI parameters, including previous treatment type, in predicting its efficacy.


METHODS
Clinical and MRI data was collected on 127 patients assigned to treatment with FTY in six multiple sclerosis centers in Emilia-Romagna, Italy, between August 2011 and June 2013.


RESULTS
During a mean follow-up period of 10 months (range 1-22), we observed a total of 47 relapses in 39 patients (30.7%); new T2 lesions or gadolinium-enhancing (Gd+) lesions were present at follow-up MRI in 32/71 patients (45%). Expanded disability status scale (EDSS) at the end of the follow-up period was not different when compared to the baseline EDSS. Serious adverse events occurred in three patients (2.4%). A higher proportion of patients previously treated with natalizumab showed clinical (41%) or MRI activity (54%). Previous treatment with natalizumab increased the risk of a relapse within 30 days (versus immunomodulatory drugs; OR: 4.3; p = 0.011) and at survival analysis (versus remaining patients; HR: 1.9; p = 0.046). Study limitations include a small population sample, a short observation period with variable timing of follow-up MRI and different baseline characteristics of patients previously treated with natalizumab compared to those treated with immunomodulatory drugs.


CONCLUSIONS
This study confirms the efficacy of FTY in reducing relapse rate in patients previously treated with immunomodulatory drugs, while it seems to be less effective in patients discontinuing natalizumab. Due to the short duration of follow-up it is not possible to evaluate disability progression; however, no difference was observed between the groups.
Neurology Unit, Department of Neuroscience/Rehabilitation, Azienda Ospedaliera-Universitaria S. Anna , Ferrara , Italy.
Eleonora
E
Baldi
Angelica
A
Guareschi
Francesca
F
Vitetta
Caterina
C
Senesi
Erica
E
Curti
Sara
S
Montepietra
Anna Maria
AM
Simone
Paolo
P
Immovilli
Luisa
L
Caniatti
Maria Rosaria
MR
Tola
Ilaria
I
Pesci
Enrico
E
Montanari
Patrizia
P
Sola
Franco
F
Granella
Luisa
L
Motti
Diana
D
Ferraro
D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D004185:Disability Evaluation; D018450:Disease Progression; D005260:Female; D000068876:Fingolimod Hydrochloride; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy*; D000069442:Natalizumab; D011409:Propylene Glycols / Q000627:therapeutic use*; D012008:Recurrence; D013110:Sphingosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000069442:Natalizumab; D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine
Efficacy; Fingolimod; Multiple sclerosis; Natalizumab; Relapses; Relapsing; remitting