Previous treatment influences fingolimod efficacy in relapsing–remitting multiple sclerosis: results from an observational study

Abstract

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.

Keywords::

• Efficacy
• Fingolimod
• Multiple sclerosis
• Natalizumab
• Relapses
• Relapsing
• remitting

Transparency

Declaration of funding

Realized with the contribution of an unconditional grant from Novartis Farma Spa through the contest ‘Best in Class – Experience with Oral Therapies in MS’, ‘Thenewway Ltd’, Milan, Italy.

Twenty-six out of 127 patients started FTY through the Expanded Access Program, an open-label study protocol (CFTY720DIT03), sponsored by Novartis, that provided FTY at no charge until FTY was commercialized.

Declaration of financial/other relationships

E.M. has disclosed that he has received travel grants and fees for consultancies and scientific production from Novartis, Merck-Serono, Biogen Idec, Sanofi-Genzyme and TEVA. P.S., M.R.T. and L.C. have disclosed that they have received travel grants and/or speaking honoraria from Bayer-Schering, Biogen Idec, Merck-Serono, Novartis, Sanofi-Genzyme and TEVA. D.F. has disclosed that she has received travel grants and/or speaking honoraria from Bayer-Schering, Biogen Idec, Merck-Serono, Novartis and TEVA. E.B. has disclosed that she has received travel grants and/or speaking honoraria from Biogen Idec, Merck-Serono, Novartis and TEVA. F.V., A.G., C.S., E.C., A.M.S., S.M., P.I., I.P., F.G. and L.M. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.