Abstract Details

Title Efficacy of Fingolimod Treatment in Multiple Sclerosis Patients: A Multicenter Experience in Clinical Practice

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 204

Objective

Background BACKGROUND: Fingolimod is the first oral drug approved for the treatment of MS patients. Fingolimod use in clinical practice is reserved to patients with inadequate response to other disease-modifying drugs or with a rapidly evolving disease. No data about the real impact in patients who satisfy eligibility criteria are reported.

Design/Methods DESIGN/METHODS: We report data of the first consecutive 84 patients receiving fingolimod at 3 Italian MS centers. Patients have been chosen in accord to AIFA Eligibility Criteria. Main efficacy endpoints were the proportion of patients free from relapses, from MRI activity, from EDSS progression, and from any disease activity.

Results RESULTS: Out of 84 patients included, 58 were women and 26 men. Mean age was 38.5±8.3 years. Sixteen patients were treated with natalizumab before starting fingolimod and were shifted to this treatment because of risk of progressive multifocal leukoencephalopaty.Fourteen patients received fingolimod <6 months, 21 patients received treatment between 6 and 11 months, 42 patients between 12 and 18 months, and 7 patients >18 months. Therapy was stopped in 4 patients (4.8%) within the first 6 months of treatment. In 2 patients was stopped due to inefficacy and in 2 patients due their decision. Mean EDSS score at baseline was 2.4±1.1, at 6 months it decreased in 10 patients while increased in 1 patient, at 12 and 18 months it remained stable. During the treatment, 95.2% of patients were relapse-free, 86.8% were free form MRI activity, 98.8% were free from EDSS progression, and 90.5% were free from any disease activity.

Conclusions CONCLUSIONS: In clinical practice, fingolimod is effective in reducing disease activity and progression of disability over the treatment period. The amount of efficacy was more pronounced than reported in the pivotal registration trials.

Authors/Disclosures
Rocco Totaro, MD (Clinica Neurologica Università degli Studi de) PRESENTER	No disclosure on file
Christine Clerc (CHG Andre Boulloche-EEG)	No disclosure on file
Roberta Fantozzi, MD	No disclosure on file
Paolo Bellantonio, MD (Istituto Neurologico Mediterraneo - Neuromed)	No disclosure on file
	No disclosure on file
	No disclosure on file
Aurora Fuiani, MD	No disclosure on file
	No disclosure on file
Stefano Ruggieri (Universita La Sapienza, Clinica Neurologica)	No disclosure on file
Massimo Filippi, MD, FAAN (Ospedale San Raffaele, Neuroimaging Research Unit)	Dr. Filippi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion, Almirall, Biogen, Merck, Novartis, Roche, Sanofi. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion, Biogen, Bristol-Myers Squibb, Merck, Novartis, Roche, Sanofi, Sanofi-Aventis, Sanofi-Genzyme, Takeda. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer, Biogen, Celgene, Chiesi Italia SpA, Eli Lilly, Genzyme, Janssen, Merck-Serono, Neopharmed Gentili, Novartis, Novo Nordisk, Roche, Sanofi, Takeda, and TEVA. Dr. Filippi has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer Nature. The institution of Dr. Filippi has received research support from Biogen Idec, Merck-Serono, Novartis, Roche, the Italian Ministry of Health, the Italian Ministry of University and Research, and Fondazione Italiana Sclerosi Multipla.
Antonio Carolei, MD (Clinica Neurologica, Univ Degli Studi)	No disclosure on file

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