Core Evidence clinical impact summary for [fingolimod/relapsing multiple sclerosis]

Outcome measure	Evidence	Implications
Disease-oriented evidence		Clear efficacy in relapsing-remitting multiple sclerosis as measured on both clinical and MRI parameters. It may promote the prevention of disability accumulation and disease progression overtime (long-term follow-up studies are needed).
Clinical	54% reduction compared to placebo*
Annualized Relapse-rate	52% reduction compared to IFNB-1a i.m.§
EDSS progression	HR for disease progression confirmed after 6 months = 0.63*
MRI
Brain volume	Approximately 30% reduction in the rate of brain atrophy*§
No. of gadolinium-enhancing lesions	Significant reduction compared to placebo and IFNB 1a i.m.*§
No. of new or enlarged lesions on T2-weighted images
Patient-oriented evidence
Discontinuation rate	10.2% at 12 months§	High rate of adherence, mainly due to the oral administration and the good tolerability. It may promote the efficacy of the drug in the long-term.
	16.8% at 24 months*
Quality of life measures	Not available
Economic evidence
	Not available

Notes:

^*FREEDOMS Study,

^§TRANSFORMS Study.

Abbreviations: IFNB, interferon beta; EDSS, Expanded disability status scale; MRI, magnetic resonance imaging.