Eficacia y seguridad de fingolimod en pacientes con esclerosis múltiple recurrente-remitente (EMRR): Los resultados de un 24 meses doble ciego adicional, controlado con placebo (LIBERTADES II Estudio)

OBJECTIVES:

To evaluate the efficacy and safety of fingolimod 0.5mg vs. placebo in patients with RRMS.

BACKGROUND:

Fingolimod 0.5mg, once-daily, is the first approved oral treatment in many countries for relapsing MS.

METHODS:

1083 RRMS patients were randomized to fingolimod 0.5mg, 1.25mg, or placebo (1:1:1). The study enrolled 95% patients in the USA. 75% patients had undergone prior treatment with other DMTs. Annualized relapse rate (ARR) at Month (M) 24 was the primary endpoint. Secondary endpoints included percent brain volume change (PBVC) from baseline and time to 3-M confirmed disability progression.

RESULTS:

At M24, fingolimod 0.5mg significantly reduced ARR by 48% vs. placebo (0.21 vs. 0.40; pConclusions: Results confirm the beneficial effects of fingolimod on clinical and MRI parameters including brain atrophy. Safety findings were consistent with previous trials. STUDY SUPPORTED BY.: The study was supported by Novartis Pharma AG, Basel, Switzerland.