The ACROSS study: Long-term efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis.

Abstract

BACKGROUND:

In chronic diseases such as multiple sclerosis requiring lifelong treatment, studies on long-term outcomes are important.

OBJECTIVE:

To assess disability and magnetic resonance imaging-related outcomes in relapsing multiple sclerosis patients from a Phase 2 study of fingolimod 10 or more years after randomization and to compare outcomes in patients who had a higher fingolimod exposure versus those with a lower fingolimod exposure.

METHODS:

ACROSS was a cross-sectional follow-up study of patients originally enrolled in a Phase 2 fingolimod proof-of-concept study (NCT00333138). Disability and magnetic resonance imaging-related outcomes were assessed in patients grouped according to fingolimod treatment duration, based on an arbitrary cut-off: ≥8 years (high exposure) and <8 years (low exposure).

RESULTS:

Overall, 175/281 (62%) patients participated in ACROSS; 104 (59%) of these were classified "high exposure." At 10 years, patients in the high-exposure group had smaller increases in Expanded Disability Status Scale (+0.55 vs. +1.21), and lower frequencies of disability progression (34.7% vs. 56.1%), wheelchair use (4.8% vs. 16.9%), or transition to secondary progressive multiple sclerosis (9.6% vs. 22.5%) than those in the low-exposure group. The high-exposure patients also had less progression in most magnetic resonance imaging-related outcomes.

CONCLUSION:

After 10 years of fingolimod treatment, disability progression was lower in the high-exposure group than in the low-exposure group.

• Authors: T Derfuss, J Sastre-Garriga, X Montalban, M Rodegher, J Wuerfel, L Gaetano, D Tomic, A Azmon, C Wolf, L Kappos
• Journal: Multiple sclerosis journal - experimental, translational and clinical (Mult Scler J Exp Transl Clin) 2020 Jan-Mar Vol. 6 Issue 1 Pg. 2055217320907951 ISSN: 2055-2173 [Print] United States
• PMID: 32284874 (Publication Type: Journal Article)
• Copyright: © The Author(s) 2020.