The ACROSS study : Long-term efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis
Derfuss, Tobias (University Hospital Basel (Basilea, Suïssa))
Sastre-Garriga, Jaume (Hospital Universitari Vall d'Hebron)
Montalban, Xavier (Hospital Universitari Vall d'Hebron)
Rodegher, M. (IRCCS Fondazione Don Carlo Gnocchi)
Wuerfel, Jens (Medical Image Analysis Center Basel)
Gaetano, Laura (Medical Image Analysis Center Basel)
Tomic, D. (Novartis Pharma, Basel)
Azmon, Amin (Novartis Pharma, Basel)
Wolf, C. (Lycalis sprl)
Kappos, Ludwig (University Hospital Basel (Basilea, Suïssa))
Universitat Autònoma de Barcelona

Data:	2020
Resum:	In chronic diseases such as multiple sclerosis requiring lifelong treatment, studies on long-term outcomes are important. 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. 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). 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. After 10 years of fingolimod treatment, disability progression was lower in the high-exposure group than in the low-exposure group.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Relapsing-remitting multiple sclerosis ; Fingolimod ; Oral therapy ; Long-term treatment ; Ambulatory assistance ; Disability progression
Publicat a:	Multiple Sclerosis Journal - Experimental, Translational and Clinical, Vol. 6 (march 2020) , ISSN 2055-2173

DOI: 10.1177/2055217320907951
PMID: 32284874

10 p, 694.0 KB

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