Delayed-release dimethyl fumarate and disability assessed by the Multiple Sclerosis Functional Composite: Integrated analysis of DEFINE and CONFIRM

Gavin Giovannoni; Ralf Gold; Ludwig Kappos; Douglas L Arnold; Amit Bar-Or; Jing L Marantz; Minhua Yang; Andrew Lee

doi:10.1177/2055217316634111

Delayed-release dimethyl fumarate and disability assessed by the Multiple Sclerosis Functional Composite: Integrated analysis of DEFINE and CONFIRM

Mult Scler J Exp Transl Clin. 2016 Feb 19:2:2055217316634111. doi: 10.1177/2055217316634111. eCollection 2016 Jan-Dec.

Authors

Gavin Giovannoni¹, Ralf Gold², Ludwig Kappos³, Douglas L Arnold⁴, Amit Bar-Or⁴, Jing L Marantz, Minhua Yang, Andrew Lee⁵

Affiliations

¹ Queen Mary University London, UK.
² St Josef Hospital, Ruhr University, Germany.
³ University Hospital, Basel Neurology, Switzerland.
⁴ Montreal Neurological Institute, McGill University, Canada.
⁵ Biogen, USA.

Abstract

The effect of delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on the Multiple Sclerosis Functional Composite (MSFC) was assessed using integrated Phase 3 DEFINE and CONFIRM data. Patients treated with DMF (n = 769) demonstrated significant superiority on the MSFC, and each component, compared with placebo (n = 771) over two years: mean change for DMF vs placebo was 0.054 vs -0.053 on MSFC; -0.088 vs -0.286 on Timed 25-Foot Walk, 0.047 vs 0.003 on 9-Hole Peg Test and 0.178 vs 0.123 on Paced Auditory Serial Addition Test. DMF was an efficacious treatment for patients with MS.

Keywords: Delayed-release dimethyl fumarate; Multiple Sclerosis Functional Composite; disability evaluation; disease progression; multiple sclerosis; neuropsychological tests.