RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.

Summary

A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.

Timeline

Start

2016-05

Primary completion

2021-07

Completion

2021-08

Outcome

Met primary endpoint

paper corresponding to a risk ratio of 0·19 (95% CI 0·06-0·62; p=0·0060). PMID 35841908 ↗

paper rituximab given as 1000 mg followed by 500 mg every 6 months is superior to dimethyl fumarate in preventing relapses over 24 months PMID 35841908 ↗

Publications

• Svenningsson A, Frisell T, Burman J, Salzer J, Fink K, Hallberg S, Hambraeus J, Axelsson M, Nimer FA, Sundstrom P, Gunnarsson M, Johansson R, Mellergard J, Rosenstein I, Ayad A, Sjoblom I, Risedal A, de Flon P, Gilland E, Lindeberg J, Shawket F, Piehl F, Lycke J. Safety and efficacy of rituximab versus dimethyl fumarate in patients with relapsing-remitting multiple sclerosis or clinically isolated syndrome in Sweden: a rater-blinded, phase 3, randomised controlled trial. Lancet Neurol. 2022 Aug;21(8):693-703. doi: 10.1016/S1474-4422(22)00209-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	500 mg	Intravenous
Comparator	dimethyl fumarate	Unknown	240 mg	Oral

Indications