Development of rituximab for relapsing remitting and primary progressive MS has been terminated. A very similar drug, ocrelizumab is now under development.
Other names: Rituxan
In development for: Relapsing remitting and primary progressive MS
Status: development terminated
Last updated: November 2011
How does it work?
Rituximab is a monoclonal antibody licensed to treat leukaemia and non-Hodgkins lymphoma.
It reduces the numbers of B-cells in the immune system. Most of the current treatments for MS interact with or deplete T-cells, so rituximab provides a means for investigating the role of B-cells in the immunological changes in MS.
How is it given?
Intravenous infusion. In the 48 week phase II study of relapsing remitting MS, intravenous infusions were given on days 1 and 15.
In a phase II, 48 week, clinical trial, rituximab was given by iv infusion on days 1 and 15. There were significantly fewer active lesions and relapses in the rituximab group.
- Thirty people who had experienced a relapse in the last 18 months despite use of an injectable disease modifying treatment received four cycles of rituximab by intravenous infusion over a 52 week study period.
MRI scans were conducted before, during, and after treatment with rituximab. After treatment with rituximab, 74% of MRI scans were free of active areas of inflammation compared with 26% seen before treatment with rituximab. The authors conclude that rituximab remains a potential option for treatment of people with relapsing remitting MS who show inadequate response to standard licensed injectable drugs.
439 participants with PPMS received two 1,000 mg intravenous rituximab or placebo infusions every 24 weeks, over a treatment period of 96 weeks (4 courses). Measuring increases in disability, no difference was found between rituximab and placebo, leading researchers to conclude that rituximab has no effect in primary progressive MS. However, further analysis of subgroups suggested some evidence of efficacy in younger people with PPMS and those with some evidence of active inflammation.
Relapsing remitting MS
As add-on treatment for disease modifying treatments
Primary progressive MS
Side effects and contra indications
Rituximab has been associated with a number of severe side effects including progressive multifocal leukoencephalopathy (PML) and fatal infusion reactions, although these have not been reported in MS trials.
Hauser SL et al.
B-cell depletion with rituximab in relapsing-remitting multiple sclerosis.
New England Journal Mededicine 2008 358(7):676-688.
Naismith RT, Piccio L, Lyons JA, et al.
Rituximab add-on therapy for breakthrough relapsing multiple sclerosis: A 52-week phase II trial.
Neurology 2010; 74(23):1860-67.
Hawker K, O'Connor P, Freedman MS, et al.
Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial.
Annals of Neurolology 2009 Oct;66(4):460-71.