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PLoS One. 2013 Jul 2;8(7):e66308. doi: 10.1371/journal.pone.0066308. Print 2013.

Rituximab in relapsing and progressive forms of multiple sclerosis: a systematic review.

Author information

1
Multiple Sclerosis Center, Department of Neurology, University of California San Francisco, San Francisco, California, USA. tamara.castillo@biodonostia.org

Abstract

BACKGROUND:

Rituximab is an anti-CD20 monoclonal antibody approved for non Hodgkin lymphoma and rheumatoid arthritis. It is being considered for the treatment of MS.

OBJECTIVES:

To evaluate the efficacy and safety of rituximab for MS treatment.

DATA COLLECTION:

Studies were selected if they were clinical trials, irrespective of the dosage or combination therapies.

MAIN RESULTS:

Four studies with a total of 599 patients were included. One assessed the efficacy of rituximab for primary progressive (PP) MS while the other three focused on relapsing-remitting (RR) MS. In the PPMS study, rituximab delayed time to confirmed disease progression (CDP) in pre-planned sub-group analyses. The increase in T2 lesion volume was lower in the rituximab group at week 96 compared with placebo. For the RRMS studies, an open-label phase I study found that rituximab reduced the annualized relapse rate to 0.25 from pre-therapy baseline to week 24, while in the randomized placebo-controlled phase II trial, annualized relapse rates were 0.37 in the rituximab group and 0.84 in the placebo group (p = 0.04) at week 24. Rituximab dramatically reduced the number of gadolinium-enhancing lesions on brain MRI scans for both RRMS studies. Off-label rituximab as an add-on therapy in patients with breakthrough disease on first-line agents was associated with an 88% reduction when comparing the mean number of gadolinium-enhancing lesions prior to and after the treatment. Although frequent adverse events classified as mild or moderate occurred in up to 77% of the patients, there were no grade 4 infusion-related adverse events. AUTHOR’S CONCLUSION: Despite the frequent mild/moderate adverse events related to the drug, rituximab appears overall safe for up to 2 years of therapy and has a substantial impact on the inflammatory disease activity (clinical and/or radiological) of RRMS. The effect of rituximab on disease progression in PPMS appears to be marginal.

PMID:
23843952
PMCID:
PMC3699597
DOI:
10.1371/journal.pone.0066308
[Indexed for MEDLINE]
Free PMC Article
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