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

Rituximab is an anti-CD20 monoclonal antibody approved for non Hodgkin lymphoma and rheumatoid arthritis. It is being considered for the treatment of MS. To evaluate the efficacy and safety of rituximab for MS treatment. Studies were selected if they were clinical trials, irrespective of the dosage...

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Veröffentlicht in:PloS one 2013-07, Vol.8 (7), p.e66308-e66308
Hauptverfasser: Castillo-Trivino, Tamara, Braithwaite, Dejana, Bacchetti, Peter, Waubant, Emmanuelle
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Braithwaite, Dejana
Bacchetti, Peter
Waubant, Emmanuelle
description Rituximab is an anti-CD20 monoclonal antibody approved for non Hodgkin lymphoma and rheumatoid arthritis. It is being considered for the treatment of MS. To evaluate the efficacy and safety of rituximab for MS treatment. Studies were selected if they were clinical trials, irrespective of the dosage or combination therapies. 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.
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subjects Adolescent
Adult
Aged
Antibodies, Monoclonal, Murine-Derived - therapeutic use
Arthritis
Brain
CD20 antigen
Central Nervous System - drug effects
Central Nervous System - immunology
Central Nervous System - pathology
Clinical trials
Clinical Trials as Topic
Complications and side effects
Data collection
Databases, Bibliographic
Drug therapy
Epidemiology
Gadolinium
Humans
Immunologic Factors - therapeutic use
Immunotherapy
Interferon
Lesions
Lymphocytes
Lymphoma
Magnetic resonance imaging
Mathematics
Medical research
Medicine
Middle Aged
Monoclonal antibodies
Multiple sclerosis
Multiple Sclerosis, Chronic Progressive - drug therapy
Multiple Sclerosis, Chronic Progressive - immunology
Multiple Sclerosis, Chronic Progressive - pathology
Multiple Sclerosis, Relapsing-Remitting - drug therapy
Multiple Sclerosis, Relapsing-Remitting - immunology
Multiple Sclerosis, Relapsing-Remitting - pathology
Neurology
Pathogenesis
Patients
Quality
Rheumatoid arthritis
Rituximab
Studies
Systematic review
Targeted cancer therapy
Therapy
Treatment Outcome
title Rituximab in relapsing and progressive forms of multiple sclerosis: a systematic review
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