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Rituximab in Relapsing and Progressive Forms of Multiple Sclerosis: A Systematic Review

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 cli...

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Autores principales: Castillo-Trivino, Tamara, Braithwaite, Dejana, Bacchetti, Peter, Waubant, Emmanuelle
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3699597/
https://www.ncbi.nlm.nih.gov/pubmed/23843952
http://dx.doi.org/10.1371/journal.pone.0066308
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author Castillo-Trivino, Tamara
Braithwaite, Dejana
Bacchetti, Peter
Waubant, Emmanuelle
author_facet Castillo-Trivino, Tamara
Braithwaite, Dejana
Bacchetti, Peter
Waubant, Emmanuelle
author_sort Castillo-Trivino, Tamara
collection PubMed
description 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.
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spelling pubmed-36995972013-07-10 Rituximab in Relapsing and Progressive Forms of Multiple Sclerosis: A Systematic Review Castillo-Trivino, Tamara Braithwaite, Dejana Bacchetti, Peter Waubant, Emmanuelle PLoS One Research Article 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. Public Library of Science 2013-07-02 /pmc/articles/PMC3699597/ /pubmed/23843952 http://dx.doi.org/10.1371/journal.pone.0066308 Text en © 2013 Castillo-Trivino et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Castillo-Trivino, Tamara
Braithwaite, Dejana
Bacchetti, Peter
Waubant, Emmanuelle
Rituximab in Relapsing and Progressive Forms of Multiple Sclerosis: A Systematic Review
title Rituximab in Relapsing and Progressive Forms of Multiple Sclerosis: A Systematic Review
title_full Rituximab in Relapsing and Progressive Forms of Multiple Sclerosis: A Systematic Review
title_fullStr Rituximab in Relapsing and Progressive Forms of Multiple Sclerosis: A Systematic Review
title_full_unstemmed Rituximab in Relapsing and Progressive Forms of Multiple Sclerosis: A Systematic Review
title_short Rituximab in Relapsing and Progressive Forms of Multiple Sclerosis: A Systematic Review
title_sort rituximab in relapsing and progressive forms of multiple sclerosis: a systematic review
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3699597/
https://www.ncbi.nlm.nih.gov/pubmed/23843952
http://dx.doi.org/10.1371/journal.pone.0066308
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