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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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. |
doi_str_mv | 10.1371/journal.pone.0066308 |
format | Article |
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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.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0066308</identifier><identifier>PMID: 23843952</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>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</subject><ispartof>PloS one, 2013-07, Vol.8 (7), p.e66308-e66308</ispartof><rights>COPYRIGHT 2013 Public Library of Science</rights><rights>2013 Castillo-Trivino et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2013 Castillo-Trivino et al 2013 Castillo-Trivino et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-e4e597f7adbfdb7c785b8c878e364ffbd6e00de2071fba61cef4d618670acd273</citedby><cites>FETCH-LOGICAL-c692t-e4e597f7adbfdb7c785b8c878e364ffbd6e00de2071fba61cef4d618670acd273</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3699597/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3699597/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,2103,2929,23871,27929,27930,53796,53798</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23843952$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Jacobson, Steven</contributor><creatorcontrib>Castillo-Trivino, Tamara</creatorcontrib><creatorcontrib>Braithwaite, Dejana</creatorcontrib><creatorcontrib>Bacchetti, Peter</creatorcontrib><creatorcontrib>Waubant, Emmanuelle</creatorcontrib><title>Rituximab in relapsing and progressive forms of multiple sclerosis: a systematic review</title><title>PloS one</title><addtitle>PLoS One</addtitle><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. 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drug therapy</subject><subject>Multiple Sclerosis, Chronic Progressive - immunology</subject><subject>Multiple Sclerosis, Chronic Progressive - pathology</subject><subject>Multiple Sclerosis, Relapsing-Remitting - drug therapy</subject><subject>Multiple Sclerosis, Relapsing-Remitting - immunology</subject><subject>Multiple Sclerosis, Relapsing-Remitting - pathology</subject><subject>Neurology</subject><subject>Pathogenesis</subject><subject>Patients</subject><subject>Quality</subject><subject>Rheumatoid arthritis</subject><subject>Rituximab</subject><subject>Studies</subject><subject>Systematic review</subject><subject>Targeted cancer therapy</subject><subject>Therapy</subject><subject>Treatment Outcome</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNkttu1DAQhiMEoqXwBggiISG42MWxEx-4QKoqDitVqlROl5bjjHddOXGwk6V9e7xsWm1QL5AvbI2_-ccz_rPseYGWBWHFuys_hk65Ze87WCJEKUH8QXZcCIIXFCPy8OB8lD2J8QqhinBKH2dHmPCSiAofZz8v7TBe21bVue3yAE710XbrXHVN3ge_DhCj3UJufGhj7k3ejm6wvYM8agfBRxvf5yqPN3GAVg1WJ42thd9Ps0dGuQjPpv0k-_7p47ezL4vzi8-rs9PzhaYCDwsooRLMMNXUpqmZZryqueaMA6GlMXVDAaEGMGKFqRUtNJiyoQWnDCndYEZOspd73d75KKeZRFkIVlacCMoTsdoTjVdXsg-p13AjvbLyb8CHtVQhPdyBFBgJhTEmGKmSV0QUjFRGmVogUSOlktaHqdpYt9Bo6Iag3Ex0ftPZjVz7rSRUiNRoEngzCQT_a4Q4yNZGDc6pDvyY3k2EEJgWVCT01T_o_d1N1FqlBmxnfKqrd6LytGS8LEtMUaKW91BpNdBanQxkbIrPEt7OEhIzwPWwVmOMcvX18v_Zix9z9vUBuwHlhk30bhys7-IcLPegTh6LAczdkAskd_6_nYbc-V9O_k9pLw4_6C7p1vDkD5ZkAS4</recordid><startdate>20130702</startdate><enddate>20130702</enddate><creator>Castillo-Trivino, Tamara</creator><creator>Braithwaite, Dejana</creator><creator>Bacchetti, Peter</creator><creator>Waubant, Emmanuelle</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20130702</creationdate><title>Rituximab in relapsing and progressive forms of multiple sclerosis: a systematic review</title><author>Castillo-Trivino, Tamara ; Braithwaite, Dejana ; Bacchetti, Peter ; Waubant, Emmanuelle</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-e4e597f7adbfdb7c785b8c878e364ffbd6e00de2071fba61cef4d618670acd273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibodies, Monoclonal, Murine-Derived - 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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.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>23843952</pmid><doi>10.1371/journal.pone.0066308</doi><tpages>e66308</tpages><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
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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