Utility and safety of rituximab in pediatric autoimmune and inflammatory CNS disease
Identifieur interne : 003385 ( Main/Merge ); précédent : 003384; suivant : 003386Utility and safety of rituximab in pediatric autoimmune and inflammatory CNS disease
Auteurs : Russell C. Dale ; Fabienne Brilot ; Lisa V. Duffy ; Marinka Twilt ; Amy T. Waldman ; Sona Narula ; Eyal Muscal ; Kumaran Deiva ; Erik Andersen ; Michael R. Eyre ; Despina Eleftheriou ; Paul A. Brogan ; Rachel Kneen ; Gulay Alper ; Banu Anlar ; Evangeline Wassmer ; Kirsten Heineman ; Cheryl Hemingway ; Catherine J. Riney ; Andrew Kornberg ; Marc Tardieu ; Amber Stocco ; Brenda Banwell ; Mark P. Gorman ; Susanne M. Benseler ; Ming LimSource :
- Neurology [ 0028-3878 ] ; 2014.
Descripteurs français
- KwdFr :
- Adolescent, Anti-inflammatoires non stéroïdiens (usage thérapeutique), Anticorps monoclonaux d'origine murine (effets indésirables), Anticorps monoclonaux d'origine murine (usage thérapeutique), Enfant, Enfant d'âge préscolaire, Femelle, Humains, Immunité cellulaire (), Immunosuppresseurs (effets indésirables), Immunosuppresseurs (usage thérapeutique), Infection (épidémiologie), Infection (étiologie), Inflammation (traitement médicamenteux), Maladie du système nerveux central (traitement médicamenteux), Maladies auto-immunes (traitement médicamenteux), Mâle, Nourrisson, Numération formule sanguine, Perfusions veineuses (effets indésirables), Rituximab, Résultat thérapeutique, Vieillissement (physiologie), Études de cohortes, Études rétrospectives.
- MESH :
- effets indésirables : Anticorps monoclonaux d'origine murine, Immunosuppresseurs, Perfusions veineuses.
- physiologie : Vieillissement.
- traitement médicamenteux : Inflammation, Maladie du système nerveux central, Maladies auto-immunes.
- usage thérapeutique : Anti-inflammatoires non stéroïdiens, Anticorps monoclonaux d'origine murine, Immunosuppresseurs.
- épidémiologie : Infection.
- étiologie : Infection.
- Adolescent, Enfant, Enfant d'âge préscolaire, Femelle, Humains, Immunité cellulaire, Mâle, Nourrisson, Numération formule sanguine, Rituximab, Résultat thérapeutique, Études de cohortes, Études rétrospectives.
English descriptors
- KwdEn :
- Adolescent, Aging (physiology), Anti-Inflammatory Agents, Non-Steroidal (therapeutic use), Antibodies, Monoclonal, Murine-Derived (adverse effects), Antibodies, Monoclonal, Murine-Derived (therapeutic use), Autoimmune Diseases (drug therapy), Blood Cell Count, Central Nervous System Diseases (drug therapy), Child, Child, Preschool, Cohort Studies, Female, Humans, Immunity, Cellular (drug effects), Immunosuppressive Agents (adverse effects), Immunosuppressive Agents (therapeutic use), Infant, Infection (epidemiology), Infection (etiology), Inflammation (drug therapy), Infusions, Intravenous (adverse effects), Male, Retrospective Studies, Rituximab, Treatment Outcome.
- MESH :
- chemical , adverse effects : Antibodies, Monoclonal, Murine-Derived, Immunosuppressive Agents.
- chemical , therapeutic use : Anti-Inflammatory Agents, Non-Steroidal, Antibodies, Monoclonal, Murine-Derived, Immunosuppressive Agents.
- adverse effects : Infusions, Intravenous.
- drug effects : Immunity, Cellular.
- drug therapy : Autoimmune Diseases, Central Nervous System Diseases, Inflammation.
- epidemiology : Infection.
- etiology : Infection.
- physiology : Aging.
- Adolescent, Blood Cell Count, Child, Child, Preschool, Cohort Studies, Female, Humans, Infant, Male, Retrospective Studies, Rituximab, Treatment Outcome.
Abstract
To assess the utility and safety of rituximab in pediatric autoimmune and inflammatory disorders of the CNS.
Multicenter retrospective study.
A total of 144 children and adolescents (median age 8 years, range 0.7–17; 103 female) with NMDA receptor (NMDAR) encephalitis (n = 39), opsoclonus myoclonus ataxia syndrome (n = 32), neuromyelitis optica spectrum disorders (n = 20), neuropsychiatric systemic lupus erythematosus (n = 18), and other neuroinflammatory disorders (n = 35) were studied. Rituximab was given after a median duration of disease of 0.5 years (range 0.05–9.5 years). Infusion adverse events were recorded in 18/144 (12.5%), including grade 4 (anaphylaxis) in 3. Eleven patients (7.6%) had an infectious adverse event (AE), including 2 with grade 5 (death) and 2 with grade 4 (disabling) infectious AE (median follow-up of 1.65 years [range 0.1–8.5]). No patients developed progressive multifocal leukoencephalopathy. A definite, probable, or possible benefit was reported in 125 of 144 (87%) patients. A total of 17.4% of patients had a modified Rankin Scale (mRS) score of 0–2 at rituximab initiation, compared to 73.9% at outcome. The change in mRS 0–2 was greater in patients given rituximab early in their disease course compared to those treated later.
While limited by the retrospective nature of this analysis, our data support an off-label use of rituximab, although the significant risk of infectious complications suggests rituximab should be restricted to disorders with significant morbidity and mortality.
This study provides Class IV evidence that in pediatric autoimmune and inflammatory CNS disorders, rituximab improves neurologic outcomes with a 7.6% risk of adverse infections.
Url:
DOI: 10.1212/WNL.0000000000000570
PubMed: 24920861
PubMed Central: 4117174
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PMC:4117174Le document en format XML
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<author><name sortKey="Brilot, Fabienne" sort="Brilot, Fabienne" uniqKey="Brilot F" first="Fabienne" last="Brilot">Fabienne Brilot</name>
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<author><name sortKey="Duffy, Lisa V" sort="Duffy, Lisa V" uniqKey="Duffy L" first="Lisa V." last="Duffy">Lisa V. Duffy</name>
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<author><name sortKey="Waldman, Amy T" sort="Waldman, Amy T" uniqKey="Waldman A" first="Amy T." last="Waldman">Amy T. Waldman</name>
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<author><name sortKey="Narula, Sona" sort="Narula, Sona" uniqKey="Narula S" first="Sona" last="Narula">Sona Narula</name>
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<author><name sortKey="Muscal, Eyal" sort="Muscal, Eyal" uniqKey="Muscal E" first="Eyal" last="Muscal">Eyal Muscal</name>
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<author><name sortKey="Deiva, Kumaran" sort="Deiva, Kumaran" uniqKey="Deiva K" first="Kumaran" last="Deiva">Kumaran Deiva</name>
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<author><name sortKey="Andersen, Erik" sort="Andersen, Erik" uniqKey="Andersen E" first="Erik" last="Andersen">Erik Andersen</name>
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<author><name sortKey="Eyre, Michael R" sort="Eyre, Michael R" uniqKey="Eyre M" first="Michael R." last="Eyre">Michael R. Eyre</name>
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<author><name sortKey="Eleftheriou, Despina" sort="Eleftheriou, Despina" uniqKey="Eleftheriou D" first="Despina" last="Eleftheriou">Despina Eleftheriou</name>
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<author><name sortKey="Brogan, Paul A" sort="Brogan, Paul A" uniqKey="Brogan P" first="Paul A." last="Brogan">Paul A. Brogan</name>
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<author><name sortKey="Kneen, Rachel" sort="Kneen, Rachel" uniqKey="Kneen R" first="Rachel" last="Kneen">Rachel Kneen</name>
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<author><name sortKey="Alper, Gulay" sort="Alper, Gulay" uniqKey="Alper G" first="Gulay" last="Alper">Gulay Alper</name>
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<author><name sortKey="Anlar, Banu" sort="Anlar, Banu" uniqKey="Anlar B" first="Banu" last="Anlar">Banu Anlar</name>
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<author><name sortKey="Wassmer, Evangeline" sort="Wassmer, Evangeline" uniqKey="Wassmer E" first="Evangeline" last="Wassmer">Evangeline Wassmer</name>
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<author><name sortKey="Heineman, Kirsten" sort="Heineman, Kirsten" uniqKey="Heineman K" first="Kirsten" last="Heineman">Kirsten Heineman</name>
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<author><name sortKey="Hemingway, Cheryl" sort="Hemingway, Cheryl" uniqKey="Hemingway C" first="Cheryl" last="Hemingway">Cheryl Hemingway</name>
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<author><name sortKey="Riney, Catherine J" sort="Riney, Catherine J" uniqKey="Riney C" first="Catherine J." last="Riney">Catherine J. Riney</name>
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<author><name sortKey="Kornberg, Andrew" sort="Kornberg, Andrew" uniqKey="Kornberg A" first="Andrew" last="Kornberg">Andrew Kornberg</name>
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<author><name sortKey="Tardieu, Marc" sort="Tardieu, Marc" uniqKey="Tardieu M" first="Marc" last="Tardieu">Marc Tardieu</name>
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<author><name sortKey="Stocco, Amber" sort="Stocco, Amber" uniqKey="Stocco A" first="Amber" last="Stocco">Amber Stocco</name>
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<author><name sortKey="Banwell, Brenda" sort="Banwell, Brenda" uniqKey="Banwell B" first="Brenda" last="Banwell">Brenda Banwell</name>
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<author><name sortKey="Gorman, Mark P" sort="Gorman, Mark P" uniqKey="Gorman M" first="Mark P." last="Gorman">Mark P. Gorman</name>
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<author><name sortKey="Benseler, Susanne M" sort="Benseler, Susanne M" uniqKey="Benseler S" first="Susanne M." last="Benseler">Susanne M. Benseler</name>
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<author><name sortKey="Lim, Ming" sort="Lim, Ming" uniqKey="Lim M" first="Ming" last="Lim">Ming Lim</name>
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<series><title level="j">Neurology</title>
<idno type="ISSN">0028-3878</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term>
<term>Aging (physiology)</term>
<term>Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)</term>
<term>Antibodies, Monoclonal, Murine-Derived (adverse effects)</term>
<term>Antibodies, Monoclonal, Murine-Derived (therapeutic use)</term>
<term>Autoimmune Diseases (drug therapy)</term>
<term>Blood Cell Count</term>
<term>Central Nervous System Diseases (drug therapy)</term>
<term>Child</term>
<term>Child, Preschool</term>
<term>Cohort Studies</term>
<term>Female</term>
<term>Humans</term>
<term>Immunity, Cellular (drug effects)</term>
<term>Immunosuppressive Agents (adverse effects)</term>
<term>Immunosuppressive Agents (therapeutic use)</term>
<term>Infant</term>
<term>Infection (epidemiology)</term>
<term>Infection (etiology)</term>
<term>Inflammation (drug therapy)</term>
<term>Infusions, Intravenous (adverse effects)</term>
<term>Male</term>
<term>Retrospective Studies</term>
<term>Rituximab</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term>
<term>Anti-inflammatoires non stéroïdiens (usage thérapeutique)</term>
<term>Anticorps monoclonaux d'origine murine (effets indésirables)</term>
<term>Anticorps monoclonaux d'origine murine (usage thérapeutique)</term>
<term>Enfant</term>
<term>Enfant d'âge préscolaire</term>
<term>Femelle</term>
<term>Humains</term>
<term>Immunité cellulaire ()</term>
<term>Immunosuppresseurs (effets indésirables)</term>
<term>Immunosuppresseurs (usage thérapeutique)</term>
<term>Infection (épidémiologie)</term>
<term>Infection (étiologie)</term>
<term>Inflammation (traitement médicamenteux)</term>
<term>Maladie du système nerveux central (traitement médicamenteux)</term>
<term>Maladies auto-immunes (traitement médicamenteux)</term>
<term>Mâle</term>
<term>Nourrisson</term>
<term>Numération formule sanguine</term>
<term>Perfusions veineuses (effets indésirables)</term>
<term>Rituximab</term>
<term>Résultat thérapeutique</term>
<term>Vieillissement (physiologie)</term>
<term>Études de cohortes</term>
<term>Études rétrospectives</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal, Murine-Derived</term>
<term>Immunosuppressive Agents</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Inflammatory Agents, Non-Steroidal</term>
<term>Antibodies, Monoclonal, Murine-Derived</term>
<term>Immunosuppressive Agents</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Infusions, Intravenous</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Immunity, Cellular</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Autoimmune Diseases</term>
<term>Central Nervous System Diseases</term>
<term>Inflammation</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps monoclonaux d'origine murine</term>
<term>Immunosuppresseurs</term>
<term>Perfusions veineuses</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Infection</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Infection</term>
</keywords>
<keywords scheme="MESH" qualifier="physiologie" xml:lang="fr"><term>Vieillissement</term>
</keywords>
<keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>Aging</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Inflammation</term>
<term>Maladie du système nerveux central</term>
<term>Maladies auto-immunes</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anti-inflammatoires non stéroïdiens</term>
<term>Anticorps monoclonaux d'origine murine</term>
<term>Immunosuppresseurs</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Infection</term>
</keywords>
<keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Infection</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Blood Cell Count</term>
<term>Child</term>
<term>Child, Preschool</term>
<term>Cohort Studies</term>
<term>Female</term>
<term>Humans</term>
<term>Infant</term>
<term>Male</term>
<term>Retrospective Studies</term>
<term>Rituximab</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Enfant</term>
<term>Enfant d'âge préscolaire</term>
<term>Femelle</term>
<term>Humains</term>
<term>Immunité cellulaire</term>
<term>Mâle</term>
<term>Nourrisson</term>
<term>Numération formule sanguine</term>
<term>Rituximab</term>
<term>Résultat thérapeutique</term>
<term>Études de cohortes</term>
<term>Études rétrospectives</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Objective:</title>
<p>To assess the utility and safety of rituximab in pediatric autoimmune and inflammatory disorders of the CNS.</p>
</sec>
<sec><title>Methods:</title>
<p>Multicenter retrospective study.</p>
</sec>
<sec><title>Results:</title>
<p>A total of 144 children and adolescents (median age 8 years, range 0.7–17; 103 female) with NMDA receptor (NMDAR) encephalitis (n = 39), opsoclonus myoclonus ataxia syndrome (n = 32), neuromyelitis optica spectrum disorders (n = 20), neuropsychiatric systemic lupus erythematosus (n = 18), and other neuroinflammatory disorders (n = 35) were studied. Rituximab was given after a median duration of disease of 0.5 years (range 0.05–9.5 years). Infusion adverse events were recorded in 18/144 (12.5%), including grade 4 (anaphylaxis) in 3. Eleven patients (7.6%) had an infectious adverse event (AE), including 2 with grade 5 (death) and 2 with grade 4 (disabling) infectious AE (median follow-up of 1.65 years [range 0.1–8.5]). No patients developed progressive multifocal leukoencephalopathy. A definite, probable, or possible benefit was reported in 125 of 144 (87%) patients. A total of 17.4% of patients had a modified Rankin Scale (mRS) score of 0–2 at rituximab initiation, compared to 73.9% at outcome. The change in mRS 0–2 was greater in patients given rituximab early in their disease course compared to those treated later.</p>
</sec>
<sec><title>Conclusion:</title>
<p>While limited by the retrospective nature of this analysis, our data support an off-label use of rituximab, although the significant risk of infectious complications suggests rituximab should be restricted to disorders with significant morbidity and mortality.</p>
</sec>
<sec><title>Classification of evidence:</title>
<p>This study provides Class IV evidence that in pediatric autoimmune and inflammatory CNS disorders, rituximab improves neurologic outcomes with a 7.6% risk of adverse infections.</p>
</sec>
</div>
</front>
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