Randomized Trial of Tocilizumab in Systemic Juvenile Idiopathic Arthritis
In a randomized trial involving children with severe systemic juvenile idiopathic arthritis, the anti–interleukin-6 receptor antibody tocilizumab was effective (response rate, 85% with tocilizumab vs. 24% with placebo). Adverse events included serious infections and neutropenia. Systemic juvenile id...
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Veröffentlicht in: | The New England journal of medicine 2012-12, Vol.367 (25), p.2385-2395 |
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creator | De Benedetti, Fabrizio Brunner, Hermine I Ruperto, Nicolino Kenwright, Andrew Wright, Stephen Calvo, Inmaculada Cuttica, Ruben Ravelli, Angelo Schneider, Rayfel Woo, Patricia Wouters, Carine Xavier, Ricardo Zemel, Lawrence Baildam, Eileen Burgos-Vargas, Ruben Dolezalova, Pavla Garay, Stella M Merino, Rosa Joos, Rik Grom, Alexei Wulffraat, Nico Zuber, Zbigniew Zulian, Francesco Lovell, Daniel Martini, Alberto |
description | In a randomized trial involving children with severe systemic juvenile idiopathic arthritis, the anti–interleukin-6 receptor antibody tocilizumab was effective (response rate, 85% with tocilizumab vs. 24% with placebo). Adverse events included serious infections and neutropenia.
Systemic juvenile idiopathic arthritis (JIA) is characterized by chronic arthritis, systemic manifestations (spiking fever, rash, hepatosplenomegaly, lymphadenopathy, and serositis), and substantially elevated inflammatory markers.
1
It is the most severe subtype of JIA; approximately half the patients have an unremitting course of chronic polyarthritis (with or without persistent systemic features). Substantial joint damage and disability often develop in these patients.
2
,
3
Treatment remains challenging because of the limited efficacy of methotrexate
4
and tumor necrosis factor inhibitors
5
,
6
and because of the major toxicity of high-dose glucocorticoids. Efficacy of the interleukin-1 inhibitor anakinra has been reported in a subset of patients.
7
– . . . |
doi_str_mv | 10.1056/NEJMoa1112802 |
format | Article |
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Systemic juvenile idiopathic arthritis (JIA) is characterized by chronic arthritis, systemic manifestations (spiking fever, rash, hepatosplenomegaly, lymphadenopathy, and serositis), and substantially elevated inflammatory markers.
1
It is the most severe subtype of JIA; approximately half the patients have an unremitting course of chronic polyarthritis (with or without persistent systemic features). Substantial joint damage and disability often develop in these patients.
2
,
3
Treatment remains challenging because of the limited efficacy of methotrexate
4
and tumor necrosis factor inhibitors
5
,
6
and because of the major toxicity of high-dose glucocorticoids. Efficacy of the interleukin-1 inhibitor anakinra has been reported in a subset of patients.
7
– . . .</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMoa1112802</identifier><identifier>PMID: 23252525</identifier><identifier>CODEN: NEJMAG</identifier><language>eng</language><publisher>Waltham, MA: Massachusetts Medical Society</publisher><subject>Adolescent ; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use ; Antibodies, Monoclonal, Humanized - adverse effects ; Antibodies, Monoclonal, Humanized - therapeutic use ; Arthritis, Juvenile - blood ; Arthritis, Juvenile - drug therapy ; Biological and medical sciences ; Child ; Child, Preschool ; Clinical trials ; Cytokines ; Data processing ; Diseases of the osteoarticular system ; Double-Blind Method ; Drug Therapy, Combination ; Female ; General aspects ; Glucocorticoids - therapeutic use ; Humans ; Infections - chemically induced ; Inflammatory joint diseases ; Male ; Medical sciences ; Methotrexate - therapeutic use ; Neutropenia - chemically induced ; Pediatrics ; Receptors, Interleukin-6 - antagonists & inhibitors ; Rheumatology ; Statistical analysis ; Transaminases - blood</subject><ispartof>The New England journal of medicine, 2012-12, Vol.367 (25), p.2385-2395</ispartof><rights>Copyright © 2012 Massachusetts Medical Society. All rights reserved.</rights><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c530t-515e675e1abda00cfd8ac30777af009963ea5810a9265ce390a80aa8ef1bc1b73</citedby><cites>FETCH-LOGICAL-c530t-515e675e1abda00cfd8ac30777af009963ea5810a9265ce390a80aa8ef1bc1b73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.nejm.org/doi/pdf/10.1056/NEJMoa1112802$$EPDF$$P50$$Gmms$$H</linktopdf><linktohtml>$$Uhttps://www.nejm.org/doi/full/10.1056/NEJMoa1112802$$EHTML$$P50$$Gmms$$H</linktohtml><link.rule.ids>314,776,780,2746,2747,26080,27901,27902,52357,54039</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26727155$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23252525$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>De Benedetti, Fabrizio</creatorcontrib><creatorcontrib>Brunner, Hermine I</creatorcontrib><creatorcontrib>Ruperto, Nicolino</creatorcontrib><creatorcontrib>Kenwright, Andrew</creatorcontrib><creatorcontrib>Wright, Stephen</creatorcontrib><creatorcontrib>Calvo, Inmaculada</creatorcontrib><creatorcontrib>Cuttica, Ruben</creatorcontrib><creatorcontrib>Ravelli, Angelo</creatorcontrib><creatorcontrib>Schneider, Rayfel</creatorcontrib><creatorcontrib>Woo, Patricia</creatorcontrib><creatorcontrib>Wouters, Carine</creatorcontrib><creatorcontrib>Xavier, Ricardo</creatorcontrib><creatorcontrib>Zemel, Lawrence</creatorcontrib><creatorcontrib>Baildam, Eileen</creatorcontrib><creatorcontrib>Burgos-Vargas, Ruben</creatorcontrib><creatorcontrib>Dolezalova, Pavla</creatorcontrib><creatorcontrib>Garay, Stella M</creatorcontrib><creatorcontrib>Merino, Rosa</creatorcontrib><creatorcontrib>Joos, Rik</creatorcontrib><creatorcontrib>Grom, Alexei</creatorcontrib><creatorcontrib>Wulffraat, Nico</creatorcontrib><creatorcontrib>Zuber, Zbigniew</creatorcontrib><creatorcontrib>Zulian, Francesco</creatorcontrib><creatorcontrib>Lovell, Daniel</creatorcontrib><creatorcontrib>Martini, Alberto</creatorcontrib><creatorcontrib>PRCSG</creatorcontrib><creatorcontrib>PRINTO</creatorcontrib><title>Randomized Trial of Tocilizumab in Systemic Juvenile Idiopathic Arthritis</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>In a randomized trial involving children with severe systemic juvenile idiopathic arthritis, the anti–interleukin-6 receptor antibody tocilizumab was effective (response rate, 85% with tocilizumab vs. 24% with placebo). Adverse events included serious infections and neutropenia.
Systemic juvenile idiopathic arthritis (JIA) is characterized by chronic arthritis, systemic manifestations (spiking fever, rash, hepatosplenomegaly, lymphadenopathy, and serositis), and substantially elevated inflammatory markers.
1
It is the most severe subtype of JIA; approximately half the patients have an unremitting course of chronic polyarthritis (with or without persistent systemic features). Substantial joint damage and disability often develop in these patients.
2
,
3
Treatment remains challenging because of the limited efficacy of methotrexate
4
and tumor necrosis factor inhibitors
5
,
6
and because of the major toxicity of high-dose glucocorticoids. Efficacy of the interleukin-1 inhibitor anakinra has been reported in a subset of patients.
7
– . . .</description><subject>Adolescent</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Arthritis, Juvenile - blood</subject><subject>Arthritis, Juvenile - drug therapy</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Clinical trials</subject><subject>Cytokines</subject><subject>Data processing</subject><subject>Diseases of the osteoarticular system</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>General aspects</subject><subject>Glucocorticoids - therapeutic use</subject><subject>Humans</subject><subject>Infections - chemically induced</subject><subject>Inflammatory joint diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Methotrexate - therapeutic use</subject><subject>Neutropenia - chemically induced</subject><subject>Pediatrics</subject><subject>Receptors, Interleukin-6 - antagonists & inhibitors</subject><subject>Rheumatology</subject><subject>Statistical analysis</subject><subject>Transaminases - 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Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>De Benedetti, Fabrizio</au><au>Brunner, Hermine I</au><au>Ruperto, Nicolino</au><au>Kenwright, Andrew</au><au>Wright, Stephen</au><au>Calvo, Inmaculada</au><au>Cuttica, Ruben</au><au>Ravelli, Angelo</au><au>Schneider, Rayfel</au><au>Woo, Patricia</au><au>Wouters, Carine</au><au>Xavier, Ricardo</au><au>Zemel, Lawrence</au><au>Baildam, Eileen</au><au>Burgos-Vargas, Ruben</au><au>Dolezalova, Pavla</au><au>Garay, Stella M</au><au>Merino, Rosa</au><au>Joos, Rik</au><au>Grom, Alexei</au><au>Wulffraat, Nico</au><au>Zuber, Zbigniew</au><au>Zulian, Francesco</au><au>Lovell, Daniel</au><au>Martini, Alberto</au><aucorp>PRCSG</aucorp><aucorp>PRINTO</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized Trial of Tocilizumab in Systemic Juvenile Idiopathic Arthritis</atitle><jtitle>The New England journal of medicine</jtitle><addtitle>N Engl J Med</addtitle><date>2012-12-20</date><risdate>2012</risdate><volume>367</volume><issue>25</issue><spage>2385</spage><epage>2395</epage><pages>2385-2395</pages><issn>0028-4793</issn><eissn>1533-4406</eissn><coden>NEJMAG</coden><abstract>In a randomized trial involving children with severe systemic juvenile idiopathic arthritis, the anti–interleukin-6 receptor antibody tocilizumab was effective (response rate, 85% with tocilizumab vs. 24% with placebo). Adverse events included serious infections and neutropenia.
Systemic juvenile idiopathic arthritis (JIA) is characterized by chronic arthritis, systemic manifestations (spiking fever, rash, hepatosplenomegaly, lymphadenopathy, and serositis), and substantially elevated inflammatory markers.
1
It is the most severe subtype of JIA; approximately half the patients have an unremitting course of chronic polyarthritis (with or without persistent systemic features). Substantial joint damage and disability often develop in these patients.
2
,
3
Treatment remains challenging because of the limited efficacy of methotrexate
4
and tumor necrosis factor inhibitors
5
,
6
and because of the major toxicity of high-dose glucocorticoids. Efficacy of the interleukin-1 inhibitor anakinra has been reported in a subset of patients.
7
– . . .</abstract><cop>Waltham, MA</cop><pub>Massachusetts Medical Society</pub><pmid>23252525</pmid><doi>10.1056/NEJMoa1112802</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adolescent Anti-Inflammatory Agents, Non-Steroidal - therapeutic use Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Arthritis, Juvenile - blood Arthritis, Juvenile - drug therapy Biological and medical sciences Child Child, Preschool Clinical trials Cytokines Data processing Diseases of the osteoarticular system Double-Blind Method Drug Therapy, Combination Female General aspects Glucocorticoids - therapeutic use Humans Infections - chemically induced Inflammatory joint diseases Male Medical sciences Methotrexate - therapeutic use Neutropenia - chemically induced Pediatrics Receptors, Interleukin-6 - antagonists & inhibitors Rheumatology Statistical analysis Transaminases - blood |
title | Randomized Trial of Tocilizumab in Systemic Juvenile Idiopathic Arthritis |
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