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Please use this identifier to cite or link to this item: http://acervodigital.unesp.br/handle/11449/13201
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dc.contributor.authorRuperto, Nicolino-
dc.contributor.authorLovell, Daniel J.-
dc.contributor.authorQuartier, Pierre-
dc.contributor.authorPaz, Eliana-
dc.contributor.authorRubio-Perez, Nadina-
dc.contributor.authorSilva, Clovis A.-
dc.contributor.authorAbud-Mendoza, Carlos-
dc.contributor.authorBurgos-Vargas, Ruben-
dc.contributor.authorGerloni, Valeria-
dc.contributor.authorMelo-Gomes, Jose A.-
dc.contributor.authorSaad-Magalhaes, Claudia-
dc.contributor.authorChavez-Corrales, J.-
dc.contributor.authorHuemer, Christian-
dc.contributor.authorKivitz, Alan-
dc.contributor.authorBlanco, Francisco J.-
dc.contributor.authorFoeldvari, Ivan-
dc.contributor.authorHofer, Michael-
dc.contributor.authorHorneff, Gerd-
dc.contributor.authorHuppertz, Hans-Iko-
dc.contributor.authorJob-Deslandre, Chantal-
dc.contributor.authorLoy, Anna-
dc.contributor.authorMinden, Kirsten-
dc.contributor.authorPunaro, Marilynn-
dc.contributor.authorFlores Nunez, Alejandro-
dc.contributor.authorSigal, Leonard H.-
dc.contributor.authorBlock, Alan J.-
dc.contributor.authorNys, Marleen-
dc.contributor.authorMartini, Alberto-
dc.contributor.authorGiannini, Edward H.-
dc.date.accessioned2014-05-20T13:38:03Z-
dc.date.accessioned2016-10-25T16:54:27Z-
dc.date.available2014-05-20T13:38:03Z-
dc.date.available2016-10-25T16:54:27Z-
dc.date.issued2010-06-01-
dc.identifierhttp://dx.doi.org/10.1002/art.27431-
dc.identifier.citationArthritis and Rheumatism. Hoboken: Wiley-liss, v. 62, n. 6, p. 1792-1802, 2010.-
dc.identifier.issn0004-3591-
dc.identifier.urihttp://hdl.handle.net/11449/13201-
dc.identifier.urihttp://acervodigital.unesp.br/handle/11449/13201-
dc.description.abstractObjective. We previously documented that abatacept was effective and safe in patients with juvenile idiopathic arthritis (JIA) who had not previously achieved a satisfactory clinical response with disease-modifying antirheumatic drugs or tumor necrosis factor blockade. Here, we report results from the long-term extension (LTE) phase of that study.Methods. This report describes the long-term, open-label extension phase of a double-blind, randomized, controlled withdrawal trial in 190 patients with JIA ages 6-17 years. Children were treated with 10 mg/kg abatacept administered intravenously every 4 weeks, with or without methotrexate. Efficacy results were based on data derived from the 153 patients who entered the open-label LTE phase and reflect >= 21 months (589 days) of treatment. Safety results include all available open-label data as of May 7, 2008.Results. of the 190 enrolled patients, 153 entered the LTE. By day 589, 90%, 88%, 75%, 57%, and 39% of patients treated with abatacept during the double-blind and LTE phases achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement, respectively. Similar response rates were observed by day 589 among patients previously treated with placebo. Among patients who had not achieved an ACR Pedi 30 response at the end of the open-label lead-in phase and who proceeded directly into the LTE, 73%, 64%, 46%, 18%, and 5% achieved ACR Pedi 30, Pedi 50, Pedi 70, Pedi 90, and Pedi 100 responses, respectively, by day 589 of the LTE. No cases of tuberculosis and no malignancies were reported during the LTE. Pneumonia developed in 3 patients, and multiple sclerosis developed in 1 patient.Conclusion. Abatacept provided clinically significant and durable efficacy in patients with JIA, including those who did not initially achieve an ACR Pedi 30 response during the initial 4-month open-label lead-in phase.en
dc.description.sponsorshipBristol-Myers Squibb-
dc.format.extent1792-1802-
dc.language.isoeng-
dc.publisherWiley-liss-
dc.sourceWeb of Science-
dc.titleLong-Term Safety and Efficacy of Abatacept in Children With Juvenile Idiopathic Arthritisen
dc.typeoutro-
dc.contributor.institutionUniv Genoa-
dc.contributor.institutionCincinnati Childrens Hosp Med Ctr-
dc.contributor.institutionHop Necker Enfants Malad-
dc.contributor.institutionInst Salud Nino-
dc.contributor.institutionHosp Univ Dr JE Gonzalez-
dc.contributor.institutionHosp Das Clin-
dc.contributor.institutionHosp Cent Dr Ignacio Morones Prieto-
dc.contributor.institutionUniv Nacl Autonoma Mexico-
dc.contributor.institutionHosp Gen Mexico City-
dc.contributor.institutionIst Gaetano Pini-
dc.contributor.institutionInst Portugues Reumatol-
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)-
dc.contributor.institutionHosp Nacl Edgardo Rebagliati-
dc.contributor.institutionLandeskrankenhaus Bregenz-
dc.contributor.institutionAltoona Arthrit & Osteoporosis Ctr-
dc.contributor.institutionHosp Univ A Coruna-
dc.contributor.institutionHamburger Zentrum Kinder & Jugendrheumatol-
dc.contributor.institutionCtr Multisite Romand Rhumatol Pediat-
dc.contributor.institutionZentrum Allgemeine Paediat & Nenatol-
dc.contributor.institutionProf Hess Kinderklin-
dc.contributor.institutionHop St Vincent de Paul-
dc.contributor.institutionCharite-
dc.contributor.institutionTexas Scottish Rite Hosp Crippled Children-
dc.contributor.institutionHosp Nino Poblano-
dc.contributor.institutionBristol Myers Squibb-
dc.description.affiliationUniv Genoa, Ist Ricovero Cura Carattere Sci G Gaslini, Pediatria PRINTO 2, I-16147 Genoa, Italy-
dc.description.affiliationCincinnati Childrens Hosp Med Ctr, Cincinnati, OH USA-
dc.description.affiliationHop Necker Enfants Malad, Paris, France-
dc.description.affiliationInst Salud Nino, Lima, Peru-
dc.description.affiliationHosp Univ Dr JE Gonzalez, Monterrey, Mexico-
dc.description.affiliationHosp Das Clin, São Paulo, Brazil-
dc.description.affiliationHosp Cent Dr Ignacio Morones Prieto, San Luis Potosi, Mexico-
dc.description.affiliationUniv Nacl Autonoma Mexico, Mexico City 04510, DF, Mexico-
dc.description.affiliationHosp Gen Mexico City, Mexico City, DF, Mexico-
dc.description.affiliationIst Gaetano Pini, Milan, Italy-
dc.description.affiliationInst Portugues Reumatol, Lisbon, Portugal-
dc.description.affiliationUniv Estadual Paulista, Botucatu, SP, Brazil-
dc.description.affiliationHosp Nacl Edgardo Rebagliati, Lima, Peru-
dc.description.affiliationLandeskrankenhaus Bregenz, Bregenz, Austria-
dc.description.affiliationAltoona Arthrit & Osteoporosis Ctr, Duncansville, PA USA-
dc.description.affiliationHosp Univ A Coruna, Coruna, Spain-
dc.description.affiliationHamburger Zentrum Kinder & Jugendrheumatol, Hamburg, Germany-
dc.description.affiliationCtr Multisite Romand Rhumatol Pediat, Lausanne, Switzerland-
dc.description.affiliationZentrum Allgemeine Paediat & Nenatol, St Augustin, Germany-
dc.description.affiliationProf Hess Kinderklin, Bremen, Germany-
dc.description.affiliationHop St Vincent de Paul, F-75674 Paris, France-
dc.description.affiliationCharite, Berlin, Germany-
dc.description.affiliationTexas Scottish Rite Hosp Crippled Children, Dallas, TX USA-
dc.description.affiliationHosp Nino Poblano, Puebla, Mexico-
dc.description.affiliationBristol Myers Squibb, Princeton, NJ USA-
dc.description.affiliationBristol Myers Squibb, Braine Lalleud, Belgium-
dc.description.affiliationUnespUniv Estadual Paulista, Botucatu, SP, Brazil-
dc.identifier.doi10.1002/art.27431-
dc.identifier.wosWOS:000279432500031-
dc.rights.accessRightsAcesso restrito-
dc.relation.ispartofArthritis and Rheumatism-
Appears in Collections:Artigos, TCCs, Teses e Dissertações da Unesp

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