Long-Term Safety and Efficacy of Abatacept in Children With Juvenile Idiopathic Arthritis

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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 [UNESP]
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.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.date.accessioned2014-05-20T13:38:03Z
dc.date.available2014-05-20T13:38:03Z
dc.date.issued2010-06-01
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.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.description.sponsorshipBristol-Myers Squibb
dc.format.extent1792-1802
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.doi10.1002/art.27431
dc.identifier.issn0004-3591
dc.identifier.lattes7098310008371632
dc.identifier.orcid0000-0002-7631-7093
dc.identifier.urihttp://hdl.handle.net/11449/13201
dc.identifier.wosWOS:000279432500031
dc.language.isoeng
dc.publisherWiley-liss
dc.relation.ispartofArthritis and Rheumatism
dc.rights.accessRightsAcesso restrito
dc.sourceWeb of Science
dc.titleLong-Term Safety and Efficacy of Abatacept in Children With Juvenile Idiopathic Arthritisen
dc.typeArtigo
dcterms.licensehttp://olabout.wiley.com/WileyCDA/Section/id-815640.html
dcterms.rightsHolderWiley-liss
unesp.author.lattes7098310008371632[11]
unesp.author.orcid0000-0001-9821-7635[15]
unesp.author.orcid0000-0002-1769-549X[3]
unesp.author.orcid0000-0002-7631-7093[11]
unesp.campusUniversidade Estadual Paulista (Unesp), Faculdade de Medicina, Botucatupt

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