Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial

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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.authorSztajnbok, Flavio
dc.contributor.authorGoldenstein-Schainberg, Claudia
dc.contributor.authorScheinberg, Morton
dc.contributor.authorCalvo Penades, Immaculada
dc.contributor.authorFischbach, Michael
dc.contributor.authorOrozco, Javier
dc.contributor.authorHashkes, Philip J.
dc.contributor.authorHom, Christine
dc.contributor.authorJung, Lawrence
dc.contributor.authorLepore, Loredana
dc.contributor.authorOliveira, Sheila
dc.contributor.authorWallace, Carol A.
dc.contributor.authorSigal, Leonard H.
dc.contributor.authorBlock, Alon J.
dc.contributor.authorCovucci, Allison
dc.contributor.authorMartini, Alberto
dc.contributor.authorGiannini, Edward H.
dc.contributor.institutionIRCCS Ist G Gaslini Pediat 2
dc.contributor.institutionChildrens Hosp
dc.contributor.institutionHop Necker Enfants Malad
dc.contributor.institutionInst Salud Nino
dc.contributor.institutionHosp Univ JE Gonzalez
dc.contributor.institutionInst Crianca Hosp Clin
dc.contributor.institutionHosp Gen Dr Ignacio Morones Prieto
dc.contributor.institutionHosp Gen Mexico City
dc.contributor.institutionUniv Nacl Autonoma Mexico
dc.contributor.institutionGaetano Pini Inst
dc.contributor.institutionInst Portugues Reumatol Paediat Rheumatol
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.contributor.institutionHosp Univ Pedro Ernesto
dc.contributor.institutionUniversidade de São Paulo (USP)
dc.contributor.institutionHosp Israelita Albert Einstein
dc.contributor.institutionHosp La Fe
dc.contributor.institutionHop Univ Hautepierre
dc.contributor.institutionHosp San Javier
dc.contributor.institutionCleveland Clin Fdn
dc.contributor.institutionMaria Fareri Childrens Hosp
dc.contributor.institutionCreighton Univ
dc.contributor.institutionUniv Trieste
dc.contributor.institutionInst Puericultura & Pediat Martagao Gesteira
dc.contributor.institutionChildrens Hosp & Reg Med Ctr
dc.contributor.institutionBristol Myers Squibb Co
dc.contributor.institutionUniv Genoa
dc.date.accessioned2014-05-20T15:33:31Z
dc.date.available2014-05-20T15:33:31Z
dc.date.issued2008-08-02
dc.description.abstractBackground Some children with juvenile idiopathic arthritis either do not respond, or are intolerant to, treatment with disease-modifying antirheumatic drugs, including anti-tumour necrosis factor (TNF) drugs. We aimed to assess the safety and efficacy of abatacept, a selective T-cell costimulation modulator, in children with juvenile idiopathic arthritis who had failed previous treatments.Methods We did a double-blind, randomised controlled withdrawal trial between February, 2004, and June, 2006. We enrolled 190 patients aged 6-17 years, from 45 centres, who had a history of active juvenile idiopathic arthritis; at least five active joints; and an inadequate response to, or intolerance to, at least one disease-modifying antirheumatic drug. All 190 patients were given 10 mg/kg of abatacept intravenously in the open-label period of 4 months. of the 170 patients who completed this lead-in course, 47 did not respond to the treatment according to predefined American College of Rheumatology (ACR) paediatric criteria and were excluded. of the patients who did respond to abatacept, arthritis, and 62 were randomly assigned to receive placebo at the same dose and timing. The primary endpoint was time to flare of arthritis. Flare was defined as worsening of 30% or more in at least three of six core variables, with at least 30% improvement in no more than one variable. We analysed all patients who were treated as per protocol. This trial is registered, number NCT00095173.Findings Flares of arthritis occurred in 33 of 62 (53%) patients who were given placebo and 12 of 60 (20%) abatacept patients during the double-blind treatment (p=0.0003). Median time to flare of arthritis was 6 months for patients given placebo (insufficient events to calculate IQR); insufficient events had occurred in the abatacept group for median time to flare to be assessed (p=0.0002). The risk of flare in patients who contined abatacept was less than a third of that for controls during that double-blind period (hazard ratio 0.31, 95% CI 0.16-0.95). During the double-blind period, the frequency of adverse events did not differ in the two treatment groups, Adverse events were recorded in 37 abatacept recipients (62%) and 34 (55%) placebo recipients (p=0.47); only two serious adverse events were reported, bouth in controls (p=0.50).Interpretation Selective modulation of T-cell costimulation with abatacept is a rational alternative treatment for children with juvenile idiopathic arthritis.Funding Bristol-Myers Squibb.en
dc.description.affiliationIRCCS Ist G Gaslini Pediat 2, PRINTO, I-16147 Genoa, Italy
dc.description.affiliationChildrens Hosp, Med Ctr, Cincinnati, OH 45229 USA
dc.description.affiliationHop Necker Enfants Malad, Paris, France
dc.description.affiliationInst Salud Nino, Lima, Peru
dc.description.affiliationHosp Univ JE Gonzalez, Monterrey, Mexico
dc.description.affiliationInst Crianca Hosp Clin, São Paulo, Brazil
dc.description.affiliationHosp Gen Dr Ignacio Morones Prieto, San Luis Potosi, Mexico
dc.description.affiliationHosp Gen Mexico City, Dept Rheumatol, Mexico City, DF, Mexico
dc.description.affiliationHosp Gen Mexico City, Fac Med, Mexico City, DF, Mexico
dc.description.affiliationUniv Nacl Autonoma Mexico, Mexico City 04510, DF, Mexico
dc.description.affiliationGaetano Pini Inst, Milan, Italy
dc.description.affiliationInst Portugues Reumatol Paediat Rheumatol, Lisbon, Portugal
dc.description.affiliationUniv Estadual Paulista, Fac Med Botucatu, Botucatu, SP, Brazil
dc.description.affiliationHosp Univ Pedro Ernesto, Rio de Janeiro, Brazil
dc.description.affiliationUniv São Paulo, São Paulo, Brazil
dc.description.affiliationHosp Israelita Albert Einstein, Res Inst, São Paulo, Brazil
dc.description.affiliationHosp La Fe, E-46009 Valencia, Spain
dc.description.affiliationHop Univ Hautepierre, Strasbourg, France
dc.description.affiliationHosp San Javier, Guadalajara, Jalisco, Mexico
dc.description.affiliationCleveland Clin Fdn, Dept Rheumat Dis, Cleveland, OH 44195 USA
dc.description.affiliationMaria Fareri Childrens Hosp, NYMC, Dept Pediat, New York, NY USA
dc.description.affiliationCreighton Univ, Med Ctr, Omaha, NE USA
dc.description.affiliationUniv Trieste, Paediat Clin, Trieste, Italy
dc.description.affiliationInst Puericultura & Pediat Martagao Gesteira, Rio de Janeiro, Brazil
dc.description.affiliationChildrens Hosp & Reg Med Ctr, Seattle, WA USA
dc.description.affiliationBristol Myers Squibb Co, Princeton, NJ USA
dc.description.affiliationUniv Genoa, Genoa, Italy
dc.description.affiliationUnespUniv Estadual Paulista, Fac Med Botucatu, Botucatu, SP, Brazil
dc.format.extent383-391
dc.identifierhttp://dx.doi.org/10.1016/S0140-6736(08)60998-8
dc.identifier.citationLancet. New York: Elsevier B.V., v. 372, n. 9636, p. 383-391, 2008.
dc.identifier.doi10.1016/S0140-6736(08)60998-8
dc.identifier.issn0140-6736
dc.identifier.lattes7098310008371632
dc.identifier.orcid0000-0002-7631-7093
dc.identifier.scopus2-s2.0-48349093002
dc.identifier.urihttp://hdl.handle.net/11449/42111
dc.identifier.wosWOS:000258196000029
dc.language.isoeng
dc.publisherElsevier B.V.
dc.relation.ispartofLancet
dc.relation.ispartofjcr53.254
dc.relation.ispartofsjr14,934
dc.rights.accessRightsAcesso restrito
dc.sourceWeb of Science
dc.titleAbatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trialen
dc.typeArtigo
dcterms.licensehttp://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dcterms.rightsHolderElsevier B.V.
unesp.author.lattes7098310008371632[11]
unesp.author.orcid0000-0002-2426-716X[22]
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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