Cumulative long-term safety, efficacy and patient-reported outcomes in children with juvenile idiopathic arthritis treated with intravenous abatacept: up to 7 years of treatment

dc.contributorCincinnati Childrens Hosp Med Ctr
dc.contributorIst Giannina Gaslini
dc.contributorHop Necker Enfants Malad
dc.contributorInst Salud Nino
dc.contributorHosp Univ Dr Jose Eleuterio Gonzalez
dc.contributorUniversidade de São Paulo (USP)
dc.contributorHosp Cent Dr Ignacio Morones Prieto
dc.contributorPRINTO
dc.contributorIst Gaetano Pini
dc.contributorInst Portugues Reumatol
dc.contributorUniversidade Estadual Paulista (Unesp)
dc.contributorHosp Nacl E Rebagliti ESSALUD
dc.contributorLandeskrankenhaus Bregenz
dc.contributorAltoona Ctr Clin Res
dc.contributorHosp Univ A Coruna
dc.contributorKlinikum Eilbek
dc.contributorCtr Multisite Romand Rhumatol Pediat
dc.contributorUniv Gottingen
dc.contributorCochin Hosp
dc.contributorBristol Myers Squibb Co
dc.creatorLovell, Daniel J.
dc.creatorRuperto, Nicolino
dc.creatorMouy, Richard
dc.creatorPaz, Eliana
dc.creatorRubio-Perez, Nadina
dc.creatorSilva, Clovis A.
dc.creatorAbud-Mendoza, Carlos
dc.creatorBurgos-Vargas, Ruben
dc.creatorGerloni, Valeria
dc.creatorMelo-Gomes, Jose A.
dc.creatorMagalhaes, Claudia Saad [UNESP]
dc.creatorChavez-Corrales, Jose
dc.creatorHuemer, Christian
dc.creatorKivitz, Alan J.
dc.creatorBlanco, Francisco J.
dc.creatorFoeldvari, Ivan
dc.creatorHofer, Michael
dc.creatorHuppertz, Hans-Iko
dc.creatorDeslandre, Chantal
dc.creatorMinden, Kirsten
dc.creatorBlock, Alan J.
dc.creatorGiannini, Edward H.
dc.creatorMartini, Alberto
dc.date2015-11-03T15:30:34Z
dc.date2015-11-03T15:30:34Z
dc.date2014-03-01
dc.date.accessioned2023-09-12T07:11:18Z
dc.date.available2023-09-12T07:11:18Z
dc.identifierhttp://onlinelibrary.wiley.com/doi/10.1002/art.38595/abstract
dc.identifierArthritis &rheumatology. Hoboken: Wiley-blackwell, v. 66, p. S218-S219, 2014.
dc.identifier2326-5191
dc.identifierhttp://hdl.handle.net/11449/130244
dc.identifier10.1002/art.38595
dc.identifierWOS:000349950900171
dc.identifier7098310008371632
dc.identifier0000-0002-7631-7093
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8779557
dc.descriptionThe long-term efficacy and safety of intravenous abatacept in patients (pts) with juvenile idiopathic arthritis (JIA) have been reported previously from the Phase III AWAKEN trial ([1, 2]). Here, we report efficacy, safety and pt-reported outcomes from the open-label, long-term extension (LTE) of AWAKEN, with up to 7 years of follow-up. Pts entered the LTE if they were JIA ACR 30 non-responders (NR) at the end of the 4-month lead-in period (abatacept only), or if they received abatacept or placebo (pbo) in the 6-month double-blind (DB) period. The Child Health Questionnaire was used to evaluate health-related quality of life (HRQoL); physical (PhS) and psychosocial (PsS) summary and pain scores were analyzed. Pain was assessed by parent global assessment using a 100 mm visual analog scale. Efficacy and HRQoL evaluations are reported up to Day 1765 (~ Year 5.5). Safety is presented for the cumulative period (lead-in, DB and LTE), for all pts who received abatacept during the LTE. Of the 153 pts entering the LTE (58 from DB abatacept group, 59 from DB pbo group, 36 NR), 69 completed the trial (29 abatacept, 27 pbo, 13 NR). For pts treated in the LTE, mean (range) exposure to abatacept was 53.6 (5.6–85.6) months. During the LTE, incidence rates of AEs and serious AEs per 100 pt-years were 209.1 and 5.6. Thirty pts (19.6%) had serious AEs; most were unrelated and were musculoskeletal (8.5%) or infectious events (6.5%). No malignancy was reported. There was one death (accidental; unrelated). At Day 169, JIA ACR 50 and 70 response rates were 79.3% and 55.2% in the abatacept group, and 52.5% and 30.5% in the pbo group; 31.0% and 10.2% of pts in the abatacept and pbo groups, respectively, had inactive disease. By Day 1765, JIA ACR 50 and 70 response rates were 93.9% and 78.8% in the abatacept group, and 80.0% and 63.3% in the pbo group; 51.5% and 33.3% had inactive disease. In the NR group, 69.2% and 53.8% of pts achieved JIA ACR 50 and 70 responses at Day 1765, and 30.8% had inactive disease. In pts who entered the LTE, mean baseline PhS scores were below the range for healthy children (abatacept 30.2, pbo 31.0, NR 29.5). At Day 169, 38.3% of pts had reached a PhS score >50 ((1). By the end of the LTE, 43.5% of pts had reached a PhS score >50. At baseline, mean PsS scores for those who entered the LTE were slightly lower than the mean for healthy children (abatacept 43.5, pbo 44.2, NR 47.0). At Day 169, 54.9% of pts had a PsS score >50 (1). By Day 1765, 58.1% of pts had reached a PsS score >50. At baseline, the mean pain score was 42.9. By Day 169, 13.9% of pts were considered pain free (pain score = 0); this was maintained over the LTE (1).
dc.descriptionCincinnati Children's Hospital Medical Center, Cincinnati, OH
dc.descriptionIstituto Giannina Gaslini, Genova, Italy
dc.descriptionHôpital Necker-Enfants Malades, Paris, France
dc.descriptionInstituto de Salud del Nino, Lima, Peru
dc.descriptionHospital Universitario Dr. José Eleuterio Gonzalez, Monterrey, Mexico
dc.descriptionFaculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
dc.descriptionHospital Central Dr. Ignacio Morones Prieto, San Luis Potosyi, Mexico
dc.descriptionPRINTO, Genoa, Italy
dc.descriptionIstituto Gaetano Pini, Milan, Italy
dc.descriptionInstituto Portugues de Reumatologia, Lisbon, Portugal.
dc.descriptionSao Paulo State University (UNESP), Botucatu, Brazil
dc.formatS218-S219
dc.languageeng
dc.publisherWiley-Blackwell
dc.relationArthritis &rheumatology
dc.relation7.871
dc.rightsAcesso restrito
dc.sourceWeb of Science
dc.titleCumulative long-term safety, efficacy and patient-reported outcomes in children with juvenile idiopathic arthritis treated with intravenous abatacept: up to 7 years of treatment
dc.typeResumo


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