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Long‐Term Safety, Efficacy, and Quality of Life in Patients With Juvenile Idiopathic Arthritis Treated With Intravenous Abatacept for Up to Seven Years by Daniel J. Lovell; Nicolino Ruperto; Richard Mouy; Eliana Paz; Nadina Rubio‐Pérez; Clovis A. Silva; Carlos Abud‐Mendoza; Ruben Burgos‐Vargas; Valeria Gerloni; Jose A. Melo‐Gomes; Claudia Saad‐Magalhaes; J. Chavez‐Corrales; Christian Huemer; Alan Kivitz; Francisco J. Blanco; Ivan Foeldvari; Michael Hofer; Hans‐Iko Huppertz; Chantal Job Deslandre; Kirsten Minden; Marilynn Punaro; Alan J. Block; Edward H. Giannini; Alberto Martini; for the Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation is a Medicine article available to read on EtoBox.

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## Objective The efficacy and safety of abatacept in patients with juvenile idiopathic arthritis (JIA) who experienced an inadequate response to disease‐modifying antirheumatic drugs were previously established in a phase III study that included a 4‐month open‐label lead‐in period, a 6‐month double‐blind withdrawal period, and a long‐term extension (LTE) phase. The aim of this study was to present the safety, efficacy, and patient‐reported outcomes of abatacept treatment (10 mg/kg every 4 weeks) during the LTE phase, for up to 7 years of followup. ## Methods Patients enrolled in the phase III trial could enter the open‐label LTE phase if they had not achieved a response to treatment at month 4 or if they had received abatacept or placebo during the double‐blind period. ## Results One hundred fifty‐three (80.5%) of 190 patients entered the LTE phase, and 69 patients (36.3%) completed it. The overall incidence rate (events per 100 patient‐years) of adverse events decreased during the LTE phase (433.61 events during the short‐term phase [combined lead‐in and double‐blind periods] versus 132.39 events during the LTE phase). Similar results were observed for serious adverse events (6.82

Who reads Long‐Term Safety, Efficacy, and Quality of Life in Patients With Juvenile Idiopathic Arthritis Treated With Intravenous Abatacept for Up to Seven Years?

Author

Daniel J. Lovell; Nicolino Ruperto; Richard Mouy; Eliana Paz; Nadina Rubio‐Pérez; Clovis A. Silva; Carlos Abud‐Mendoza; Ruben Burgos‐Vargas; Valeria Gerloni; Jose A. Melo‐Gomes; Claudia Saad‐Magalhaes; J. Chavez‐Corrales; Christian Huemer; Alan Kivitz; Francisco J. Blanco; Ivan Foeldvari; Michael Hofer; Hans‐Iko Huppertz; Chantal Job Deslandre; Kirsten Minden; Marilynn Punaro; Alan J. Block; Edward H. Giannini; Alberto Martini; for the Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation

Publisher

Wiley (John Wiley & Sons); John Wiley and Sons Ltd; Wiley; Research Square (ISSN 2326-5191)

Published

2015

Language

EN

Field

Medicine (Health Sciences)