title: Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years.
abstract: 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 versus 5.60), serious infections (1.13 versus 1.72), malignancies (1.12 versus 0), and autoimmune events (2.26 versus 1.18). American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) responses, Pedi 70 responses, and clinically inactive disease status were maintained throughout the LTE phase in patients who continued to receive therapy. Improvements in the Child Health Questionnaire physical and psychosocial summary scores were maintained over time.
  
  
  CONCLUSIONS
  Long-term abatacept treatment for up to 7 years was associated with consistent safety, sustained efficacy, and quality-of-life benefits in patients with JIA.
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Lovell
authors.affiliation: IRCCS G. Gaslini, Genoa, Italy.
authors.forename: Nicolino
authors.initials: N
authors.lastname: Ruperto
authors.affiliation: Hôpital Necker-Enfants Malades, AP-HP, Paris, France.
authors.forename: Richard
authors.initials: R
authors.lastname: Mouy
authors.affiliation: Instituto de Salud del Nino, Lima, Peru.
authors.forename: Eliana
authors.initials: E
authors.lastname: Paz
authors.affiliation: Hospital Universitario Dr. J. E. Gonzalez, Monterrey, Mexico.
authors.forename: Nadina
authors.initials: N
authors.lastname: Rubio-Pérez
authors.affiliation: Children's Institute, Hospital das Clinicas, and Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Clovis A
authors.initials: CA
authors.lastname: Silva
authors.affiliation: Hospital Central Dr. Ignacio Morones Prieto y Facultad de Medicina and Universidad Autonoma de San Luis Potosi, San Luis Potosi, Mexico.
authors.forename: Carlos
authors.initials: C
authors.lastname: Abud-Mendoza
authors.affiliation: Hospital General de Mexico and Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.
authors.forename: Ruben
authors.initials: R
authors.lastname: Burgos-Vargas
authors.affiliation: Istituto Ortopedico Gaetano Pini, Milan, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Gerloni
authors.affiliation: Instituto Portugues de Reumatologia, Lisbon, Portugal.
authors.forename: Jose A
authors.initials: JA
authors.lastname: Melo-Gomes
authors.affiliation: Universidade Estadual Paulista, Botucatu, Brazil.
authors.forename: Claudia
authors.initials: C
authors.lastname: Saad-Magalhaes
authors.affiliation: Hospital Nacional Edgardo Rebagliati, Lima, Peru.
authors.forename: J
authors.initials: J
authors.lastname: Chavez-Corrales
authors.affiliation: Landeskrankenhaus Bregenz, Bregenz, Austria.
authors.forename: Christian
authors.initials: C
authors.lastname: Huemer
authors.affiliation: Altoona Arthritis and Osteoporosis Center, Duncansville, Pennsylvania.
authors.forename: Alan
authors.initials: A
authors.lastname: Kivitz
authors.affiliation: Hospital Universitario A Coruña, A Coruña, Spain.
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Blanco
authors.affiliation: Hamburger Zentrum für Kinder und Jugendrheumatologie, Hamburg, Germany.
authors.forename: Ivan
authors.initials: I
authors.lastname: Foeldvari
authors.affiliation: Centre Multisite Romand de Rhumatologie Pédiatrique, Lausanne, Switzerland.
authors.forename: Michael
authors.initials: M
authors.lastname: Hofer
authors.affiliation: Professor Hess Kinderklinik, Bremen, Germany.
authors.forename: Hans-Iko
authors.initials: HI
authors.lastname: Huppertz
authors.affiliation: Hôpital St. Vincent de Paul, AP-HP, Paris, France.
authors.forename: Chantal
authors.initials: C
authors.lastname: Job Deslandre
authors.affiliation: Charité University Hospital Berlin, Berlin, Germany.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Minden
authors.affiliation: Texas Scottish Rite Hospital, Dallas.
authors.forename: Marilynn
authors.initials: M
authors.lastname: Punaro
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey.
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Block
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
authors.forename: Edward H
authors.initials: EH
authors.lastname: Giannini
authors.affiliation: IRCCS G. Gaslini and Università degli Studi di Genova, Genoa, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Martini
mesh_terms: D000069594:Abatacept / Q000009:adverse effects* / Q000627:therapeutic use*; D000203:Activities of Daily Living / Q000523:psychology; D000293:Adolescent; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001171:Arthritis, Juvenile / Q000188:drug therapy* / Q000523:psychology*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D011584:Psychology; D011788:Quality of Life / Q000523:psychology*; D057566:Self Report; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000069594:Abatacept