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Arthritis Rheumatol. 2015 Oct;67(10):2759-70. doi: 10.1002/art.39234.

Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years.

Author information

1
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
2
IRCCS G. Gaslini, Genoa, Italy.
3
Hôpital Necker-Enfants Malades, AP-HP, Paris, France.
4
Instituto de Salud del Nino, Lima, Peru.
5
Hospital Universitario Dr. J. E. Gonzalez, Monterrey, Mexico.
6
Children's Institute, Hospital das Clinicas, and Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
7
Hospital Central Dr. Ignacio Morones Prieto y Facultad de Medicina and Universidad Autonoma de San Luis Potosi, San Luis Potosi, Mexico.
8
Hospital General de Mexico and Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.
9
Istituto Ortopedico Gaetano Pini, Milan, Italy.
10
Instituto Portugues de Reumatologia, Lisbon, Portugal.
11
Universidade Estadual Paulista, Botucatu, Brazil.
12
Hospital Nacional Edgardo Rebagliati, Lima, Peru.
13
Landeskrankenhaus Bregenz, Bregenz, Austria.
14
Altoona Arthritis and Osteoporosis Center, Duncansville, Pennsylvania.
15
Hospital Universitario A Coruña, A Coruña, Spain.
16
Hamburger Zentrum für Kinder und Jugendrheumatologie, Hamburg, Germany.
17
Centre Multisite Romand de Rhumatologie Pédiatrique, Lausanne, Switzerland.
18
Professor Hess Kinderklinik, Bremen, Germany.
19
Hôpital St. Vincent de Paul, AP-HP, Paris, France.
20
Charité University Hospital Berlin, Berlin, Germany.
21
Texas Scottish Rite Hospital, Dallas.
22
Bristol-Myers Squibb, Princeton, New Jersey.
23
IRCCS G. Gaslini and Università degli Studi di Genova, Genoa, Italy.

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.

CONCLUSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00095173.

PMID:
26097215
PMCID:
PMC5054936
DOI:
10.1002/art.39234
[Indexed for MEDLINE]
Free PMC Article

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