TY - JOUR
T1 - Long-Term Safety, Efficacy, and Quality of Life in Patients With Juvenile Idiopathic Arthritis Treated With Intravenous Abatacept for Up to Seven Years
AU - Lovell, Daniel J.
AU - Ruperto, Nicolino
AU - Mouy, Richard
AU - Paz, Eliana
AU - Rubio-Pérez, Nadina
AU - Silva, Clovis A.
AU - Abud-Mendoza, Carlos
AU - Burgos-Vargas, Ruben
AU - Gerloni, Valeria
AU - Melo-Gomes, Jose A.
AU - Saad-Magalhaes, Claudia
AU - Chavez-Corrales, J.
AU - Huemer, Christian
AU - Kivitz, Alan
AU - Blanco, Francisco J.
AU - Foeldvari, Ivan
AU - Hofer, Michael
AU - Huppertz, Hans Iko
AU - Job Deslandre, Chantal
AU - Minden, Kirsten
AU - Punaro, Marilynn
AU - Block, Alan J.
AU - Giannini, Edward H.
AU - Martini, Alberto
AU - Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation
N1 - Funding Information:
Dr. Lovell has received consulting fees from AstraZeneca, Janssen, Bristol-Myers Squibb, Abbott, Pfizer, Hoffman La-Roche, Novartis, UBC, and Horizon (less than $10,000 each), speaking fees from Abbott and Amgen (less than $10,000 each), and honoraria from Forest Research for Data and Safety Monitoring Board service (less than $10,000). Dr. Ruperto has received consulting fees from Astellas, CD Pharma, Italfarmaco, MedImmune, Novo Nordisk, Pfizer, Roche, Sanofi-Aventis, and Vertex (less than $10,000 each), speaking fees from Abbott, AbbVie, Boehringer, Bristol-Myers Squibb, Crescendo Bioscience, Medac, MedImmune, Novartis, and Pfizer (less than $10,000 each), and research grant support from Bristol-Myers Squibb, Janssen Biologics, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi-Aventis, Schwarz Biosciences, Sobi, and Wyeth Pharmaceuticals. Dr. Mouy has received honoraria from Bristol-Myers Squibb (less than $10,000). Dr. Paz has received research grant support from Bristol-Myers Squibb. Dr. Burgos-Vargas has received consulting fees and/or speaking fees from AbbVie, Bristol-Myers Squibb, Pfizer, Roche, and UCB (less than $10,000 each) and research grant support from AbbVie. Dr. Kivitz has received consulting fees and/or speaking fees from Bristol-Myers Squibb (less than $10,000) and research grant support from Bristol-Myers Squibb. Dr. Blanco has received consulting fees from Gebro Pharma, UCB, and Pierre-Fabre
Funding Information:
Laboratories (less than $10,000 each), speaking fees from Pfizer, Bioiberica, and UCB (less than $10,000 each), and research grant support from AbbVie, Amgen, Bioiberica, Bristol-Myers Squibb, Celgene, Celltrion, Cellerix, Gru€nenthal, Lilly, MSD, Pfizer, Roche, Sanofi, and UCB. Dr. Hofer has received consulting fees from Novartis (less than $10,000) and research grant support from Bristol-Myers Squibb. Dr. Huppertz has received consulting fees and/or honoraria from AbbVie, Chugai, and Pfizer (less than $10,000 each), speaking fees from Pfizer (less than $10,000), and research grant support from AbbVie, Chugai, Novartis, and Pfizer. Dr. Minden has received consulting fees from Pfizer and AbbVie (less than $10,000 each) and research grant support from Pfizer and AbbVie. Dr. Block owns stock or stock options in Bristol-Myers Squibb. Dr. Martini has received consulting fees from Astellas, Boehringer, Italfarmaco, MedImmune, Vertex, Novo Nordisk, Roche, and Sanofi-Aventis (less than $10,000 each), speaking fees from Abbott, Bristol-Myers Squibb, Crescendo Bioscience, Novartis, and Pfizer (less than $10,000 each), and research grant support from Bristol-Myers Squibb, Janssen Biologics, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi-Aventis, Schwarz Biosciences, Sobi, and Wyeth Pharmaceuticals.
Publisher Copyright:
© 2015 The Authors.
PY - 2015/10
Y1 - 2015/10
N2 - 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 doubleblind 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.
AB - 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 doubleblind 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.
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U2 - 10.1002/ART.39234
DO - 10.1002/ART.39234
M3 - Article
C2 - 26097215
AN - SCOPUS:84959376044
SN - 2326-5191
VL - 67
SP - 2759
EP - 2770
JO - Arthritis and Rheumatology
JF - Arthritis and Rheumatology
IS - 10
ER -