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

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 & 5 others Marilynn Punaro, Alan J. Block, Edward H. Giannini, Alberto Martini, Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation

Research output: Contribution to journalArticle

32 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)2759-2770
Number of pages12
JournalArthritis & rheumatology (Hoboken, N.J.)
Volume67
Issue number10
DOIs
StatePublished - Oct 1 2015

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Juvenile Arthritis
Quality of Life
Safety
Antirheumatic Agents
Therapeutics
Abatacept
Placebos
Pediatrics
Incidence
Infection
Neoplasms

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

Lovell, D. J., Ruperto, N., Mouy, R., Paz, E., Rubio-Pérez, N., Silva, C. A., ... Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation (2015). Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. Arthritis & rheumatology (Hoboken, N.J.), 67(10), 2759-2770. https://doi.org/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. / Lovell, Daniel J.; Ruperto, Nicolino; Mouy, Richard; Paz, Eliana; Rubio-Pérez, Nadina; Silva, Clovis A.; Abud-Mendoza, Carlos; Burgos-Vargas, Ruben; Gerloni, Valeria; Melo-Gomes, Jose A.; Saad-Magalhaes, Claudia; Chavez-Corrales, J.; Huemer, Christian; Kivitz, Alan; Blanco, Francisco J.; Foeldvari, Ivan; Hofer, Michael; Huppertz, Hans Iko; Job Deslandre, Chantal; Minden, Kirsten; Punaro, Marilynn; Block, Alan J.; Giannini, Edward H.; Martini, Alberto; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation.

In: Arthritis & rheumatology (Hoboken, N.J.), Vol. 67, No. 10, 01.10.2015, p. 2759-2770.

Research output: Contribution to journalArticle

Lovell, DJ, Ruperto, N, Mouy, R, Paz, E, Rubio-Pérez, N, Silva, CA, Abud-Mendoza, C, Burgos-Vargas, R, Gerloni, V, Melo-Gomes, JA, Saad-Magalhaes, C, Chavez-Corrales, J, Huemer, C, Kivitz, A, Blanco, FJ, Foeldvari, I, Hofer, M, Huppertz, HI, Job Deslandre, C, Minden, K, Punaro, M, Block, AJ, Giannini, EH, Martini, A & Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation 2015, 'Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years', Arthritis & rheumatology (Hoboken, N.J.), vol. 67, no. 10, pp. 2759-2770. https://doi.org/10.1002/art.39234
Lovell, Daniel J. ; Ruperto, Nicolino ; Mouy, Richard ; Paz, Eliana ; Rubio-Pérez, Nadina ; Silva, Clovis A. ; Abud-Mendoza, Carlos ; Burgos-Vargas, Ruben ; Gerloni, Valeria ; Melo-Gomes, Jose A. ; Saad-Magalhaes, Claudia ; Chavez-Corrales, J. ; Huemer, Christian ; Kivitz, Alan ; Blanco, Francisco J. ; Foeldvari, Ivan ; Hofer, Michael ; Huppertz, Hans Iko ; Job Deslandre, Chantal ; Minden, Kirsten ; Punaro, Marilynn ; Block, Alan J. ; Giannini, Edward H. ; Martini, Alberto ; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. / Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. In: Arthritis & rheumatology (Hoboken, N.J.). 2015 ; Vol. 67, No. 10. pp. 2759-2770.
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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.",
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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

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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 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.

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