Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis

Nicolino Ruperto, Daniel J. Lovell, Pierre Quartier, Eliana Paz, Nadina Rubio-Pérez, Clovis A. Silva, Carlos Abud-Mendoza, Ruben Burgos-Vargas, Valeria Gerloni, Jose A. Melo-Gomes, Claudia Saad-Magalhães, J. Chavez-Corrales, Christian Huemer, Alan Kivitz, Francisco J. Blanco, Ivan Foeldvari, Michael Hofer, Gerd Horneff, Hans Iko Huppertz, Chantal Job-DeslandreAnna Loy, Kirsten Minden, Marilynn Punaro, Alejandro Flores Nunez, Leonard H. Sigal, Alan J. Block, Marleen Nys, Alberto Martini, Edward H. Giannini

Research output: Contribution to journalArticle

138 Citations (Scopus)

Abstract

Objective. We previously documented that abatacept was effective and safe in patients with juvenile idiopathic arthritis (JIA) who had not previously achieved a satisfactory clinical response with disease-modifying antirheumatic drugs or tumor necrosis factor blockade. Here, we report results from the long-term extension (LTE) phase of that study. Methods. This report describes the long-term, open-label extension phase of a double-blind, randomized, controlled withdrawal trial in 190 patients with JIA ages 6-17 years. Children were treated with 10 mg/kg abatacept administered intravenously every 4 weeks, with or without methotrexate. Efficacy results were based on data derived from the 153 patients who entered the open-label LTE phase and reflect ≥21 months (589 days) of treatment. Safety results include all available open-label data as of May 7, 2008. Results. Of the 190 enrolled patients, 153 entered the LTE. By day 589, 90%, 88%, 75%, 57%, and 39% of patients treated with abatacept during the double-blind and LTE phases achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement, respectively. Similar response rates were observed by day 589 among patients previously treated with placebo. Among patients who had not achieved an ACR Pedi 30 response at the end of the open-label lead-in phase and who proceeded directly into the LTE, 73%, 64%, 46%, 18%, and 5% achieved ACR Pedi 30, Pedi 50, Pedi 70, Pedi 90, and Pedi 100 responses, respectively, by day 589 of the LTE. No cases of tuberculosis and no malignancies were reported during the LTE. Pneumonia developed in 3 patients, and multiple sclerosis developed in 1 patient. Conclusion. Abatacept provided clinically significant and durable efficacy in patients with JIA, including those who did not initially achieve an ACR Pedi 30 response during the initial 4-month open-label lead-in phase.

Original languageEnglish (US)
Pages (from-to)1792-1802
Number of pages11
JournalArthritis and Rheumatism
Volume62
Issue number6
DOIs
StatePublished - Jun 2010

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Juvenile Arthritis
Safety
Rheumatology
Pediatrics
Abatacept
Antirheumatic Agents
Methotrexate
Multiple Sclerosis
Pneumonia
Tuberculosis
Randomized Controlled Trials
Tumor Necrosis Factor-alpha
Placebos

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy
  • Rheumatology
  • Pharmacology (medical)

Cite this

Ruperto, N., Lovell, D. J., Quartier, P., Paz, E., Rubio-Pérez, N., Silva, C. A., ... Giannini, E. H. (2010). Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis and Rheumatism, 62(6), 1792-1802. https://doi.org/10.1002/art.27431

Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. / Ruperto, Nicolino; Lovell, Daniel J.; Quartier, Pierre; Paz, Eliana; Rubio-Pérez, Nadina; Silva, Clovis A.; Abud-Mendoza, Carlos; Burgos-Vargas, Ruben; Gerloni, Valeria; Melo-Gomes, Jose A.; Saad-Magalhães, Claudia; Chavez-Corrales, J.; Huemer, Christian; Kivitz, Alan; Blanco, Francisco J.; Foeldvari, Ivan; Hofer, Michael; Horneff, Gerd; Huppertz, Hans Iko; Job-Deslandre, Chantal; Loy, Anna; Minden, Kirsten; Punaro, Marilynn; Nunez, Alejandro Flores; Sigal, Leonard H.; Block, Alan J.; Nys, Marleen; Martini, Alberto; Giannini, Edward H.

In: Arthritis and Rheumatism, Vol. 62, No. 6, 06.2010, p. 1792-1802.

Research output: Contribution to journalArticle

Ruperto, N, Lovell, DJ, Quartier, P, Paz, E, Rubio-Pérez, N, Silva, CA, Abud-Mendoza, C, Burgos-Vargas, R, Gerloni, V, Melo-Gomes, JA, Saad-Magalhães, C, Chavez-Corrales, J, Huemer, C, Kivitz, A, Blanco, FJ, Foeldvari, I, Hofer, M, Horneff, G, Huppertz, HI, Job-Deslandre, C, Loy, A, Minden, K, Punaro, M, Nunez, AF, Sigal, LH, Block, AJ, Nys, M, Martini, A & Giannini, EH 2010, 'Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis', Arthritis and Rheumatism, vol. 62, no. 6, pp. 1792-1802. https://doi.org/10.1002/art.27431
Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Pérez N, Silva CA et al. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis and Rheumatism. 2010 Jun;62(6):1792-1802. https://doi.org/10.1002/art.27431
Ruperto, Nicolino ; Lovell, Daniel J. ; Quartier, Pierre ; Paz, Eliana ; Rubio-Pérez, Nadina ; Silva, Clovis A. ; Abud-Mendoza, Carlos ; Burgos-Vargas, Ruben ; Gerloni, Valeria ; Melo-Gomes, Jose A. ; Saad-Magalhães, Claudia ; Chavez-Corrales, J. ; Huemer, Christian ; Kivitz, Alan ; Blanco, Francisco J. ; Foeldvari, Ivan ; Hofer, Michael ; Horneff, Gerd ; Huppertz, Hans Iko ; Job-Deslandre, Chantal ; Loy, Anna ; Minden, Kirsten ; Punaro, Marilynn ; Nunez, Alejandro Flores ; Sigal, Leonard H. ; Block, Alan J. ; Nys, Marleen ; Martini, Alberto ; Giannini, Edward H. / Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. In: Arthritis and Rheumatism. 2010 ; Vol. 62, No. 6. pp. 1792-1802.
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abstract = "Objective. We previously documented that abatacept was effective and safe in patients with juvenile idiopathic arthritis (JIA) who had not previously achieved a satisfactory clinical response with disease-modifying antirheumatic drugs or tumor necrosis factor blockade. Here, we report results from the long-term extension (LTE) phase of that study. Methods. This report describes the long-term, open-label extension phase of a double-blind, randomized, controlled withdrawal trial in 190 patients with JIA ages 6-17 years. Children were treated with 10 mg/kg abatacept administered intravenously every 4 weeks, with or without methotrexate. Efficacy results were based on data derived from the 153 patients who entered the open-label LTE phase and reflect ≥21 months (589 days) of treatment. Safety results include all available open-label data as of May 7, 2008. Results. Of the 190 enrolled patients, 153 entered the LTE. By day 589, 90{\%}, 88{\%}, 75{\%}, 57{\%}, and 39{\%} of patients treated with abatacept during the double-blind and LTE phases achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement, respectively. Similar response rates were observed by day 589 among patients previously treated with placebo. Among patients who had not achieved an ACR Pedi 30 response at the end of the open-label lead-in phase and who proceeded directly into the LTE, 73{\%}, 64{\%}, 46{\%}, 18{\%}, and 5{\%} achieved ACR Pedi 30, Pedi 50, Pedi 70, Pedi 90, and Pedi 100 responses, respectively, by day 589 of the LTE. No cases of tuberculosis and no malignancies were reported during the LTE. Pneumonia developed in 3 patients, and multiple sclerosis developed in 1 patient. Conclusion. Abatacept provided clinically significant and durable efficacy in patients with JIA, including those who did not initially achieve an ACR Pedi 30 response during the initial 4-month open-label lead-in phase.",
author = "Nicolino Ruperto and Lovell, {Daniel J.} and Pierre Quartier and Eliana Paz and Nadina Rubio-P{\'e}rez and Silva, {Clovis A.} and Carlos Abud-Mendoza and Ruben Burgos-Vargas and Valeria Gerloni and Melo-Gomes, {Jose A.} and Claudia Saad-Magalh{\~a}es and J. Chavez-Corrales and Christian Huemer and Alan Kivitz and Blanco, {Francisco J.} and Ivan Foeldvari and Michael Hofer and Gerd Horneff and Huppertz, {Hans Iko} and Chantal Job-Deslandre and Anna Loy and Kirsten Minden and Marilynn Punaro and Nunez, {Alejandro Flores} and Sigal, {Leonard H.} and Block, {Alan J.} and Marleen Nys and Alberto Martini and Giannini, {Edward H.}",
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T1 - Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis

AU - Ruperto, Nicolino

AU - Lovell, Daniel J.

AU - Quartier, Pierre

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-Magalhães, Claudia

AU - Chavez-Corrales, J.

AU - Huemer, Christian

AU - Kivitz, Alan

AU - Blanco, Francisco J.

AU - Foeldvari, Ivan

AU - Hofer, Michael

AU - Horneff, Gerd

AU - Huppertz, Hans Iko

AU - Job-Deslandre, Chantal

AU - Loy, Anna

AU - Minden, Kirsten

AU - Punaro, Marilynn

AU - Nunez, Alejandro Flores

AU - Sigal, Leonard H.

AU - Block, Alan J.

AU - Nys, Marleen

AU - Martini, Alberto

AU - Giannini, Edward H.

PY - 2010/6

Y1 - 2010/6

N2 - Objective. We previously documented that abatacept was effective and safe in patients with juvenile idiopathic arthritis (JIA) who had not previously achieved a satisfactory clinical response with disease-modifying antirheumatic drugs or tumor necrosis factor blockade. Here, we report results from the long-term extension (LTE) phase of that study. Methods. This report describes the long-term, open-label extension phase of a double-blind, randomized, controlled withdrawal trial in 190 patients with JIA ages 6-17 years. Children were treated with 10 mg/kg abatacept administered intravenously every 4 weeks, with or without methotrexate. Efficacy results were based on data derived from the 153 patients who entered the open-label LTE phase and reflect ≥21 months (589 days) of treatment. Safety results include all available open-label data as of May 7, 2008. Results. Of the 190 enrolled patients, 153 entered the LTE. By day 589, 90%, 88%, 75%, 57%, and 39% of patients treated with abatacept during the double-blind and LTE phases achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement, respectively. Similar response rates were observed by day 589 among patients previously treated with placebo. Among patients who had not achieved an ACR Pedi 30 response at the end of the open-label lead-in phase and who proceeded directly into the LTE, 73%, 64%, 46%, 18%, and 5% achieved ACR Pedi 30, Pedi 50, Pedi 70, Pedi 90, and Pedi 100 responses, respectively, by day 589 of the LTE. No cases of tuberculosis and no malignancies were reported during the LTE. Pneumonia developed in 3 patients, and multiple sclerosis developed in 1 patient. Conclusion. Abatacept provided clinically significant and durable efficacy in patients with JIA, including those who did not initially achieve an ACR Pedi 30 response during the initial 4-month open-label lead-in phase.

AB - Objective. We previously documented that abatacept was effective and safe in patients with juvenile idiopathic arthritis (JIA) who had not previously achieved a satisfactory clinical response with disease-modifying antirheumatic drugs or tumor necrosis factor blockade. Here, we report results from the long-term extension (LTE) phase of that study. Methods. This report describes the long-term, open-label extension phase of a double-blind, randomized, controlled withdrawal trial in 190 patients with JIA ages 6-17 years. Children were treated with 10 mg/kg abatacept administered intravenously every 4 weeks, with or without methotrexate. Efficacy results were based on data derived from the 153 patients who entered the open-label LTE phase and reflect ≥21 months (589 days) of treatment. Safety results include all available open-label data as of May 7, 2008. Results. Of the 190 enrolled patients, 153 entered the LTE. By day 589, 90%, 88%, 75%, 57%, and 39% of patients treated with abatacept during the double-blind and LTE phases achieved responses according to the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement, respectively. Similar response rates were observed by day 589 among patients previously treated with placebo. Among patients who had not achieved an ACR Pedi 30 response at the end of the open-label lead-in phase and who proceeded directly into the LTE, 73%, 64%, 46%, 18%, and 5% achieved ACR Pedi 30, Pedi 50, Pedi 70, Pedi 90, and Pedi 100 responses, respectively, by day 589 of the LTE. No cases of tuberculosis and no malignancies were reported during the LTE. Pneumonia developed in 3 patients, and multiple sclerosis developed in 1 patient. Conclusion. Abatacept provided clinically significant and durable efficacy in patients with JIA, including those who did not initially achieve an ACR Pedi 30 response during the initial 4-month open-label lead-in phase.

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