Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: Findings from an open-label treatment extension

Nicolino Ruperto, Daniel J. Lovell, Ruben Cuttica, Patricia Woo, Silvia Meiorin, Carine Wouters, Earl D. Silverman, Z. Balogh, Michael Henrickson, Joyce Davidson, Ivan Foeldvari, Lisa Imundo, Gabriele Simonini, Joachim Oppermann, Stephen Xu, Yaung Kaung Shen, Sudha Visvanathan, Adedigbo Fasanmade, Alan Mendelsohn, Alberto MartiniEdward H. Giannini

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Abstract

Objective: To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA). Methods: Patients eligible for the open-label extension (OLE, weeks 52-204) received infliximab 3-6 mg/kg every 8 weeks plus methotrexate. Results: Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (eight patients) or patient/physician/sponsor requirement (eight patients). Infliximab (mean dose 4.4 mg/kg per infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24% and 13%, respectively. Conclusions: In the limited population of JRA patients remaining in the study at 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate. Clinical trials registration number NCT00036374.

Original languageEnglish
Pages (from-to)718-722
Number of pages5
JournalAnnals of the Rheumatic Diseases
Volume69
Issue number4
DOIs
Publication statusPublished - Apr 2010

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Juvenile Arthritis
Methotrexate
Labels
Safety
Therapeutics
Infliximab
Antibodies
Clinical Trials
Physicians

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

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Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis : Findings from an open-label treatment extension. / Ruperto, Nicolino; Lovell, Daniel J.; Cuttica, Ruben; Woo, Patricia; Meiorin, Silvia; Wouters, Carine; Silverman, Earl D.; Balogh, Z.; Henrickson, Michael; Davidson, Joyce; Foeldvari, Ivan; Imundo, Lisa; Simonini, Gabriele; Oppermann, Joachim; Xu, Stephen; Shen, Yaung Kaung; Visvanathan, Sudha; Fasanmade, Adedigbo; Mendelsohn, Alan; Martini, Alberto; Giannini, Edward H.

In: Annals of the Rheumatic Diseases, Vol. 69, No. 4, 04.2010, p. 718-722.

Research output: Contribution to journalArticle

Ruperto, N, Lovell, DJ, Cuttica, R, Woo, P, Meiorin, S, Wouters, C, Silverman, ED, Balogh, Z, Henrickson, M, Davidson, J, Foeldvari, I, Imundo, L, Simonini, G, Oppermann, J, Xu, S, Shen, YK, Visvanathan, S, Fasanmade, A, Mendelsohn, A, Martini, A & Giannini, EH 2010, 'Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: Findings from an open-label treatment extension', Annals of the Rheumatic Diseases, vol. 69, no. 4, pp. 718-722. https://doi.org/10.1136/ard.2009.100354
Ruperto, Nicolino ; Lovell, Daniel J. ; Cuttica, Ruben ; Woo, Patricia ; Meiorin, Silvia ; Wouters, Carine ; Silverman, Earl D. ; Balogh, Z. ; Henrickson, Michael ; Davidson, Joyce ; Foeldvari, Ivan ; Imundo, Lisa ; Simonini, Gabriele ; Oppermann, Joachim ; Xu, Stephen ; Shen, Yaung Kaung ; Visvanathan, Sudha ; Fasanmade, Adedigbo ; Mendelsohn, Alan ; Martini, Alberto ; Giannini, Edward H. / Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis : Findings from an open-label treatment extension. In: Annals of the Rheumatic Diseases. 2010 ; Vol. 69, No. 4. pp. 718-722.
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T1 - Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis

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AU - Lovell, Daniel J.

AU - Cuttica, Ruben

AU - Woo, Patricia

AU - Meiorin, Silvia

AU - Wouters, Carine

AU - Silverman, Earl D.

AU - Balogh, Z.

AU - Henrickson, Michael

AU - Davidson, Joyce

AU - Foeldvari, Ivan

AU - Imundo, Lisa

AU - Simonini, Gabriele

AU - Oppermann, Joachim

AU - Xu, Stephen

AU - Shen, Yaung Kaung

AU - Visvanathan, Sudha

AU - Fasanmade, Adedigbo

AU - Mendelsohn, Alan

AU - Martini, Alberto

AU - Giannini, Edward H.

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N2 - Objective: To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA). Methods: Patients eligible for the open-label extension (OLE, weeks 52-204) received infliximab 3-6 mg/kg every 8 weeks plus methotrexate. Results: Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (eight patients) or patient/physician/sponsor requirement (eight patients). Infliximab (mean dose 4.4 mg/kg per infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24% and 13%, respectively. Conclusions: In the limited population of JRA patients remaining in the study at 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate. Clinical trials registration number NCT00036374.

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