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, Zsolt 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 Martini, Edward H Giannini, Paediatric Rheumatology INternational Trials Organization (PRINTO), Pediatric Rheumatology Collaborative Study Group (PRCSG), Nicolino Ruperto, Daniel J Lovell, Ruben Cuttica, Patricia Woo, Silvia Meiorin, Carine Wouters, Earl D Silverman, Zsolt 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 Martini, Edward H Giannini, Paediatric Rheumatology INternational Trials Organization (PRINTO), Pediatric Rheumatology Collaborative Study Group (PRCSG)

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.

Trial registration: ClinicalTrials.gov NCT00036374.

Conflict of interest statement

Competing interests: EHG, DJL, AM, NR and PW served as members of the Steering Committee, as well as consultants for Centocor Ortho Biotech, Inc. The members of the Steering Committee had full access to analysis reports from Centocor Ortho Biotech, Inc. SX, Y-KS, SV, AF and AM are employees of Centocor Ortho Biotech, Inc.

Figures

Figure 1
Figure 1
Patient disposition. MTX, methotrexate; OLE, open-label extension.
Figure 2
Figure 2
Proportions of juvenile rheumatoid arthritis (JRA) patients meeting the American College of Rheumatology Pediatric 30 (ACR-Pedi-30), ACR-Pedi-50, ACR-Pedi-70 and ACR-Pedi-90 response criteria (A) and with inactive disease (B) over time. These efficacy summaries are based on the intent-to-treat efficacy population (n=75). For these intent-to-treat summaries, patients who did not return for efficacy evaluations or who had no efficacy data available to assess their JRA core set response were considered non-responders.

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Source: PubMed

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