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.

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.

• Authors: 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)
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 69 Issue 4 Pg. 718-22 (Apr 2010) ISSN: 1468-2060 [Electronic] England
• PMID: 20237125 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antirheumatic Agents
• Infliximab
• Methotrexate

Topics

• Adolescent
• Antibodies, Monoclonal (administration & dosage, therapeutic use)
• Antirheumatic Agents (administration & dosage, adverse effects, therapeutic use)
• Arthritis, Juvenile (drug therapy)
• Child
• Child, Preschool
• Drug Administration Schedule
• Drug Therapy, Combination
• Epidemiologic Methods
• Humans
• Infliximab
• Methotrexate (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome