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Ann Rheum Dis. 2010 Apr;69(4):718-22. doi: 10.1136/ard.2009.100354.

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.

Author information

1
IRCCS Istituto G Gaslini, Pediatria II-PRINTO, Largo Gaslini 5, EULAR Centre of Excellence in Rheumatology 2008-13, Genoa, Italy. nicolaruperto@ospedale-gaslini.ge.it

Erratum in

  • Ann Rheum Dis. 2011 Nov;70(11):2060.
  • Ann Rheum Dis. 2012 Jun;71(6):1106.

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.

PMID:
20237125
PMCID:
PMC2946101
DOI:
10.1136/ard.2009.100354
[Indexed for MEDLINE]
Free PMC Article

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