Development of Inflammatory Bowel Disease in Patients with JIA Treated with Enbrel

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Development of Inflammatory Bowel Disease in Patients with Juvenile

Idiopathic Arthritis Treated with Etanercept

http://jrheum.org/content/early/2011/03/30/jrheum.100809.abstract

Address correspondence to Dr. N.M. Wulffraat, Department of Pediatric

Immunology, University Medical Centre Utrecht, Utrecht, The Netherlands.

E-mail: n.wulffraat@...

Abstract

Objective With the increasing use of etanercept for juvenile idiopathic

arthritis (JIA) new possible adverse events are reported including new

autoimmune diseases. Our purpose was to examine if the incidence of

inflammatory bowel disease (IBD) in patients with JIA using etanercept is

higher than in the healthy age-matched population. We give the clinical

characteristics of the IBD in patients with JIA using etanercept.

Methods The national JIA registries for etanercept of The Netherlands,

Germany, Finland, Denmark, and Italy were searched for patients with JIA and

IBD. The total number of patient-years was used to calculate incidence. The

physicians of the identified patients were asked to give clinical details.

Results Thirteen cases of IBD in JIA patients were identified in the

registries between 1999 and 2008. The IBD incidence in JIA patients while

using etanercept was 362 per 100,000 patient-years under etanercept, about

43 times higher than in the general pediatric population. Clinical

presentation of IBD in JIA patients using etanercept was similar to that in

non-JIA patients. The median time between onset of JIA and onset of IBD was

6 years and 10 months. The time between the start of etanercept and the

first appearance of IBD symptoms was between 9 days and 4.5 years.

Conclusion The incidence of IBD in JIA patients using etanercept seems to be

markedly increased, analyzing data from European registries. This incidence

of IBD in the etanercept registries cannot be compared to the incidence of

IBD in JIA patients using other treatment without etanercept, because such

registries do not exist yet in all European countries. These findings are in

keeping with a report of 8 new IBD cases occurring in French children with

JIA using etanercept. These findings illustrate the need for large

international disease-specific registries focused on outcome and

pharmacovigilance.