Research Article: Surveillance of adverse drug events associated with etanercept prescribed for juvenile idiopathic arthritis in a single center up to 9-years: A retrospective observational study

Date Published: November 9, 2018

Publisher: Public Library of Science

Author(s): Jeong Yun Choi, Jee Eun Chung, Ji Hyun Park, Yoon Sook Cho, Yong Woo Jung, Soo An Choi, Andrea Martinuzzi.


The introduction of biologic agents opened a new era of treatment of juvenile idiopathic arthritis (JIA) over the past decade. From clinical experience, it appears that biological agents are well tolerated overall, and serious adverse events are rare. However, such clinical studies have not been conducted in Korea. Therefore, we examined the safety profile of JIA patients with biologics in a single center in Korea. All JIA outpatients treated from April 2004 to June 2013 were enrolled and retrospectively reviewed. Pharmacy-based surveillance of adverse drug events (ADEs) was identified by recording the patient’s symptoms in the medical record and suspected ADEs were additionally explored by screening laboratory test values and observing changes in medication orders. Finally, 83 patients were enrolled and experienced 109 ADEs in 52 patients. Most ADEs (99.1%) were mild to moderate in severity assessment. The total follow-up time was 328 patient-treatment years and the overall rate of ADEs was 0.33 per patient-years for etanercept. Infection including upper respiratory tract was the most common ADE and concomitant corticosteroids contributed to the risk of infections. If the dose of prednisolone increases 0.34 mg/kg/day, the probability of developing infections increases 3.29 times. Also, all 11 patients who stopped etanercept with injection site reactions were receiving a single use prefilled syringe. In our study, etanercept appears well tolerated and safe. Children affected by JIA should be carefully monitoring so as to limit the risk of ADEs during etanercept as much as possible. To gain further knowledge about risk profiles, national collaboration for the accumulation of long-term data should be encouraged in Korea.

Partial Text

Juvenile idiopathic arthritis (JIA) is not a single disease, but a heterogeneous group of diseases characterized by arthritis of unknown etiology with onset before the age of 16 years and lasts more than 6 weeks [1]. JIA is one of the most common chronic diseases of children, with a prevalence of approximately 19.8 cases per 100,000 [2]. Most patients with JIA continue to have the active disease even after 10 years of onset, leading to disease progression into adulthood in many patients [3]. Joint damage can lead to physical disability in many affected children if proper treatment is not provided. Additional morbidity associated with JIA can be due to its treatment or effects on growth and development [4].

The introduction of BAs opened a new era of treatment of JIA over the past decade. Data on long-term efficacy and safety are now available and are of great importance. Extension studies of original clinical trials and national registries were performed in Europe or North America [12, 14–17, 23]. However, until recently, data from other long-term studies were not available in Korea. We have had experience with the use of biologics in JIA treatment since 2002 and performed ADE surveillance in all pediatric patients who received BAs for the past 9 years. To the best of our knowledge, our retrospective study on the safety of biologics, such as etanercept, in JIA patients is the longest study conducted to date in Korea.




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