Long‐term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis

Abstract

Objective. This study was undertaken to evaluate the long-term safety and effectiveness of etanercept alone or in combination with methotrexate (MTX) in children with selected categories of juvenile idiopathic arthritis (JIA).Methods Results. A total of 197, 103, and 294 patients were enrolled in the MTX, etanercept, and etanercept plus MTX groups, respectively. Exposure-adjusted rates of adverse events were similar among the 3 treatment groups (18.3, 18.7, and 21.6 per 100 patient-years in the MTX, etanercept, and etanercept plus MTX groups, respectively). Respective rates per 100 patient-years of serious adverse events (4.6, 7.1, and 6.0) and medically important infections (1.3, 1.8, and 2.1) were also similar among the 3 treatment groups. Scores for physician's global assessment and total active joints improved from baseline, and improvement was maintained for the duration of the study.Conclusion. These data confirm the findings of other long-term studies and suggest that etanercept or etanercept plus MTX has an acceptable safety and effectiveness profile in children with selected categories of JIA. Improvement was maintained for 3 years in those continuing to receive medication.Juvenile idiopathic arthritis (JIA) is the most common childhood rheumatic disease (1,2), and it often extends into or relapses during adulthood (3). The pain and functional disability associated with JIA cause a significant burden for patients and their families and caregivers. Indeed, JIA has an important adverse impact on health-related quality of life and well-being that is ClinicalTrials.gov identifier: NCT00078793.

Circulating complexes between tumour necrosis factor‐alpha and etanercept predict long‐term efficacy of etanercept in juvenile idiopathic arthritis

“…Drugs that efficiently bind and neutralise soluble TNF‐ α have been used to treat these conditions for nearly two decades. Since their introduction, the short‐term outcome for these patients has improved dramatically, but there are fewer studies of the long‐term efficacy of TNF‐ α inhibitors, especially in children 4, 5, 6. High levels of TNF‐ α in the joint are associated with increased inflammation 3, but levels of TNF‐ α in serum are low or undetectable in patients with RA and JIA.…”

Novel Method to Collect Medication Adverse Events in Juvenile Arthritis: Results From the Childhood Arthritis and Rheumatology Research Alliance Enhanced Drug Safety Surveillance Project

“…However, only a small proportion of physicians submit MedWatch reports, and the interpretation of these data is hampered by a lack of denominator data (i.e., the total number of patients exposed to the medication of interest) (9). Postmarketing registries have been developed specifically to assess adverse events via incidence rates in a defined cohort of patients over the long term, and there are 2 completed postapproval registries (etanercept and celecoxib) that are particularly noteworthy regarding JIA management (10,11). Although these postmarketing registries may seem to be an ideal approach, they were designed to address specific safety questions in a modest number of children with JIA, focused on specific medications, and used specific inclusion and exclusion criteria (e.g., medication doses, use of concomitant medications, comorbidities, and specific age groups) that may limit the study population, similar to long-term extension studies (10,11).…”

“…Postmarketing registries have been developed specifically to assess adverse events via incidence rates in a defined cohort of patients over the long term, and there are 2 completed postapproval registries (etanercept and celecoxib) that are particularly noteworthy regarding JIA management (10,11). Although these postmarketing registries may seem to be an ideal approach, they were designed to address specific safety questions in a modest number of children with JIA, focused on specific medications, and used specific inclusion and exclusion criteria (e.g., medication doses, use of concomitant medications, comorbidities, and specific age groups) that may limit the study population, similar to long-term extension studies (10,11). In addition, the German Biologics JIA Registry (BiKeR) and the Dutch Arthritis and Biologicals in Children (ABC) Registry are observational registries developed specifically to monitor the effectiveness and safety of methotrexate and a limited number of biologic agents (12,13).…”

Etanercept Treatment Results in Children With Non-Systemic Juvenile Idiopathic Arthritis: Remission, Recrudescence, and Adverse Events. Retrospective Cohort Study

“…Так, у пациентов с несистемными вариантами ЮИА при отсутствии увеита наиболее часто применяется этанерцепт [3] -раство-римый рецептор к фактору некроза опухоли ␣, один из наиболее значимых провоспалительных цитокинов, участвующих в патогенезе ЮИА [4]. Этанерцепт -хоро-шо изученный с точки зрения эффективности и безопас-ности ГИБП, применяемый в терапии ЮИА [5], -исполь-зуется в клинической практике с 2000 г., а общемировое число пролеченных им пациентов превышает 150 тыс., из них более 50 тыс. -дети [6].…”

“…-дети [6]. Причинами такой привер-женности являются высокая эффективность препарата, хороший профиль его безопасности, а также наилучшие фармакоэкономические показатели применения в срав-нении с другими ГИБП [5,7,8].…”