Background/Purpose: Etanercept (Eta) has been the most frequently used biologic drug in patients with JIA. In Germany, about one in three patients with polyarticular JIA received Eta in 2010. However, published data on its long-term safety are limited. The data of the German JIA biologic registers BiKeR and JuMBO were used to determine the rates of serious adverse events or events of special interest in order to assess the long-term safety of Eta.

Methods: Patients who were included at start with Eta in the BiKeR registry until March 2007 and have been half-yearly observed into adulthood were considered for this analysis. All adverse events recorded by physicians over the whole observation period (mean 7.5 years) were categorized on the basis of MedDRA. Total exposure-adjusted rates for serious adverse events (SAEs) and for events of special interest (i.e., deaths, malignancies, medically important infections [MII], and newly emerged other immune-mediated inflammatory diseases [IMID]) per 100 patient years (PY) were calculated.

Results: During the 1,815 years of Eta exposure in 386 patients (mean age 23 years, mean disease duration 14 years) 77 SAEs were recorded (4.2 SUEs/100 PY), of which 8% were possibly related to therapy. The SAE rates for each year of Eta exposure per 100 PY varied somewhat over the first nine years of treatment, but did not differ significantly (p=0.312). The JIA-associated mortality rate was 1% in this study population. Two deaths occurred in patients treated with Eta within the last three months before death, but no patient died in suspected causal relationship to Eta. Two malignancies were reported (that were already published¹), resulting in 0.11 event per 100 PY of exposure. Twenty MII were recorded which led to drug discontinuation in five patients. 75% of the MII occurred within the first three years of Eta treatment. The exposure-adjusted MII rate was 1.1 per 100 PY. Tuberculosis or other opportunistic infections were not registered. A total of 17 incident IMID (0.9/100 PY) were reported: among them were eight cases with new onset inflammatory bowel disease (0.44/100 PY) and eight cases with uveitis (0.44/100 PY).

Conclusion: The hitherto most comprehensive study of the long-term safety of Eta confirms the good tolerability of the substance. SAEs with possible relationship to therapy occur only rarely (0.3/100 PY). However, reliable risk rates for events of particular interest can only be calculated in larger patient cohorts. Moreover, a comprehensive control group is necessary to put the results into perspective.

Reference: 1 – Horneff G, Foeldvari I, Minden K, Moebius D, Hospach T. Report on malignancies in the German juvenile idiopathic arthritis registry. Rheumatology (Oxford) 2011;50:230-6.

---

« Back to 2012 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-safety-of-etanercept-in-patients-with-juvenile-idiopathic-arthritis-jia/