Abstract: 682: Safety and Efficacy of Over 8 Years of Continuous Etanercept (Enbrel®) Therapy in Patients With Juvenile Rheumatoid Arthritis
Sangeeta Sule
Authors:
A. O. Reiff, D. J. Lovell, N. T. Ilowite, C. A. Wallace, Y. Chon, S-L Lin, S. W. Baumgartner, E. H. Giannini
Background:
Etanercept, a tumor necrosis factor alpha receptor fusion protein, has been shown to be effective in the treatment of JIA. In this abstract, the authors report on eight year safety and efficacy data from a previous double-blind, randomized controlled trial of etanercept.
Methods:
Patients who had previously participated in the double-blind, randomized controlled trial were eligible to enroll as a subset in a multicenter open-label extension study examining the safety of etanercept. Safety assessments include recording serious adverse events (SAE), medically important infections, opportunistic infections, malignancies, lymphomas, and death. Efficacy data is limited to the 58 patients who entered the open label extension.
Results:
58/69 (84%) of the original patients enrolled in the open label extension for a total of 318 years of etanercept exposure. 42 (61%) had 4 years of continuous etanercept exposure, 26 (38%) had 8 years of continuous etanercept exposure. 10 patients withdrew from the study secondary to patient/guardian refusal. 9 patients withdrew because of suboptimal response to medication, 5 withdrew because of adverse events, and 5 because of physician decision. 16 patients reported 39 SAE. The rate of SAE did not increase with continue etanercept treatment (Years 1-8, 0.00-0.20/pt-year). No cases of lupus, demyelinating disorders, malignancies, or lymphomas were reported. No cases of tuberculosis or opportunistic infections were reported. 90% of patients reported achieving an ACR 30 at 7 years, 90% achieved an ACR 50, 86% achieved an ACR 70, 67% achieved an ACR 90, and 29% achieved an ACR 100.
Conclusions:
The safety profile of etanercept is good with up to 8 years of treatment. These patients also showed a maintained response to etanercept therapy.
Editorial Comments:
This abstract is important in defining the long-term safety profile of an important biologic therapy in JIA. It is also encouraging that a sustained efficacy of etanercept was noted. Given potential complications of biological therapy noted in adults with rheumatoid arthritis, it is encouraging that the data in children shows no increased risk of malignancy or serious adverse events. However, the number of patients who remained on therapy for 8 years was small. Maintaining registries of adverse reactions in children maintained on etanercept would be important.
