Abstract: 681: Adalimumab is Safe and Effective During Long-Term Treatment of Patients with Juvenile Rheumatoid Arthritis: Results from a 2-Year Study
Sangeeta Sule
Authors:
D. J. Lovell, N. Ruperto, S. Goodman, A. Reiff, D. Nĕmcová, A. Prieur, R. Joos, V. Gerloni, J. Bohnsack, L. Wagner-Weiner, H. Huppertz, N. Olson, M. McIlraith, J. Medich, E. Giannini, A. Martini
Background:
Adalimumab, a tumor necrosis factor alpha antagonist, is effective in the treatment of adults with rheumatoid arthritis. This study examines the safety and efficacy of adalimumab in the treatment of juvenile idiopathic arthritis (JIA).
Methods:
171 patients with polyarticular JIA (aged 4-17 years) were enrolled in this Phase III, randomized, double-blind, placebo-controlled withdrawal study. After a 16 week open label period in which patients received adalimumab (24 mg/m2; maximum dose 40 mg every other week), patients who achieved an ACR Pedi 30 response were stratified based on methotrexate use to receive adalimumab or placebo every other week for 32 weeks or until disease flare (primary end point). Patients could also enter the open-label extension study. An intention-to-treat analysis was used to analyze the data.
Results:
84% of patients achieved an ACR Pedi 30 response at week 16, 77% an ACR Pedi 50 response, 58% an ACR Pedi 70 response, and 27% an ACR Pedi 90 response. At the end of the double-blind study, patients treated with adalimumab achieved higher ACR responses than placebo patients (ACR 30, 50, 70 of 60%, 59%, and 56%, respectively, in treated group and 35%, 35%, and 28%, respectively, in placebo group). In the 128 patients who entered the open-label phase, 75% had available data at 1 year. 94% sustained an ACR Pedi 30 response, 93% an ACR Pedi 50, 81% an ACR Pedi 70, and 60% an ACR Pedi 90 response. There was no difference between methotrexate and non-methotrexate strata.
Conclusions:
Patients with polyarticular JIA had significant and sustained response after treatment with adalimumab for 2 years.
Editorial:
The results of this Phase III study are positive with a significant percentage of patients achieving ACR Pedi 30, 50, 70, and even 90 responses. The effect was noted even in patients not treated with MTX. This is encouraging for the treatment of children with polyarticular JIA who do not respond to methotrexate alone. However, the differences in response between biologic agents, such as etanercept, infliximab, or adalimumab, are not clear and studies directly comparing efficacy of these agents would be important.
