Juvenile RA/Pediatric Rheumatology
Sangeeta Sule, M.D.
Abstract 659: Long-Term Efficacy and Safety of Adalimumab in Children with Juvenile Rheumatoid Arthritis (JRA): 48 Week Results
Authors: D. J. Lovell1, N. Ruperto2, L. Jung1, A. Reiff3, D. Nemcova2, K. Jarosova2, A. Prieur2, C. Sandborg1, J. Rovensky2, J. Bohnsack1, K. Minden2, L. Wagner Weiner1, R. Vehe1, G. Horneff2, J. Medich4, E. H. Giannini1, A. Martini2. 1PRCSG, Cincinnati, OH; 2PRINTO-IRCCS G Gaslini, Genova, Italy; 3Children’s Hospital of Los Angeles, Los Angeles, CA; 4Abbott, Parsipanny, NJ
Purpose: This is a multi-center, randomized, double-blind, placebo-controlled withdrawal study to evaluate the long-term efficacy and safety of adalimumab (ADA) in patients with JRA.
Methods: 171 polyarticular JRA patients were enrolled in this Phase II, randomized, double-blind, placebo-controlled withdrawal study. At the end of a 16 week open label phase, patients with an ACR Ped 30 response were randomized to receive either ADA at 24 mg/m2 or placebo sc injection every other week for 32 weeks or until disease flare. After 32 weeks or at time of flare, patients were allowed to receive open label ADA. Randomization was stratified by methotrexate use.
Results: At the end of the open label phase, 83% of patients had an ACR Ped 30 response, 74% an ACR Ped 50 response, and 52% and ACR Ped 70 response. 133 patients entered the double-blind phase of the study. In this phase, patients receiving ADA had significantly fewer disease flares compared to the placebo group, both without methotrexate (43.3% vs. 71.4%, p=0.031) and with methotrexate (36.8% vs. 64.9%, p=0.015). Four ADA and two placebo patients experienced adverse reactions. No TB or opportunistic infections were noted.
Conclusions: Adalimumab, with or without concomitant methotrexate, provided these polyarticular JRA patients with improvement in signs and symptoms of disease activity.
Editorial Comments: This is the first randomized, double-blind, placebo-controlled study of adalimumab in the treatment of JRA. The results are positive with a significantly fewer flares noted in patients treated with ADA. The ADA effect was noted even in patients treated with MTX. What is not clear is how to interpret these results in comparison to other TNF-alpha antagonists, such as etanercept or infliximab. All of these medications have been shown to be effective in polyarticular JRA, however, the cost, mode and frequency of administration varies significantly. In the future, comparison studies between TNF-alpha antagonists would be helpful.