Etanercept in Juvenile Rheumatoid Arthritis (JRA)
Daniel J. Lovell, MD, MPH, Associate Director of the Multidisciplinary Clinical Research Center (MCRC), and Edward H. Giannini, MSc, DrPH, Director of the methodology core, were leaders in securing approval from the FDA to test the treatment in children; the study design resulted from their work with Immunex Corporation. The Methodology Core of the MCRC was involved in the study along with the Cincinnati pediatric rheumatology clinical trials unit and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Translational research funded as a pilot project in an earlier center grant demonstrated that both TNF-a and TNF-b and their receptors were expressed in JRA tissues. This data was also a key component for the subsequent FDA approval of etanercept (Enbrel") for children with juvenile rheumatoid arthritis (JRA).
Publications
Lovell DJ, Giannini EH, Reiff A, Cawkwell GD, Silverman ED, Olson JC, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore J, Finck B. Efficacy and safety of Etanercept (Tumor necrosis factor receptor p75 Fc fusion protein; ENBRELÔ) in children with polyarticular-course juvenile rheumatoid arthritis. N Eng J Med 2000;342:763-9.
Grom AA, Murray KJ, Luyrink L, Emery H, Passo MH, Glass DN, Bowlin T, Edward CK III. Patterns of expression of TNF-a, TNF-b and their receptors in synovia of juvenile rheumatoid arthritis and juvenile spondyloarthropathy patients. 1996; Arthritis Rheum 39:1703-1710.
