Pediatric Rheumatology Online Journal → June 2003 → Methotrexate→ Abstract #49

ETANERCEPT/METHOTREXATE REGISTRY IN JUVENILE RHEUMATOID ARTHRITIS (JRA)

E. H. Giannini,¹ D. J. Lovell,¹ T. M. Sherrard,¹ N. T. Ilowite,² A. A. Reiff,³ the PRCSG

¹Division of Rheumatology, Cincinnati Childrens Hospital Medical Center, Cincinnati, OH, United States; ²Division of Pediatric Rheumatology, Schneider Childrens Hospital, New Hyde Park, NY, United States; ³Division of Rheumatology, Childrens Hospital Los Angeles, Los Angeles, CA, United States

Objectives: To compare the long-term safety of etanercept to methotrexate (MTX) in a cohort of children with JRA recently started on these agents.
Background: There exists a need to determine the longer-term health outcomes of children with JRA who have received etanercept compared to MTX. The study is ongoing and this report considers data through November, 2002.
Methods: Phase IV, 36 mo registry begun in 2000. Enrollment goal is 400 etanercept-treated (0.4 mg/kg [25 mg max>, given 2 times/w s.q.) and 200 MTX-treated (0.3-1 mg/kg/w, p.o. or s.q.) children with polyarticular or systemic course JRA. Study drug must have been started 6 mo prior to baseline. Physicians are permitted to switch a MTX-treated child to the etanercept arm, but not from etanercept to MTX.
Results: 359 children have been registered to date; 217 into the etanercept arm and 142 into the MTX arm. Information is now available on 285 pts, including 164 etanercept and 121 MTX treated subjects. Median follow-up time for the etanercept group is 16 mo (183 pt-yrs) and 14 mo (128 pt-yrs) for the MTX group. Safety: 24 adverse events (AEs) graded as either 3 or 4 according to the NCI Common Toxicity Criteria have been recorded in the etanercept arm (0.13/pt-yr), and 6 in the MTX arm (.047/pt-yr). None were judged to be serious or unexpected. Dropouts: 35 have dropped from etanercept (median follow-up of 11 mo). 36 have dropped from MTX (median follow-up of 5.7 mo). Efficacy: Physician[rsquo>s global assessment (PGA) of overall disease severity (10 cm VAS, 0 is inactive, 10 is severe) at baseline was 4.5 cm for both arms. At the final recorded visit to date the PGA averages 2.5 cm for etanercept and 2.6 cm for MTX.
Conclusions: These data suggest that MTX and etanercept are not producing serious AEs, but grade 3 and 4 AEs are occurring at a higher rate in the etanercept arm. Both drugs are reducing disease severity according to the PGA.