title: Anakinra in the treatment of polyarticular-course juvenile rheumatoid arthritis: safety and preliminary efficacy results of a randomized multicenter study.
abstract: This study assessed the safety and preliminary efficacy of the interleukin-1 receptor antagonist anakinra in patients with polyarticular-course juvenile rheumatoid arthritis (JRA). Eighty-six patients entered a 12-week open-label run-in phase (1 mg/kg anakinra daily, < or =100 mg/day). Fifty responders were randomized to anakinra or placebo in a 16-week blinded phase, followed by a 12-month open-label extension (N = 44). Due to low enrollment, the primary endpoint was changed from efficacy to safety. The incidence and nature of adverse events were similar across all study phases, with the exception of injection site reactions, which were mild to moderate and decreased with time. Anakinra produced a nonsignificant (P = 0.11) reduction in disease flares compared with placebo. When normalized to 1 mg/kg dose, anakinra plasma concentrations were similar to values in adult patients with rheumatoid arthritis. These results indicate that anakinra 1 mg/kg once daily (< or =100 mg/day) is safe and well tolerated in patients with JRA.
authors.affiliation: Schneider Children's Hospital, New Hyde Park, NY 10467, USA. nilowite@montefiore.org
authors.forename: Norman
authors.initials: N
authors.lastname: Ilowite
authors.forename: Oscar
authors.initials: O
authors.lastname: Porras
authors.forename: Andreas
authors.initials: A
authors.lastname: Reiff
authors.forename: Sue
authors.initials: S
authors.lastname: Rudge
authors.forename: Marilynn
authors.initials: M
authors.lastname: Punaro
authors.forename: Alan
authors.initials: A
authors.lastname: Martin
authors.forename: Roger
authors.initials: R
authors.lastname: Allen
authors.forename: Terry
authors.initials: T
authors.lastname: Harville
authors.forename: Yu-Nien
authors.initials: YN
authors.lastname: Sun
authors.forename: Terry
authors.initials: T
authors.lastname: Bevirt
authors.forename: Gary
authors.initials: G
authors.lastname: Aras
authors.forename: Brent
authors.initials: B
authors.lastname: Appleton