Long‐term efficacy and safety of etanercept in children with polyarticular‐course juvenile rheumatoid arthritis: Interim results from an ongoing multicenter, open‐label, extended‐treatment trial

Abstract

Objective. To evaluate the long-term efficacy and safety of etanercept in children with juvenile rheumatoid arthritis (JRA) participating in an ongoing multicenter, open-label, extended-treatment trial. All patients had been participants in an initial randomized efficacy and safety trial of etanercept.Methods. Etanercept was administered at a dosage of 0.4 mg/kg (maximum 25 mg) subcutaneously twice each week. Safety and efficacy evaluations were performed every 3-4 months. The JRA 30% definition of improvement (DOI) was defined as improvement of >30% in at least 3 of 6 response variables used to assess disease activity, with no more than 1 variable worsening by more than 30%.Results. At the time of analysis, 48 of the 58 patients (83%) were still enrolled in the study; 43 of them (74%) had completed 2 years of treatment. Of these 43 patients, 81% met the JRA 30% DOI, 79% met the JRA 50% DOI, and 67% met the JRA 70% DOI. Ten children started low-dose methotrexate after year 1. Of the 32 children taking prednisone, the dosage was decreased to <5 mg/day in 26 (81%). Two children had serious infections (varicella with aseptic meningitis in one and complicated sepsis in the other). In general, adverse events were of the types seen in a general pediatric patient population.Conclusion. Children with severe, longstanding, methotrexate-resistant polyarticular JRA demonstrated sustained clinical improvement with >2 years of continuous etanercept treatment. Etanercept was generally well-tolerated. There were no increases in the rates of adverse events over time. However, children taking etanercept should be monitored closely for infections.Juvenile rheumatoid arthritis (JRA) is the most common rheumatic disease in children (1,2). The proinSupported by Immunex Corporation, Seattle, WA, who provided the study drug and grants to investigational sites.

Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: A randomized, controlled trial

“…Etanercept is an approved and well-documented therapy for patients with other inflammatory disorders, including rheumatoid arthritis (RA) (15)(16)(17), juvenile RA (18), and psoriatic arthritis (8), and has shown efficacy in early studies in patients with psoriasis (19).…”

“…The long-term safety of etanercept in patients with RA and juvenile RA has also been well established (18,20).…”

Early outcomes and improvement of patients with juvenile idiopathic arthritis enrolled in a Canadian multicenter inception cohort

“…The ACR Pedi 30, 50, and 70 criteria responses between enrollment and the 6-month followup were calculated (19,20). In patients with a complete 6 core criteria set of measures at both time points, the ACR Pedi 30, 50, or 70 criteria responses corresponded to Ն30%, Ն50%, or Ն70% improvement, respectively, in 3 of 6 measures with Յ30% deterioration in no more than one measure, as originally defined (19,20).…”

“…In patients with a complete 6 core criteria set of measures at both time points, the ACR Pedi 30, 50, or 70 criteria responses corresponded to Ն30%, Ն50%, or Ն70% improvement, respectively, in 3 of 6 measures with Յ30% deterioration in no more than one measure, as originally defined (19,20). In patients lacking one of the measures, most commonly ESR or CRP level, at one or both time points, the definition of response was modified and based on a Ն30%, Ն50%, or Ն70% improvement, respectively, in 3 of 5 measures with Յ30% deterioration in no more than one of the 5 remaining measures.…”

A randomized, placebo‐controlled trial of infliximab plus methotrexate for the treatment of polyarticular‐course juvenile rheumatoid arthritis

“…Weekly methotrexate (MTX), at parenteral dosages of up to 15 mg/m 2 /week, has been established as an effective and safe therapy for polyarticular-course JRA (5)(6)(7). For children whose disease does not respond to MTX, anti-tumor necrosis factor (anti-TNF) therapy is a treatment option (8)(9)(10)(11). One such anti-TNF agent, infliximab, is a chimeric monoclonal antibody that specifically and potently binds and neutralizes soluble TNF␣ and its membrane-bound precursor.…”