Quartier Pierre, Taupin Pierre, Bourdeaut Franck, Lemelle Irène, Pillet Pascal, Bost Michel, Sibilia Jean, Koné-Paut Isabelle, Gandon-Laloum Sylvie, LeBideau Marc, Bader-Meunier Brigitte, Mouy Richard, Debré Marianne, Landais Paul, Prieur Anne-Marie
Hôpital Necker-Enfants Malades, Paris, France.
Arthritis Rheum. 2003 Apr;48(4):1093-101. doi: 10.1002/art.10885.
To assess the efficacy of etanercept in patients with juvenile idiopathic arthritis (JIA), and to assess the tolerance of these patients to etanercept.
All JIA patients with active chronic polyarthritis, who were first treated with etanercept between November 1999 and June 2001 in 18 French centers because of poor response or intolerance to methotrexate, were included in this open-label, prospective, multicenter study. A standardized questionnaire was sent to the treating physicians. We assessed the validated international core-set score for JIA activity every 3 months and performed an intent-to-treat analysis. We also compared the risk of treatment failure in patients defined as having systemic-onset, oligoarticular-onset, or polyarticular-onset JIA.
Sixty-one patients were enrolled and were followed up for a median of 13 months. Treatment had to be stopped in 1 patient who became pregnant and in 12 patients due to severe side effects, including neurologic or psychiatric disorders, retrobulbar optic neuropathy, major weight gain, severe infection, cutaneous vasculitis with systemic symptoms, hemorrhagic diarrhea, uveitis flare, and pancytopenia. All of these side effects disappeared after discontinuation of etanercept. Crohn's disease was subsequently diagnosed in 1 child. Scores improved by > or =30% in 73% of patients after 3 months, but this proportion decreased to 39% after 12 months. The response rate was significantly lower in patients with systemic-onset JIA than in those with oligoarticular- or polyarticular-onset JIA.
Treatment of JIA with etanercept may be associated with a wide spectrum of severe side effects. Although most patients initially respond to etanercept, this initial response is not always followed by sustained improvement over longer periods of time. In addition, the higher rate of treatment failure in the group with systemic-onset JIA indicates that these patients in particular may require alternative treatments.
评估依那西普治疗幼年特发性关节炎(JIA)患者的疗效,并评估这些患者对依那西普的耐受性。
所有患有活动性慢性多关节炎的JIA患者,因对甲氨蝶呤反应不佳或不耐受,于1999年11月至2001年6月期间在法国18个中心首次接受依那西普治疗,被纳入这项开放标签、前瞻性、多中心研究。向治疗医师发送标准化问卷。我们每3个月评估一次经验证的JIA活动国际核心集评分,并进行意向性分析。我们还比较了被定义为全身型、少关节型或多关节型JIA患者的治疗失败风险。
61例患者入组,中位随访时间为13个月。1例怀孕患者和12例因严重副作用(包括神经或精神障碍、球后视神经炎、体重显著增加、严重感染、伴有全身症状的皮肤血管炎、出血性腹泻、葡萄膜炎发作和全血细胞减少)而停止治疗。停用依那西普后,所有这些副作用均消失。随后1名儿童被诊断为克罗恩病。3个月后73%的患者评分改善≥30%,但12个月后这一比例降至39%。全身型JIA患者的缓解率显著低于少关节型或多关节型JIA患者。
依那西普治疗JIA可能会伴有多种严重副作用。虽然大多数患者最初对依那西普有反应,但这种初始反应并不总是伴随着较长时间的持续改善。此外,全身型JIA组较高的治疗失败率表明,这些患者尤其可能需要替代治疗。