De Marco G, Gerloni V, Pontikaki I, Luriati A, Teruzzi B, Salmaso A, Valcamonica E, Gattinara M, Fantini F
Ist. Ortopedico Gaetano Pini, U.O. di Reumatologia e U.O.S. Reumatologia Infantile, Cattedra di Reumatologia, Università di Milano.
Reumatismo. 2007 Jan-Mar;59(1):50-6. doi: 10.4081/reumatismo.2007.50.
To evaluate, in long-term open label prospective study, infliximab as therapeutic choice for Juvenile Idiopathic Arthritis (JIA) non responsive to conventional therapy.
We enrolled to treat with infliximab 78 JIA patients (66 females, 12 males): the mean age was 20.7+/-7.1 years (median 20.9, range 5.4-34.9); mean JIA duration was 13.6+/-7.6 years (median 13.5, range 0.4-31.4). Infliximab, at dose of 3-10 mg/kg/infusion added to weekly subcutaneous Methotrexate or other previous DMARDs, was administered by intravenous infusions at weeks 0, 2, 6 and every 8 weeks thereafter. Chest X-ray, Mantoux's test, electrocardiogram were performed at baseline; laboratory tests and clinical evaluation were performed at each infusion. Response was evaluated according to ACR improvement criteria.
Mean treatment period was 21.6 months+/-18.8 (median 14.7, range 1.4-72.4). Just after first infusion most of patients reported significant improvement in pain, fatigue, morning stiffness. Infliximab is still successfully administered to 23 patients (29.5%); 55 (70.5%) patients suspended because of: inefficacy (7), infusion reactions (17), adverse events (9), disease flare-up after a period of effectiveness on synovitis, pain, and morning stiffness (19), remission (2), lack of compliance to treatment (1). Infusion reactions, like dyspnea, flushing, chills, headache, hypotension, anxiety, throat oedema, were observed in 29 patients (34.5%). Anti-DNA antibodies were present in 7 patients (none developed Systemic Lupus Erythematous).
Infliximab showed impressive effectiveness treating refractory JIA, although most of patients had to discontinue treatment because of disease flare-up or adverse events. Infliximab may represent a good therapeutic choice in patients non-responders to Methotrexate.
在一项长期开放标签前瞻性研究中,评估英夫利昔单抗作为对传统治疗无反应的幼年特发性关节炎(JIA)的治疗选择。
我们纳入了78例接受英夫利昔单抗治疗的JIA患者(66例女性,12例男性):平均年龄为20.7±7.1岁(中位数20.9,范围5.4 - 34.9);JIA平均病程为13.6±7.6年(中位数13.5,范围0.4 - 31.4)。英夫利昔单抗剂量为3 - 10mg/kg/次静脉输注,加用每周皮下注射甲氨蝶呤或其他先前使用的改善病情抗风湿药(DMARDs),在第0、2、6周静脉输注,此后每8周输注一次。基线时进行胸部X线、结核菌素试验、心电图检查;每次输注时进行实验室检查和临床评估。根据美国风湿病学会(ACR)改善标准评估反应。
平均治疗期为21.6个月±18.8(中位数14.7,范围1.4 - 72.4)。首次输注后大多数患者报告疼痛、疲劳、晨僵有显著改善。仍有23例患者(占29.5%)成功接受英夫利昔单抗治疗;55例(占70.5%)患者因以下原因停药:无效(7例)、输注反应(17例)、不良事件(9例)、在滑膜炎、疼痛和晨僵有一段时间起效后疾病复发(19例)、缓解(2例)、治疗依从性差(1例)。29例患者(占34.5%)出现输注反应,如呼吸困难、潮红、寒战、头痛、低血压、焦虑、咽喉水肿。7例患者存在抗DNA抗体(均未发展为系统性红斑狼疮)。
英夫利昔单抗在治疗难治性JIA方面显示出令人印象深刻的疗效,尽管大多数患者因疾病复发或不良事件而不得不停止治疗。英夫利昔单抗可能是对甲氨蝶呤无反应患者的一种良好治疗选择。