Ilaris获准用于治疗全身性幼年特发性关节炎

圣路易斯(MD Consult)——2013年5月10日，诺华公司宣布美国食品药品管理局(FDA)已经批准Ilaris(康纳单抗)用于治疗≤2岁的活动性全身性幼年特发性关节炎(SJIA)患儿。Ilaris是一种白介素-1β抑制剂，用法为每月1次皮下注射。

FDA批准此药是基于2项针对SJIA患儿的Ⅲ期试验的数据。第1项研究的结果显示，在第15天时，接受1剂Ilaris皮下注射治疗的患儿中有84%达到了美国风湿病学会30(ACR30)儿科版的主要终点；相比之下，安慰剂对照组患儿只有10%达到了此终点。在第2项研究的开放标记部分，128例患儿中有92例尝试了皮质类固醇剂量递减治疗。在这92例患儿中，有62%能够大幅减少皮质类固醇的使用，46%完全停用了皮质类固醇。在第2项研究的对照部分，与安慰剂对照组相比，Ilaris治疗组病情加剧的风险相对减少了64%。

使用Ilaris治疗SJIA时最常见的不良反应包括感冒症状、上呼吸道感染、肺炎、鼻漏、咽喉痛、泌尿道感染、恶心、胃肠炎、腹痛及注射部位反应。

使用Ilaris可增加感染风险。在开始Ilaris治疗前应该对患儿进行结核病检测，并应该在治疗期间监测感染的发生。

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ST LOUIS (MD Consult) - On May 10, 2013, Novartis announced that the US Food and Drug Administration (FDA) has approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is an interleukin-1 beta inhibitor and is administered as a once-monthly subcutaneous injection.

This approval was granted on the basis of data from 2 phase 3 trials in patients with SJIA. Results from the first study showed that 84% of patients treated with 1 subcutaneous dose of Ilaris achieved the primary end point of the adapted pediatric American College of Rheumatology 30 (ACR30), compared with 10% achievement of ACR30 for placebo-treated patients at Day 15. In the open-label part of the second study, 92 of 128 patients attempted corticosteroid tapering. Of those 92 patients, 62% were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids. In the controlled portion of the second study, a 64% relative reduction in the risk of flare for patients in the Ilaris group was achieved, as compared with patients in the placebo group.

The most common adverse effects of Ilaris when used for the treatment of SJIA include cold symptoms, upper respiratory tract infection, pneumonia, rhinorrhea, sore throat, urinary tract infection, nausea, gastroenteritis, abdominal pain, and injection-site reactions.

The use of Ilaris can increase the risk of infection. Patients should be tested for tuberculosis before starting Ilaris therapy, and should be monitored for infections during treatment.

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