Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis
Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis
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DOI：
10.1056/nejmoa1900750
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发表时间：
2019-09-26
影响因子：
158.5
通讯作者：
Marano, C.
中科院分区：
文献类型：
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作者：
Sands, B. E.;Sandborn, W. J.;Marano, C.
背景白介素12和白介素23的p40亚单位拮抗剂Ustekinumab作为溃疡性结肠炎患者的诱导和维持治疗的疗效尚不清楚。共有961名患者被随机分配接受静脉诱导剂量的Ustekinumab(130毫克[320名患者]或基于体重范围的剂量，约为每公斤体重6毫克[322])或安慰剂(319名)。在静脉注射Ustekinumab 8周后对诱导治疗有反应的患者被随机分配到接受90 mg Ustekinumab皮下维持注射(每12周[172名患者]或每8周[176]名)或安慰剂(175名)。诱导试验(第8周)和维持试验(第44周)的主要终点是临床缓解(定义为4个Mayo量表组成部分的总分为1[范围0到3])。结果静脉注射乌司他单抗130 mg(15.6%)或6 mg/kg(15.5%)的患者在第8周临床缓解的百分比(15.6%)显著高于安慰剂组(5.3%)(P
BackgroundThe efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.MethodsWe evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of 1 [range, 0 to 3] on any of the four Mayo scale components).ResultsThe percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P