UNASSIGNED: In this phase 2 single-center, double-blind, randomized controlled trial, we assigned 19 patients with Crohn\'s disease with a Crohn\'s disease activity index (CDAI) equal to or greater than 220 and less than 450 in a 1:1 ratio to receive ustekinumab and budesonide or ustekinumab for 32 weeks. The primary endpoint was the clinical remission rate at 8 weeks. The secondary endpoints were the clinical remission rate at 32 weeks and mucosal healing rates at 8 and 32 weeks.
UNASSIGNED: Of 19 patients, the mean age was 37.8 years, and 42.1% were women (CDAI ≥220 and <450). There was no difference between combination therapy and ustekinumab monotherapy in terms of clinical remission rates (50.0% vs. 30.0%, p = 0.39 at 8 weeks and 37.5% vs. 20.0%, p = 0.41) and mucosal healing rates (75.0% vs. 90.0%, p = 0.40 and 37.5% vs. 60.0%, p = 0.34 at 8 and 32 weeks, respectively). The most common adverse event was an exacerbation of Crohn\'s. There were no differences in safety profiles between the two groups.
UNASSIGNED: Our study showed no difference between ustekinumab monotherapy and ustekinumab and budesonide combination therapy in terms of the induction and maintenance of remission (trial registration number: jRCTs021200013).
■在此阶段2单中心,双盲,随机对照试验,我们以1∶1的比例将19例克罗恩疾病活动指数(CDAI)等于或大于220且小于450的克罗恩病患者分配到接受ustekinumab和布地奈德或ustekinumab治疗32周.主要终点是8周时的临床缓解率。次要终点是32周时的临床缓解率和8周和32周的粘膜愈合率。
■在19名患者中,平均年龄为37.8岁,42.1%为女性(CDAI≥220和<450)。在临床缓解率方面,联合治疗和ustekinumab单药治疗之间没有差异(50.0%vs.30.0%,8周时p=0.39,37.5%vs.20.0%,p=0.41)和粘膜愈合率(75.0%vs.90.0%,p=0.40和37.5%与60.0%,第8周和第32周p=0.34,分别)。最常见的不良事件是克罗恩病加重。两组之间的安全性没有差异。
■我们的研究显示,在诱导和维持缓解方面,ustekinumab单药治疗与ustekinumab和布地奈德联合治疗之间没有差异(试验登记号:jRCTs021200013)。