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Abstract：
UNASSIGNED: Limited data exist on the efficacy of combination therapy with ustekinumab and budesonide in patients with Crohn\'s disease. Our objective was to compare the clinical outcomes of ustekinumab and budesonide combination therapy with those of ustekinumab monotherapy.
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).
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).
摘要：
■关于乌司他单抗和布地奈德联合治疗克罗恩病患者的疗效数据有限。我们的目的是比较ustekinumab和布地奈德联合治疗与ustekinumab单药治疗的临床结果。
■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）。
■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）。
