Comparison of the efficacy of ustekinumab and vedolizumab in achieving transmural healing in active Crohn′s disease
10.3760/cma.j.cn311367-20240429-00172
- VernacularTitle:乌司奴单克隆抗体与维得利珠单克隆抗体治疗活动期克罗恩病达到透壁愈合的效果比较
- Author:
Long JU
1
;
Yujie ZHAO
1
;
Changqin LIU
1
;
Yanhong SHI
1
;
Xiaomin SUN
1
;
Zhanju LIU
1
;
Xiaolei WANG
1
Author Information
1. 同济大学附属第十人民医院消化内科，上海 200072
- Publication Type:Journal Article
- Keywords:
Crohn′s disease;
Ustekinumab;
Vedolizumab;
Transmural healing;
Clinical remission;
Endoscopic remission
- From:
Chinese Journal of Digestion
2025;45(2):107-116
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the efficacy of ustekinumab (UST) and vedolizumab (VDZ) in achieving transmural healing in active Crohn′s disease (CD).Methods:From March 1, 2020 to November 30, 2024, 112 patients with active CD treated with UST or VDZ at the Department of Gastroenterology, Tenth People′s Hospital of Tongji University were retrospectively enrolled. According to the medication regimen, the 112 patients were divided into UST group (61 cases) and VDZ group (51 cases). Collected the data at baseline, such as the disease phenotype, other medication history, and clinical indicators including C-creative protein (CRP), etc. Clinical disease activity and endoscopic disease activity were assessed by Harvey-Bradshaw index (HBI) and simplified endoscopic score for Crohn′s disease (SES-CD), respectively. Transmural healing was evaluated according to the intestinal wall thickness measured by intestinal imaging examination of the affected intestinal segment. Transmural healing was defined as bowel wall thickness <0.3 cm and 110 obvious signs of inflammation, clinical remission was defined as HBI≤4, and endoscopic remission was defined as a reduction in SES-CD ≥50% or a score of ≤2. The primary endpoint was transmural healing rate within one year after treatment. The secondary endpoints were endoscopic healing rate and clinical remission rate at 13 to 24th week and 30 to 52nd week after treatment. Chi-square test or Fisher′s exact test was used to compare the efficacy of the 2 medications.Results:There was no significant difference in transmural healing rate between UST group and VDZ group within 1 year after treatment (16.4% (10/61) vs. 23.5% (12/51), χ2=0.90, P=0.344). There were no significant differences in the healing rate between UST group and VDZ group in patients with specific baseline characteristics before treatment, including CD with stenosis, with perianal disease, no history of glucocorticoid use, secondary loss of response to anti-tumor necrosis factor (TNF)-α, SES-CD 7 to 15, decreased body mass index, and increased CRP (18.2%(6/33) vs. 19.4%(7/36), 17.9%(7/39) vs. 19.4%(6/31), 17.1%(6/35) vs. 24.2%(8/33), 20.0%(8/40) vs. 3/18, 14.3%(5/35) vs. 19.2%(5/26), 15.0%(3/20) vs. 3/10, 21.4%(6/28) vs. 5/16), all P>0.05). There was no significant difference in the clinical remission rate or endoscopic remission rate between the UST group and the VDZ group from 13 to 24th week (7/14 vs. 9/18, 3/14 vs. 7/18, RR=1.000 and 0.551, 95% confidence interval: 0.497to 2.011, 0.173to 1.755, χ2=<0.01, Fisher′s exact test, both P>0.05). There was no significant difference in clinical remission rate or endoscopic remission rate between UST group and VDZ group from week 30 to week 52 after treatment (68.5% (37/54) vs. 74.4% (32/43), 27.8% (15/54) vs. 32.6% (14/43), RR=0.921 and 0.853, 95% confidence interval: 0.716 to 1.184, 0.464 to 1.568, χ2=0.41 and 0.26, both P>0.05). In UST group, the proportion of patients with normal hemoglobin after transmural healing was higher than that of patients without transmural healing (9/10 vs. 45.1% (23/51), and the difference was statistically significant ( χ2=5.08, P=0.024). However, there were no significant differences in the proportion of patients with normal body mass index, CRP, platelet count, prealbumin, albumin, interleukin-6 or TNF-α levels after treatment between those who achieved transmural healing and those who did not in either UST group or VDZ group (all P>0.05). And in VDZ group there was no significant difference in the proportion of patients with normal hemoglobin between those who achieved transmural healing and who did not (all P>0.05). Conclusion:UST and VDZ exhibit similar efficacy in transmural healing within one year of treatment in patients with active CD.
