Short-term Efficacy and Safety of Ustekinumab in Treatment of Crohn's Disease:A Single-center Real-world Study
10.3969/j.issn.1008-7125.2024.05.002
- VernacularTitle:乌司奴单抗治疗克罗恩病的短期疗效和安全性:一项单中心真实世界研究
- Author:
Qiyin CHEN
1
;
Juan LUO
;
Mingzhi DONG
;
Hanyu ZHANG
;
Xiaolin LIU
;
Zihong CHEN
;
Yinglei MIAO
Author Information
1. 昆明医科大学第一附属医院消化内科(650032);云南省消化系统疾病临床医学研究中心
- Publication Type:Journal Article
- Keywords:
Ustekinumab;
Crohn Disease;
Short-Term Efficacy;
Safety
- From:
Chinese Journal of Gastroenterology
2024;29(5):261-267
- CountryChina
- Language:Chinese
-
Abstract:
Background:The burden of Crohn's disease(CD)is rising globally,and the efficacy and safety of ustekinumab(UST)in treatment of CD need to be further verified.Aims:To assess the short-term efficacy and safety of UST in CD patients.Methods:A single-center retrospective observational study was conducted in the First Affiliated Hospital of Kunming Medical University.The clinical data of CD patients treated with UST from January 2020 to December 2023 were analyzed retrospectively.The clinical activity and endoscopic severity of the disease were assessed using Crohn's disease activity index(CDAI)and simple endoscopic score for Crohn's disease(SES-CD),respectively.The primary outcomes were clinical response(CDAI score decreased≥70 points,or CDAI score decreased<70 points but the total score<150)and clinical remission(CDAI score<150),while the secondary outcomes included endoscopic response(SES-CD decreased≥50%),endoscopic remission(SES-CD≤2),changes of inflammatory and nutritional indicators,and the adverse events.Results:Twenty-seven CD patients were included,of which,16 were males,and 11 were females,with median disease duration of 3.00 years.After treatment with UST,the median CDAI score decreased from 213.00(178.83,302.98)at baseline to 129.83(89.67,151.33)at week 16/20 and 95.07(67.45,178.34)at week 32(all P<0.017).The clinical response rate and remission rate at week 16/20 were 92.6%and 70.4%,respectively,and those at week 32 were 95.5%and 72.7%,respectively.When patients were stratified as biologic na?ve and exposure,or as with and without dose optimization,no significant differences were found in clinical response and remission rates among various subgroups.Seventeen patients reviewed endoscopy at week 16/20,the SES-CD decreased significantly from baseline(5.47±4.53 vs.9.88±4.58,P<0.05),with the endoscopic response rate and remission rate of 35.3%and 23.5%,respectively.C-reactive protein decreased significantly from baseline at week 16/20 and week 32 of treatment(all P<0.017),while the platelet count,hemoglobin,albumin and body mass index only showed insignificant improving trends.No serious adverse events were observed during the medication period.Conclusions:UST can improve the clinical symptoms,endoscopic manifestations,and systemic inflammation effectively in CD patients in short-term follow-up,and represents a good safety profile.
