Efficacy comparison of anti-tumor necrosis factor-α and anti-interleukin-12/23 biologics as first-line treatment in Crohn′s disease
10.3760/cma.j.cn311367-20241014-00389
- VernacularTitle:抗肿瘤坏死因子-α与抗白细胞介素-12/23生物制剂一线治疗克罗恩病的疗效比较
- Author:
Bingqing YUAN
1
;
Yanjun CHEN
1
;
Ji LIU
1
;
Lanxiang ZHU
1
;
Xueqin PANG
1
;
Weichang CHEN
1
Author Information
1. 苏州大学附属第一医院消化内科，苏州 215006
- Publication Type:Journal Article
- Keywords:
Crohn′s disease;
Anti-tumor necrosis factor-α;
Anti interleukin-12/23;
Efficacy
- From:
Chinese Journal of Digestion
2025;45(6):384-392
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To comparatively evaluate the efficacy of anti-tumor necrosis factor (TNF)-α and anti-interleukin (IL)-12/23 biologics as the first-line treatment in Crohn′s disease (CD).Methods:From January 1, 2016 to December 31, 2024, at the Department of Gastroenterology of the First Affiliated Hospital of Soochow University, the clinical data of patients with CD treated with anti-TNF-α (infliximab or adalimumab) or anti-IL-12/23 biologics (ustekinumab) as first-line treatment were retrospectively collected. All the patients were followed up for 1 year since the initiation of first-line biologic treatment, with the follow-up concluding on December 31, 2024. The primary outcomes were the clinical efficacy (including clinical response rate and clinical remission rate) of anti-TNF-α or anti-IL-12/23 treatment at week 24 and week 48, and the endoscopic efficacy(including endoscopic response rate and endoscopic remission rate) at week 48. The clinical efficacy was assessed based on Crohn′s disease activity index(CDAI). The clinical response was defined as a reduction in CDAI by ≥ 70 from baseline (week 0), and clinical remission was defined as CDAI < 150. The endoscopic efficacy was assessed based on simple endoscopic score for Crohn′s disease (SES-CD), the endoscopic response was defined as a reduction in SES-CD by ≥50% from baseline (week 0), and endoscopic remission was defined as SES-CD ≤2. Chi-square test or Fisher′s exact test was used for statistical analysis.Results:A total of 215 CD patients were enrolled, including 160 males and 55 females, with the age of (31.88±11.55) years old. Among them, 179 patients completed the clinical efficacy evaluation, 110 cases were treated with anti-TNF-α, 69 cases were treated with anti-IL-12/23. The clinical response rates of patients treated with anti-TNF-α and anti-IL-12/23 at week 24 were 95.5%(105/110) and 95.7%(66/69), respectively, and the clinical remission rates at week 24 were 86.4%(95/110) and 85.5%(59/69), respectively; the clinical response rates at week 48 were 95.5%(105/110) and 97.1%(67/69), respectively, and the clinical remission rates at week 48 were 89.1%(98/110) and 88.4%(61/69), respectively; and the differences were not statistically significant(Fisher′s exact test, χ2=0.03, Fisher′s exact test, χ2=0.02; P=1.000, 0.708, 0.872, and 0.887). A total of 76 patients completed endoscopic efficacy evaluation, among which 55 cases were treated with anti-TNF-α, and 21 cases were treated with anti-IL-12/23. The endoscopic response rates of patients treated with anti-TNF-α and anti-IL-12/23 were 74.5%(41/55) and 66.7%(14/21), respectively, and the endoscopic remission rates at week 48 were 49.1%(27/55) and 28.6%(6/21), respectively; and the differences were not statistically significant( χ2=0.47 and 2.60, P=0.492 and 0.107). Conclusion:Both anti-TNF-α and anti-IL-12/23 are effective as first-line biological therapies for CD, and there are no significant differences in both clinical and endoscopic efficacy between these 2 biologics.
