The real-world efficacy and safety of vedolizumab in the treatment of active Crohn′s disease: a single center retrospective study
10.3760/cma.j.cn101480-20220110-00009
- VernacularTitle:单中心回顾性研究维得利珠单克隆抗体治疗活动期克罗恩病的真实世界疗效及安全性
- Author:
Jian TANG
1
;
Jun DENG
;
Zicheng HUANG
;
Zhaopeng HUANG
;
Huili GUO
;
Na DIAO
;
Hongsheng YANG
;
Kang CHAO
;
Qin GUO
;
Pinjin HU
;
Xiang GAO
Author Information
1. 中山大学附属第六医院消化内科，广州 510655
- Publication Type:Journal Article
- Keywords:
Crohn′s disease;
Active period;
Vedolizumab;
Real-world;
Efficacy;
Safety
- From:
Chinese Journal of Inflammatory Bowel Diseases
2022;06(3):217-222
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of vedolizumab (VDZ) in the treatment of active Crohn′s disease (CD) .Methods:A retrospective cohort study was conducted. Clinical data of 45 patients with active CD at the Sixth Affiliated Hospital of Sun Yat-sen University from November 2020 to May 2022 were analyzed. All of the patients received VDZ at the dose of 300 mg per time at 0, 2th, 6th weeks and subsequently once every 8 weeks. The clinical response and remission were evaluated by Crohn′s disease activity index (CDAI) . The endoscopic response and remission were evaluated by simple endoscopic score for Crohn′s disease (SES-CD) . All of the adverse effects occurred during the treatment of VDZ were recorded in order to evaluate the safety. The primary endpoint was the clinical remission rate at 22 weeks after treatment. The secondary endpoints included the clinical response rate at 22 weeks after treatment, the clinical response rate and clinical remission rate at 52 weeks after treatment, the endoscopic response rate and remission rate at (22 ± 8) weeks after treatment. Thirty-one patients who had previously used infliximab (IFX) and adalimumab (ADA) were set as non-Bio-Na?ve group, and 14 patients who had not previously used biologics were set as Bio-Na?ve group. The differences of the primary endpoint and some secondary endpoints between the two groups were compared.Results:At 22 weeks after treatment, the CDAI score of 45 patients decreased from baseline (261.4 ± 98.3) points to (166.6 ± 93.5) points, the difference was statistically significant ( t = 4.6, P<0.01) . Among them, 64.4% (29/45) patients achieved clinical response and 46.7% (21/45) patients achieved clinical remission. There were no significant difference in clinical response rate [71.4% (10/14) vs. 61.3% (19/31) , χ 2 = 0.4, P = 0.4] and clinical remission rate [42.9% (6/14) vs. 48.4% (15/31) , χ 2 = 0.1, P = 0.8] between the Bio-Na?ve group and non-Bio-Na?ve group at 22 weeks after treatment. At 52 weeks after treatment, the CDAI score of 33 patients decreased from baseline (306.9 ± 130.7) points to (126.6 ± 92.7) points, the difference was statistically significant ( t = 8.5, P<0.01) . Among them, 39.4% (13/33) of the patients achieved clinical response, 33.3% (11/33) of the patients achieved clinical remission, but 41.4% (12/29) of the patients had secondary loss of response. At (22 ± 8) weeks after treatment, the SES-CD score of 25 patients in active phase under endoscopy at baseline decreased from baseline 13.0 (7.0, 19.0) points to 8.0 (2.5, 18.5) points, the difference was statistically significant ( Z = -2.6, P<0.05) . Among them, 40.0% (10/25) patients achieved endoscopic response and 20.0% (5/25) patients achieved endoscopic remission. The new facial rash occurred in 1 patient (2.2%) , new joint pain in 2 (4.4%) and there was no new active tuberculosis and hepatitis B virus infection during the treatment of VDZ for 45 patients. Conclusions:Single drug of VDZ has a good effect on inducing remission in patients with mild to moderate CD and has a good safety. The previous use of IFX or ADA does not affect the efficacy of VDZ, but part of patients still have secondary loss of response.
