Analysis on the occurrence and influencing factors of adverse drug reactions during long-term therapy with vedolizumab in patients with inflammatory bowel diseases
10.3760/cma.j.cn114015-20240711-00558
- VernacularTitle:炎症性肠病患者长期应用维得利珠单抗的不良反应发生情况及影响因素分析
- Author:
Dong XIE
1
;
Xiaocang CAO
;
Hengjie YUAN
;
Zhengxiang LI
Author Information
1. 天津医科大学总医院药剂科，天津 300052
- Publication Type:Journal Article
- Keywords:
Inflammatory bowel diseases;
Colitis, ulcerative;
Crohn disease;
Risk factors;
Adverse drug reactions;
Vedolizumab
- From:
Adverse Drug Reactions Journal
2025;27(4):193-199
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the occurrence and influencing factors of adverse reactions in patients with inflammatory bowel disease (IBD) during the long-term treatment with vedolizumab (VDZ).Methods:The study was a retrospective observational design. The study subjects were selected from patients who long-termly used VDZ to treat moderate-to-severe active IBD in Tianjin Medical University General Hospital from February 1, 2021 to December 31, 2023. Clinical data of patients were collected through the hospital system of clinical pharmacy management, including general information, IBD condition, VDZ maintenance treatment plan, combination of drugs, laboratory test results, etc. The adverse reactions of VDZ were screened and their clinical manifestations, severity, intervention and outcomes were analyzed descriptively. The patients were divided into 2 groups according to whether VDZ adverse reactions occurred, and the differences in clinical data between them were compared; the influencing factors of adverse reactions were analyzed by multivariate logistic regression method.Results:A total of 142 patients were included in the study, including 81 males and 61 females, aged (37.6±6.4) years with a range from 18 to 57 years. There were 103 patients (72.5%) developed VDZ adverse reactions, which mainly involved skin (52 patients, account for 50.5%), digestive system (33 patients, account for 32.0%) and respiratory system (18 patients, account for 17.5%). All 103 patients did not stop VDZ treatment, and the adverse reaction symptoms disappeared or were relieved after symptomatic treatments. Compared with patients without VDZ adverse reactions, the age of patients with VDZ adverse reactions were higher [(39.5±5.4) years vs. (32.4±6.7) years], and the proportions of patients with chronic relapsing clinical type [65.0%(67/103) vs. 41.0%(16/39)], severe disease activity [60.2%(62/103) vs. 33.3%(13/39)], combined drug use [67.0%(69/103) vs. 46.2%(18/39)], and injecting VDZ once every 4 weeks during maintenance treatment [27.2%(28/103) vs. 10.3%(4/39)] in the group were larger, with statistical significance (all P<0.05). Multivariate logistic regression analysis showed that the chronic relapsing clinical type [odds ratio ( OR)=1.012, 95% confidence interval ( CI): 1.001-1.028, P=0.002], severe disease activity ( OR=1.096, 95% CI: 1.010-1.158, P=0.040), combination drugs ( OR=1.035, 95% CI: 1.003-1.122, P=0.041), VDZ maintenance therapy injection interval of 4 weeks ( OR=1.014, 95% CI: 1.002-1.113, P=0.005) were the risk factors for VDZ adverse reactions. Conclusions:Among IBD patients receiving long-term treatment of VDZ, the incidence of adverse reactions of VDZ was 72.5%, mainly involving skin, digestive system and respiratory system. Symptomatic treatments could be given, and the prognosis was good. Patients with chronic relapsing clinical type, severe disease activity, combination therapy, and shorter VDZ maintenance injection interval were at higher risk of adverse reactions.
