Influencing factors of adverse drug reactions in patients with inflammatory bowel disease treated with adalimumab
10.3760/cma.j.cn101721-20240618-00188
- VernacularTitle:炎症性肠病患者阿达木单抗治疗药物不良反应的影响因素
- 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 disease;
Adalimumab;
Adverse drug reactions;
Risk factors
- From:
Clinical Medicine of China
2025;41(2):122-127
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To observe and analyze the adverse drug reactions (ADRs) caused by adalimumab in patients with inflammatory bowel disease (IBD) and its influencing factors.Methods:A retrospective study was conducted on 106 patients with inflammatory bowel disease treated with adalimumab at Tianjin Medical University General Hospital from November 2019 to November 2023. Among them, 31 patients who experienced adverse reactions were included in the ADR group (case group), while 75 patients who did not experience adverse reactions were included in the non-ADR group (control group). Patients' basic information, laboratory tests, adverse drug reactions, etc were collected. Measurement data with normal distribution were expressed as xˉ± s and means between two groups were compared using independent samples t-test. The percentage of count data was calculated, and the rate between groups was compared by χ2 test. The risk factors of adverse drug reactions caused by adalimumab in patients with inflammatory bowel disease were analyzed by single factor screening and multivariable Logistic regression model. Results:ADR occurred in 31 of 106 patients, accounting for 29.25% (31/106), among those patients which infection was the most common,accounting for 18.87%(20/106). The number of combined drugs (≥3 kinds), drug allergy history, drug duration (≥3 months), blood concentration (>12 μg/mL) in ADR group were higher than those in non-ADR group ( χ2-values were 5.90, 5.78, 6.94 and 10.07, respectively,t-values were 8.55 and 0.97 respectively; all P<0.05). Multivariate Logistic regression results showed that the number of combined drugs ≥3, drug allergy history, drug duration >3 months, blood concentration >12 ng/L, creatinine and total bilirubin levels were all risk factors for adverse drug reactions of adalimumab in IBD patients (O R values were 2.680, 2.394, 3.228, 4.415, 3.673 and 4.646, respectively;95% CI:1.563~3.798, 1.434-3.354, 2.070-4.387, 3.803-5.027, 2.364-4.982 and 3.449-5.843, respectively; all P<0.05). Conclusion:The number of combined drugs ≥3, drug allergy history, drug duration >3 months, blood concentration >12 ng/L, creatinine and total bilirubin levels are all risk factors for adverse drug reactions in IBD patients with adalimumab. In clinical practice, it is necessary to strengthen monitoring and take timely preventive measures for IBD patients with the above-mentioned factors, in order to reduce the incidence of ADR.
