肿瘤坏死因子α拮抗剂和维得利珠单抗治疗炎症性肠病的持久性及影响因素
Long-term treatment persistence and influencing factors of tumor necrosis factor α antagonists and vedolizumab in patients with inflammatory bowel diseases
陈春燕 1丁振东 1吴巧艳 2朱素燕1
作者信息
- 1. 宁波大学附属第一医院药学部,宁波 315010
- 2. 宁波大学附属第一医院消化科,宁波 315010
- 折叠
摘要
目的 评估炎症性肠病(IBD)患者接受肿瘤坏死因子α(TNF-α)拮抗剂或维得利珠单抗治疗的持久性及治疗失败的危险因素.方法 采用回顾性队列研究方法,收集过去8年内在研究中心接受TNF-α拮抗剂或维得利珠单抗治疗的患者资料.采用Kaplan-Meier法计算治疗持续时间,并使用log-rank检验法进行比较.采用多因素Cox回归分析,探讨治疗失败的危险因素.结果 本研究共纳入210例患者(168例使用TNF-α拮抗剂,42例使用维得利珠单抗),中位治疗时间为3.2年[35(29,50)个月],近一半患者在5年内退出治疗.40岁以上患者的治疗持续时间显著低于年轻患者[<40岁:39(31,62)个月;≥40岁:25(20,50)个月;P=0.013].生物制剂起始治疗时,基线红细胞沉降率(ESR)<25 mm·h-1的患者的治疗持续时间要长于基线ESR ≥ 25 mm·h-1的患者(P=0.06).100例终止治疗的患者中,治疗失败患者占56%,疾病缓解患者占18%,因药物不良反应而终止治疗患者占17%.生物制剂起始治疗时的C-反应蛋白水平被确定为TNF-α拮抗剂治疗失败的独立预测因素(HR:1.03,95%CI:1.01~1.04,P=0.009).结论 IBD患者接受生物制剂治疗的长期持久性有限,终止治疗的主要原因是治疗失败、疾病缓解和药物不良反应.
Abstract
AIM To assess the durability of treatment and risk factors for treatment failure in the patients with inflammatory bowel diseases(IBD)receiving tumor necrosis factor α antagonist(anti-TNF)or vedolizumab(VDZ)therapy.METHODS Single-centre,retrospective study from a register including patients who received anti-TNF or VDZ therapy in the last 8 years at the study centre.The Kaplan-Meier method was used to calculate the treatment persistence,and the log-rank method was used for comparison.With multivariable Cox regression analysis,risk factors for treatment failure were investigated.RESULTS Among the 210 patients included,168 received anti-TNF and 42 received VDZ.Median(95%confidence interval)treatment persistence in the total cohort was 3.2 years(35(29,50)months),and nearly half of patients withdrew from treatment within 5 years.The time duration was strikingly decreased in patients who were older than 40 years compared to younger patients(<40 years:39(31,62)months,≥ 40 years:25(20,50)months,P=0.013).Patients with low erythrocyte sedimentation rate(ESR)concentrations(<25 mm·h-1)at biologics initiation were treated longer than with a high concentration(≥ 25 mm·h-1)(P=0.06).Among the 100 patients who withdrew from therapy,treatment failure was the condition for 56%,disease remission was the condition for 18%,and adverse drug reactions were the condition for 17%to withdrawal from therapy.C-reactive protein level at biologics initiation was identified as the independent predictor for treatment failure in anti-TNF therapy(HR:1.03,95%CI:1.01-1.04,P=0.009).CONCLUSION Long-term treatment persistence of biologics therapy was limited in patients with IBD,primarily due to treatment failure,remission and adverse drug reactions.
关键词
肿瘤坏死因子α拮抗剂/维得利珠单抗/炎症性肠病/治疗持久性Key words
tumor necrosis factor a antagonist/vedolizumab/inflammatory bowel diseases/treatment persistence引用本文复制引用
基金项目
浙江省医药卫生科技计划项目(2023RC259)
宁波市自然科学基金(2023J166)
出版年
2024