生物制剂在老年炎症性肠病患者中的疗效、安全性和药物可持续性:一项回顾性研究。
Effectiveness, safety, and drug sustainability of biologics in elderly patients with inflammatory bowel disease: A retrospective study.
机构信息
Division of Gastroenterology, IBD Center, McGill University Health Center, Montreal H3G 1A4, Quebec, Canada.
School of Medicine, Graduate Course Sciences in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul, Porto Alegre 90000-000, Brazil.
出版信息
World J Gastroenterol. 2022 Sep 7;28(33):4823-4833. doi: 10.3748/wjg.v28.i33.4823.
BACKGROUND
Biologic therapy resulted in a significant positive impact on the management of inflammatory bowel disease (IBD) however data on the efficacy and side effects of these therapies in the elderly is scant.
AIM
To evaluate retrospectively the drug sustainability, effectiveness, and safety of the biologic therapies in the elderly IBD population.
METHODS
Consecutive elderly (≥ 60 years old) IBD patients, treated with biologics [infliximab (IFX), adalimumab (ADAL), vedolizumab (VDZ), ustekinumab (UST)] followed at the McGill University Inflammatory Bowel Diseases Center were included between January 2000 and 2020. Efficacy was measured by clinical scores at 3, 6-9 and 12-18 mo after initiation of the biologic therapy. Patients completing induction therapy were included. Adverse events (AEs) or serious AE were collected during and within three months of stopping of the biologic therapy.
RESULTS
We identified a total of 147 elderly patients with IBD treated with biologicals during the study period, including 109 with Crohn's disease and 38 with ulcerative colitis. Patients received the following biologicals: IFX (28.5%), ADAL (38.7%), VDZ (15.6%), UST (17%). The mean duration of biologic treatment was 157.5 (SD = 148) wk. Parallel steroid therapy was given in 34% at baseline, 19% at 3 mo, 16.3% at 6-9 mo and 6.5% at 12-18 mo. The remission rates at 3, 6-9 and 12-18 mo were not significantly different among biological therapies. Kaplan-Meyer analysis did not show statistical difference for drug sustainability ( = 0.195), time to adverse event ( = 0.158) or infection rates ( = 0.973) between the four biologics studied. The most common AEs that led to drug discontinuation were loss of response, infusion/injection reaction and infection.
CONCLUSION
Current biologics were not different regarding drug sustainability, effectiveness, and safety in the elderly IBD population. Therefore, we are not able to suggest a preferred sequencing order among biologicals.
背景
生物疗法对炎症性肠病(IBD)的治疗产生了显著的积极影响,但关于这些疗法在老年人中的疗效和副作用的数据却很少。
目的
回顾性评估生物疗法在老年 IBD 人群中的药物可持续性、疗效和安全性。
方法
纳入 2000 年 1 月至 2020 年期间在麦吉尔大学炎症性肠病中心接受生物制剂(英夫利昔单抗(IFX)、阿达木单抗(ADAL)、维得利珠单抗(VDZ)、乌司奴单抗(UST))治疗的连续老年(≥60 岁)IBD 患者。在开始生物治疗后 3、6-9 和 12-18 个月,通过临床评分来衡量疗效。完成诱导治疗的患者被纳入研究。在停止生物治疗期间和停药后三个月内收集不良事件(AE)或严重 AE。
结果
在研究期间,我们共确定了 147 例接受生物制剂治疗的老年 IBD 患者,其中 109 例为克罗恩病患者,38 例为溃疡性结肠炎患者。患者接受了以下生物制剂:IFX(28.5%)、ADAL(38.7%)、VDZ(15.6%)、UST(17%)。生物治疗的平均持续时间为 157.5(SD=148)周。基线时有 34%的患者同时接受皮质类固醇治疗,3 个月时为 19%,6-9 个月时为 16.3%,12-18 个月时为 6.5%。在 3、6-9 和 12-18 个月时,不同生物制剂的缓解率无显著差异。通过 Kaplan-Meier 分析,在药物可持续性(=0.195)、不良反应时间(=0.158)或感染率(=0.973)方面,四种研究生物制剂之间无统计学差异。导致药物停药的最常见 AE 是无应答、输注/注射反应和感染。
结论
在老年 IBD 人群中,目前的生物制剂在药物可持续性、疗效和安全性方面没有差异。因此,我们无法在生物制剂中建议首选的排序顺序。