Faculty of Medicine, University of Iceland, Reykjavík, Iceland.
Department of Internal Medicine, National University Hospital, Reykjavík, Iceland.
Scand J Gastroenterol. 2021 Jan;56(1):46-52. doi: 10.1080/00365521.2020.1854847. Epub 2020 Dec 5.
Immune-mediated diseases are on the rise after the introduction of powerful immunomodulating drugs. The objective of this study was to determine the population-based incidence rate of inflammatory bowel disease (IBD) among patients treated with the monoclonal antibody rituximab in Iceland and compare it to the baseline incidence rate of IBD in the general population.
We identified all patients treated with rituximab in Iceland from 2001 to 2018 through a central medicine database. IBD cases were indexed from medical records and ICD-10 codes and further confirmed by colonoscopy- and pathology reports. An experienced pathologist compared the pathology of IBD cases with matched controls of IBD patients.
Lymphomas and related neoplasms were the most frequent indication for treatment with rituximab ( = 367) among the 651 patients included in the analysis. Following treatment, seven patients developed IBD: two cases of Crohn's disease, three with ulcerative colitis, and two with indeterminate IBD. The incidence rate of IBD among rituximab treated patients was 202 cases per 100,000 person-years. Comparing our data to IBD incidence in Iceland, rituximab treated patients have an age-adjusted hazard ratio of 6.6 for developing IBD. The risk did not correlate with dose or treatment duration. Prior diagnosis of an autoimmune illness did not increase the risk of IBD in rituximab treated patients.
Patients on rituximab have a sixfold increased risk of developing IBD compared to the general population. This risk was not affected by the indication for treatment and was not associated with concurrent immune-mediated diseases. Summary This population-based retrospective cohort study included all patients receiving treatment with rituximab between 2001 and 2018 in Iceland and identified a sixfold increased risk of developing IBD when compared to the general population.
在引入强效免疫调节药物后，免疫介导性疾病的发病率有所上升。本研究的目的是确定冰岛接受单克隆抗体利妥昔单抗治疗的患者中炎症性肠病（IBD）的人群发病率，并将其与一般人群中 IBD 的基线发病率进行比较。
我们通过中央药物数据库确定了 2001 年至 2018 年期间冰岛所有接受利妥昔单抗治疗的患者。通过病历和 ICD-10 编码索引 IBD 病例，并通过结肠镜和病理报告进一步确认。一位经验丰富的病理学家将 IBD 病例的病理与 IBD 患者的匹配对照进行了比较。
在纳入分析的 651 例患者中，利妥昔单抗治疗的最常见适应证是淋巴瘤和相关肿瘤（367 例）。治疗后，7 例患者发生 IBD：2 例克罗恩病，3 例溃疡性结肠炎，2 例不确定 IBD。接受利妥昔单抗治疗的患者 IBD 发病率为每 100,000 人年 202 例。将我们的数据与冰岛的 IBD 发病率进行比较，接受利妥昔单抗治疗的患者发生 IBD 的年龄调整风险比为 6.6。该风险与剂量或治疗持续时间无关。自身免疫性疾病的既往诊断并未增加接受利妥昔单抗治疗的患者发生 IBD 的风险。
与普通人群相比，接受利妥昔单抗治疗的患者发生 IBD 的风险增加了六倍。这种风险不受治疗适应证的影响，也与同时发生的免疫介导性疾病无关。
这项基于人群的回顾性队列研究包括 2001 年至 2018 年期间在冰岛接受利妥昔单抗治疗的所有患者，并确定与普通人群相比，接受利妥昔单抗治疗的患者发生 IBD 的风险增加了六倍。
