应用 RAND/UCLA 适宜性方法评估生物制剂在克罗恩病治疗中的适宜性。

Appropriateness of Biologics in the Management of Crohn's Disease Using RAND/UCLA Appropriateness Methodology.

机构信息

Division of Gastroenterology, Department of Medicine, Mount Sinai Hospital, University of Toronto Toronto, Ontario, Canada.

Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.

出版信息

Inflamm Bowel Dis. 2019 Jan 10;25(2):328-335. doi: 10.1093/ibd/izy333.

DOI:10.1093/ibd/izy333

PMID:30346529

Abstract

BACKGROUND

3 classes of biologics are now available for the treatment of Crohn's disease. The availability of multiple treatment options has led to questions regarding the appropriateness of each agent for a given patient. We aimed to evaluate physician preferences for the use of specific biologic agents in a variety of Crohn's disease management scenarios using the RAND/UCLA Appropriateness Methodology.

METHODS

A panel consisting of members of the CINERGI group (Canadian IBD Network for Research and Growth in Quality Improvement) was assembled. A literature review was performed on factors identified as influential upon choice of biologic therapy. Clinical scenarios were developed, and panelists rated the appropriateness of biologic therapy classes in each scenario individually and again during a face-to-face meeting after moderated discussion.

RESULTS

Two hundred eighty-eight modifications of 3 clinical scenarios were rated. Factors that influenced biologic choice included perianal disease, antidrug antibody status, extraintestinal manifestations, consideration of potential pregnancy, and history of serious infection or malignancy. Anti-TNF therapy was considered appropriate in the postoperative patient. Ustekinumab and vedolizumab were considered appropriate in patients without perianal disease over the age of 65 with a history of malignancy or serious infection. The use of anti-TNF therapy was considered inappropriate in some scenarios whereby drug level was adequate and no antidrug antibody (ADA) was detectable.

CONCLUSIONS

We evaluated the appropriateness of the 3 available classes of biologics in a number of scenarios for the treatment of Crohn's disease. History of serious infection and malignancy, particularly in individuals over 65 years, and consideration of future pregnancy were patient-specific variables that impacted treatment decisions. These findings can serve as a guide for providers considering biologic therapy in patients with Crohn's disease.

UNLABELLED

10.1093/ibd/izy333_video1izy333.video15850922807001.

摘要

背景

目前有 3 类生物制剂可用于治疗克罗恩病。由于有多种治疗选择，因此出现了关于每种药物对特定患者是否合适的问题。我们旨在使用 RAND/UCLA 适宜性方法评估医生在各种克罗恩病管理情况下使用特定生物制剂的偏好。

方法

组成了一个由 CINERGI 小组（加拿大 IBD 网络研究和质量改进）成员组成的小组。对影响生物治疗选择的因素进行了文献回顾。制定了临床方案，小组成员单独评估了每种方案中生物治疗类别的适宜性，然后在经过 moderator 讨论的面对面会议上再次评估。

结果

对 3 个临床方案的 288 个修改进行了评估。影响生物选择的因素包括肛周疾病、抗药性抗体状态、肠外表现、潜在妊娠的考虑以及严重感染或恶性肿瘤的病史。在术后患者中，抗 TNF 治疗被认为是合适的。对于没有肛周疾病、65 岁以上且有恶性肿瘤或严重感染病史的患者，认为乌司奴单抗和 vedolizumab 是合适的。在一些情况下，药物水平足够且无法检测到抗药性抗体 (ADA)，使用抗 TNF 治疗被认为是不合适的。