Barnes Edward L, Deepak Parakkal, Beniwal-Patel Poonam, Raffals Laura, Kayal Maia, Dubinsky Marla, Chang Shannon, Higgins Peter D R, Barr Jennifer I, Galanko Joseph, Jiang Yue, Cross Raymond K, Long Millie D, Herfarth Hans H
Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, USA.
Center for Gastrointestinal Biology and Disease, University of North Carolina, Chapel Hill, North Carolina, USA.
Crohns Colitis 360. 2022 Aug 2;4(3):otac030. doi: 10.1093/crocol/otac030. eCollection 2022 Jul.
Much of our understanding about the natural history of pouch-related disorders has been generated from selected populations. We designed a geographically diverse, prospective registry to study the disease course among patients with 1 of 4 inflammatory conditions of the pouch. The primary objectives in this study were to demonstrate the feasibility of a prospective pouch registry and to evaluate the predominant treatment patterns for pouch-related disorders.
We used standardized diagnostic criteria to prospectively enroll patients with acute pouchitis, chronic antibiotic-dependent pouchitis (CADP), chronic antibiotic refractory pouchitis (CARP), or Crohn's disease (CD) of the pouch. We obtained detailed clinical and demographic data at the time of enrollment, along with patient-reported outcome (PRO) measures.
We enrolled 318 patients (10% acute pouchitis, 27% CADP, 12% CARP, and 51% CD of the pouch). Among all patients, 55% were on a biologic or small molecule therapy. Patients with CD of the pouch were more likely to use several classes of therapy ( < .001). Among patients with active disease at the time of enrollment, 23% with CARP and 40% with CD of the pouch were in clinical remission at 6 months after enrollment.
In a population where most patients had refractory inflammatory conditions of the pouch, we established a framework to evaluate PROs and clinical effectiveness. This infrastructure will be valuable for long-term studies of real-world effectiveness for pouch-related disorders.
我们对储袋相关疾病自然史的大部分了解都来自特定人群。我们设计了一项地域多样的前瞻性登记研究，以研究患有4种储袋炎症性疾病之一的患者的疾病进程。本研究的主要目的是证明前瞻性储袋登记的可行性，并评估储袋相关疾病的主要治疗模式。
我们使用标准化诊断标准前瞻性纳入患有急性储袋炎、慢性抗生素依赖型储袋炎（CADP）、慢性抗生素难治型储袋炎（CARP）或储袋克罗恩病（CD）的患者。我们在入组时获取了详细的临床和人口统计学数据，以及患者报告结局（PRO）指标。
我们纳入了318例患者（10%为急性储袋炎，27%为CADP，12%为CARP，51%为储袋CD）。在所有患者中，55%正在接受生物制剂或小分子治疗。储袋CD患者更有可能使用几类治疗（<0.001）。在入组时患有活动性疾病的患者中，23%的CARP患者和40%的储袋CD患者在入组后6个月达到临床缓解。
在大多数患者患有难治性储袋炎症性疾病的人群中，我们建立了一个评估PRO和临床疗效的框架。该基础设施对于储袋相关疾病真实世界疗效的长期研究将具有重要价值。
