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. 2022 Aug 2;4(3):otac030.
doi: 10.1093/crocol/otac030. eCollection 2022 Jul.

Treatment Patterns and Standardized Outcome Assessments Among Patients With Inflammatory Conditions of the Pouch in a Prospective Multicenter Registry

Edward L Barnes  1   2 , Parakkal Deepak  3 , Poonam Beniwal-Patel  4 , Laura Raffals  5 , Maia Kayal  6 , Marla Dubinsky  7 , Shannon Chang  8 , Peter D R Higgins  9 , Jennifer I Barr  2 , Joseph Galanko  2 , Yue Jiang  10 , Raymond K Cross  11 , Millie D Long  1   2 , Hans H Herfarth  1   2
Affiliations

Treatment Patterns and Standardized Outcome Assessments Among Patients With Inflammatory Conditions of the Pouch in a Prospective Multicenter Registry

Edward L Barnes et al. Crohns Colitis 360. .

Abstract

Background: 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.

Methods: 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.

Results: 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 (P < .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.

Conclusions: 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.

Keywords: Crohn’s disease of the pouch; ileal pouch-anal anastomosis; pouchitis; real-world effectiveness.

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Figures

Graphical Abstract
Graphical Abstract
FIGURE 1.
FIGURE 1.
Comparison of proportion of patients with Crohn’s disease of the pouch in clinical remission at 6 months after enrollment, stratified by disease activity at enrollment (remission vs active disease) and initial therapy. Abbreviation: anti-TNF, anti-tumor necrosis factor alpha. Only those patients with available data at 6 months presented.
See this image and copyright information in PMC

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