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Observational Study
. 2022 Mar;10(2):190-197.
doi: 10.1002/ueg2.12206. Epub 2022 Mar 1.

Predictive value of Milan ultrasound criteria in ulcerative colitis: A prospective observational cohort study

Mariangela Allocca  1 , Cecilia Dell'Avalle  2 , Vincenzo Craviotto  3 , Federica Furfaro  3 , Alessandra Zilli  1 , Ferdinando D'Amico  1   2 , Stefanos Bonovas  2   3 , Laurent Peyrin-Biroulet  4 , Gionata Fiorino  1 , Silvio Danese  1
Affiliations
Observational Study

Predictive value of Milan ultrasound criteria in ulcerative colitis: A prospective observational cohort study

Mariangela Allocca et al. United European Gastroenterol J. 2022 Mar.

Abstract

Background: Endoscopic healing is an established treatment target for ulcerative colitis (UC). We have recently validated the Milan ultrasound criteria (MUC) to assess endoscopic activity in UC; a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity (Mayo endoscopic subscore > 1).

Objective: The aim of this study was to assess the predictive value of MUC on disease course in a prospective cohort of UC patients.

Methods: UC patients regardless of disease activity and current therapy, underwent colonoscopy and bowel ultrasound (US) at baseline in a blinded fashion. Correlations between baseline MUC and Mayo endoscopic subscore were assessed using Spearman's rank correlation. UC-related negative course (defined as the need for corticosteroids, or treatment escalation, or hospitalization, or need for colectomy: a composite outcome) over a median 20 months follow-up, was investigated using the Kaplan-Meier method and Cox regression analysis.

Results: 98 UC patients were followed up for a median time of 1.6 years (IQR 0.9¬2.7). Milan ultrasound criteria and Mayo endoscopic subscore significantly correlated at baseline (ρ = 0.653; p < 0.001). 70 patients (71%) had negative disease course during the follow-up period. Milan ultrasound criteria > 6.2 at baseline was statistically significantly associated with negative disease course (HR: 3.87, 95% CI: 2.25-6.64, p < 0.001). Kaplan-Meier analyses drawed a statistically significantly lower cumulative probability of treatment escalation, need of corticosteroids, hospitalization and colectomy, among patients who had MUC ≤ 6.2 at baseline as compared to patients with MUC > 6.2 (p < 0.05 for all outcomes).

Conclusion: we have demonstrated for the first time the value of bowel US and an US score in predicting disease course in UC. Milan ultrasound criteria, a validated US-based score, predicts disease course in UC. Milan ultrasound criteria ≤ 6.2 may be the new treatment target to achieve to reduce the risk of worse outcomes.

Keywords: Milan ultrasound criteria; inflammatory bowel disease; outcomes; predictive value; ulcerative colitis; ultrasound.

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Conflict of interest statement

Mariangela Allocca received consulting fees from Nikkiso Europe, Mundipharma, Janssen, Abbvie, Ferring and Pfizer; Federica Furfaro received consulting fees form Amgen, Abbvie and lecture fees from Janssen and Pfizer; LP‐B reports personal fees from Merck, Abbvie, Janssen, Genentech, Mitsubishi, Ferring, Norgine, Tillots, Vifor, Hospira/Pfizer, Celltrion, Takeda, Biogaran, Boerhinger‐Ingelheim, Lilly, HAC‐Pharma, Index Pharmaceuticals, Amgen, Sandoz, Forward Pharma GmbH, Celgene, Biogen, Lycera, and Samsung Biosepsis; Gionata Fiorino received consultancy fees from Ferring, MSD, AbbVie, Takeda, Janssen, Amgen, Sandoz, Samsung Bioepis, Celltrion; Silvio Danese served as a speaker, consultant and advisory board member for Schering‐Plough, Abbott (AbbVie) Laboratories, Merck, UCB Pharma, Ferring, Cellerix, Millenium Takeda, Nycomed, Pharmacosmos, Actelion, Alfa Wasserman, Genentech, Grunenthal, Pfizer, AstraZeneca, Novo Nordisk, Cosmo Pharmaceuticals, Vifor and Johnson and Johnson. Cecilia Dell’Avalle, Vincenzo Craviotto, Alessandra Zilli, Ferdinando D’Amico and Stefanos Bonovas have no conflicts of interest to declare.

Figures

FIGURE 1
FIGURE 1
Kaplan–Meier curves for the cumulative probability of negative course in patients with Milan ultrasound criteria (MUC) ≤ 6.2 at baseline (solid line) or MUC > 6.2 at baseline (dotted line) (log‐rank test, p < 0.001)
FIGURE 2
FIGURE 2
(a) Kaplan–Meier curves for the cumulative probability of treatment escalation in patients with Milan ultrasound criteria (MUC) ≤ 6.2 at baseline (solid line) or MUC > 6.2 at baseline (dotted line) (log‐rank test, p < 0.001). (b) Kaplan–Meier curves for the cumulative probability of need of corticosteroids in patients with MUC ≤ 6.2 at baseline (solid line) or MUC > 6.2 at baseline (dotted line) (log‐rank test, p = 0.008). (c) Kaplan–Meier curves for the cumulative probability of hospitalization in patients with MUC ≤ 6.2 at baseline (solid line) or MUC > 6.2 at baseline (dotted line) (log‐rank test, p = 0.045). (d) Kaplan–Meier curves for the cumulative probability of colectomy in patients with MUC ≤ 6.2 at baseline (solid line) or MUC > 6.2 at baseline (dotted line) (log‐rank test, p = 0.019)
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