Assessment, endoscopy, and treatment in patients with acute severe ulcerative colitis during the COVID-19 pandemic (PROTECT-ASUC): a multicentre, observational, case-control study

PROTECT-ASUC Study Group

doi:10.1016/S2468-1253(21)00016-9

Original language	English
Pages (from-to)	271-281
Number of pages	11
Journal	The Lancet Gastroenterology and Hepatology
Volume	6
Issue number	4
DOIs	https://doi.org/10.1016/S2468-1253(21)00016-9
Accepted/In press	2021
Published	Apr 2021
Additional links	Link to publication in Scopus

Bibliographical note

Funding Information: We thank the clinical and research teams at the participating sites for identification of patients, data collection, and data entry. UK gastroenterology trainees and trainee networks (MaGNET—Mersey Gastroenterology Network, GLINT—Gastro London Investigative Network for Trainees, WMRIG—West Midlands Research In Gastroenterology, GasTRIN NoW—Gastroenterology Trainee Research and Improvement Network North-West, OxYGEN—The Oxford and Thames Valley Young Gastroenterologists Network, and TReNDD NI—Trainee Research Network in Digestive Diseases Northern Ireland) were integral in data collection for this study. CAL acknowledges support from the National Institute for Health Research Newcastle Biomedical Research Centre. We appreciate support from Crohn's & Colitis UK and the British Society of Gastroenterology for promotion of this study. Funding Information: We thank the clinical and research teams at the participating sites for identification of patients, data collection, and data entry. UK gastroenterology trainees and trainee networks (MaGNET?Mersey Gastroenterology Network, GLINT?Gastro London Investigative Network for Trainees, WMRIG?West Midlands Research In Gastroenterology, GasTRIN NoW?Gastroenterology Trainee Research and Improvement Network North-West, OxYGEN?The Oxford and Thames Valley Young Gastroenterologists Network, and TReNDD NI?Trainee Research Network in Digestive Diseases Northern Ireland) were integral in data collection for this study. CAL acknowledges support from the National Institute for Health Research Newcastle Biomedical Research Centre. We appreciate support from Crohn's & Colitis UK and the British Society of Gastroenterology for promotion of this study. Funding Information: SSe reports grants from Biogen, Takeda, AbbVie, Tillotts Pharma, Ferring, and Biohit, advisory board fees from Takeda, AbbVie, Pharmacocosmos, Ferring, Falk Pharma, Cellgene, Tillots Pharma, Biohit, and Janssen, and personal speaker fees from AbbVie, Biogen, Janssen, Merck, Tillotts, and Falk Pharma, outside the submitted work. GJW reports personal fees from AbbVie, Falk, Janssen, and Norgine, during the conduct of the study. NAK reports personal fees from Dr Falk, Janssen, Takeda, and Tillots and grants and personal fees from Pharmacosmos, outside the submitted work. KVP reports personal fees and non-financial support from Janssen, AbbVie, Takeda, and Dr Falk and non-financial support from Ferring, outside the submitted work. SSu reports personal fees from Celltrion, Janssen, Takeda, Vifor Pharma, and Boehringer-Ingelheim, outside the submitted work. AJK reports personal fees from Pfizer, Celgene-BMS, Tillotts, and Janssen and personal fees and non-financial support from Dr Falk and Takeda, outside the submitted work. MJB reports grants from Vifor International and Tillotts Pharma, travel costs and meeting expenses from Tillotts Pharma, and personal fees from Vifor International, outside the submitted work. CAL reports grants from Genentech, AbbVie, Eli Lilly, Pfizer, Roche, UCB Biopharma, Sanofi Aventis, Biogen IDEC, Orion OYJ, and AstraZeneca, grants and personal fees from Janssen and Takeda, and personal fees from Ferring and Dr Falk Pharma, outside the submitted work. All other authors report no competing interests. Publisher Copyright: © 2021 Elsevier Ltd Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

Abstract

Background: There is a paucity of evidence to support safe and effective management of patients with acute severe ulcerative colitis during the COVID-19 pandemic. We sought to identify alterations to established conventional evidence-based management of acute severe ulcerative colitis during the early COVID-19 pandemic, the effect on outcomes, and any associations with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and severe COVID-19 outcomes. Methods: The PROTECT-ASUC study was a multicentre, observational, case-control study in 60 acute secondary care hospitals throughout the UK. We included adults (≥18 years) with either ulcerative colitis or inflammatory bowel disease unclassified, who presented with acute severe ulcerative colitis and fulfilled the Truelove and Witts criteria. Cases and controls were identified as either admitted or managed in emergency ambulatory care settings between March 1, 2020, and June 30, 2020 (COVID-19 pandemic period cohort), or between Jan 1, 2019, and June 30, 2019 (historical control cohort), respectively. The primary outcome was the proportion of patients with acute severe ulcerative colitis receiving rescue therapy (including primary induction) or colectomy. The study is registered with ClinicalTrials.gov, NCT04411784. Findings: We included 782 patients (398 in the pandemic period cohort and 384 in the historical control cohort) who met the Truelove and Witts criteria for acute severe ulcerative colitis. The proportion of patients receiving rescue therapy (including primary induction) or surgery was higher during the pandemic period than in the historical period (217 [55%] of 393 patients vs 159 [42%] of 380 patients; p=0·00024) and the time to rescue therapy was shorter in the pandemic cohort than in the historical cohort (p=0·0026). This difference was driven by a greater use of rescue and primary induction therapies with biologicals, ciclosporin, or tofacitinib in the COVID-19 pandemic period cohort than in the historical control period cohort (177 [46%] of 387 patients in the COVID-19 cohort vs 134 [36%] of 373 patients in the historical cohort; p=0·0064). During the pandemic, more patients received ambulatory (outpatient) intravenous steroids (51 [13%] of 385 patients vs 19 [5%] of 360 patients; p=0·00023). Fewer patients received thiopurines (29 [7%] of 398 patients vs 46 [12%] of 384; p=0·029) and 5-aminosalicylic acids (67 [17%] of 398 patients vs 98 [26%] of 384; p=0·0037) during the pandemic than in the historical control period. Colectomy rates were similar between the pandemic and historical control groups (64 [16%] of 389 vs 50 [13%] of 375; p=0·26); however, laparoscopic surgery was less frequently performed during the pandemic period (34 [53%] of 64] vs 38 [76%] of 50; p=0·018). Five (2%) of 253 patients tested positive for SARS-CoV-2 during hospital treatment. Two (2%) of 103 patients re-tested for SARS-CoV-2 during the 3-month follow-up were positive 5 days and 12 days, respectively, after discharge from index admission. Both recovered without serious outcomes. Interpretation: The COVID-19 pandemic altered practice patterns of gastroenterologists and colorectal surgeons in the management of acute severe ulcerative colitis but was associated with similar outcomes to a historical cohort. Despite continued use of high-dose corticosteroids and biologicals, the incidence of COVID-19 within 3 months was low and not associated with adverse COVID-19 outcomes. Funding: None.

King's College London

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