Ambulatory care management of 69 patients with acute severe ulcerative colitis in comparison to 695 inpatients: insights from a multicentre UK cohort study.

Acute severe ulcerative colitis (ASUC) traditionally requires inpatient hospital management for intravenous therapies and/or colectomy. Ambulatory ASUC care has not yet been evaluated in large cohorts. We used data from PROTECT, a UK multicentre observational COVID-19 inflammatory bowel disease study, to report the extent, safety and effectiveness of ASUC ambulatory pathways. Adults (≥18 years old) meeting Truelove and Witts criteria between 1 January 2019-1 June 2019 and 1 March 2020-30 June 2020 were recruited to PROTECT. We used demographic, disease phenotype, treatment outcomes and 3-month follow-up data. Primary outcome was rate of colectomy during the index ASUC episode. Secondary outcomes included corticosteroid response, time to and rate of rescue or primary induction therapy, response to rescue or primary induction therapy, time to colectomy, mortality, duration of inpatient treatment and hospital readmission and colectomy within 3 months of index flare. We compared outcomes in three cohorts: (1) patients treated entirely in inpatient setting; ambulatory patients subdivided into; (2) patients managed as ambulatory from diagnosis and (3) patients hospitalised and subsequently discharged to ambulatory care for continued intravenous steroids. 37% (22/60) participating hospitals used ambulatory pathways. Of 764 eligible patients, 695 (91%) patients received entirely inpatient care, 15 (2%) patients were managed as ambulatory from diagnosis and 54 (7%) patients were discharged to ambulatory pathways. Aside from younger age in patients treated as ambulatory from diagnosis, no significant differences in disease or patient phenotype were observed. The rate of colectomy (15.0% (104/695) vs 13.3% (2/15) vs 13.0% (7/54), respectively, p=0.96) and secondary outcomes were similar among all three cohorts. Stool culture and flexible sigmoidoscopy were less frequently performed in ambulatory cohorts. Forty per cent of patients treated as ambulatory from diagnosis required subsequent hospital admission. In a post hoc analysis of one of the largest ASUC cohorts collected to date, we report an emerging UK ambulatory practice which challenges treatment paradigms. However, our analysis remains underpowered to detect key outcome measures and further studies exploring clinical and cost-effectiveness as well as patient and physician acceptability are needed. NCT04411784.

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Competing interests: SS holds research grants from Biogen, Takeda, AbbVie, Tillotts Pharma, Ferring and Biohit; served on the advisory boards of Takeda, AbbVie, Merck, Ferring, Pharmacocosmos, Warner Chilcott, Janssen, Falk Pharma, Biohit, TriGenix, Celgene and Tillots Pharma; and has received speaker fees from AbbVie, Biogen, AbbVie, Janssen, Merck, Warner Chilcott and Falk Pharma. GW has served as a speaker and/or advisory board member for AbbVie, Falk and Janssen. He has had support to attend meetings from AbbVie, Falk, Janssen and Norgine. His department has received research funding from Tillotts. NAK has served as a speaker and/or advisory board member for Allergan, Falk, Janssen, Mylan, Pharmacosmos, Takeda and Tillotts. He has had support to attend meetings from AbbVie, Falk, Janssen and Norgine. His department has received research funding from AbbVie, Celgene, Celtrion, MSD, Napp, Pfizer, Pharmacosmos and Takeda. SSu has received speaker fees from MSD, Actavis, Abbvie, Dr Falk pharmaceuticals, Shire and received educational grants from MSD, Abbvie, Actavis and is an advisory board member for Celltrion, Dr Falk pharmaceuticals and Vifor pharmaceuticals. CAL has received research support and/or has received fees for delivery of non-promotional education from: Genentech, Janssen, Takeda, Abbvie, Dr Falk, AstraZeneca, Eli Lilly, Orion, Pfizer, Roche, Sanofi Aventis, Ferring, UCB and Biogen. MJBB has received research grants from Vifor International, Pharmacosmos and Tillots Pharma; has received speaker fee from Abbvie and Vifor International; has been an advisory board member for Tillots Pharma, Vifor International; and received travel/conference expenses from Vifor International, Abbvie and Tillots Pharma. AK has served on the advisory boards for Abbvie, Janssen and BMS Celgene and has received speaker fees from Takeda, Pfizer and Janssen; and received travel/conference expenses from Tillotts, Janssen, Abbvie and Shield Therapeutics. KVP has received honoraria for educational meetings and speaker fees from Abbvie, Janssen, Takeda, DrFalk and Ferring. KVP has received Advisory Board fees from Abbvie and Janssen.