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Observational Study
. 2022 Nov;56(10):1460-1474.
doi: 10.1111/apt.17223. Epub 2022 Oct 5.

Treatment adaptations and outcomes of patients experiencing inflammatory bowel disease flares during the early COVID-19 pandemic: the PREPARE-IBD multicentre cohort study

Aamir Saifuddin  1 , Alexandra J Kent  2 , Shameer J Mehta  3 , Lucy C Hicks  4 , Haidee A Gonzalez  5   6 , Jonathan P Segal  4 , Matthew J Brookes  7   8 , Sreedhar Subramanian  9   10 , Neeraj Bhala  11   12 , Thomas E Conley  9 , Kamal V Patel  13 ; PREPARE-IBD Collaborators; Christopher A Lamb  14   15 , Gareth J Walker  16 , Nicholas A Kennedy  17   18 , Shaji Sebastian  5   6
Collaborators, Affiliations
Observational Study

Treatment adaptations and outcomes of patients experiencing inflammatory bowel disease flares during the early COVID-19 pandemic: the PREPARE-IBD multicentre cohort study

Aamir Saifuddin et al. Aliment Pharmacol Ther. 2022 Nov.

Abstract

Background: The COVID-19 pandemic offered a unique opportunity to understand inflammatory bowel disease (IBD) management during unexpected disruption. This could help to guide practice overall.

Aims: To compare prescribing behaviour for IBD flares and outcomes during the early pandemic with pre-pandemic findings METHODS: We performed an observational cohort study comprising patients who contacted IBD teams for symptomatic flares between March and June 2020 in 60 National Health Service trusts in the United Kingdom. Data were compared with a pre-pandemic cohort after propensity-matching for age and physician global assessment of disease activity.

Results: We included 1864 patients in each of the pandemic and pre-pandemic cohorts. The principal findings were reduced systemic corticosteroid prescription during the pandemic in Crohn's disease (prednisolone: pandemic 26.5% vs. 37.1%; p < 0.001) and ulcerative colitis (UC) (prednisolone: pandemic 33.5% vs. 40.7%, p < 0.001), with increases in poorly bioavailable oral corticosteroids in Crohn's (pandemic 15.6% vs. 6.8%; p < 0.001) and UC (pandemic 11.8% vs. 5.2%; p < 0.001). Ustekinumab (Crohn's and UC) and vedolizumab (UC) treatment also significantly increased. Three-month steroid-free remission in each period was similar in Crohn's (pandemic 28.4% vs. 32.1%; p = 0.17) and UC (pandemic 36.4% vs. 40.2%; p = 0.095). Patients experiencing a flare and suspected COVID-19 were more likely to have moderately-to-severely active disease at 3 months than those with a flare alone.

Conclusions: Despite treatment adaptations during the pandemic, steroid-free outcomes were comparable with pre-pandemic levels, although concurrent flare and suspected COVID-19 caused worse outcomes. These findings have implications for IBD management during future pandemics and for standard practice.

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Conflict of interest statement

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. GJW 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. SrS 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. MJB 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. AJK 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. KP has received honoraria for educational meetings and speaker fees from Abbvie, Janssen, Takeda, DrFalk and Ferring. KP has received Advisory Board fees from Abbvie and Janssen. TEC has received speaker fees from Celltrion. LCH, HAG, SJM, AS have no conflicts of interest to declare.

Figures

FIGURE 1
FIGURE 1
Flow diagram demonstrating the number of patients initially recruited, those remaining after propensity score matching and the final numbers of patients included in each group of analyses. IBD‐U, inflammatory bowel disease‐unclassified.
FIGURE 2
FIGURE 2
(A) Medications used to treat Crohn's disease flares in the pre‐pandemic and pandemic cohorts, following propensity score matching for age and physician global assessment of disease activity. (B) Proportion of patients with a Crohn's disease flare treated with different biologics and IMMs in the pre‐pandemic and pandemic cohorts, following propensity score matching for age and physician global assessment of disease activity. “n” numbers represent the total number of patients in each cohort. 5‐ASA , 5‐aminosalicylate; IMM, immunomodulator; TNF, tumour necrosis factor; ns, not significant.
FIGURE 3
FIGURE 3
(A) Medications used to treat ulcerative colitis or IBD‐U flares in the pre‐pandemic and pandemic cohorts, following propensity score matching for age and physician global assessment of disease activity. (B) Proportion of patients with a Crohn's disease flare treated with different biologics and IMMs in the pre‐pandemic and pandemic cohorts, following propensity score matching for age and physician global assessment of disease activity. “n” numbers represent the total number of patients in each cohort. 5‐ASA, 5‐ aminosalicylate; IBD‐U, inflammatory bowel disease‐unspecified; IMM, immunomodulator; ns, not significant; TNF, tumour necrosis factor.
FIGURE 4
FIGURE 4
Physician global assessment (PGA) of disease activity 3 months post‐flare in ulcerative colitis and Crohn's disease in the pre‐pandemic and pandemic cohorts, which had been propensity matched for age and initial PGA. “n” numbers depict the total number in the group following propensity matching but follow‐up data are not available for all patients. The differences in disease activity between the groups are not statistically significant using Fisher's exact test.
FIGURE 5
FIGURE 5
Clinical outcomes in the Crohn's disease and ulcerative colitis/IBD‐unclassified pre‐pandemic groups following propensity score matching for age and initial physician global assessment for disease activity. None of the comparisons between the disease‐specific pre‐pandemic and pandemic groups were statistically significant using Fisher's exact test. IBD, inflammatory bowel disease.
FIGURE 6
FIGURE 6
Comparison of selected laboratory markers, including CRP, albumin, faecal calprotectin and haemoglobin, between patients suffering an IBD flare, COVID‐19 infection or both, using Kruskal–Wallis test. CRP, C‐reactive protein; IBD, inflammatory bowel disease.
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