P401 Risk of severe COVID-19 outcomes associated with inflammatory bowel disease medications: Reassuring insights from the United Kingdom PREPARE-IBD multicentre cohort study

Abstract

Background During the early COVID-19 pandemic, the British Society of Gastroenterology (BSG) developed a risk stratification grid to inform the United Kingdom (UK) government regarding strict social isolation, termed “shielding”. This advised inflammatory bowel disease (IBD) patients thought to be most clinically vulnerable to SARS-CoV-2 infection or severe COVID-19 outcomes, to stay at home and minimize face to face contact, even with household members. Those considered at highest risk included recent commencement of combination biologic and immunomodulator therapy, prednisolone ≥20mg/day, presence of comorbidities, age ≥70 years or clinically active disease in those receiving immunosuppression. Mesalazine was not considered to increase risk. An acknowledged limitation was an absence of COVID-19 risk data. This study sought to identify patient or IBD medication-related factors associated with severe outcomes from COVID-19. Methods PREPARE-IBD was a multi-centre observational United Kingdom (UK) cohort study including adult IBD patients (≥18 years) diagnosed with COVID-19 by PCR between 1st March 2020 and 31st August 2020. The primary outcome was severe COVID-19 defined as requirement for intensive care admission, invasive ventilation or death. We tested associations of severe outcomes with medications and other covariates using multiple logistic regression. Results 211 patients were included from 60 UK centres. 56 of 211 patients (26.5%) met the primary outcome. Severe COVID-19 was more common in ulcerative colitis relative to Crohn’s disease patients (33.9% [37/109] vs. 18.6% [16/86], p=0.018). Shortness of breath, nausea and vomiting were more common with severe COVID-19 (p<0.001 and p=0.023 respectively). Multivariable analysis identified co-morbidities and age as associated with severe COVID-19 outcomes; odds ratio (OR [95% CI]) 1.68 (1.23-2.35) for each co-morbidity, and an OR 1.03 (1.00-1.05) with each successive year of age. Neither clinically active IBD (OR 0.58 [0.26-1.26]), non-white ethnicity (OR 1.98 [0.92-4.28]), nor prednisolone use (OR 2.42 [0.47-11.26]) were associated with increased risk. On multivariable analysis, mesalazine was associated with severe COVID-19 outcomes (OR 2.03 [1.01-4.12]). Univariable analysis identified biologics and thiopurines as protective (OR 0.38 [0.15-0.87] and 0.32 [0.092-0.86] respectively). On multivariable analysis no association of severe COVID-19 outcomes with thiopurine or biologic exposure was seen. Conclusion Our data provide reassurance for the continued evidence-based use of corticosteroids, immunomodulators and biologic therapies in IBD during the ongoing COVID-19 pandemic, and is consistent with an as yet unexplained association between mesalazine use and severe COVID-19 outcomes.

Impact of biologics and small molecules for inflammatory bowel disease on COVID‐19‐related hospitalization and mortality: A systematic review and meta‐analysis

“…From the initial 811 studies identified in the search, 18 studies 17–33 met the inclusion criteria (Fig. 1).…”

“…Search results. From the initial 811 studies identified in the search, 18 studies [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] met the inclusion criteria (Fig. 1).…”

“…From the initial 811 studies identified in the search, 18 studies 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 met the inclusion criteria (Fig. 1 ).…”

Risk of adverse outcomes in inflammatory bowel disease patients infected with SARS-CoV-2: a systematic review and meta-analysis

“…Data used in evaluating the association between adverse outcomes and IBD drugs were obtained from the 12 included studies and the SECURE-IBD registry, including 1474 adverse and 7445 mild cases [ 23 , 33 , 41 , 42 , 44 – 47 , 50 – 52 ]. The pooled OR of mesalazine (1.79; 95% CI 1.59–2.02; I 2 = 44%; P = 0.05), corticosteroids (1.66; 95% CI 0.99–2.78; I 2 = 64%; P < 0.01), IMS (1.30; 95% CI 1.10–1.53; I 2 = 45%; P = 0.04), anti-TNF (0.47; 95% CI 0.41–0.53; I 2 = 0%; P = 0.59) are shown in Fig.…”

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

“…17,18 However, data from the SECURE-IBD registry, including 525 patients internationally with IBD and COVID-19 infection, and analyses of 600 patients with rheumatic disease from the Global Rheumatology Alliance registry, suggest that systemic corticosteroids increase the risk of severe COVID. [19][20][21] Our primary finding that 3-month steroidfree outcomes were comparable pre-and mid-pandemic despite the shift towards poorly bioavailable steroid flare induction treatment is therefore important and reassuring. Biologics can then be safely instituted, notwithstanding the potential effect on vaccine efficacy, which may influence the timing of biologic commencement, as we move towards consideration of long-term disease management in the context of COVID-19 risk.…”