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N01: Does physical activity positively impact fatigue in individuals with Inflammatory Bowel Disease?15th N-ECCO Network Meeting
Year: 2021
Authors: Dawn Farrell
Background

Patients with Inflammatory Bowel Disease (IBD) often experience the problematic and burdensome symptom of fatigue, both during periods of relapse and remission. The optimal management of fatigue in IBD is uncertain, however there is evidence suggesting that physical activity is likely to be a beneficial way of managing the symptom. The aim of this study is to explore the relationship between fatigue and objective measurements of both physical activity metrics and varying intensities of physical activity for individuals with IBD.

Methods

A multi-centred, European, cross-sectional, correlational study was employed. A consecutive sample of 187 patients with Crohn’s disease (59%) or ulcerative colitis (41%) were recruited from six IBD centres in the Republic of Ireland (42%), United Kingdom (40%) and Denmark (18%). Fatigue was measured using the IBD-Fatigue (IBD-F) scale, including both the level of fatigue (IBD-F, Section 1) and impact of fatigue (IBD-F, Section 2). Physical activity was objectively measured using scientifically validated triaxial accelerometers (ActiGraph wGT3X-BT) during seven consecutive days.

Results

A moderate level of fatigue (IBD-F Section 1 Md (IQR) = 10 (6 – 13)), predominantly intermittent in nature (72%) was reported by participants (57.4% female; 59% Crohn’s disease; 43% active disease). Participants self-reported sleeping an average of 8.7 hours over the seven nights. During the week, the intensity of activity was predominantly sedentary (Md 5 days, 22 hours, 20 minutes) or light (Md 19 hours, 35 minutes). The median moderate-to-vigorous intensity of physical activity per day was 32.2 minutes and step count over the week was 47052 steps. There was no evidence of a unique linear or non-linear relationship between each of the objective measurements of physical activity with IBD-related fatigue. This lack of evidence extended separately to patients in remission and to patients with active disease. These findings are in the context of a statistically significant moderately-strong relationship between disease activity (measured using both HBI and SCCAI) and level of fatigue for both patients of Crohn’s disease (rs = .327, p = .001, n = 96) and ulcerative colitis (rs = .353, p = .003, n = 71).

Conclusion

This large multi-centred study shows no association between objective measurements of physical activity and IBD-fatigue. These findings suggest that engaging or not engaging in physical activity has no differential impact on self-assessment of fatigue.

N02: PREVIEW study: Factors associated with willingness to switch from intravenous to subcutaneous formulations of CT-P13 and vedolizumab in patients with Inflammatory Bowel Disease.15th N-ECCO Network Meeting
Year: 2021
Authors: Katrien Asnong
Background

Subcutaneous (SC) formulations were recently approved for CT-P13 and vedolizumab (VED). No insights in the willingness of patients with Inflammatory Bowel Disease (IBD) to switch from intravenous (IV) to SC maintenance therapy with CT-P13 and VED are available. The aims of this study were (1) to evaluate the percentage of patients with IBD in favour of switching to SC formulations, (2) to define the factors influencing this decision, and (3) to explore the role of the IBD nurse in the process of switching.

Methods

This was a monocentric study in patients with IBD on maintenance IV CT-P13 or VED. All patients attending the infusion unit were invited to complete a survey exploring the willingness to switch to SC formulations. Prior to completing the survey, patients were informed on the new SC formulations and the accompanying care pathway. The survey was performed prior to the market introduction of SC CT-P13 and VED. Demographics, patient reported outcomes, willingness to switch and reason for IV vs. SC preferences were captured.

Results

In total, 183 (91%) patients completed the survey (m/f: 84/99; CD/UC/IBD-U: 120/57/6; median age 45 IQR 34-59; remission CD/UC: 67%/75%). The majority of patients preferred switching to SC (56% yes, 12% no, 32% doubt). The main driver to switch was an anticipated decrease in hospital visits (90%); the main reason to continue IV was fear of change (61%). Patients doubting to switch had a lower stool frequency compared with patients making a definite decision (p=0.012). Factors significantly associated with the willingness to switch in the univariate analysis were younger age (p<0.0001), experience with SC therapy (p=0.03), full time work occupancy (p=0.001), younger age at start IV therapy (p=0.001), shorter disease duration (p=0.012), and compliance level (p<0.0001). Multivariate analysis retained younger age as the only independent factor. For patients doubting to switch, an electronic alert (71%), an information brochure (69%), and a personal teaching moment (60%) were recognised as valuable support. An information package should cover patient-focused efficacy and safety data of SC therapy, therapeutic options in case of disease worsening, and practical concerns including information about administrative issues and travelling.

Conclusion

This is the first study exploring the willingness to switch from IV to SC maintenance therapy with CT-P13 and VED in patients with IBD. The majority prefers to switch to a SC formulation, with willingness to switch being most likely in younger patients. Further studies are required to investigate the impact of nurse led interventions on the willingness to switch, patient satisfaction, and treatment compliance.

N03: Information flow experiences during COVID-19 in IBD patients: a prospective observational study15th N-ECCO Network Meeting
Year: 2021
Authors: Els De Dycker
Background

During the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, several patients contacted members of the IBD team with coronavirus disease 2019 (COVID-19) related questions. Some patients intended to cancel scheduled IBD clinic outpatient visits or endoscopic examinations and/or stop or postpone their medication. We surveyed the need for information by IBD patients during the SARS-CoV-2 pandemic and the role of the IBD team in this regard.

Methods

We performed an anonymous survey at the IBD department of our tertiary referral center. The questionnaire contained 15 closed questions, including on basic demographic data, medication use, testing for COVID-19, information sources, and intention to stop or postpone medication or follow-up. The questionnaire was available to all adult patients attending the IBD outpatient clinic and infusion unit from July 1st until October 30th 2020. All questionnaires were collected before the second COVID-19 wave. Patients on subcutaneous medication that did not attend the IBD clinic during these months were contacted via e-mail.

Results

We collected 965 questionnaires. The majority of patients (44.3%) was 18-40 years old. There were more patients with Crohn’s disease (66%) than ulcerative colitis (32%) and IBD unclassified (2%). Demographics and medication use are presented in table 1. A third of the patients (31.7%) was tested for SARS-CoV-2, of whom 8.3% tested positive. Twenty-six percent of patients considered they had higher need for information about COVID-19 than the general population. News websites were a source of information about COVID-19 for 52.5% of patients, followed by hospital websites (43.8%), direct contact with the IBD physician (24.6%), direct contact with the IBD nurse (23.1%), and state sponsored websites (20.9%). In fact, 35.9% of patients contacted the IBD nurse since the start of the pandemic. The majority of patients reported they were satisfied by the information (80.5%) and/or reassured (85%) by the IBD nurse. Ten percent of patients had considered to stop IBD medication due to the pandemic, and 80% of these refrained to do so following the advice of the IBD nurses. Finally, 12.5% of the patients expressed true fear of hospital visits due to the pandemic, which was associated with female gender and higher need for information.

Conclusion

Treatment cessation and anxiety could be avoided by direct interaction with the IBD nurses and in particular with the IBD nurse as first point of contact for the patient. Patients with IBD may profit from an optimized information platform with scientifically correct information addressing the concerns of this specific population.

N04: Being an IBD Clinical Nurse Specialist in the UK National Health Service: Challenges, Stressors and Coping Mechanisms (Tandem Talk)15th N-ECCO Network Meeting
Year: 2021
Authors: Lesley Dibley, Karen Kemp
Background

Inflammatory Bowel Disease Clinical Nurse Specialists (IBD-CNSs) provide essential therapeutic and emotional support services to patients with often complex disease. The ever-increasing role expectations, treatment modalities and rising patient population places significant demands on IBD-CNSs (Stansfield, 2019), many of whom enter the role soon after qualifying. Posts in the UK-based RCN IBD Nurse Facebook© page suggest stress is high amongst members. Sustaining IBD-CNSs wellbeing is essential for ensuring sustainability of services. Our aim was to explore experiences of being an IBD-CNS in the UK, in order to inform the wider dialogue around workforce and the wellbeing of specialist nurses.    

Methods

This hermeneutic phenomenological study used purposive sampling with maximum variation to recruit Band 6-8 IBD-CNSs who currently, or until recently, worked in NHS Trusts across the UK. Data were collected between July and September 2020, via online or telephone interviews. Focussing on personal perceptions, participants were invited to ‘Tell me what it means to be an IBD-CNS’ with follow-up prompts and probes as needed. Diekelmann et al’s (1989) team analysis method was used.  

Results

Twenty-five IBD-CNSs participated [92% Female; Band 6 (n=3), Band 7 (n=10), Band 8 (n=13); 0.5–19 (mean 5.8) years in post; ex-NHS (n=4)]. Two constitutive patterns: 'Giving and receiving support', and 'Developing potential' were revealed, informed by relational themes addressing patients’ needs, service design/delivery challenges, workload, professional development opportunities, and peer support. Junior IBD-CNSs worried more about workload and learning the role, whilst senior nurses often struggled with the shift towards management responsibilities which they were expected to take on often without any managerial skills or training. The IBD-CNS role was often poorly understood by senior service managers, whose level of support varied widely. Some participants had techniques to mitigate against stressors, but there were also limited professional development opportunities especially in senior roles. 

Conclusion

IBD-CNSs are committed to patients, despite an often-burdensome workload. Structural, institutional, and hierarchical issues undermine confidence. Many IBD-CNSs are stressed by mixed messages of delivering an excellent service yet being criticised/under-appreciated by the system. Robust senior support structures lead to better experiences for IBD-CNSs. This work contributes to the UK and global data evidencing the need to pursue strategies which promote wellbeing of all specialist nurses. 

Neuroendocrine proliferations in IBD6th H-ECCO IBD Masterclass
Year: 2021
Authors: Shaun Walsh
Summary content

1. To review the literature concerning neuroendocrine proliferations in IBD

2. To look at some examples of cases of neuroendocrine tumours

3. To discuss neuroendocrine micronests/microcarcinoids

New surgical approaches for perianal diseaseECCO'21 Virtual
Year: 2021
Authors: Paulo Gustavo Kotze
Summary content

Several surgical techniques have been described aiming perianal fistula healing in CD.
In this lecture, we will discuss evidence of the following approaches: advancement flaps, LIFT, anal plug, fibrin glue injection, VAAFS, stem cells, vaccum assisted dressing among others.
There is still no superior technique aiming healing of perianal fistulas in CD.
Treatment should be individualized.

Newer and rarer mimics of IBD histology6th H-ECCO IBD Masterclass
Year: 2021
Authors: Ann Driessen
Summary content

1. Diagnosis of the uncommon mimickers of IBD, which should be morphologically distinguished as treatment is totally different from IBD. The mimickers discussed are infection, drugs, vascular disorders and immune-related disorders.

The characteristic histological features of inflammatory bowel disease are a disturbed crypt architecture, basal plasmocytosis and granulomas. Numerous diseases may clinically as well morphologically mimic IBD. Hence to make a diagnosis of IBD close communication between clinicians and pathologists is essential. Mimics of IBD include SCAD (segmental colitis associated with diverticulitis), diversion colitis, infections, drugs, vascular disorders and immune disorders, of which the latter are less common. In order that the pathologist can make a distinction between these mimics, information about the clinical  history, endoscopy, imaging, microbiology, serology is required. This information as well as subtle histological features may help in this differential diagnostic process. Exclusion of these mimickers is essential as they most commonly require a totally different treatment.

Nonepithelial neoplasia in IBD6th H-ECCO IBD Masterclass
Year: 2021
Authors: Pamela Baldin
Summary content

An increased rate of non epithelial neoplasm in IBD is described. They could be related to inflammation or to immunosuppressive treatment. The increased risk of infection related lymphomas in IBD is debated. Concerning non epithelial neoplasm related to immunosuppressive treatment they are mainly lymphomas, skin tumours and Kaposi’s sarcomas.

The main educational objective is to know and to  be aware about the presence of this rare entities.

Nurses role in surgical pathway - A Tandem talk15th N-ECCO Network Meeting
Year: 2021
Authors: Karen Kemp, Joy Odita
Summary content

1. To understand the role of the IBD nurse in the surgical pathway for patients with IBD
2. To understand the role of the Stoma Care nurse for patients who have stoma formation and pouch surgery
3. Recommendations for care 

Nursing roles in IBD management12th N-ECCO School
Year: 2021
Authors: Ana Ibarra
Summary content

To explore the role and scope of the IBD nurse.
To emphasise the importance of the impact and perspective of IBD in our patients.
To overview the UK IBD standards and how they enhance the provision of quality of care for all patients with IBD.
To provide an overview of the N-ECCO Consensus statements and the different levels in IBD nursing.

Nutritional assessment6th D-ECCO Workshop
Year: 2021
Authors: Emma Halmos
Summary content

Educational objectives:
1) To understand the various definitions of malnutrition and how they related to clinical outcomes
2) To learn the various assessment techniques for determining malnutrition, including body composition analyses
3) To learn the emerging point-of-care assessment techniques that may improve clinical assessment and monitoring of malnutrition

Summary:
Malnutrition is very common in IBD patients, but historically, attention has been mostly placed on undernutrition.  It is becoming evident that overnutrition is increasing amongst the IBD population, with similar negative impacts on clinical outcomes.  This presentation will describe various definitions of malnutrition, including protein energy malnutrition, myopenia, sacropenia, myosteatosis, visceral obesity and micronutrient deficiencies and their relevance in predicting clinical outcomes.  Identification of such forms of malnutrition, such as use of imaging for body composition analyses, BMI, bioimpedance, handgrip devices and ultrasound will also be detailed.  In clinical practice, use of BMI has limited value and does not predict poor outcomes.  Nutritional assessment should encompass both detailed body composition analysis, often through imaging that IBD patients already undergo, and cheap, quick and easily applied point-of-care techniques to assess and monitor myopenia, sarcopenia are visceral adiposity.  

Nutritional assessment in IBD12th N-ECCO School
Year: 2021
Authors: Lihi Godny
Summary content

1. To present and discuss the evidence that malnutrition and its various presentations are important in IBD
2. To present and discuss the various approaches for nutritional screening and assessment in routine clinical practice in patients with IBD
3. To discuss the interaction between IBD nurses and dietitians within the setting of a multidisciplinary team
3. To provide practical recommendations for use by nursing staff in routine clinical practice

Nutritional issues at transition in IBD8th P-ECCO Educational Course
Year: 2021
Authors: Marina Aloi
Summary content

Educational Objectives:
1.To have an overview of growth and pubertal development at transition in IBD 
2.To emphasize the role of food restrictions, adequacy, and beliefs in patients with IBD
3. To have an overview of body perception and eating disorders and IBD

Nutritional management in IBD12th N-ECCO School
Year: 2021
Authors: Catherine Wall
Summary content

1. To provide an overview of some of the nutrition and dietary management options for IBD
2. To highlight the role of the IBD nurse in relation to nutrition and dietary management of IBD

OMG it's OFG: Dietary management of Orofacial Granulomatosis6th D-ECCO Workshop
Year: 2021
Authors: Dearbhaile O'Hanlon
Summary content
  • •       To understand what is orofacial granulomatosis & its association with Crohn’s Disease
  • •       Provide an overview of treatment options
  • •       To explain the background to the Cinnamon, Benzoate free diet (CBFD)
  • •       Provide an overview of how to implement CBFD
  • •       Highlight some of the challenges to doing CBFD

OFG is a rare disease affecting the mouth and oral cavity. It is associated with Crohn’s disease. A significant proportion of people have a positive response to dietary treatment via the cinnamon, benzoate (& chocolate) free diet (CBFD). This talk will give an overview of OFG, its treatment options and dietary management. It will look at the evidence base for CBFD and how the diet show be implemented.

Ongoing Symptoms in patients in remission - How to deal with them?15th N-ECCO Network Meeting
Year: 2021
Authors: Gerhard Rogler
Summary content

1. To understand the frequency and impact of disease symptoms in patients in remission
2. To review the impact on the quality of life
3. To discuss causes for GI symptoms and extra intestinal symptoms in IBD patients in remission
4. To provide a rational clinical approach to such symptoms.

OP01: Comparison of fecal transplantation, fecal transplantation with the novel UC diet or the UC diet alone for Refractory Mild to Moderate Active Ulcerative Colitis: The CRAFT UC randomized controlled trialECCO'21 Virtual
Year: 2021
Authors: Arie Levine
Background

We evaluated if integration of novel diets for donors and patients in addition to fecal transplantation (FT) could increase FT remission in refractory ulcerative colitis (UC) or have an independent effect on remission. We developed a novel diet specifically designed for the dysbiosis of UC and to decrease factors that impair goblet cells or mucous production.

Methods

This was a blinded randomized controlled pilot trial in adults with UC, defined by a simple clinical colitis activity index (SCCAI) of ≥5 and < 11 and endoscopic Mayo score 2-3, refractory to medication. Group 1 received free diet and standard FT by colonoscopy on day 1and rectal enemas from a single donor on days 2 and 14 without dietary conditioning of the donor. Group 2: FT as above but with dietary pre-conditioning of the donor for 14 days and a diet (UC Diet- UCD) for the patients after FT. Group 3 received the UC Diet alone without FT. Patients underwent a repeat endoscopy at week 8. The primary endpoint was clinical steroid free remission, defined as SCCAI <3, at week 8.

Results

Fifty-one of the 96 planned patients were enrolled. The mean age was 40.4 ±12.5 years, 28/51(54.9%) had failed a biologic, 15/40 (29.4%) were on steroids at enrolment.  Remission week 8 in Group 1 was 2/17(11.8%), Group 2 was 4/19 (21.1%), and 6/15 (40%) Group 3 (NS).  Endoscopic remission was present in Group 1: 2/17(12%), Group 2: 3/19(16%) and 4/15 (27%) Group 3. Mucosal healing (Mayo 0) was achieved only in Group 3 (3/15, 20%) vs. 0/36 patients receiving FT (P=0.022). Exacerbation of disease occurred in 3/17 (17.6%) Group1, 4/19 (21.1%) Group 2, and 1/15 (6.7%) Group 3 (NS). The study was stopped for futility by a safety monitoring board.

Conclusion

Fecal transplantation was not effective in this UC cohort. A UC Diet alone appeared to achieve higher clinical remission (40%) and mucosal healing than single donor FT with or without diet in mild to moderate UC failing medical therapy. This diet should be investigated further in a RCT specifically designed for the UCD. This study was supported by an ECCO Pioneer grant

OP02: Ustekinumab versus adalimumab for induction and maintenance therapy in Moderate-to-Severe Crohn’s Disease: The SEAVUE studyECCO'21 Virtual
Year: 2021
Authors: Peter Miles Irving

Background

We studied the efficacy and safety of ustekinumab (UST) vs adalimumab (ADA) through 1 year in biologic-naïve patients (pts) with moderate-to-severe Crohn's disease.

Methods

SEAVUE was a multicenter, randomized, blinded, parallel-group, active-controlled study in adults with CD Activity Index (CDAI) scores ≥220/≤450. Biologic-naïve pts failing/intolerant to conventional therapy with any size ulcer on baseline (BL) ileocolonoscopy were eligible. Pts were randomized 1:1 to UST (⁓6mg/kg IV at BL then 90mg SC every 8 weeks [Ws]) or ADA (160/80mg SC at BL/W2, then 40mg SC every 2 Ws) per US-approved regimens (no dose modifications). Primary endpoint was clinical remission at W52 (CDAI <150). Major secondary endpoints were corticosteroid-free remission, clinical response (≥100-point CDAI decrease from BL), remission in pt-reported CDAI components (PRO-2 symptom remission: abdominal pain mean daily score ≤1 and stool frequency mean daily score ≤3), and endoscopic remission (SES-CD score ≤3/0 for pts with BL score=3) at W52 and clinical remission at W16.

Results

386 pts were randomized to UST or ADA. BL demographics and disease characteristics were balanced between groups and indicative of pts with early, moderate-to-severe CD (median CD duration, 2.58 years; CDAI, 289.5; SES-CD, 8.0). At W52, 65% of UST-treated and 61% of ADA-treated pts achieved clinical remission (Δ=4.0%; 95% CI, -5.5%, 13.5%; p=0.417). Major secondary endpoints, including endoscopic remission, were similar between groups (Table 1), as were remission rates at assessment points through W52. Some other secondary endpoints showed numerical (not statistical) differences between UST and ADA (Table 1). Key safety events are summarized in Table 2. Among UST-treated and ADA-treated pts, 34.0% and 40.5% had infections, 2.6% and 7.2% had serious adverse events (AEs) of worsening CD, and 6.3% and 11.3% had AEs that led to discontinuation (DC) of study drug, respectively. One ADA-treated pt had active pulmonary TB. Injection-site reactions associated with active treatment occurred in 1.0% of UST-treated and 10.3% of ADA-treated pts. Overall, 15.2% of UST-treated and 23.6% of ADA-treated pts DC before W52. Reasons for DC were primarily lack of efficacy (UST, 2.1% vs ADA, 5.1%), AEs (UST, 5.7% vs ADA, 10.7%), and withdrawal of consent (UST, 5.8% vs ADA, 5.1%). Time to treatment DC was longer with UST vs ADA (post hoc analysis).

Conclusion

Both UST and ADA were highly effective in this population of biologic-naïve pts. Rates of clinical remission at W52 were not statistically significantly different between treatment groups. DC rates were numerically lower for UST. Safety results were consistent with prior experience for both treatments.

OP03: Anti-SARS-CoV2 antibody responses are attenuated in patients with Inflammatory Bowel Disease treated with infliximabECCO'21 Virtual
Year: 2021
Authors: Nicholas Alexander Kennedy
Background

Anti-TNF drugs increase the risk of serious respiratory infections and impair protective immunity following pneumococcal, influenza, and viral hepatitis vaccinations. Therefore, we sought to determine whether patients with inflammatory bowel disease treated with infliximab have attenuated serological responses following SARS-CoV-2 infection.

Methods

CLARITY IBD is a multicentre, prospective observational cohort study. Antibody responses in participants treated with infliximab were compared to a reference cohort treated with vedolizumab, a gut-selective anti-integrin α4β7 monoclonal antibody that is not associated with impaired vaccine responses or increased susceptibility to systemic infections. 6935 patients were recruited from 92 UK hospitals between 22nd September and 23rd December 2020.  Nucleocapsid anti-SARS-CoV2 antibodies were measured using the Roche Elecsys assay. Clinical data and serum were collected every 8 weeks. Durability was defined as nonreduction in antibody level by at least 50% from baseline.

Results

At baseline, rates of symptomatic and proven SARS-CoV-2 infection were similar between groups. Seroprevalence was lower in infliximab- than vedolizumab-treated patients (3.4% [161/4685], vs 6.0% [134/2250], p<0.0001). Multivariable logistic regression analyses confirmed that infliximab (vs vedolizumab; odds ratio [OR] 0.66 [95% CI 0.51-0.87], p=0.0027) and immunomodulator use (OR 0.70 [95% CI 0.53-0.92], p=0.012) were independently associated with lower seropositivity (Fig 1). In patients with confirmed SARS-CoV-2 infection seroconversion was observed in fewer infliximab- than vedolizumab-treated patients (48% [39/81], vs 83% [30/36], p=0.00044) and the magnitude of anti-SARS-CoV2 reactivity was lower (median 0.8 cut off index (COI) [0.2-5.6] vs 37.0 [15.2-76.1], p<0.0001). An initial increase in anti-SARS-Cov2 antibody reactivity was observed four weeks after a positive PCR test, in vedolizumab-(47.2 COI [IQR 24.1 - 113.0] vs 14.5 COI [IQR 0.4 – 30.7], p=0.0079), but not infliximab-treated patients (0.7 COI [IQR 0.2 - 7.5] vs 1.1 COI [IQR 0.4 - 4.5], p=0.70) (Fig 2). Antibody responses after an initial positive reading were also less durable in infliximab-treated patients (hazard ratio 5.15 [95%CI 2.95-9.00]; Fig 3), but durability was not influenced by immunomodulator use.

Conclusion

Seroprevalence, seroconversion in PCR-confirmed cases, and the magnitude and durability of anti-SARS-CoV2 antibodies were reduced in infliximab- compared with vedolizumab-treated patients. Serological testing and virus surveillance should be considered in patients treated with anti-TNF drugs to detect suboptimal vaccine responses, persistent infection, and viral evolution to inform public health policy.

OP06: 5-aminosalicylates are not associated with adverse outcomes in Inflammatory Bowel Disease patients with COVID-19: Analysis from an international registryECCO'21 Virtual
Year: 2021
Authors: Ryan Ungaro
Background

Prior data have suggested that 5-aminosalicylates (5-ASA) may be associated with an increased risk of severe COVID-19 among inflammatory bowel disease (IBD) patients. We aimed to evaluate the association of 5-ASA with severe COVID-19 in a large cohort of IBD patients.

Methods

We analyzed data from the Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, a large, international database of IBD patients with confirmed COVID-19. The primary outcome was severe COVID-19, defined as intensive care unit admission, ventilator use, and/or death. Hospitalization due to COVID-19 was a secondary outcome. We performed multivariable regression modeling with a generalized estimating equation accounting for country as a random effect to analyze the association of 5-ASA with severe COVID-19. Models a priori included age, sex, race, disease phenotype (CD or UC/IBD-U), corticosteroid use, azathioprine/6-mercaptopurine use, TNF antagonist use, disease activity by physician global assessment, number of comorbidities, and days from SECURE-IBD inception to reporting. We constructed three models examining 5-ASA use as binary covariate using 1) all patients, 2) only patients on any biologic, and 3) only patients on TNF antagonists.

Results

5,174patients were included with 212 (4.1%) severe COVID-19 events. At the time of COVID-19 infection, 1,504 patients were taking 5-ASA. 5-ASA patients were older (mean age 44 vs. 38.3 years, p<0.001), more likely to have UC (70.7% vs. 27.7%, p<0.001), less likely to be in remission (49.6% vs. 57.2%, p<0.001), and more likely to have at least one comorbidity (33.6% vs. 26.7%, p<0.001) compared to patients not on 5-ASA. 3,325 patients were on any biologic and 2,216 were on a TNF antagonist. Among all patients, 5-ASA was not associated with severe COVID-19 (adjusted OR [aOR] 1.14, 95% confidence interval [CI] 0.86-1.52) (Table 1). Prior associations of age, comorbidities, TNF antagonists, and corticosteroids with severe COVID-19 were similar to prior analyses (Table 1). In analyses restricting to those on any biologic or only TNF antagonists, there was also no significant association between 5-ASA and severe COVID-19 (aOR 0.76, 95% CI 0.38-1.50 and aOR 0.99, 95% CI 0.43-2.32, respectively). Use of 5-ASA was not associated with risk of COVID-19 related hospitalization in any analysis.

Conclusion

In an analysis of updated data from the SECURE-IBD registry, 5-ASA use was not associated with worse outcomes among IBD patients with COVID-19.