The Risk of Mild, Moderate, and Severe Infections in IBD patients - A prospective, multicentre observational cohort
Ashkan Rezazadeh Ardabili1,2, Dirk Van Esser1, Dion Wintjens1,3
1Department of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Background:
In light of the growing number of treatment options, the benefit-risk balance of IBD drugs is increasingly important in clinical decision-making. Post-marketing surveillance studies are pivotal to assess infection risk, yet mainly focus on severe infections. This study aimed to assess the incidence and risk factors associated with mild, moderate, and severe infections in IBD patients.
Methods:
We previously developed and validated a Patient-Reported Infections Questionnaire (PRIQ) which accurately assesses 15 infection categories with a 3-month recall period. The current prospective, multicentre, observational cohort study was performed between June 1, 2020 and July 1, 2021, enrolling consecutive IBD patients using myIBDcoach. Incidence rates (IR) were calculated for all infections and negative binomial regression was utilized to identify risk factors for infections over time.
Results:
In total, 629 IBD patients (n=346 CD, n=283 UC, 58.3% female) were included, completing 2397 PRIQs during 573.8 person-years (PY) of follow-up. This resulted in 991 reported infections and an overall IR of 172.7 per 100PY, predominantly characterized by mild (IR 117.5 per 100PY) and moderate (IR 50.9 per 100PY) infections. Risk factors significantly associated with increased overall infection rates included female sex, higher comorbidity burden, smoking, and specific treatments, such as steroids, immunomodulators, anti-TNF agents, and JAK-inhibitors, with steroids doubling infection risk (IRR 2.02).
Conclusion:
Mild and moderate infections are common among IBD patients and are particularly associated with both patient characteristics and specific immunosuppressive treatments. These findings emphasize the need for vigilant monitoring, especially for patients at higher infection risk, and allow for more personalized advice on benefit-risk of IBD treatments.
Insights
Mild and moderate infections are common in inflammatory bowel disease (IBD) patients, influenced by patient factors and immunosuppressive treatments. Vigilant monitoring is crucial for personalized IBD drug benefit-risk assessments.
Area of Science:
- Gastroenterology and Hepatology
- Immunology
- Pharmacovigilance
Background:
- Assessing the benefit-risk balance of Inflammatory Bowel Disease (IBD) drugs is critical due to numerous treatment options.
- Post-marketing surveillance often overlooks mild to moderate infections, focusing primarily on severe cases.
- This study investigates the incidence and risk factors for all infection severities in IBD patients.
Purpose of the Study:
- To determine the incidence of mild, moderate, and severe infections in Inflammatory Bowel Disease (IBD) patients.
- To identify patient characteristics and treatment-related risk factors associated with infection development.
- To inform personalized risk-benefit analyses of IBD therapies.
Main Methods:
- Prospective, multicentre, observational cohort study utilizing the validated Patient-Reported Infections Questionnaire (PRIQ).
- Infections assessed across 15 categories with a 3-month recall period over 573.8 person-years of follow-up.
- Negative binomial regression analysis employed to identify infection risk factors.
Main Results:
- A total of 629 IBD patients (346 Crohn's disease, 283 ulcerative colitis) reported 991 infections.
- Overall infection incidence rate (IR) was 172.7 per 100 person-years, with mild (117.5/100PY) and moderate (50.9/100PY) infections predominating.
- Risk factors included female sex, comorbidities, smoking, steroids (IRR 2.02), immunomodulators, anti-TNF agents, and JAK-inhibitors.
Conclusions:
- Mild and moderate infections are frequent in IBD patients, linked to patient traits and immunosuppressive therapies.
- Findings highlight the necessity of close monitoring for IBD patients at elevated infection risk.
- This data supports personalized guidance on the benefit-risk profiles of IBD treatments.
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