TOPLINE

A large Swedish registry study of patients with inflammatory bowel disease (IBD) found that adding corticosteroids to any baseline therapy was associated with two- to fourfold higher risk for serious infections, with risk climbing alongside cumulative steroid dose. The relative risk increase was steepest in children; however, older adults still bore the highest absolute infection burden.

METHODOLOGY

• Despite corticosteroids' known association with increased risk for infection in IBD, prior studies were largely limited to case-control designs lacking absolute risk estimates, prompting this nationwide Swedish study to assess the risk for serious infection across IBD therapies with and without concomitant corticosteroid use.
• IBD cases were identified using validated diagnostic codes and biopsy records from Swedish national registers (2007–2024) and matched to up to 10 comparators from the general population; patients with conditions like HIV, cancer, or a history of organ transplant were excluded.
• Researchers identified 145,125 exposure periods in treatment-naive patients with IBD, 82,675 periods involving immunomodulators, and 90,181 involving advanced therapies; advanced therapies included TNF inhibitors alone or with an immunomodulator, vedolizumab, ustekinumab, risankizumab, and JAK inhibitors.
• Propensity score matching was performed to directly compare corticosteroid-exposed and unexposed treatment periods within each IBD therapy group; corticosteroid courses were assumed to last 12 weeks and doses were converted to prednisolone equivalents to assess dose-response.
• Serious infection — defined as hospitalization for which infection was either the primary reason for admission or a secondary contributing factor — served as the primary endpoint.

TAKEAWAY

• Across all IBD treatment groups, adding corticosteroids was linked to substantially higher risk for serious infection compared with the general population — rising from roughly 2.5- to fourfold higher without steroids to 8- to 16-fold higher with them among patients on immunomodulators or advanced therapies, and from 1.6- to 4.5-fold among treatment-naive patients.
• Children younger than 18 years of age had the greatest increase in relative risk for infection vs the general population, with the risk 30-50 times higher when corticosteroids were added to immunomodulators or advanced therapies, and 6-16 times higher even without steroids. Adults aged 60 years or older had the highest absolute rates of infection.
• Comparing propensity-matched corticosteroid-exposed and unexposed periods within the same therapy, concomitant corticosteroid use was associated with a two- to fourfold higher risk for serious infection.
• Infection risk climbed steadily with cumulative corticosteroid dose — from about 1.6 times as likely at low doses to roughly three times as likely above 1500 mg in treatment-naive patients — though no single dose threshold predicted higher risk consistently across all therapies.

IN PRACTICE

"Our findings address important knowledge gaps regarding the real-world safety profiles of immunosuppressive regimens. They highlight that when corticosteroids are required, infection risk-stratification should be individualized, and preventive measures may need to be considered," the authors wrote.

SOURCE

The study was led by Anders Forss, MD, PhD, Karolinska Institutet in Stockholm, Sweden. It was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS

Residual confounding may have persisted because key disease and lifestyle factors were not fully captured. As the study had an observational design, the authors could not determine whether the increased risk reflected corticosteroid use, disease severity, a combination of these factors, or other factors. The analysis included only infections during hospitalization and did not capture milder infections managed in primary care.

DISCLOSURES

The study was supported by grants from the Bengt Ihre Research Fellowship, the Regional Agreement on Medical Training and Clinical Research between Stockholm County Council and Karolinska Institutet, the Crohn's & Colitis Foundation, the Helmsley Charitable Trust, the National Institutes of Health, the Swedish Research Council, and other funding sources. Several authors reported receiving consulting fees, speaker fees, or honoraria from; serving on advisory boards for; or acting as principal investigators on projects funded by multiple companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.