Risk of infection in IBD with IL-targeting agents

April 29, 2024

Issue 09

Clinical Question

Do interleukin-targeting treatments increase the risk of infection in IBD?

Editor’s Bottom Line

These data provide additional reassurance about the safety of anti-p19 and anti-p40 therapies for treatment of inflammatory bowel disease

Reference

Ouranos K, Saleem H, Vassilopoulos S, et al. Risk of Infection in Patients With Inflammatory Bowel Disease Treated With Interleukin-Targeting Agents: A Systematic Review and Meta-Analysis. Inflamm Bowel Dis. Epub ahead of print March 24, 2024; https://academic.oup.com/ibdjournal

Synopsis

This systematic review and meta-analysis included 26 randomized, controlled trials examining 6,063 IBD patients receiving an interleukin (IL)-targeting agent and 2,549 IBD patients receiving a placebo or a non-IL-targeting treatment. The most common agents were the IL-12/23p40-targeting ustekinumab, and anti-IL-23p19 monoclonal antibodies, including brazikumab, risakinzumab, mirikizumab and guselkumab.

Patients were a mean of 39 years of age at the time of study outset and 65% had Crohn’s disease. Roughly 38% of all patients were receiving concomitant corticosteroids, 25–27% were receiving immunosuppressants, and 35–38% were receiving aminosalicylates or sulfasalazine. Between 41 and 44% of patients had received prior biologic therapy.

Results showed that there was no difference in the risk of any grade of infection (Risk Ratio [RR]: 0.98; 95% Confidence Interval [CI]: 0.89–1.09) or of severe infection (RR, 0.64; 95% CI: 0.38–1.10) in patients receiving IL-targeting agents, compared with control patients.

The authors found the cumulative incidence of any grade of infection with maintenance treatment with an IL-12/23p40–targeting agent was 34.82% over a mean follow-up of 29 weeks and the cumulative incidence of severe infection in this group was 3.07%. The cumulative incidence of any grade of infection in patients receiving IL-23p19-targeting agents was 32.16% over a mean follow-up of 40.9 weeks and the cumulative incidence of severe infection in this group was 1.75%.

In the control group, including those who had received either a placebo or a non-IL-targeting treatment, the incidence of any grade of infection during maintenance treatment was 30.7%, while the incidence of severe infection was 1.6%.

Additional analyses found no impact on infection risk when considering IBD subtype, sex, use of corticosteroids or immunosuppressants, or disease severity. However, age was correlated with a higher risk of any grade of infection among those receiving IL-12/23p40 or IL23p19-targeting agents (correlation coefficient: 0.11; p=0.026)

Details

Study Design: Meta-analysis and systematic review
Funding: None
Allocation: Not applicable
Setting: Multicenter
Level of Evidence: 1a