Comparative Risk of Serious Infections Associated With Treatment of Inflammatory Bowel Disease.

BACKGROUND

There is paucity of data on the risk of infection-related hospitalization among inflammatory bowel disease (IBD) patients exposed to newer biologics. Our aim was to assess the overall and comparative risk of infection-related hospitalization, among IBD patients exposed to different IBD medication classes.

METHODS

This was a retrospective cohort study of adult IBD patients in the Veterans Health Administration. New initiators of different IBD medication classes were identified, and the primary outcome was infection requiring hospitalization. Survival analysis methods were used to evaluate the association between time-updated IBD medications and these outcomes, adjusted for key confounders.

RESULTS

The cohort included 14 554 IBD patients. There were 3131 infection hospitalizations over a median follow-up of 49.5 months (interquartile range, 21.2-60.0 months). No other class of medication was associated with a statistically significant difference in the risk of acquiring an infection-related hospitalization compared with patients exposed to a combination therapy of anti-tumor necrosis factor (TNF) inhibitors and thiopurines (TPs). There was a significantly increased risk of gastrointestinal infections with vedolizumab (hazard ration, 1.42; 95% confidence interval, 1.13-1.80; P = .003) relative to anti-TNF inhibitors + TPs. Anti-TNF inhibitor monotherapy had a lower risk when compared with vedolizumab.

CONCLUSIONS

In this nationwide IBD cohort, there was not an increased risk of infection-related hospitalization among patients exposed to vedolizumab, ustekinumab, and tofacitinib as compared with patients on anti-TNF inhibitor and TP combination therapy and rates of infection-related hospitalization were low overall. These findings should guide clinical decision making and patient-physician discussions when selecting a therapeutic agent with the primary emphasis on efficacy.