Treatment failure risk in older IBD patients higher with vedolizumab vs TNF antagonists

The use of vedolizumab in the treatment of older patients with inflammatory bowel disease (IBD) appears to not only pose a higher risk of treatment failure but also offer no significant safety advantage when compared with tumour necrosis factor (TNF) antagonists, according to a study.

The active comparator, new-user design, comparative effectiveness study used data from the Danish National Patient Register and included 754 older IBD patients (aged ≥50 years). The mean follow-up after treatment initiation was between 32 and 40 weeks.

Of the patients, 377 had incident use of vedolizumab (mean age 61.2 years, 53.6 percent female, 46.9 percent had Crohn’s disease [CD]) or TNF antagonists (mean age 61.3 years, 54.6 percent female, 48.3 percent had CD).

The primary effectiveness outcome was treatment failure, which was defined as the composite risk of IBD-related hospitalization, IBD-related surgery, or a new corticosteroid prescription more than 6 weeks after initiation of treatment with biologic therapy. The primary safety outcome was the risk of serious infections, which was characterized as infections requiring hospitalization.

Compared with TNF antagonists, vedolizumab was associated with a 31-percent higher risk of treatment failure over 1 year (45.4 percent vs 34.7 percent; adjusted hazard ratio [HR], 1.31, 95 percent confidence interval [CI], 1.02–1.69), including higher risk of IBD-related hospitalization (27.8 percent vs 16.3 percent; adjusted HR, 1.48, 95 percent CI, 1.03–2.15) and IBD-related major abdominal surgery (21.3 percent vs 8.0 percent; adjusted HR, 2.39, 95 percent CI, 1.45–3.94).

Results of subgroup analysis by IBD phenotype showed a similar pattern. Specifically, the risk of treatment failure was higher by 77 percent with vedolizumab vs TNF antagonists among patients with CD (adjusted HR, 1.77, 95 percent CI, 1.21–2.58), whereas the risk was similar in the two treatment groups among patients with ulcerative colitis group (adjusted HR, 1.04, 95 percent CI, 0.75–1.43; p=0.03 for interaction).

There was no significant difference observed in the risk of serious infections, overall (1-year risk, 8.2 percent vs 8.7 percent; adjusted HR, 1.04, 95 percent CI, 0.58–1.85) and by IBD phenotype.