Older patients with IBD at higher risk for treatment failure with vedolizumab
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Older patients with inflammatory bowel disease receiving vedolizumab, particularly those with Crohn’s disease, faced higher risk of treatment failure compared with patients receiving tumor necrosis factor antagonists.
The comparative effectiveness study, published in JAMA Network Open, also did not find any significant safety advantage with vedolizumab treatment.
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“There is considerable need for evidence-based treatment guidance for older patients with IBD,” Siddharth Singh, MD, MS, of the divisions of gastroenterology and biomedical informatics in the department of medicine at University of California, San Diego, and colleagues wrote.
“With a paucity of head-to-head comparisons and low representation of older patients with multiple comorbidities in clinical trials, observational studies on the comparative effectiveness and safety of different therapies can inform routine clinical practice in this understudied but increasingly prevalent and vulnerable older population,” the researchers continued.
Singh and colleagues used the Danish Civil Registration System to identify and compare 377 older patients with IBD using vedolizumab (53.6% women; mean age, 61.2 years; 46.9% with CD) with 377 older patients using TNF antagonists (54.6% women; mean age, 61.3 years; 48.3% with CD). TNF antagonists included infliximab, adalimumab and golimumab.
The study was conducted between Jan. 1, 2005, and Dec. 31, 2018, with statistical analysis performed from Feb. 1 to April 27, 2022.
The primary outcome was treatment failure, which the researchers defined as receiving a new corticosteroid prescription more than 6 weeks after biologic therapy treatment initiation or composite risk of IBD-related hospitalization or surgery. Risk of serious infections, which the researchers defined as infections requiring hospitalization, was the primary safety outcome.
Vedolizumab was associated with an increased treatment failure risk at 1 year compared with TNF antagonists (45.4% vs. 34.7%; adjusted HR = 1.31; 95% CI, 1.02-1.69). Patients taking vedolizumab compared with those taking TNF antagonists also had a higher risk of IBD-related hospitalization at 1 year (27.8% vs. 16.3%; aHR = 1.48; 95% CI, 1.03-2.15) and IBD-related major abdominal surgery at 1 year (21.3% vs. 8%; aHR = 2.39; 95% CI, 1.45-3.94).
A subgroup analysis by IBD phenotype further revealed that patients with CD have a 77% higher risk of treatment failure when taking vedolizumab (aHR = 1.77; 95% CI, 1.21-2.58). However, there was no treatment failure difference seen in patients with ulcerative colitis (aHR = 1.04; 95% CI, 0.75-1.43).
The researchers also did not find a significant difference in overall risk of serious infections at 1 year for those treated with vedolizumab compared with TNF antagonists (8.2% vs. 8.7%; aHR = 1.04; 95% CI, 0.58-1.85), nor did they find one when analyzing by IBD phenotype, including CD (aHR = 1.17; 95% CI, 0.51-2.7) and UC (aHR = 0.93; 95% CI, 0.43-1.99).
“In the absence of predictive biomarkers, these findings suggest that older patients with CD, particularly those at higher risk of disease-associated complications, may be preferentially treated with TNF antagonists rather than vedolizumab,” Singh and colleagues wrote. “Future prospective registry and observational studies are warranted to confirm these findings and evaluate the comparative effectiveness and safety of other non-TNF antagonist biologic therapies such as ustekinumab and Janus kinase inhibitors.”
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