Vedolizumab associated with Higher Risk of Treatment Failure in Older IBD Patients: JAMA

Observational comparative effectiveness studies can inform the positioning of biologic therapies for older patients with inflammatory bowel disease (IBD) who are underrepresented in clinical trials.

A study was conducted to compare the effectiveness and safety of vedolizumab vs tumour necrosis factor (TNF) for older patients with IBD.

This active comparator, new-user design, and comparative effectiveness study were conducted between January 1, 2005, and December 31, 2018, among 754 older patients (aged ≥50 years) with IBD from the Danish National Patient Register. The mean follow-up after treatment initiation took place at 32 to 40 weeks. Statistical analysis was performed from February 1 to April 27, 2022. The primary effectiveness outcome was treatment failure, 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. Secondary effectiveness outcomes were time to each individual component of the composite effectiveness outcome. The primary safety outcome was the risk of serious infections, defined as infections requiring hospitalization. A 1:1 propensity score-matched analysis was conducted, accounting for patient-, disease-, and treatment-associated factors.

The Results:

• The study compared 377 older patients with IBD with incident use of vedolizumab vs 377 patients with incident use of TNF antagonists.
• Overall, vedolizumab was associated with an increased risk of treatment failure compared with TNF antagonists and IBD-related major abdominal surgery
• In subgroup analysis by IBD phenotype, among patients with Crohn disease, vedolizumab was associated with a 77% higher risk of treatment failure
• There was no significant difference in the risk of serious infections, overall and by IBD phenotype.

Thus, in this comparative effectiveness study of older patients with IBD, vedolizumab was associated with a higher risk of treatment failure compared with TNF antagonists, particularly among patients with Crohn disease, without offering a significant safety advantage.

Reference:

Singh S, Iversen AT, Allin KH, Jess T. Comparative Outcomes and Safety of Vedolizumab vs Tumor Necrosis Factor Antagonists for Older Adults With Inflammatory Bowel Diseases. JAMA Netw Open. 2022;5(9):e2234200. doi:10.1001/jamanetworkopen.2022.34200

Keywords:

Singh S, Iversen AT, Allin KH, Jess T, comparative, outcomes, safety, vedolizumab, tumor Necrosis, Factor, Antagonists, Older, Adults, Inflammatory, Bowel Diseases, JAMA Netw Open.