Medicare Data Suggest Vedolizumab Safe, Effective in Older Adults with IBD

Journal Published on January 18, 2022

Originally published on Clinical Gastroenterology and Hepatology

Key findings

This retrospective study of adults age ≥65 with inflammatory bowel disease compared 1,152 who initiated a tumor necrosis factor-α (TNF) inhibitor and 480 who initiated vedolizumab between 2014 and 2017
The median age was 71 in both cohorts; 64% of patients were ≥70 years old and 11% were ≥80
The risk of infection-related hospitalization was significantly decreased in the vedolizumab group compared with the TNF inhibitor group (adjusted HR, 0.33)
On four surrogate measures of effectiveness, there was no difference between TNF inhibitors and vedolizumab in older adults

Reflecting the bimodal incidence of Crohn's disease (CD) and ulcerative colitis (UC), at least 20% of diagnoses occur in adults ages 60 and older. However, clinical trials of biological therapies for inflammatory bowel disease (IBD) have not focused on older adults.

Bharati Kochar, MD, MS, a gastroenterologist in the Division of Gastroenterology at Massachusetts General Hospital; Ashwin N. Ananthakrishnan, MBBS, MPH, director of the Crohn's and Colitis Center; Andrew T. Chan, MD, MPH, director of cancer epidemiology in the Mass General Cancer Center, chief of the Clinical and Translational Epidemiology Unit in the Department of Medicine and vice chief for clinical research in the Division of Gastroenterology, and colleagues have published reassuring findings in the journal Clinical Gastroenterology and Hepatology of the safety and effectiveness of vedolizumab in older adults with IBD.

Study Methods

Using a 20% random sample from the 50-state Medicare claims database, the researchers identified patients ages ≥65 with IBD who began using a tumor necrosis factor-α (TNF) inhibitor (n=1,152) or vedolizumab (n=480) between May 2014 and December 2017. The median age was 71 in both cohorts; 64% of patients were ≥70 years old and 11% were ≥80.

The researchers weighted the cohorts to account for confounding and adjusted for clinically pertinent covariates, including frailty. Safety and effectiveness were co-primary outcomes.

Safety

The safety outcome was infection-related hospitalization, excluding infections that could be attributable to disease (intra-abdominal or perianal infections). Compared with TNF inhibitors, vedolizumab was associated with significantly decreased risk:

In the primary analysis—HR, 0.33
In a sensitivity analysis (excluding patients who concomitantly used an immunomodulator)—HR, 0.35
In patients with CD—HR, 0.33
In patients with UC—HR, 0.68

Effectiveness

Vedolizumab did not differ significantly from TNF inhibitors on any surrogate measure of effectiveness:

IBD-related hospitalizations
IBD-related surgery
New corticosteroid prescription ≥60 days after biologic initiation among patients who did not use steroids at baseline
All-cause hospitalization

Applying to the Clinic

These real-world data come from a large and generalizable cohort, so they provide guidance for counseling older patients with IBD about the risk-benefit ratio of vedolizumab. It is important to recognize, though, that treatment selection should be tailored to patient characteristics and disease severity.

67%

less risk of infection-related hospitalization in older adults with Crohn's disease who initiated vedolizumab than in those who initiated a TNF inhibitor

32%

less risk of infection-related hospitalization in older adults with ulcerative colitis who initiated vedolizumab than in those who initiated a TNF inhibitor

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Clinical Gastroenterology and Hepatology

Journal Article Published: September 2, 2021 Dates of Study: May 1, 2014 - December 31, 2017

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