Among older adults with inflammatory bowel disease (IBD), vedolizumab (Entyvio) appeared to be safer than tumor necrosis factor (TNF) inhibitors, a large retrospective study suggested.
After weighting using standardized mean differences, new users of vedolizumab had a lower likelihood of all-cause hospitalization during the 12 months after initiating biologic treatment compared with those starting TNF inhibitors, with a hazard ratio of 0.81 (95% CI 0.68-0.96), according to Bharati Kochar, MD, of Massachusetts General Hospital in Boston.
In addition, while there was no difference between vedolizumab and anti-TNF initiators in IBD-related hospitalizations, those on vedolizumab had a lower risk of infection-related hospitalization, with a hazard ratio of 0.39 (95% CI 0.23-0.65), she reported at the virtual Crohn’s and Colitis Congress.
“The American population is rapidly aging, and the number of Americans 65 and older in 2060 will be more than double what it was in 2014,” she said. “The combination of increasing IBD incidence, improvements in disease treatment-related knowledge, and decreasing IBD mortality is resulting in a high prevalence of older adults with IBD,” she noted.
One estimate is that more than one-quarter of Americans with IBD are 65 and older, yet older adults are less likely to receive effective immunosuppression.
Older adults with IBD are not adequately represented in clinical trials. Fewer than 1% of adults in clinical trials of approved IBD therapies have been 65 or older, and in most clinical trials, subgroup analyses of results in older patients were not published.
“So we don’t know how well these medications work and how safe they are in older adults,” she said.
To address this knowledge gap, Kochar and colleagues analyzed data from a 20% random sample of the 50-state Medicare claims database. Included patients were diagnosed with Crohn’s disease or ulcerative colitis and initiated treatment with vedolizumab, infliximab (Remicade), adalimumab (Humira), golimumab (Simponi), or certolizumab (Cimzia) from 2014 to 2018 following 12-month enrollment in Medicare without receiving any of those medications.
The analysis included 488 new users of vedolizumab and 2,213 initiators of TNF inhibitors. Mean age was 71, and 12% of each group was 80 or older. More than half were women and almost all were white. The diagnosis was ulcerative colitis in 44%, and more than half of patients had Carlson Comorbidity Index scores of 2 or higher.
In the 6-month period prior to biologic initiation, nearly one-third had a prescription for budesonide, 58% had a prescription for a systemic corticosteroid, and nearly one-third were being prescribed immunomodulators.
Other outcomes of interest that did not differ significantly between vedolizumab and TNF inhibitors included:
- IBD-related hospitalization: HR 0.77 (95% Ci 0.53-1.12)
- IBD-related surgery: HR 0.78 (95% CI 0.49-1.22)
- New steroid prescription within 60 days of starting the biologic: HR 1.01 (95% CI 0.86-1.18)
“In conclusion, I think it’s important to use your clinical judgment to treat the patient in front of you, and these data should simply help contextualize risk for older IBD patients newly initiating vedolizumab or TNF inhibitors,” Kochar said.
“There is a vast need for additional large and robust comparative effectiveness and safety studies for older adults with IBD, with the rapid proliferation of new IBD medications,” she concluded.
Kochar disclosed support from the Crohn’s and Colitis Foundation.