A large analysis of Medicare data from all 50 states suggests that vedolizumab may be just as effective as anti–tumor necrosis factor (anti-TNF) agents in controlling inflammatory bowel disease (IBD) in patients aged over 65 years, with fewer infectious disease hospitalizations.
The study was prompted by the fact that older adults are greatly underrepresented in clinical trials of approved IBD medications. There is a second peak in IBD diagnosis among people in their 50s and 60s, and IBD patients are living longer with more effective medications. So although a significant number of IBD patients are aged 65 years or older, that group encompasses less than 1% of adults in clinical trials, Bharati Kochar, MD, reported at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
“Therefore, we don’t know how well these medications work and how safe they are specifically in older adults,” said Dr. Kochar, a gastroenterologist at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, both in Boston.
The data largely support what had been known mechanistically about vedolizumab. “It suggests that both drugs work well enough to prevent [IBD-related] hospitalizations, but clearly there was a benefit toward the safer medication, Entyvio [vedolizumab], in the infection-related hospitalizations. That’s not the only readout in infections, but it is an important readout because infections that get hospitalized are the ones that predict mortality and disability,” said Matthew Ciorba, MD, who attended the session. Dr. Ciorba is director of the IBD Center at Washington University in St. Louis and was not involved in the study.
“I think this study is reassuring to clinicians. It provides important clinical data that support what we know about the mechanisms of vedolizumab. The safety data we predicted is borne out in this large and well-done study,” said Dr. Ciorba.
Dr. Matthew Ciorba
The researchers collected a 20% random sample from a 50-state Medicare claims database, including patients who were aged 65 years or older, who had two or more codes for Crohn’s disease or ulcerative colitis, and had 18 months of continuous enrollment. It excluded Medicare Part C patients; those who used ustekinumab, natalizumab, cyclosporine, or tacrolimus during the look back and study period; and those with two or more codes for rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, or ankylosing spondylitis during the study period.
Among those included, 480 patients were on vedolizumab, while 1,152 were on anti-TNF medications. The two groups were broadly similar in their characteristics: Twenty-nine percent of both groups took budesonide, although the anti-TNF group had a higher frequency use of systemic corticosteroids (68% vs. 57%), 5-ASA drugs (62% vs. 42%), and immunomodulators (32% vs. 28%).
There were no significant differences between the two groups with respect to frequency of IBD-related hospitalizations, IBD-related surgery, steroid prescription rate after induction, or all-cause hospitalization. However, infection-related hospitalizations were less frequent in the vedolizumab group (crude incidence, 0.03 vs. 0.05 per person-year; adjusted hazard ratio, 0.47; 95% confidence interval, 0.25-0.86).
“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 and anti-TNF agents,” said Dr. Kochar. However, recognizing the limitations of any retrospective study based on administrative data, she called for additional research. “There is a vast need for additional large and robust comparative effectiveness and safety studies in older adults of the rapidly proliferating arsenal of IBD medications,” Dr. Kochar concluded.
Dr. Kochar and Dr. Ciorba have no relevant financial disclosures.