Among the biologics, vedolizumab (Entivio) and ustekinumab (Stelara) are associated with lower rates of infection-related hospitalizations than anti-tumor necrosis factor (TNF) drugs in older patients with inflammatory bowel disease (IBD), but only if older patients also have comorbidities, discovered by American researchers.
The researchers examined U.S. health insurance claims for three cohorts—of patients with IBD who were treated with the anti-TNF drugs, vedolizumab and ustekinumab—and found no overall difference in infections or infection-related hospitalizations between the groups.
But in patients with a greater burden of comorbidities, the monoclonal antibodies vedolizumab and ustekinumab were associated with lower rates of infection-related hospitalizations compared with anti-TNF drugs: 22% less for vedolizumab and 34% less for ustekinumab.
In “the first pharmacoepidemiological study comparing all approved classes of biological agents for the treatment of IBD targeting the elderly,” the authors say they “demonstrated that comorbidity is a mediator of infections requiring hospitalization.”
“These data could help older people who are about to start using a biological agent in clinical practice,” they write.
The study was published online in the American Journal of Gastroenterology.
Co-lead author Bharati Kochar, MD, a gastroenterologist at Massachusetts General Hospital in Boston, told Medscape Medical News that the real question when we see an elderly patient is which drugs are safer?
“Not surprisingly, we found that there was no overall difference across the three drug classes,” she said, adding that “if you are taking your healthy seniors without any major comorbidities, anti-TNF drugs do not differ in terms of safety.” . profile.”
Because more selective biologics such as vedolizumab and ustekinumab appear to reduce the risk of serious infections in patients with comorbidities, Kochar said he hopes their study will help doctors feel more confident in prescribing drugs. [and] encourage thinking about the patient beyond their chronological age.
A real study of older people with IBD
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The authors note that the number of older people with IBD is growing rapidly. It is estimated that nearly 1 million people aged 60 and over in the United States are living with the condition.
They add that there is a proliferation of treatment options for both Crohn’s disease and ulcerative colitis, but the likelihood of achieving remission may vary depending on the mechanism of immunosuppression.
The authors emphasize that older people have a higher baseline risk of infections than younger people, regardless of the type of treatment; however, older people with IBD are disproportionately underrepresented in clinical trials of IBD therapy.
Recognizing the need for real-life research focused on older adults, Kochar and her colleagues collected claims data from a US commercial health insurance plan that covered nearly 86 million people between 2008 and 2019.
They identified patients with IBD aged 60 years or older (mean age 67 years) who had at least one application for vedolizumab, ustekinumab, or anti-TNF agents, including adalimumab, infliximab, golimumab, or certolizumab pegol.
The cohorts included 2369 patients treated with anti-TNF drugs, 972 patients initiated treatment with vedolizumab, and 352 patients treated with ustekinumab.
Patients were excluded from the study if they received vedolizumab or ustekinumab during the first 6 months of treatment and then switched to anti-TNF therapy.
The treatment period was defined as starting from the date of initiation of treatment and ending with the date of discontinuation of treatment. The treatment had to last more than 90 days.
The overall incidence rates for any infection were similar across the three treatment arms: 3606/1000 person-years in the anti-TNF group, 3748/1000 person-years in the vedolizumab-treated group, and 3139/1000 person-years in the treated group. with ustekinumab.
There were also no significant differences in infection-related hospitalizations, with a hazard ratio of 0.94 for vedolizumab versus TNF inhibitors and ustekinumab, again, versus TNF inhibitors of 0.92. .
However, the authors found a “significant relationship” between comorbidities and treatment in terms of infection-related hospitalizations.
Among patients with IBD over 60 years of age with a Charlson Comorbidity Index (CCI) >1, treatment with vedolizumab and ustekinumab was associated with significantly lower rates of infection-related hospitalizations compared with anti-TNF drugs, with hazard ratios of 0.78 and 0. 66. respectively.
In contrast, hospitalization rates were similar across treatment groups among patients without significant comorbidities.
Interestingly, patients with ulcerative colitis treated with vedolizumab also had a lower infection rate compared to those treated with anti-TNF drugs, with a hazard ratio of 0.96, while no such difference was observed in patients with Crohn’s disease.
Findings help improve clinical practice
Dana J. Lukin, MD, clinical director of translational research at the Jill Roberts Center for Inflammatory Bowel Disease in New York, reached out to Dana J. Lukin for comment, who said the study is limited by a lack of detailed data on disease activity.
What’s more, he told Medscape Medical News that because this is not a randomized controlled trial, drug selection in the claims database may have accounted for some non-material contraindications to anti-TNF drugs.
“It makes sense that comorbidities pose the greatest risk of hospitalization due to infections,” Lukin said, adding that “what is interesting is that in general there is no difference in infection rates between any of the drug classes.”
As such, he said the study “rejects the conventional wisdom” that among older people, anti-TNF drugs would be associated with a higher risk of infections per se, “because it’s actually especially important for those patients who have more comorbidities.
Most importantly, Lukin said, the results will help improve clinical practice, as clinicians specifically focus on treating inflammatory bowel disease, but not necessarily focusing on the comorbidities that patients develop more and more with age.
Lukin continued that for patients with comorbidities, “we should carefully consider using a non-anti-TNF agent.”
“We also shouldn’t be afraid to continue using anti-TNF agents” in people without comorbidities, he added, as they are “very effective in patients who may need them because of their disease-related characteristics.”
The study was supported in part by grants from the National Institutes of Health, the Crohn and Colitis Foundation, and the Chlek Family Foundation.
Lukin claims relationships with Takeda, Abbvie and Janssen. No other relevant financial relationships have been stated.
American Journal of Gastroenterology. Published online July 20, 2022 Abstract.
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