Entyvio linked with lower serious infection risk in UC
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Patients with ulcerative colitis treated with Entyvio had a lower risk for serious infections compared with those who received anti-TNF, according to study results.
Siddharth Singh, MD, MS, from the University of California, San Diego, and colleagues wrote that with expanding options for inflammatory bowel disease treatment, there has been limited safety comparisons of therapies.
“Tumor necrosis factor alpha have been associated with an increased risk of serious infections in clinical registries and real-world observational studies,” they wrote. “In contrast, [Entyvio (vedolizumab, Takeda)], a gut-specific anti-integrin agent, is presumed to be associated with lower risk of serious infections, although there is paucity of registry or large real-world observational studies.”
Using information from an administrative claims database, researchers compared the risk for serious infection between patients treated with anti-TNF vs. vedolizumab. In their analysis, they adjusted for baseline disease characteristics, health care use, comorbidities, and time-varying use of corticosteroids, immunomodulators and opiates.
Among 4,881 patients with IBD treated with anti-TNF, 434 developed a serious infection over 5,786 person-years of follow-up. Among 1,106 patients treated with vedolizumab, 86 developed serious infections over 1,040 person-years of follow-up.
Vedolizumab was associated with a 46% lower risk for serious infections among patients with ulcerative colitis (HR = 0.54; 95% CI, 0.35-0.83) compared with anti-TNF. There was no significant difference among patients with Crohn’s disease.
Additionally, vedolizumab was associated with lower risk for extra-intestinal serious infections in patients with UC, no higher risk for gastrointestinal serious infections in patients with CD.
“The interplay of effectiveness and relative safety of different agents, in patients who respond vs. do not respond to therapy also merits close evaluation to understand risk-benefit trade-offs of novel therapies,” Singh and colleagues wrote. “These findings will inform optimal choice of different biologics depending on a patient’s risk of disease- and treatment-related complications.”
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