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Vedolizumab Safety Hampered by Immunosuppressive Agents, Smoking
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A study published in Clinical Gastroenterology and Hepatology revealed that Entyvio was well tolerated and had an overall favorable safety profile in patients with inflammatory bowel disease.
However, Joseph Meserve, MD, of the University of California San Diego, and colleagues found that concomitant use of immunosuppressive agents and active smoking damaged that favorable profile, with both factors associated with infections.
“In review of the VICTORY consortium database, we found that [Entyvio (vedolizumab, Takeda)] is overall well-tolerated with a favorable safety profile,” Meserve told Healio Gastroenterology and Liver Disease. “Real-world safety data from this large cohort is comparable to the preceding GEMINI trials while also detailing independent risk-factors for adverse events.”
Investigators conducted a retrospective review of data from the multicenter consortium database detailing infectious and non-infectious adverse events, defined as those requiring antibiotics, hospitalization, vedolizumab discontinuation or resulting in death. They quantified rates as proportions and events per 100 patient years of exposure (PYE) or follow up (PYF).
The study comprised 1,087 patients (650 with Crohn’s disease; 437 with ulcerative colitis; 55% female; median age, 37 years) with 861 PYE and 955 PYF.
The researchers observed infections in 68 patients (6.3%; 7.9 per 100 PYE; 7.1 per 100 PYF), with the most common being gastrointestinal infections (n = 31; 2.4 per 100 PYE; 2.2 per 100 PYF) and respiratory infections (n = 14; 1.6 per 100 PYE; 1.5 per 100 PYF). The most common non-infectious adverse event was arthralgias (n = 31; 2.9%; 3.6 per 100 PYE).
Meserve and colleagues found that active smoker status (OR = 3.39) and number of concomitant immunosuppressive agents, including corticosteroids or immunomodulators (OR = 1.72 per agent), were independently associated with infections.
They wrote that their findings will help clinicians understand the relative safety of vedolizumab in patients with IBD.
“This evidence bolsters the favorable benefit-risk profile of vedolizumab,” Meserve said. “It is important for gastroenterologists to note that this may become less favorable with the addition of immunosuppressive agents, particularly corticosteroids, which were independent risk factors for the development of infectious and non-infectious adverse events.” – by Alex Young
Disclosures: Meserve reports no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures.
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