Recently compiled safety data from all clinical trials on Entyvio (vedolizumab) for patients with inflammatory bowel disease (IBD) show the drug is associated with low rates of new serious infections, infusion-related reactions, and cancers.
The review of Entyvio’s safety data, published in the journal Gut, is the most comprehensive analysis of six clinical trials. The study was performed by Jean-Frédéric Colombel, director of the Susan and Leonard Feinstein IBD Clinical Center at Mount Sinai in New York.
“Entyvio is a monoclonal antibody that targets the [alpha-4/beta-7] integrin and selectively prevents the infiltration of leukocytes into the gastrointestinal submucosa. It is thus an almost ‘gut-selective’ agent as opposed to previous biologics, which have a more systemic effect,” Colombel said in a press release.
The trials were placebo-controlled, double-blind, and open-label, and included a total of 2,830 patients from May 2003 to June 2013. Patients with both ulcerative colitis (UC) and Crohn’s disease (CD) took part in the study, and altogether they added up to a total of 4,811 person-years of exposure. Patients were followed up to five years, providing reliable long-term data.
The study, titled “The safety of vedolizumab for ulcerative colitis and Crohn’s disease,“ found that Entyvio treatment was not associated with an increased risk for infections, either serious or benign. Serious infections did occur during the trials, but severe infections with Clostridium, sepsis, tuberculosis, and Listeria meningitis occurred in only 0.6 percent of the patients.
Risk factors associated with serious infections in ulcerative colitis patients included previous treatment failure with anti-TNF-alpha antibodies, and simultaneous use of narcotic analgesics. In Crohn’s disease, risk factors for severe infections included younger age, use of corticosteroids, and use of narcotic analgesics.
Multifocal leukoencephalopathy is a serious condition damaging the white matter of the brain. It usually affects people with a compromised immune response, and has been associated with the use of some biological drugs. No cases of multifocal leukoencephalopathy were reported during the trials.
Only about 5 percent of the patients in each trial experienced adverse events related to the infusion. Also, fewer than 1 percent of patients who were administered Entyvio were diagnosed with cancer.
“The rate of malignancy (0.1 per 100 person-years) was consistent with that observed in patients with IBD normally. In conclusion, a favorable benefit-risk profile makes Entyvio a useful option for the long-term treatment of IBD. Still, appropriate long-term registries are needed to fully assess the safety profile of the drug in clinical practice,” Colombel said.