A study in the European Medical Journal aims to confirm the safety profile of vedolizumab, a treatment for inflammatory bowel disease (IBD). Specifically, they focused on acute infusion reactions. It is important that the safety profile remains consistent with prior research, as this drug is able to induce and maintain a response in one-third of patients with IBD.
About IBD
Inflammatory bowel disease (IBD) is an umbrella term used for a group of disorders that involve chronic inflammation in the digestive tract. This group includes conditions such as Crohn’s disease and ulcerative colitis. The exact cause of IBD is unknown, but many suspect that it has to do with an immune system malfunction. Healthcare professionals suspect that an abnormal response of the immune system is triggered when it attempts to fight off viruses or bacteria, which then causes the system to attack the cells within the digestive tract.
While the cause is unknown, there are risk factors that are known to lead to or aggravate the disease. These factors include diet, stress, cigarettes, and nonsteroidal anti-inflammatory medications. Age is another factor, as the majority of people are diagnosed with IBD before age 30. This disease affects mainly white people, and people of Ashkenazi Jewish descent are at an even higher risk. If one has a family history of IBD, there is a higher likelihood that they will develop this disease. Location can also affect IBD, with those living in industrialized countries or northern climates have a higher chance of developing it.
Symptoms of inflammatory bowel disease vary with the location and severity of inflammation. Many people experience periods of active symptoms followed by periods of remission. These active symptoms include diarrhea, fever, fatigue, abdominal pain, cramping, blood in stool, loss of appetite, and unintentional weight loss. Seeking treatment is important as complications of this disease include colon cancer, blood clots, primary sclerosing cholangitis, and inflammation of the eyes, joints, and skin.
About Vedolizumab
Vedolizumab is a monoclonal IgG1 antibody that targets α4β7-integrin. Prior research has shown that it is an effective treatment for up to one-third of the IBD patient population, as it can induce and maintain a response. While studies have demonstrated that infusion reactions happen at a very low rate, researchers wanted to ensure that the safety profile was correct.
About the Study
Researchers conducted a review of patients who had been treated with vedolizumab throughout four hospitals in France; any person who had been administered this drug from May of 2014 to February of 2018 was included. They looked specifically for the rate of acute infusion reactions, specifically reactions that occurred within two hours of treatment.
Of the 6,459 infusions between 550 patients that occurred within the four year period, only six acute infusion reactions were reported. Of these reactions, none were severe or included anaphylactic shock. Still, two people discontinued their treatment. When researchers tried to discover a risk factor for an adverse reaction, none were found.
In the end, the 0.1% infusion reaction rate confirms the safety profile. Therefore, physicians can continue to prescribe and utilize vedolizumab.
