PHILADELPHIA – In long-term follow-up for the treatment of inflammatory bowel disease, the novel monoclonal antibody vedolizumab continues to remain free of serious infections or other signs of major complications from altered immune function, according to pooled data presented at the annual meeting of the American College of Gastroenterology.
Over the course of follow-up, which now extends to 104 weeks in these trials, called GEMINI 1 and GEMINI 2, overall infection rates have been about the same in the vedolizumab and placebo arms even when corticosteroids or immunosuppressive agents are used concurrently, according to Dr. Edward V. Loftus Jr., professor of medicine at the Mayo Clinic, Rochester, Minn.
Dr. Edward V. Loftus Jr
There is particular focus on the safety of vedolizumab, because of the theoretical risks of biologics overall and vedolizumab specifically. Vedolizumab has been shown to provide sustained remissions relative to placebo in both Crohn’s disease and ulcerative colitis in the previously presented and updated GEMINI trials, but this agent, like other biologics, alters mediators of immune function.
The follow-up summarized at the ACG meeting, which evaluated risk of adverse events of vedolizumab alone or in combination with other inflammatory bowel disease (IBD) agents that affect immune function, suggests that the risk of adverse events is low, but the conclusion is not definitive.
“There was not a signal of more side effects with combination therapy, which is reassuring. However, the study is limited by the number of adverse events available to analyze,” said Dr. David T. Rubin, section chief of gastroenterology, hepatology, and nutrition at the University of Chicago. The likelihood of a high risk of adverse events is diminishing as follow-up and patient sample size increase, but Dr. Rubin suggested that clinicians should monitor any IBD patient taking an immunosuppressive agent for infectious complications.
“At the University of Chicago IBD Center, we have now treated more than 100 patients and are studying this therapy to better understand its performance in postmarket,” Dr. Rubin said in an interview. “So far, we have made similar observations to the clinical trials and to those made by Dr. Loftus here at the ACG.”