Another analysis focused on the total of 1,443 inflammatory bowel disease patients who received vedolizumab for both induction and maintenance in the two GEMINI studies. This safety analysis examined the incidence of total infections and serious infections among patients who started on vedolizumab while on treatment with a corticosteroid, an immunomodulating drug, both of these agents, or neither of these agents.
The analysis showed similar rates of both total infections and serious infections in all four subgroups, suggesting no interaction between vedsolizumab and other immuno-active drugs in terms of vulnerability to infection, said Dr. Jean-Frédréic Colombel, professor of medicine and director of the inflammatory bowel disease center at Mount Sinai Medical Center in New York.
The low rate of serious infections, which occurred at 0.04-0.06 infections/person-year of follow-up was “reassuring,” said Dr. Colombel, but these infections were also so rare that it limited interpretation of the findings. He also noted that the analysis only focused on concomitant drugs at the time patients began vedolizumab treatment and did not take into account subsequent medication changes.
The GEMINI 1 and 2 trials were sponsored by Takeda, the company that markets vedolizumab (Entyvio). Dr. Feagan has been a consultant to Takeda, AbbVie, Merck, and UCB. Dr. Rutgeerts has been a consultant to Takeda, AbbVie, Janssen, Merch, and UCB. Dr. van der Woude has been an advisor to Dr. Falk, Abbvie, Janssen, Johnson&Johnson, and Cosmo. Dr. Danese has been a consultant to Takeda and to several other companies. Dr. Vermeire has been a consultant to Takeda and to several other companies. Dr. Colombel has been a consultant to Takeda and to several other companies.
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