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Vedolizumab with, without corticosteroids, immunosuppressants comparably safe in IBD
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PHILADELPHIA — Patients with inflammatory bowel disease who received vedolizumab monotherapy had similar infection adverse event and serious adverse event profiles compared with patients who received vedolizumab with concomitant corticosteroids and/or immunosuppressants, according to data presented at the ACG Annual Scientific Meeting.
“The safety and efficacy of this drug were established in the Gemini 1 trial for ulcerative colitis and the Gemini 2 trial for Crohn’s disease,” Edward V. Loftus, MD, of the Mayo Clinic, said in a presentation. “It was noted in those trials in the integrated safety analysis that certain infections such as nasopharyngitis were more common with vedolizumab than with placebo. It is important to know that concomitant medication use was allowed in these trials.
Edward V. Loftus
“The aim of this study was to compare the rates of infection AEs and SAEs in patients treated with vedolizumab monotherapy or with concomitant corticosteroid or immunomodulators in Gemini 1 and 2,” he said.
Loftus and colleagues pooled data from the 6-week induction phase, during which patients received 300 mg vedolizumab or placebo at weeks 0 and 2, and the 46-week maintenance phase, during which patients received 300 mg vedolizumab or placebo every 4 or 8 weeks. Stratified by concomitant corticosteroid or immunomodulator use at baseline, they then calculated the percentage of infection AEs and SAEs among the 1,434 patients who received continuous vedolizumab or placebo throughout both phases continuously.
They found that these rates were generally similar, regardless of concomitant corticosteroid or immunomodulator use. Among patients with individual infection AEs, nasopharyngitis was less common with placebo, occurring in 4% to 12% across placebo subgroups compared with 10% to 15% across vedolizumab subgroups. Furthermore, all placebo subgroups had similar or lower percentages of patients with individual infection SAEs.
“The rarity of these individual infection SAEs is reassuring, but it makes it harder to interpret the data because there just aren’t enough of these events occurring to compare across the groups,” Loftus said. “In conclusion, we can say that infectious AE and infectious SAE profiles in patients with ulcerative colitis or Crohn’s disease were similar whether vedolizumab was used as monotherapy or with concomitant immunomodulators and/or corticosteroid therapy.”
For more information:
Loftus EV. Abstract 16. Presented at: ACG Annual Scientific Meeting, Oct. 17-22, 2014; Philadelphia, PA.
Disclosure: See the abstract for a full list of relevant financial disclosures.