As reported in Reuters Health, adding vedolizumab to Steroids May Boost Response, Remission in Crohn’s Disease according to post hoc exploratory analysis of data from the clinical trials known as GEMINI 2 and GEMENI 3. These trials assessed the outcomes after vedolizumab induction therapy over 6- and 10- week periods, respectively. Patients had a mean age of about 38 and close to half were men. Roughly 45% of patients in GEMINI 2 and 52% of patients in GEMENI 3 had been taking steroids. As reported online January 4, 2019, in Inflammatory Bowel Diseases, vedolizumab plus corticosteroids resulted in higher clinical remission rates than placebo plus corticosteroids at week 6 in GEMENI 2 (19% vs. 4.6%) and at weeks 6 (19.8 vs. 10.2%) and 10 (34.2 vs. 11.1%) in GEMENI 3. Further, compared to patients in the vedolizumab group who were not also taking corticosteroids, more patients receiving vedolizumab plus steroids achieved clinical remission at week 6 in GEMINI 2 (19% vs 10.9%) and at week 10 in GEMINI 3 (34.2% vs 22.2%). The combination also resulted in significantly higher enhanced clinical response rates compared to placebo plus corticosteroids at all timepoints in both studies. Similarly, more patients receiving vedolizumab plus corticosteroids achieved higher enhanced response rates at week 6 in GEMINI 2 (36% vs 27.7%) and at week 10 in GEMINI 3 (53.2% vs 42.3%) than patients receiving vedolizumab alone. Adverse event rates were similar across groups.
“We can’t say from these data that initiation of steroids to boost the effects of vedolizumab is the right thing to do, but we wouldn’t be concerned about adding vedolizumab if patients are already on steroids,” Dr. Sands said. “Since vedolizumab has a steroid-sparing effect, this seems to be a winning combination.”
Dr. Richard Bloomfeld, Director of the Inflammatory Bowel Disease Clinic at Wake Forest Baptist Health in Winston-Salem, NC, said in an email to Reuters Health, “While it is not surprising that those who received a stable dose of steroids plus vedolizumab had better outcomes than those who received a stable dose of steroids plus placebo, it is interesting that those who received a stable dose of steroids plus vedolizumab tended to do better than those who received vedolizumab alone.”