GEMINI: Deep remission with Entyvio in severe UC linked to drug serum concentrations
ORLANDO, Fla. — Patients with moderate to severe active ulcerative colitis more often achieved deep remission with Entyvio compared with placebo, according to a post hoc analysis of the GEMINI 1 trial shared at Advances in IBD 2017.
Investigators noted that improved endoscopic healing and symptoms correlated with higher serum concentrations of Entyvio (vedolizumab, Takeda).
“Deep remission as a new treatment goal that can go beyond the control of symptoms to include sustained control of inflammation is important for both patients and providers,” William Sandborn, MD, chief of the division of gastroenterology at University of California, San Diego, said in a press release. “This new post hoc analysis provides insight for physicians as treatment goals evolve and new therapies become available.”
This post hoc analysis aimed to assess the relationship between deep remission at week 52 and vedolizumab serum concentrations at week 46 among 373 vedolizumab responders who received maintenance therapy. Sandborn and colleagues evaluated four different definitions of deep remission, involving combinations of endoscopic and symptomatic improvement (ie, varying degrees of rectal bleeding and stool frequency), and analyzed deep remission rates against trough serum concentrations.
Significantly more patients treated with vedolizumab achieved deep remission based on all four definitions vs. placebo, and investigators found a trend toward higher deep remission rates with increased trough serum concentrations.
About half of the patients within the top 50% of vedolizumab trough serum concentrations achieved the most stringent definition of deep remission criteria, and more than 70% within the top 75% of trough serum concentrations achieved the least stringent definition of deep remission. Further, the placebo group showed lower deep remission rates than those in the lowest quartile of vedolizumab concentrations.
Sandborn and colleagues noted that these findings show a correlation and do not establish causal relationship, so further validation is required. However, they concluded that “taken together, these findings suggest that the observed improvements in endoscopic healing and symptomatic patient-reported outcomes correlate with higher [vedolizumab] serum concentrations.”
“We are pleased that this poster was recognized as a ‘Poster of Distinction’ by AIBD. Takeda is committed to investigating important therapeutic targets like deep remission in order to help the GI community determine what goals might be important for patients with the increasing number of treatment options available for IBD,” Karen Lasch, MD, medical head, GI specialty, U.S. medical office of Takeda, said in the press release. “As deep remission becomes an important and realistic treatment goal, Takeda will continue to explore this area.” – by Adam Leitenberger
Sandborn W, et al. Abstract P-008. Presented at: Advances in IBD; Nov. 9-11, 2017; Orlando, Fla.
Disclosures: Sandborn reports he has financial relationships with Takeda and numerous other disclosures, which can be viewed in the AIBD program. Lasch reports she is employed by Takeda.