Two new studies on vedolizumab, which is an investigational drug to treat Crohn’s disease (CD) and ulcerative colitis (UC) have shown promising results. The results of two vedolizumab studies, (GEMINI I and GEMINI II), were published in the August 22 edition of the New England Journal of Medicine. Vedolizumab, manufactured by Takeda Pharmaceutical Company Limited (Osaka, Japan) is an investigational, humanized monoclonal antibody for the treatment of adults with moderately to severely active UC and CD.
UC and CD are the two most common forms of inflammatory bowel disease, which is marked by inflammation in the gastrointestinal tract. Symptoms range from mild to severe; they may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. The conditions affect more than four million people worldwide, including approximately 1.4 million Americans and 2.2 million Europeans. Vedolizumab is designed to specifically reduce the inflammatory response of white blood cells that have been shown to play a role in the inflammatory process of the diseases.
“The publication of these study findings is important since the results support the potential for vedolizumab, if approved, to help manage symptoms in some patients for whom certain previous treatments have failed,” said lead investigator Brian Feagan, M.D., professor of medicine, epidemiology, and biostatistics at the University of Western Ontario, Canada. He added, “The data from the GEMINI program suggest that vedolizumab may provide people living with CD and UC an additional option for inducing and maintaining clinical remission.”
In the publication, study results from GEMINI I, a placebo-controlled induction and maintenance study in patients with UC, showed that vedolizumab met primary endpoints of improvement in clinical response (reduction in the Mayo Clinic score of 3 or more points and 30% or more from baseline, together with a decrease of at least 1 point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1) at six weeks and clinical remission (Mayo score of 2 or lower and no subscore higher than 1) at 52 weeks. In addition, a significantly greater proportion of patients receiving vedolizumab achieved mucosal healing (Mayo endoscopic subscore of 0 or 1) at six and 52 weeks, and glucocorticoid-free remission at 52 weeks, compared with placebo. Discussed in a separate publication, results from GEMINI II, a placebo-controlled induction and maintenance study in patients with CD, showed that vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission (Crohn’s disease activity index (CDAI) score of 150 points or less) at six weeks and at 52 weeks compared to placebo. At six weeks, no significant difference was observed in the co-primary endpoint of CDAI-100 response (100-point or more decrease in the CDAI score) between the vedolizumab and placebo groups. A significantly greater proportion of patients showed CDAI-100 response and glucocorticoid-free remission at 52 weeks.
GEMINI I and GEMINI II are part of the four-study GEMINI Studies, studying vedolizumab in 2,700 patients in nearly 40 nations, making it the largest Phase 3 clinical trial program conducted to date simultaneously evaluating both CD and UC. Enrolled patients had failed at least one conventional therapy, including glucocorticoids, immunomodulators and/or a tumor necrosis factor-alpha (TNF-α) antagonist. TNF-α antagonist failure patients included those with inadequate response (primary non-responders), loss of response (secondary non-responders) or those who were intolerant.
“These clinical studies suggest that vedolizumab may have the potential to maintain clinical remission in the appropriate patients,” said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. “Takeda has a strong legacy of researching and treating GI disorders globally, and vedolizumab represents our focus on and commitment to patient communities.”