Takeda Pharmaceutical (TYO:4502) touted results from a Phase III trial assessing the efficacy and safety of an investigational subcutaneous formulation of vedolizumab, a gut-selective biologic designed for adults with moderately to severely active ulcerative colitis.
The 383-patient Visible 1 pivotal Phase III trial included an intravenous vedolizumab reference arm. Patients who achieved clinical response after six weeks were randomized into one of three groups: subcutaneous vedolizumab and IV placebo, IV vedolizumab and subcutaneous placebo, or subcutaneous placebo and IV placebo.
After 52 weeks, 46.2% of people receiving subcutaneous vedolizumab achieved clinical remission compared to 14.3% of people receiving a placebo. The company also noted that 42.6% of people receiving IV vedolizumab experienced clinical remission after 52 weeks.
“The Visible 1 results highlight that the investigational subcutaneous formulation of vedolizumab helped patients with moderately to severely active ulcerative colitis achieve and maintain clinical remission, mucosal healing and durable clinical response, after responding to vedolizumab IV induction therapy. These data indicate that the subcutaneous formulation of vedolizumab had an efficacy and safety profile similar to the IV reference arm, and further add to the collective dataset for vedolizumab in ulcerative colitis,” lead investigator William Sandborn said in prepared remarks.
Takeda also reported that subcutaneous vedolizumab was statistically superior compared to the placebo in secondary endpoints of mucosal healing. The company noted that a subgroup analysis found clinical remission rates were higher with subcutaneous vedolizumab compared to placebo in anti-tumor necrosis factor-alpha naïve and anti-TNFα-failure patients.
Adverse event rates were similar in the subcutaneous and IV vedolizumab groups, Takeda reported.
“These results mark an important milestone for Takeda in our efforts to better meet the needs of patients with inflammatory bowel disease. We hope to make the subcutaneous formulation of vedolizumab available to provide more choice for patients and their physicians. The patient’s experience is very important to us, and we are committed to providing physicians with treatment options that suit the individual needs and preferences of their patients, whether that is intravenous or subcutaneous,” Jeff Bornstein, Takeda’s executive medical director, said.