Clinical data demonstrates safety, efficacy of vedolizumab for treatment of adults with UC and CD

18 abstract presentations including vedolizumab safety and efficacy data

Takeda Pharmaceuticals International GmbH (“Takeda”) today announced the presentation of data further demonstrating the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Findings from the Phase 3 pivotal GEMINI 1 (ulcerative colitis) and GEMINI 2 (Crohn’s disease) studies, as well as interim data from the ongoing, open-label extension study GEMINI LTS (long-term safety) were presented as oral digital presentations and poster presentations during the 10th Congress of European Crohn’s and Colitis Organisation (ECCO) in Barcelona, Spain. A total of 18 Takeda-sponsored abstracts were accepted for presentation at the meeting.

“As ulcerative colitis and Crohn’s disease are so complex to treat, ongoing scientific study and exchange are important to further understand the clinical benefits of vedolizumab,” said Prof. Dr. Severine Vermeire, University Hospitals Leuven, Belgium. “These findings signify its promise as an important treatment option for patients.”

The GEMINI 1 and 2 studies are two randomized double-blind, placebo-controlled induction and maintenance studies examining the efficacy and safety of vedolizumab for induction and maintenance in adult patients with moderately to severely active UC and CD, respectively. GEMINI LTS is a Phase 3, ongoing, open-label extension study examining the long-term safety and efficacy of vedolizumab for the treatment of adults with moderately to severely active UC and CD.

Key data presentations include:

• Efficacy and safety of retreatment with vedolizumab in patients with ulcerative colitis (oral presentation) (Sands, Shafran, Farraye, et al.)
• Background: The effects of vedolizumab retreatment after up to one year of drug holiday in UC patients who, after initial response, were re-randomized to placebo or lost response during GEMINI 1, were evaluated using an interim analysis (22 May 2009 – 27 June 2013) of data from GEMINI LTS.
• Key Finding(s): The analysis suggested that for patients who responded to vedolizumab induction treatment and stopped treatment for up to one year, retreatment with vedolizumab in GEMINI LTS resulted in a good efficacy and safety profile.

• Efficacy and safety of retreatment with vedolizumab in patients with Crohn’s disease (Sands, Shafran, Farraye, et al.)
• Background: An interim analysis (22 May 2009 – 27 June 2013) examined the effects of vedolizumab retreatment in GEMINI 2 patients who enrolled in GEMINI LTS after a drug holiday of up to one year.
• Key Finding(s): The analysis indicated that for patients who responded to vedolizumab induction treatment and stopped treatment for up to one year, retreatment with vedolizumab in GEMINI LTS resulted in a good efficacy and safety profile.

• Deep remission as a predictor of clinical outcomes in vedolizumab-treated patients with ulcerative colitis (Sandborn, Colombel, Panaccione, et al.)
• Background: Deep remission (combination of endoscopic and patient-reported outcomes) is an emerging treatment goal in ulcerative colitis. Post-hoc analyses of GEMINI 1 study data investigated whether deep remission is a predictor of clinical outcomes and health-related quality of life (HRQoL) in patients with UC.
• Key Finding(s): Deep remission at week 6 was a consistent predictor of positive outcomes at week 52, and vedolizumab-treated patients were nearly 3-times as likely to be in deep remission at week 52 compared with placebo-treated patients. Patients in deep remission at week 6 or 52 had better clinical and HRQoL outcomes at week 52 than those who were not in deep remission.

• Deep clinical remission in patients with ulcerative colitis: evaluating the effects of vedolizumab on various combinations of endoscopic and patient-reported outcomes (Sandborn, Colombel, Panaccione, et al.)
• Background: Post-hoc analyses of GEMINI 1 study data evaluated the impact of vedolizumab on deep remission using various combinations of endoscopic outcomes and patient-reported outcomes.
• Key Finding(s): Vedolizumab led to statistically significant and clinically meaningful improvements at week 6 for three of four deep remission endpoints and at week 52 for all four endpoints.

• Clinical response and remission with vedolizumab across a range of baseline fecal calprotectin levels in ulcerative colitis: results from GEMINI 1 (oral presentation) (Reinisch, Lewis, Dassopoulos, et al.)
• Background: It is thought that fecal calprotectin (fCal) concentration reflects intestinal inflammation. A correlation between fCal concentrations and response to vedolizumab was evaluated using GEMINI 1 measurements of fCal concentrations.
• Key Finding(s): At week 6, response and remission rates were numerically higher with vedolizumab than placebo regardless of baseline fCal, and a 69 percent decrease in geometric mean of fCal was observed for vedolizumab-treated patients, compared to a 32 percent decrease for placebo-treated patients.

• Relationship between vedolizumab pharmacokinetics and endoscopic outcomes in patients with ulcerative colitis (oral presentation) (Rosario, Abhyankar, Sankoh, et al.)
• Background: Mucosal healing in ulcerative colitis has been associated with higher serum levels of tumor necrosis factor antagonists. Investigators studied the pharmacokinetics of vedolizumab (300mg) in relation to endoscopic outcomes.
• Key Finding(s): In GEMINI 1, at week 6, mucosal healing was more common and endoscopic subscores were lower in patients with higher measured vedolizumab trough concentration values than in those with lower values.

• Cost per clinical outcomes with biologics for the treatment of moderately to severely active ulcerative colitis (Jansen, Mody, Ursan, et al.)
• Background: Cost per clinical outcomes of vedolizumab was compared with other licensed biologics over a one year treatment period for anti-tumor necrosis factor (TNF) naïve and anti-TNF experienced patients with moderate-to-severe UC from a United Kingdom perspective.
• Key Finding(s): This analysis indicated that vedolizumab had a lower number-needed-to-treat and cost per patient for sustained response/remission, potentially providing better clinical and economic value than other biologics approved for the treatment of patients with moderate-to-severe UC.

Vedolizumab is a gut-selective humanized monoclonal antibody available in the United States and the European Union, under the trade name Entyvio^® (vedolizumab). It is the first and only biologic therapy to be approved in the European Union simultaneously for the treatment of adults with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha antagonist.

“Ulcerative colitis and Crohn’s disease can seriously impact those affected, and we are committed to supporting patients with an effective treatment option,” said Dr. Michael Smyth, Global Brand Medical Director, General Medicine, Takeda Pharmaceuticals. “We are very pleased to have the opportunity to present this breadth of data at ECCO, further demonstrating that vedolizumab is a potential treatment option for this patient population and the healthcare professionals who treat them.”