Positive results from phase III VISIBLE 2 trial of subcutaneous Entyvio to treat moderate to severe Crohn's disease.- Takeda

-Takeda Pharmaceutical Company Limited announced results from the phase III VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab (Entyvio) for use during maintenance therapy in adult patients with moderately to severely active Crohn's disease (CD). The study evaluated patients who achieved clinical response at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy at weeks 0 and 2.1 The results show that at week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission (48.0% [n=132/275] vs. 34.3% [n=46/134] respectively; [p=0.008]),meeting the study’s primary endpoint. These data were announced during an oral presentation at the 15th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Vienna, Austria. “The VISIBLE 2 study showed that the investigational subcutaneous formulation of vedolizumab helped patients with moderately to severely active Crohn’s disease achieve clinical remission at week 52, after first responding to induction therapy with intravenous vedolizumab,” said Séverine Vermeire, MD PhD, Head of the Department of Chronic Diseases & Metabolism at the KU Leuven and Honorary Member of ECCO. “These results suggest that the investigational subcutaneous formulation of gut-selective vedolizumab can provide a new treatment modality for patients who might prefer a therapy that can be self-administered outside of the hospital setting.” Results for the following secondary endpoints were also presented at the congress. The enhanced clinical response rate was 52.0% (n=143/275) in patients receiving vedolizumab SC versus 44.8% (n=60/134) in patients on placebo at week 52. The difference between the treatment groups was not statistically significant, and consequently statistical testing for the remaining secondary endpoints was not performed. Among patients receiving corticosteroid treatment at baseline, the corticosteroid-free clinical remission rate at week 52 was 45.3% (n=43/95) in patients who received therapy with vedolizumab SC versus 18.2% (n=8/44) who received placebo. The study enrolled patients who were naïve to treatment with anti-tumor necrosis factor-alpha (anti-TNF?) therapy, as well as those with previous experience of anti-TNF? therapy. Of the anti-TNF?-naïve patients, 48.6% (n=52/107) vs. 42.9% (n=27/63) were the clinical remission? rates at week 52 in the vedolizumab SC and placebo arms, respectively. Patients received vedolizumab SC injections beginning at week 6 and every 2 weeks up to week 50, with an evaluation of the primary endpoint at week 52. The safety findings for vedolizumab SC were in line with the known safety profile of vedolizumab IV in patients with CD. Serious infections, malignancy, and liver injury were experienced by fewer than or equal to 5% of patients in both treatment groups. Anti-vedolizumab antibodies were detected in 2.5% of patients treated with vedolizumab SC, of whom approximately half developed neutralizing antibodies. Fewer than 3% of patients treated with vedolizumab SC reported injection-site reactions.