Additional Interim Data Supporting Long-Term Use of Vedolizumab in Patients with Ulcerative Colitis and Crohn's Disease Published in Journal of Crohn's and Colitis - Seite 2

About the Interim Analysis  
GEMINI LTS Ulcerative Colitis Analysis 
A total of 894 patients with UC were enrolled in the GEMINI LTS study and constituted the safety population, and a subset of 845 patients with moderately to severely active UC constituted the efficacy population.

As of June 27, 2013, 63 percent of the efficacy population (n=532/845) were continuing treatment. Among patients who responded to vedolizumab induction and had data available, 88 percent (n=120/136) were in remission after 104 weeks of exposure (96 percent [n=70/73] after 152 weeks). Among patients who withdrew from every-8-week vedolizumab maintenance in GEMINI I (n=32) before week 52, increased dosing to every 4 weeks in GEMINI LTS resulted in response and remission rates of 41 percent and 28 percent, respectively, after 52 weeks, an increase from 19 percent and 6 percent, respectively, from before the dose increase. Similar benefits were demonstrated regardless of prior TNF antagonist exposure. Durable benefits on HRQL were also observed.

GEMINI LTS Crohn's Disease Analysis 
A total of 1,349 patients with CD enrolled in the GEMINI LTS study and constituted the safety population. The efficacy population comprised 1,297 patients with moderately to severely active CD: 700 from GEMINI II, 372 from GEMINI III, and 225 vedolizumab-naïve patients.

Among patients with response at week 6 in GEMINI II who received vedolizumab continuously, 83 percent (n=100/120) and 89 percent (n=62/70) of patients with available data were in remission after 104 and 152 weeks, respectively. Increased dosing frequency from every 8 weeks (GEMINI II) to every 4 weeks (GEMINI LTS) improved outcomes in patients who had withdrawn early from GEMINI II, with 47 percent (n=27/57) experiencing clinical response and 32 percent (n=18/57) in remission at week 52 of GEMINI LTS (up from 39 percent and 4 percent before the dose increase). Similar improvements were observed regardless of prior TNF antagonist exposure. Long-term benefits of HRQL were also observed.

Patients who were previously exposed to vedolizumab in the GEMINI II and GEMINI III trials demonstrated a reduction in disease activity which was sustained with long-term open-label vedolizumab therapy. After an additional 100 weeks (week 152) of treatment, 74 percent (n=156/212) of all patients who completed GEMINI II were in remission including 66 percent (n=75/113) of those with prior TNF antagonist failure and 82 percent (n=69/84) of TNF antagonist naïve patients. Long-term benefits of HRQL were also observed.