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Changes in disease characteristics among patients with ulcerative colitis in VISIBLE 1 receiving 2 or 3 induction doses of vedolizumab IV. (A) Partial Mayo score; (B) rectal bleeding subscore; (C) Mayo stool frequency subscore. IV, intravenous.
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Background
Vedolizumab, an anti-α4β7 integrin approved for intravenous (IV) treatment of moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD), was evaluated as a subcutaneous (SC) formulation in maintenance therapy for UC and CD in phase 3 VISIBLE 1, 2, and open-label extension studies, and recently approved in Europe, Aus...
Contexts in source publication
Context 1
... patients included in VISIBLE 1 or 2 were adults aged 18-80 years with moderately to severely active UC or CD who previously had an inadequate response to, loss of response to, or intolerance to corticosteroid, immunomodulator, or anti-tumor necrosis factor (TNF) therapy. 10,16 In both trials, after a 28-day screening period, patients received open-label vedolizumab 300 mg IV at weeks 0 and 2, and were evaluated for clinical response at week 6 ( Figure S1, VISIBLE 1 and VISIBLE 2 study designs). Inclusion and exclusion criteria for VISIBLE 1 and 2 are shown in Table S1, study inclusion and exclusion criteria for VISIBLE 1, and Table S2, study inclusion and exclusion criteria for VISIBLE 2. ...
Context 2
... higher percentage of nonresponders had extensive colitis, especially at week 14. Partial Mayo scores in UC ( Figure 1A), mean CDAI total scores (Figure 2A), mean daily abdominal pain scores in CD ( Figure 2B), and daily average liquid or soft stool scores ( Figure 2C) were similar in both groups of responders at baseline, and were substantially different at week 6 before becoming similar again at week 14, suggesting there may not be long-term differences between the 2 groups of responders. Similar patterns were observed for rectal bleeding and stool frequency in UC (Figures 1B and 1C). ...
Context 3
... Mayo scores in UC ( Figure 1A), mean CDAI total scores (Figure 2A), mean daily abdominal pain scores in CD ( Figure 2B), and daily average liquid or soft stool scores ( Figure 2C) were similar in both groups of responders at baseline, and were substantially different at week 6 before becoming similar again at week 14, suggesting there may not be long-term differences between the 2 groups of responders. Similar patterns were observed for rectal bleeding and stool frequency in UC (Figures 1B and 1C). Mean (SD) fecal calprotectin concentrations at both baseline and week 6 were lower among patients who responded after 2 IV doses (2608.7 [3354.8] ...
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