Trial Outcomes & Findings for A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (NCT NCT04738942)

Participants took part in the study at 20 investigative sites in Japan from 04 June 2021.

A total of 56 participants with ulcerative colitis (UC) or Crohn's disease (CD) were enrolled in the study. The results in this summary are based on the study's primary completion date (30 May 2025). The study is ongoing in the open-label period, and additional results will be reported upon study completion.

A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

Clinical response was defined as a reduction of greater than or equal to (\>=) 2 points and \>=25 percent (%) in modified mayo score, and a decrease of \>=1 point in rectal bleeding sub-score or rectal bleeding sub-score of less than or equal to (\<=) 1 from baseline (Week 0). Mayo score was an instrument designed to measure disease activity of UC. Modified mayo score consisted of 3 sub-scores: stool frequency, rectal bleeding, and mayo endoscopic sub-score (findings on endoscopy), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9. Here, a higher score indicated more severe disease.

Clinical response was defined as a reduction of \>=70 points in Crohn's Disease Activity Index (CDAI) score from baseline (Week 0). A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicated greater disease activity.

Clinical remission was defined as a modified Mayo score of less than or equal to (\<=) 2, and no individual sub-score greater than (\>) 1. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score consisted of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic sub-score (findings on endoscopy), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score ranged of 0 to 9. Here, a higher score indicated a more severe disease.

Mucosal healing was defined as a Mayo endoscopic sub-score of \<=1, in participants with baseline Mayo endoscopic sub-score of \>=2. Mayo score consisted of 4 sub-scores: stool frequency, rectal bleeding, mayo endoscopic sub-score (findings on endoscopy) and physician's global assessment, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score ranged of 0 to 12. Here, a higher score indicated a more severe disease.

Corticosteroid-free remission was defined as participants using oral corticosteroids at baseline (Week 0) who have discontinued oral corticosteroids and were in clinical remission based on partial Mayo score at Week 52. Clinical remission based on partial Mayo score was defined as a partial Mayo score of =\<2, and no individual sub-score \>1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and physician's global assessment, each graded from 0 to 3 with higher scores indicated more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicated more severe disease.

Clinical remission was defined as a CDAI score of \<=150. A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicating greater disease activity.

Enhanced clinical response was defined as a reduction of \>=100 points in CDAI score from baseline (Week 0). A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicating greater disease activity.

Corticosteroid-free remission was defined as participants using oral corticosteroids at baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52.