Fig. 1
Summary of study designs for the included studies contributing data to the CD (A) and UC (B) analyses. 1For patients with W6 body weight < 80 kg or ≥ 80 kg, respectively. 2For patients with W30 body weight < 80 kg or ≥ 80 kg, respectively. 3Response defined as a ≥ 70-point reduction from baseline in CDAI score. 4Response was defined as a reduction in total Mayo score of ≥ 3 points and ≥ 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1. 5Final safety follow-up at W68. 6Patients without a clinical response at W6 received a third open-label dose of VDZ 300 mg IV and were reassessed for clinical response (see footnote 3) at W14; those achieving a clinical response had the option to enrol in an open-label extension study, and those who did not have a response were discontinued from the study. Green and red triangles indicate timing of primary and secondary endpoint assessments, respectively. CD: Crohn’s disease; CDAI: Crohn’s Disease Activity Index; IV: Intravenous; OL: Open-label; Q: Every; R: Randomisation; SC: Subcutaneous; TNFi: Tumour necrosis factor-α inhibitor; UC: Ulcerative colitis; VDZ: Vedolizumab; W: Week