Table 2.
Vedolizumab trials | Type | Patients, n | Age cutoff | Mean age | % Female | % UC | UC phenotype E1/E2/E3(%) | CD phenotype B1/B2/B3(%) | CD location L1/L2/L3(%) | Mean disease duration | Prior anti-TNF use(%) | Prior Surgery (%) | Charlson Comorbidity Score | Corticosteroids (%) | Combo Therapy (%) | Triple IS(%) | Outcomes | Remission at 3-6-12 months(%) | Surgery within 1 year(%) | Infectious risk (%) | Malignancy risk(%) |
Navaneethan et al[69], 2017 | Retrospective | 29 | 60 | 67 | 58 | 34 | 0/20/80 | NA | 21/79 (L2+L3) | NA | 69 | NA | NA | NA | NA | NA | Clinical | 38/NA/41 | 10.3 | 14 | NA |
Yajnik et al[59], 2017 | Retrospective | 112 | 55 | 61.7 | 40 | 49.5 | 11/48/41 | NA | 29/36/35 | 12.1 | 51.6 | 57 for CD | NA | 36.5 | 17.4 | 12.5 | Clinical | 41.8/NA/40.7 | NA | 77 (any) vs 0.9 (serious) | 0 |
Adar et al[53], 2019 | Retrospective | 103 | 60 | 68 | 42 | 50 | NA/NA/55 | 43/25/32 | 20/24/56/0 | 16 | 60 | 31 | 4 | 70 | 33 | 23 | Clinical | 38/45/54 | 10 | 17 (significant infections) | 2 |
UC: Ulcerative colitis; E1: Proctitis; E2: Left-sided colitis; E3: Pancolitis; CD: Crohn’s disease; B1: Nonsticturing, nonpenetrating; B2: Stricturing; B3: Penetrating; L1: Terminal ileum; L2: Colon; L3: Ileocolon; L4: Isolated upper disease; TNF: Tumor necrosis factor; triple IS: Triple immunosuppression (defined as steroids, immunomodulatory drug and vedolizumab); NA: Not available.