Vedolizumab for Inflammatory Bowel Disease: two year results of the ICC Registry, a nationwide prospective observational cohort study.

Biemans, Vince B C; van der Woude, Janneke; Dijkstra, Gerard; van der Meulen-de Jong, Andrea E; Oldenburg, Bas; de Boer, Nanne K H; Löwenberg, Mark; Srivastava, Nidhi; Bodelier, Alexander G L; West, Rachel; Jansen, Jeroen M; de Vries, Annemarie C; Haans, Jeoffrey J L; de Jong, Dirk J; Pierik, Marie J; Hoentjen, Frank

Prospective data of vedolizumab treatment for inflammatory bowel disease (IBD) patients beyond one year of treatment is scarce but needed for clinical decision making. We prospectively enrolled 310 IBD (191 Crohn's disease CD, 119 ulcerative colitis, UC) patients with a follow-up period of 104 weeks (IQR: 103-104) in a nationwide registry. The corticosteroid-free clinical remission rate (Harvey Bradshaw Index ≤4, short clinical colitis activity index ≤2) at week 52 and 104 was 28% and 19% for CD and 27% and 28% for UC, respectively. 59% maintained corticosteroid-free clinical remission between week 52 and 104. Vedolizumab with concomitant immunosuppression showed comparable effectiveness outcomes compared to vedolizumab monotherapy (week 104: 21% vs. 23%, p=0.77), while 8 out of 13 severe infections occurred in patients treated with concomitant immunosuppression. To conclude, the clinical effect was 19% for CD and 28% for UC after 2 years of follow-up regardless of concomitant immunosuppression.