Sunday Poster Session
Category: IBD
David Rubin, MD, FACG
University of Chicago Medicine, Inflammatory Bowel Disease Center
Chicago, IL
Patients, n (%) | DIVERSITY1 (Crohn’s disease) | SELECTION1 (ulcerative colitis) | |||||||
IND Study A | IND Study B | IND Studies | IND Studies | IND Studies | |||||
FIL200 | FIL100 | PBO | FIL200 | FIL100 | PBO | FIL200 | FIL100 | PBO | |
TEAEs | 114 (51.4) | 136 (55.5) | 137 (57.8) | 141 (69.8) | 154 (67.5) | 156 (68.1) | 272 (53.6) | 283 (50.4) | 157 (56.3) |
Serious TEAEs | 18 (8.1) | 16 (6.5) | 15 (6.3) | 19 (9.4) | 36 (15.8) | 26 (11.4) | 22 (4.3) | 28 (5.0) | 13 (4.7) |
TEAEs leading to discontinuation of study drug | 16 (7.2) | 15 (6.1) | 13 (5.5) | 24 (11.9) | 31 (13.6) | 19 (8.3) | 23 (4.5) | 20 (3.6) | 14 (5.0) |
Infections | 39 (17.6) | 38 (15.5) | 41 (17.3) | 47 (23.3) | 58 (25.4) | 59 (25.8) | 92 (18.1) | 82 (14.6) | 39 (14.0) |
Serious infections | 8 (3.6) | 2 (0.8) | 0 | 5 (2.5) | 8 (3.5) | 7 (3.1) | 3 (0.6) | 6 (1.1) | 3 (1.1) |
GI perforationsa | 2 (0.9) | 4 (1.6) | 0 | 1 (0.5) | 2 (0.9) | 2 (0.9) | 0 | 0 | 1 (0.4) |
Malignancies (excluding non-melanoma skin cancer) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.2) | 1 (0.2) | 0 |
VTEb | 0 | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (0.2) | 0 | 0 |
MACEb | 0 | 0 | 0 | 0 | 1 (0.4) | 0 | 0 | 0 | 1 (0.4) |