Sunday Poster Session
Category: IBD
David Rubin, MD, FACG
University of Chicago Medicine, Inflammatory Bowel Disease Center
Chicago, IL
IV Induction | Cross-over | Combined | |||
PBO IVa | GUS 200mg IVa | PBO IV → GUS 200mg IVb | GUS 200mg IV → GUS 200mg SCb | All GUSc | |
Safety analysis set, N | 280 | 421 | 165 | 125 | 586 |
Average duration of follow-up (weeks) | 12.1 | 12.3 | 13.9 | 14.6 | 15.9 |
Average exposure (number of administrations) | 2.9 | 2.9 | 2.9 | 2.8 | 3.5 |
Deathsd | 2 (0.7%) | 1 (0.2%) | 0 | 0 | 1 (0.2%) |
Patients with one or more: | |||||
Adverse events | 138 (49.3%) | 208 (49.4%) | 65 (39.4%) | 56 (44.8%) | 292 (49.8%) |
Serious adverse events | 20 (7.1%) | 12 (2.9%) | 3 (1.8%) | 3 (2.4%) | 18 (3.1%) |
Adverse events leading to discontinuation of study agent | 11 (3.9%) | 7 (1.7%) | 7 (4.2%) | 5 (4.0%) | 19 (3.2%) |
Infectionse | 43 (15.4%) | 67 (15.9%) | 26 (15.8%) | 18 (14.4%) | 104 (17.7%) |
Serious infectionse | 1 (0.4%) | 3 (0.7%) | 1 (0.6%) | 2 (1.6%) | 6 (1.0%) |
Adverse events within 1 hour of infusionf | 1 (0.4%) | 6 (1.4%) | 1 (0.6%) | 3 (2.4%) | 10 (1.7%) |
Note: Includes only pts with modified Mayo score 5-9 at induction baseline. a Includes data up to Week 12 for subjects who received treatment at Week 12. Includes all data through final safety visit (12 weeks after the last dose of study intervention) for subjects who did not receive treatment at Week 12. b Includes data from Week 12 onward. c From the first guselkumab dose onward. d All reported deaths were cardiovascular in nature and the patient in GUS arm had substantial cardiovascular risk factors. e Infections were defined as any adverse event which was coded to the MedDRA system organ class 'Infections and infestations.’ f No AEs within 1 hour of infusion were serious or resulted in treatment discontinuation. |