Oral Paper Presentation
Annual Scientific Meeting
Bruce E. Sands, MD, MS, FACG
Chief, Division of Gastroenterology
Icahn School of Medicine at Mount Sinai
New York, NY
Pts in CRMa at IP Week 10 | Pts in CRSb only at IP Week 10 | |||
OZA-PBO (n=79) | OZA-OZA (n=82) | OZA-PBO (n=148) | OZA-OZA (n=148) | |
Age, years, mean ± SD | 45.0 ± 13.5 | 42.7 ± 13.9 | 42.0 ± 13.8 | 42.3 ± 13.4 |
Males, n (%) | 45 (57.0) | 41 (50.0) | 77 (52.0) | 76 (51.4) |
Years since UC diagnosis, mean ± SD | 7.3 ± 7.0 | 7.4 ± 7.2 | 7.2 ± 7.3 | 8.9 ± 7.4 |
Prior therapies, n (%) 5-ASA CS Immunomodulator Anti-TNF Non-anti-TNF biologic |
75 (94.9) 51 (64.6) 24 (30.4) 13 (16.5) 3 (3.8) |
81 (98.8) 54 (65.9) 26 (31.7) 15 (18.3) |
146 (98.6) 117 (79.1) 61 (41.2) 52 (35.1) 30 (20.3) |
146 (98.6) 109 (73.6) 63 (42.6) 61 (41.2) 33 (22.3) |
Complete Mayo scorec >9, n (%) | 12 (15.2) | 19 (23.2) | 51 (34.5) | 76 (51.4) |
Mayo endoscopic score = 3 (severe), n (%) | 22 (27.8) | 25 (30.5) | 94 (63.5) | 107 (72.3) |
Fecal calprotectin, median IQR, mg/kg | 1027.8 (295.0, 2689.3) | 851.6 (251.4, 2694.6) | 1085.2 (434.4, 2579.3) | 1285.0 (486.5, 2673.4) |
All data are reported at IP baseline. aCRM was defined as complete Mayo score of ≤2 with no individual subscore of >1 point. bCRS was defined as decrease from baseline of ≥3 points and at least 30% in the complete Mayo score and a decrease of ≥1 in RBS or an absolute RBS of ≤1. cThe sum of the rectal bleeding subscore, stool frequency subscore, Physician’s Global Assessment subscore, and endoscopy subscore. ASA, aminosalicylic acid; CRM, clinical remission; CRS, clinical response; CS, corticosteroid; IP, induction period; SD, standard deviation; TNF, tumor necrosis factor. |