Maarten Cozijnsen

125 Chapter 6 Benefits and risks of combination therapy in children with IBD Endpoints Result** a) Clinical response wk 8 b) Clinical remission wk 8 c) Clinical remission wk 54 a) [1] 23/32 (72%) vs. [2] 21/28 (75%), P≈0.8 b) [1] 13/32 (41%) vs. [2] 11/28 (39%), P≈0.9 c) [1] 5/11 (46%) vs. [2] 3/10 (30%), P≈0.5 Colectomy rates at 3, 6, 12 and 24 months [1] vs. [2]: 13 vs. 38%, 25 vs. 38%, 26 vs. 50%, 47 vs. 78% respectively, P>0.05 a) CFCR wk 16 b) MH wk 16 c) ATIs wk 16 a) [1] 31/78 (40%) vs. [2] 17/77 (22%), P=0.017 ; [3] 18/76 (24%) b) [1] 49/78 (63%) vs. [2] 52/77 (55%), P=0.30; [3] 28/76 (37%) c) [1] 1/31 (3%) vs. [2] 7/37 (19%), P≈0.045 a) ACT I: clinical response wk 54; b) ACT I: clinical remission wk 54; c) ACT II: clinical response wk 30 d) ACT II: clinical remission wk 30 e) ACT I: ATI presence f) ACT II: ATI presence g) Median IFX concentration a) [1] 56/125 (45%) vs. [2] 53/118 (45%), P≈1.0 b) [1] 42/125 (34%) vs. [2] 42/118 (36%), P≈0.7 c) [1] 56/102 (55%) vs. [2] 73/139 (53%), P≈0.8 d) [1] 37/102 (36%) vs. [2] 37/139 (27%), P≈0.1 e) [1] 1/59 (2%) vs. 8/53 (15%), P≈0.01 f) [1] 1/43 (2%) vs. 12/53 (23%), P≈0.005 g) Overall median IFX concentrations did not differ, except in ACT II at 30 wk: IFX concentrations were higher in [2] (numbers to comprehensive to disclose) a) Steroid free remission 26 wks b) Steroid free remission 52 wks c) Steroid free remission & MH 52 wks a) [1] 63% vs. [2] 40%, P=0.009 ; [1a] 80% vs. [1b] 50%, P=0.009 b) [1] 59% vs. [2] 31%, P=0.002 ; [1a] 80% vs. [1b] 39%, P<0.001 c) [1] 42% vs. [2] 20%, P=0.008 a) Remission 52 wks b) Continued therapy c) Mean serum IFX (mg/L) d) Detectable ATIs a) [1] 20/37 (54%) vs. [2] 13/27 (48%), P=0.80 b) [1] 90% at 52 wks vs. 61% at 52 wks, P=0.016 c) [1] 20.4 ±13.2 vs. [2] 11.2 ±13.5, P=0.025 d) [1] 1/22 (4.5%) vs. [2] 5/15 (33%), P=0.031 Risk for loss of response (HR) [2] vs. [1]: 2.36 (1.10-5.08)