Maarten Cozijnsen

119 Chapter 6 Benefits and risks of combination therapy in children with IBD Endpoints Result** a) Loss of clinical response b) Necessity to change therapy c) Increase of SES-CD a) [1] 2/45 (4%) vs. [2] 2/39 (5%), P≈0.9 b) [1] 13/45 (29%) vs. [2] 11/39 (28%), P≈0.9 c) [1] 13/45 (29%) vs. [2] 11/39 (28%), P≈0.9 a) Clinical remission wk 26 b) Wk 26 responders who maintained response through wk 52 a) [1] 42/117 (36%) vs. [2] 21/71 (30%), P≈0.4 b) [1] 9/36 (25%) vs. [2] 13/44 (30%), P≈0.8 a) CFCR wk 14 b) Maintained remission wk 50 c) ATIs presence d) Median IFX trough levels a) [1] 48/63 (76%) vs. [2] 49/63 (78%), P=0.83 b) [1] 27/48 (56%) vs. [2] 28/49 (57%), P=0.86 c) [1] 3/63 (4%) vs. [2] 13/63 (20%), P=0.01 d) [1] 6.35 µg/mL vs. [2] 3.75 µg/ mL, P=0.08 a) CFCR wk 26 b) MH wk 26 c) ATIs present wk 30 d) Median IFX trough levels wk 26 a) [1] 96/169 (57%) vs. [2] 75/169 (44%), P=0.02 ; [3] 51/170 (30%) b) [1] 47/107 (43.9%) vs. [2] 28/93 (30.1%), P=0.06; [3] 18/109 (16.5%) c) [1] 1/116 (0.9%) vs. [2] 15/103 (14.6%), P<0.001 d) [1] 3.5 µg/mL vs. [2] 1.6 µg/mL, P<0.001 a) Treatment failure b) MH wk 104 c) ATIs d) Median IFX trough levels wk 8-54 a) [1] 24/40 (60%) vs. [2] 22/40 (55%), P=0.65 b) 16/25 (64%) vs. [2] 14/23 (61%), P≈0.8 c) [1] 2/40 (5%) vs. [2] 5/40 (13%), P=0.43 d) [1] 2.87 µg/mL (1.42-4.80) vs. [2] 1.65 µg/mL (0.54-3.53), P<0.0001 a) Remission 26wks b) Response induction c) Response maintenance d) Partial fistula closure e) Complete fistula closure a) [1] vs. [2], OR 1.06 (CI 0.83-1.35) [1a] vs. [2a] OR 1.79 (1.06-3.01) ; [1b] vs. [2b] OR 0.88 (0.58-1.35); [1c] vs. [2c] OR 0.93 (0.65-1.34) b) [1] vs. [2], OR 1.06 (0.81-1.40) c) [1] vs. [2], OR 1.46 (0.70-3.05) d) [1] vs. [2], OR 1.26 (0.84-1.88) e) [1] vs. [2], OR 1.1 (0.68-1.79) a) Remission induction b) Response induction c) Remission wk 52 d) Response wk 52 a) OR 0.78 (0.64-0.95) b) OR 0.75 (0.53-1.04) c) OR 1.08 (0.79-1.48) d) OR 1.21 (0.74-1.99)