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Top - Down vs Step - Up Trial Endoscopic Substudy: Mucosal Healing. P <0.001. 100. 88. P <0.001. Early combined immunosuppression (top-down; n=66) Conventional management (step-up; n=67). 80. 71. 60. Patients, %. 47. 40. 30. 20. 0. Reduction of Ulcers. Disappearance of Ulcers.
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Top-Down vs Step-Up TrialEndoscopic Substudy: Mucosal Healing P<0.001 100 88 P<0.001 Early combined immunosuppression (top-down; n=66) Conventional management (step-up; n=67) 80 71 60 Patients, % 47 40 30 20 0 Reductionof Ulcers Disappearanceof Ulcers D’Haens G, et al. Lancet. 2008;371:660-667.
Mucosal Healing Predicts Sustained Clinical Remission in Early CD • Patients in remission at years 3 and 4 100 Simple endoscopic score 0 Simple endoscopic score 1-9 80 a b b b 60 Patients, % 40 20 0 Remission Remission, No Steroids Remission, No Steroids, No Flare Remission, No Steroids, No Flare, No Anti-TNF aP<0.05; bP<0.01 (Fischer’s exact) Baert FJ, et al. Presented at Digestive Disease Week. May 17-22, 2008; San Diego, CA; #W1133.
SONICMucosal Healing at Week 26 AZA + placebo IFX + placebo IFX+ AZA 100 P<0.001 80 P=0.023 P=0.055 60 Patients, % 43.9 40 30.1 16.5 20 18/109 28/93 47/107 0 Sandborn WJ, et al. Presented at American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course. October 3-8, 2008; Orlando, FL.
74.4 55.1 The MUSIC TrialEndoscopic Mucosal Lesion Healing With Certolizumab Pegol • Observed improvement in endoscopic and histologic lesions Response, CDEISc Remission, CDEISa Remission, CDAIb 80 70 60 46.1 50 Remission and Response Rates, % 40 30 20 10 0 a CDEIS score<7; b CDAI score ≤150 points; c ≥4-point change in CDEIS score. CDAI, Crohn’s disease activity index; CDEIS, Crohn’s disease endoscopic index of severity; MUSIC, Endoscopic Mucosal Improvement in Patients with Active Crohn's Disease Treated With Certolizumab Pegol. Colombel J. Am J Gastroenterol. 2008;103:S-132(1107).