top - down vs step - up trial endoscopic substudy: mucosal healing
DESCRIPTION
Top - Down vs Step - Up Trial Endoscopic Substudy: Mucosal Healing. PTRANSCRIPT
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Top-Down vs Step-Up TrialEndoscopic Substudy: Mucosal Healing
Pat
ien
ts,
%
88
71
47
30
P<0.001
P<0.001
0
20
40
60
80
100
Reductionof Ulcers
Disappearanceof Ulcers
Early combined immunosuppression (top-down; n=66)
Conventional management (step-up; n=67)
D’Haens G, et al. Lancet. 2008;371:660-667.
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Mucosal Healing Predicts Sustained Clinical Remission in Early CD
Simple endoscopic score 0Simple endoscopic score 1-9
20
40
60
80
100
Pat
ien
ts, %
0Remission Remission,
No SteroidsRemission, No Steroids,
No Flare
Remission, No Steroids,
No Flare, No Anti-TNF
a bbb
a P<0.05; b P<0.01 (Fischer’s exact)Baert FJ, et al. Presented at Digestive Disease Week. May 17-22, 2008; San Diego, CA; #W1133.
• Patients in remission at years 3 and 4
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SONICMucosal Healing at Week 26
16.5
30.1
43.9
0
20
40
60
80
100
Pat
ien
ts,
%
P<0.001
P=0.023 P=0.055
18/109 28/93 47/107
AZA + placeboIFX + placeboIFX+ AZA
Sandborn WJ, et al. Presented at American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course. October 3-8, 2008; Orlando, FL.
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The MUSIC TrialEndoscopic Mucosal Lesion Healing
With Certolizumab Pegol
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).
55.1
74.4
46.1
0
10
20
30
40
50
60
70
80
Rem
issi
on
an
d
Res
po
nse
Rat
es,
%
Response, CDEISc Remission, CDEISa
Remission, CDAIb
• Observed improvement in endoscopic and histologic lesions