Prsentation PowerPoint

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ENDOSCOPIC REMISSION AND RESPONSE IN CROHNS
DISEASE AN OBJECTIVE DEFINITION USING THE CDEIS
JY Mary, M Lémann, JF Colombel, E Lerebours, JC
Soulé, JP Gendre, R Modigliani, and the GETAID
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Endoscopic assessment of disease activity in
Crohns disease

• Endoscopy is an important tool for management of
  patients with Crohns disease in daily practice
• Mucosal healing has become a major endpoint in
  clinical trials
• Quantitative assessment of mucosal lesions must
  be reproducible and validated

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Crohns Disease Endoscopic Index of Severity
(CDEIS)

• Developed to quantify endoscopic severity in
  patients with ileocolonic CD
• Reproducibility elementary lesions, involved and
  ulcerated surfaces, overall severity (133
  colonoscopies). Modigliani et al. Dis Dis Sci
  1987 321370-9
• 2. CDEIS construction linear combination of
  elementary lesions and surfaces correlated to
  overall severity evaluation (75
  colonoscopies) Mary JY et al. Gut 1989
  30983-9
• 3. CDEIS validation
• Use of CDEIS in an independent population (103
  colonoscopies)
• CDEIS variations in 54 patients treated by 3-7
  weeks of corticosteroids
• Modigliani et al. Gastroenterology 1990
  98811-8 Landi et al. Gastroenterology 1992
  1021647-53

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CDEIS definition of remission and response

• Which is the CDEIS level that could be used to
  define endoscopic remission ?
• Which is the CDEIS change that could be regarded
  as indicative of a clinically significant
  endoscopic response ?

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Methods
Data from 5 prospective GETAID studies 562
colonoscopies performed in 231 patients (CDAI
162 127)
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1. Endoscopic remission
All colonoscopies were included (n562)
One colonoscopy/patient selected -
priority to lower grade - random
selection among colonoscopies of the same grade
(ifgt1/pt) ? 227 colonoscopiesDefinitions
of remission using the 5-grade scale . No
lesion or scars (complete mucosal healing)
. No lesion, scars or minor lesions Sensitivity
of patients well classified by a CDEIS lower
than the cutoff value among patients in
endoscopic remissionSpecificity of patients
well classified by a CDEIS higher than the cutoff
value among patients not in endoscopic remission
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Endoscopic remission no lesions or scars
Sensitivity (Se) and Specificity (Sp) for a CDEIS
level lower than the cutoff value
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25
Grade 2-5 minor, moderate, severe or very severe
lesions
Grade 0-1 no lesion or scars
C D E I S
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of patientswith CDEIS lt 3 SENSITIVITY 80
of patientswith CDEIS gt 3 SPECIFICITY 85
15
10
5
cutoff Value3
0
0 5 10
0 5 10 15 20 25 30
Number of patients
CDEIS mean SD 1.4 1.8 9.7
6.5 median 0.5 8.8 n colonoscopies 65 162
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Endoscopic remission no lesions, scars, or minor
lesions
Sensitivity (Se) and Specificity (Sp) for a CDEIS
level lower than the cutoff value
S e n s i t i v i t y
7.0
6.5
6.0
1 - S p e c i f i c i t y
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Grade 0-2 No lesion, scars or minor lesions
Grade 3-5 Moderate, severe or very severe lesions
25
C D E I S
20
of patientswith CDEIS gt 6 SPECIFICITY 88
of patientswith CDEIS lt 6 SENSITIVITY 86
15
10
cutoff value 6
5
0
0 5
0 5 10 15 20 25 30
Number of patients
CDEIS level mean SD 3.1 2.7 12.9
5.9 median 2.8 12.1 n colonoscopies 155 72
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2. Endoscopic response (CDEIS improvement)
Pts with 2 colonoscopies were included (n142)
? 384 colonoscopiesDefinition of response
using the 5-grade scale decrease by 1
grade Sensitivity of patients well classified
by a ?-CDEIS higher than the cutoff value among
patients with endoscopic responseSpecificity
of patients well classified by a ?-CDEIS lower
than the cutoff value among patients without
endoscopic response
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Endoscopic response (CDEIS change)
Sensitivity (Se) and Specificity (Sp) for a
?-CDEIS higher than the cutoff value
S e n s i t i v i t y
5.0
4.5
4.0
1 - S p e c i f i c i t y
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? C D E I S
20.0
Stability or increase on the 5-grade scale
Decrease 1 on the 5-grade scale
17.5
15.0
of patientswith ?-CDEIS lt 4.5 SPECIFICITY 79
of patientswith ?-?CDEIS gt4.5 SENSITIVITY 77
12.5
10.0
7.5
5.0
cutoff value4.5
2.5
0
0 5 10
0 5 10 15
Number of patients
?-CDEIS mean SD 1.3 4.0 8.5
5.8 median 1.3 7.6 n patients 38 107
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Conclusion
Our data suggest that the CDEIS could be used to
define Endoscopic remission as . no lesion
or scars (complete mucosal healing) using a
CDEIS cutoff value of 3 or 3.5 . no
lesions, scars or minor lesions using a CDEIS
cutoff value of 6 or 7 Endoscopic
response as a CDEIS change of 4 or 5
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CDEIS
TOTAL (sum of all cases) N TOTAL/number of
explored segments N/1-5 3 if ulcerated
stenosis 0-3 3 if nonulcerated
stenosis 0-3 CDEIS  0 to 44
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CDEIS
Estimates of segmental areas involved by disease
and by ulcerations reported on a 10 cm linear
scale
Ileum ulcerations lesions Right
colon ulcerations lesions Transverse ulceratio
ns lesions Left colon ulcerations lesions
Rectum ulcerations lesions
x
x
0
10 cm
The number of cm of intestine involved by lesions
and ulcerations on each scale is measured and
reported on the two last columns of the table
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Bootstrap sampling