Measuring severity of disease and defining treatment benefit using the Simple Endoscopic Activity Score (SES-CD)

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1 Measuring severity of disease and defining treatment benefit using the Simple Endoscopic Activity Score (SES-CD) Jean-Frederic COLOMBEL Icahn Medical School at Mount Sinai, New York

2 J-F Colombel has served as consultant or advisory board member for Abbvie, ABScience, Amgen, Bristol Meyers Squibb, Celltrion, Danone, Ferring, Genentech, Giuliani SPA, Given Imaging, Janssen, Immune Pharmaceuticals, Medimmune, Merck & Co., Millenium Pharmaceuticals Inc., Neovacs, Nutrition Science Partners Ltd., Pfizer Inc. Prometheus Laboratories, Protagonist, Receptos, Sanofi, Schering Plough Corporation, Second Genome, Shire, Takeda, Teva Pharmaceuticals, Tigenix, UCB Pharma, Vertex, Dr. August Wolff GmbH & Co. J-F Colombel has served as speaker for Abbvie, Falk, Ferring, Janssen, Merck & Co., Nutrition Science Partners Ltd., Takeda. 2

3 The CDEIS Deep ulcerations 12 points Superficial ulcerations 6 points Surface of ulcerations (0-10 cm) Surface of lesions* (0-10 cm) Ileum 0 or 12 0 or Right colon 0 or 12 0 or Transverse 0 or 12 0 or Left colon 0 or 12 0 or Rectum 0 or 12 0 or TOTAL (sum of all cases) TOTAL/number of explored segments N/ if ulcerated stenosis if nonulcerated stenosis 0-3 CDEIS : 0 to 44 Mary JY et al. Gut 1989 N : pseudopolyp healed ulcer frank erythema frankly swollen mucosa aphtoid ulcers : 2-3mms 3

4 Development of SES-CD The Simple Endoscopic Score for Crohn s Disease (SES-CD), was developed in 2004 and was: an attempt to simplify the CDEIS based on importance and reproducibility of the most relevant endoscopic characteristics of CD. Daperno M et al. Gastrointest. Endosc

5 THE SIMPLE ENDOSCOPIC SCORE FOR CD (SES-CD) Definition - scoring of elementary lesions considered SES-CD values (evaluated for each of the 5 ileo-colonic segments) Variable Size of ulcers Ulcerated surface Affected surface Presence of narrowings Unaffected segment Daperno et al. Gastrointest Endosc

6 THE SIMPLE ENDOSCOPIC SCORE FOR CD (SES-CD) Definition - scoring of elementary lesions considered SES-CD values (evaluated for each of the 5 ileo-colonic segments) Variable Size of ulcers Aphtous ulcers ( 0.1 to 0.5 cm) Large ulcers ( 0.5 to 2 cm) Very large ulcers ( >2 cm) Ulcerated surface Affected surface Unaffected segment Presence of narrowings Daperno et al. Gastrointest Endosc

7 THE SIMPLE ENDOSCOPIC SCORE FOR CD (SES-CD) Definition - scoring of elementary lesions considered SES-CD values (evaluated for each of the 5 ileo-colonic segments) Variable Size of ulcers Aphtous ulcers ( 0.1 to 0.5 cm) Large ulcers ( 0.5 to 2 cm) Very large ulcers ( >2 cm) Ulcerated surface <10% 10-30% >30% Affected surface Presence of narrowings Unaffected segment Daperno et al. Gastrointest Endosc

8 THE SIMPLE ENDOSCOPIC SCORE FOR CD (SES-CD) Definition - scoring of elementary lesions considered SES-CD values (evaluated for each of the 5 ileo-colonic segments) Variable Size of ulcers Aphtous ulcers ( 0.1 to 0.5 cm) Large ulcers ( 0.5 to 2 cm) Very large ulcers ( >2 cm) Ulcerated surface <10% 10-30% >30% Affected surface Presence of narrowings Unaffected segment <50% 50-75% >75% Daperno et al. Gastrointest Endosc

9 THE SIMPLE ENDOSCOPIC SCORE FOR CD (SES-CD) Definition - scoring of elementary lesions considered SES-CD values (evaluated for each of the 5 ileo-colonic segments) Variable Size of ulcers Aphtous ulcers ( 0.1 to 0.5 cm) Large ulcers ( 0.5 to 2 cm) Very large ulcers ( >2 cm) Ulcerated surface <10% 10-30% >30% Affected surface Unaffected segment <50% 50-75% >75% Presence of narrowings Single, can be passed Multiple, can be passed Cannot be passed Daperno et al. Gastrointest Endosc 2004 Daperno et al. Gastrointest Endosc 2004; 60:

10 THE SIMPLE ENDOSCOPIC SCORE FOR CD (SES-CD) Ileum Right colon Transverse colon Left colon Rectum Total Presence and size of ulcers (0-3) Extent of ulcerated surface (0-3) Extent of affected surface (0-3) Presence and type of narrowings (0-3) SES-CD = 0-56 Daperno et al. Gastrointest Endosc

11 Correlation between CDEIS and SES-CD Sipponen T et al. Inflam Bowel Dis

12 Definition of endoscopic severity using SES-CD Endoscopic severity with SES-CD (in 4 of 11 studies)* : remission (inactive) (0-2) mild inflammation (3-6) moderate inflammation (7-15) severe inflammation (> or =16) * In total 6 different cut-off definitions, but 6 of 11 studies used similar cutoffs Vuiiton L et al. in preparation 12

13 SES-CD grading vs CDEIS grading SES-CD overestimates severity vs CDEIS in inactive / mild CD Sipponen T et al. Inflam Bowel Dis

14 Definition of endoscopic response with SES-CD Authors Journal Year Definition of response Sipponen et al. Scand J Gastroenterol 2010 A partial response as a one-class change in the SES-CD (inactive 0-2; mild 3-6; moderate 7-15; severe > or =16) Ferrante et al. (SONIC post hoc) Gastroenterology 2013 Decrease from baseline in SES-CD of at least 50%. Grover et al. J Gastroenterol 2014 Absolute score SES-CD 0-3 was defined as a response 14

15 Endoscopic response at wk 26 predicts corticoid-free remission at wk 50 in CD (SONIC) Roc Curve for detecting corticoid-free remission at wk 50 using the SES-CD % reduction from baseline to wk 26 Roc Curve for detecting corticoid-free remission at wk 50 using the CDEIS % reduction from baseline to wk 26 Endoscopic response (defined as a decrease from baseline in SES-CD or CDEIS of at least 50%) at week 26 identified patients most likely to be in CFREM at week 50 Ferrante M, et al. Gastroenterology;

16 Definition of endoscopic response with SESCD Endoscopic response using SES-CD* A decrease from baseline in SES-CD of at least 50%. 1 * In total 3 different definitions in 3 studies 1 Ferrante et al. GASTROENTEROLOGY

17 Definition of endoscopic remission using SES-CD Authors Journal Year Definition of Remission Moskovitz et al. Gastroenterology 2007 score 0 Sipponen et al. Aliment Pharmacol Ther 2008 score <3 Baert et al. Gastroenterology 2010 score 0 Sipponen et al. Scand J Gastroenterol 2010 score 0 2 or a two- or three-class decrease in the SES-CD from the baseline score ( i.e. change from endoscopically severely active disease to mildly active or inactive or from moderately active to inactive). Aomatsu et al. Aliment Pharmacol Ther 2011 score 0 Aomatsu et al. Dig Dis Sci 2011 score 0 af Björkesten et al. Scand J Gastroenterol 2013 score 0-2 Molander et al. J Crohns Colitis 2013 score 0-2 Beigel et al. PLoS One 2014 score 0 Fukuchi et al. BMC Gastroenterol 2014 score 0 Yüksel et al. Turk J Gastroenterol 2014 score 0-2 Yu et al. J Dig Dis 2014 score 0 Schaffer et al. J Crohns Colitis 2014 score 0-3 Dignass et al. J Crohns Colitis 2014 score 0 17

18 Definition of endoscopic remission/mh using SES-CD Endoscopic remission/mh most frequently defined as* SES-CD score 0 (8 studies) or SES-CD score 0-2 (4 studies) * In total 4 different cut-off definitions in 14 studies 18

19 IOIBD recommendations on endoscopic indices Methods of the IOIBD Consensus 12 IBD experts from 9 countries Literature reviewing Extracted definitions of endoscopic outcome parameters for remission and response in UC and CD Delphi process based on an internet survey At each voting step, participants blinded from others Vuiiton L et al. in preparation 19

20 IOIBD recommendations on endoscopic response For the definition of endoscopic response in CD retained for vote were : 1. Any improvement in edema, erythema, ulcers and strictures 2. Only mucosal patchy erythema or superficial ulceration ; 3. Near complete healing: erosions if previous large ulcers/partial healing if >33% reduction in ulcer size 4. Decrease in CDEIS (with no definition) 5. Decrease in CDEIS > 5 6. Decrease in SES-CD (ND) 7. Decrease in CDEIS of at least 3 points 8. >75 % decrease in CDEIS 9. > 50% decrease in SES-CD or CDEIS 10. Decrease in CDEIS > 4 or 5 20

21 IOIBD recommendations on endoscopic response For the 10 proposed definitions of endoscopic response in CD at the first vote 11 out of 12 investigators ranked first > 50% decrease in SES-CD No second round was organized due to the high agreement in the first voting round. 21

22 IOIBD recommendations on endoscopic remission 1. For definition of endoscopic remission in CD: 1. Physician assessment of endoscopic healing 2. Absence of edema, erythema, ulcers and strictures 3. No lesion, only scarred lesions, or minor lesions with no deep ulceration 4. Normal mucosa, scarring or pseudo polyps 5. Complete healing : no endoscopic lesion 6. Near complete healing: only aphtous ulcers <5mm 7. Endoscopic remission :CDEIS < 6 / Complete endoscopic remission : CDEIS <3 8. Absence of ulceration 9. Complete healing: resolution of all lesions/ Near complete healing :occasional aphthae, residual erosion, thickened folds 10. SES-CD : CDEIS score of 4 or less 12. CDEIS < 6 or 7 * No proposed definition of SES-CD = 0 22

23 IOIBD recommendations on endoscopic remission For the 12 proposed definitions of endoscopic remission in CD, the four definitions with the highest rank after the 1 st vote were : (1) SES-CD 0-2 (2) remission: CDEIS < 6 / complete remission : CDEIS <3 (3) absence of ulceration (4) CDEIS score of 4 or less. At the second vote the highest median score was : SES-CD 0-2 (median1, mean1.33, SD 0.49), with 100 % of the experts ranking this definition first or second. 23

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