TY - JOUR
T1 - Validation and update of the Lémann Index to measure cumulative structural bowel damage in Crohn's disease
AU - Pariente, Benjamin
AU - Torres, Joana
AU - Burisch, Johan
AU - Arebi, Naila
AU - Barberio, Brigida
AU - Duricova, Dana
AU - Ellul, Pierre
AU - Goldis, Adrian
AU - Kaimakliotis, Ioannis
AU - Katsanos, Konstantinos
AU - Krznaric, Željko
AU - McNamara, Deirdre
AU - Pedersen, Natalia
AU - Sebastian, Shaji
AU - Azahaf, Mustapha
AU - Weimers, Petra
AU - Lung, Philip
AU - Lacognata, Carmelo
AU - Horak, Martin
AU - Christodoulou, Dimitrios
AU - Domislovic, Viktor
AU - Murphy, Ian
AU - Lambert, Jérôme
AU - Ungaro, Ryan
AU - Colombel, Jean Frédéric
AU - Mary, Jean Yves
N1 - Funding Information:
Funding This study was partially funded by an Abbvie investigator-initiated study: CROCO (Crohńs disease Cohort Study) and by GEDII (Portuguese Group for the Study of IBD).
Funding Information:
Conflicts of interest These authors disclose the following: B. Pariente: Consulting fees: Abbvie, MSD, Takeda, Janssen, Lilly, Pfizer, Biogaran, Biogen, Mylan, and Sandoz; lecture fees: Abbvie, MSD, Takeda, Janssen, Ferring, Lilly, and Mylan. J. Torres: Consulting fees: Takeda, Janssen; lecture fees: Janssen. J. Burisch: Consulting fees: Abbvie, Janssen-Cilag, Celgene, MSD, Pfizer, Takeda, Tillots Pharma, Samsung Bioepis; grants: MSD, Takeda, Tillots Pharma, Novo Nordisk, and Bristol Myers Squibb. N. Arebi: Consulting fees: Janssen; lecture fees: Pfizer, Janssen. D. Duricova: Lecture fees: Takeda, Janssen, Pfizer. K. Katsanos: Honoraria from Abbvie, Enorasis, Ferring, Janssen, MSD, Shire, Takeda. Z. Krznaric: Consulting fees: Abbvie, MSD, Takeda, Janssen, Fresenius, Mylan, Oktal Pharma and Sandoz; lecture fees: Abbvie, MSD, Takeda, Janssen, Fresenius, Oktal Pharma and Mylan. S. Sebastian: Research grants: Biogen, Takeda, Abbvie, Warner Chilcott, Ferring, MSD, Biohit and Celgene; serves on the advisory boards of Takeda, Abbvie, Merck, Ferring, Pharmacocosmos, Warner Chilcott, Janssen, Falk Pharma, Biohit, TriGenix,Cellgene and Tillots Pharma, and has received speaker fees from Abbvie, Janssen, Merck, Warner Chilcott and Falk Pharma. P. Weimers: Consulting fees: Vifor Pharma Nordiska AB; grants: Ferring l?gemidler and Tillotts Pharma AG; nonfinancial support: Janssen-Cilag A/S, Calpro AS, Pharmacosmos A/S, and Vifor Pharma Nordiska AB. D. Christodoulou: Honoraria: Abbvie, Janssen, Takeda, MSD. R. Ungaro: advisory board member or consultant: Eli Lilly, Janssen, Pfizer, and Takeda; research support: Abbvie, Boehringer Ingelheim, and Pfizer; supported by a National Institutes of Health K23 Career Development Award (K23KD111995-01A1). F. Colombel: reports receiving research grants from Abbvie, Janssen Pharmaceuticals and Takeda; receiving payment for lectures from Abbvie, Amgen, Allergan, BMS, Inc. Ferring Pharmaceuticals, Shire, and Takeda; consulting fees: Abbvie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Celltrion, Eli Lilly, Enterome, Ferring Pharmaceuticals, Geneva, Genentech, Gilead, Iterative Scopes, Ipsen, Imedex, Immunic, lmtbio, Inotrem, Janssen Pharmaceuticals, Landos, LimmaTech Biologics AG, Medimmune, Merck, Novartis, O Mass, Ostuka, Pfizer, Shire, Takeda, J Tigenix, and Viela bio; and hold stock options in Intestinal Biotech Development. Funding This study was partially funded by an Abbvie investigator-initiated study: CROCO (Croh?s disease Cohort Study) and by GEDII (Portuguese Group for the Study of IBD).
Publisher Copyright:
© 2021
PY - 2021/9
Y1 - 2021/9
N2 - Background & Aims: The Lémann Index is a tool measuring cumulative structural bowel damage in Crohn's disease (CD). We reported on its validation and updating. Methods: This was an international, multicenter, prospective, cross-sectional observational study. At each center, 10 inclusions, stratified by CD duration and location, were planned. For each patient, the digestive tract was divided into 4 organs, upper tract, small bowel, colon/rectum, anus, and subsequently into segments, explored systematically by magnetic resonance imaging and by endoscopies in relation to disease location. For each segment, investigators retrieved information on previous surgical procedures, identified predefined strictures and penetrating lesions of maximal severity (grades 1–3) at each organ investigational method (gastroenterologist and radiologist for magnetic resonance imaging), provided segmental damage evaluation ranging from 0.0 to 10.0 (complete resection). Organ resection-free cumulative damage evaluation was then calculated from the sum of segmental damages. Then investigators provided a 0–10 global damage evaluation from the 4-organ standardized cumulative damage evaluations. Simple linear regressions of investigator damage evaluations on their corresponding Lémann Index were studied, as well as calibration plots. Finally, updated Lémann Index was derived through multiple linear mixed models applied to combined development and validation samples. Results: In 15 centers, 134 patients were included. Correlation coefficients between investigator damage evaluations and Lémann Indexes were >0.80. When analyzing data in 272 patients from both samples and 27 centers, the unbiased correlation estimates were 0.89, 0,97, 0,94, 0.81, and 0.91 for the 4 organs and globally, and stable when applied to one sample or the other. Conclusions: The updated Lémann Index is a well-established index to assess cumulative bowel damage in CD that can be used in epidemiological studies and disease modification trials.
AB - Background & Aims: The Lémann Index is a tool measuring cumulative structural bowel damage in Crohn's disease (CD). We reported on its validation and updating. Methods: This was an international, multicenter, prospective, cross-sectional observational study. At each center, 10 inclusions, stratified by CD duration and location, were planned. For each patient, the digestive tract was divided into 4 organs, upper tract, small bowel, colon/rectum, anus, and subsequently into segments, explored systematically by magnetic resonance imaging and by endoscopies in relation to disease location. For each segment, investigators retrieved information on previous surgical procedures, identified predefined strictures and penetrating lesions of maximal severity (grades 1–3) at each organ investigational method (gastroenterologist and radiologist for magnetic resonance imaging), provided segmental damage evaluation ranging from 0.0 to 10.0 (complete resection). Organ resection-free cumulative damage evaluation was then calculated from the sum of segmental damages. Then investigators provided a 0–10 global damage evaluation from the 4-organ standardized cumulative damage evaluations. Simple linear regressions of investigator damage evaluations on their corresponding Lémann Index were studied, as well as calibration plots. Finally, updated Lémann Index was derived through multiple linear mixed models applied to combined development and validation samples. Results: In 15 centers, 134 patients were included. Correlation coefficients between investigator damage evaluations and Lémann Indexes were >0.80. When analyzing data in 272 patients from both samples and 27 centers, the unbiased correlation estimates were 0.89, 0,97, 0,94, 0.81, and 0.91 for the 4 organs and globally, and stable when applied to one sample or the other. Conclusions: The updated Lémann Index is a well-established index to assess cumulative bowel damage in CD that can be used in epidemiological studies and disease modification trials.
KW - Bowel damage
KW - Crohn's disease
KW - Lémann index
KW - Validation
UR - http://www.scopus.com/inward/record.url?scp=85112754959&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2021.05.049
DO - 10.1053/j.gastro.2021.05.049
M3 - Article
C2 - 34052277
AN - SCOPUS:85112754959
SN - 0016-5085
VL - 161
SP - 853-864.e13
JO - Gastroenterology
JF - Gastroenterology
IS - 3
ER -