Original ResearchFull Report: Clinical—Alimentary TractDevelopment of the Lémann Index to Assess Digestive Tract Damage in Patients With Crohn's Disease
Section snippets
Methods
The study was run by the International Program to Develop New Indexes in Crohn’s Disease (IPNIC) group, which is an international working group including 28 gastroenterologists from 15 countries, 1 surgeon, 2 radiologists, and 1 biostatistician.
Patients and Investigators
From August 2008 to December 2010, 381 patients were enrolled in 20 centers and 24 sets (4 centers were allowed to recruit a new set of 10 patients after having recruited a first set). As shown on the patient flow chart (Supplementary Figure 1), 83 patients were excluded due to at least one major protocol deviation: lack of at least one mandatory investigation according to CD location at enrollment (n = 73) or time interval between the first and the last investigational methods >120 days (n =
Discussion
The Lémann Index is the first tool that measures the cumulative bowel damage by using resections and the extent and severity of lesions in the digestive tract of CD patients. In contrast to other indexes that are based only on clinical or endoscopic data and assess the severity of inflammatory activity at a specific time and fluctuate with time, the Lémann Index is more likely to increase with the longer disease duration by assessing irreversible bowel damage along with accumulation of
Acknowledgments
The authors would like to honor the memory of their friend, Prof Marc Lémann, who initiated this study.
The IPNIC Group: Walter Reinisch, Herbert Tilg (Austria), Michael Kamm (Australia), Geert D’Haens, Edouard Louis, Paul Rutgeerts, Gert Van Assche (Belgium), Brian G. Feagan (Canada), Pia Munkholm (Denmark), Jean-Frédéric Colombel, Jacques Cosnes, Maïté Lewin, Jean-Yves Mary, Benjamin Pariente, Laurent Peyrin-Biroulet (France), Jürgen Schölmerich, Stefan Schreiber (Germany), Silvio Danese,
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Conflict of interests These authors disclose the following: Benjamin Pariente has received speaker fees from AbbVie and MSD. Jean-Yves Mary has received lecture and consultation fees from AbbVie and Janssen and consultation fees from Pharmacosmos. Silvio Danese is a speaker, consultant, and advisory board member for Schering-Plough, Abbott Laboratories, Merck & Co, UCB Pharma, Ferring, Cellerix, Millenium Takeda, Nycomed, Pharmacosmos, Actelion, Alphawasserman, Genentech, Grunenthal, Pfizer, Astra Zeneca, Novo Nordisk, Cosmo Pharmaceuticals, Vifor, and Johnson and Johnson. Geert D’Haens has received consulting and/or lecture fees from AbbVie, ActoGeniX, AM Pharma, Boehringer Ingelheim GmbH, Centocor, ChemoCentryx, Cosmo Technologies, Elan Pharmaceuticals, Engene, Dr Falf Pharma, Ferring, Galapagos, Giuliani SpA, Given Imaging, GlaxoSmithKline, Jansen Biologics, Merck Sharp and Dohme Corp, Millennium Pharmaceuticals Inc. (now Takeda), Neovacs, Novonordisk, Otsuka, PDL Biopharma, Pfizer, Receptos, Salix, Setpoint, Shire Pharmaceuticals, Schering-Plough, Tillotts Pharma, UCB Pharma, Versant and Vifor Pharma; research grants from Abbott Laboratories, Jansen Biologics, Given Imaging, MSD, DrFalk Pharma, Photopill; and speaking honoraria from Abbott Laboratories, Tillotts, Tramedico, Ferring, MSD, UCB, Norgine, and Shire. Edward V. Loftus Jr has received consulting fees from AbbVie, UCB, Janssen, Takeda, Immune Pharmaceuticals and research/grant support from AbbVie, UCB, Janssen, Takeda, Amgen, Bristol-Myers Squibb, Braintree, Genentech, Pfizer, Shire, GlaxoSmithKline, and Robarts Clinical Trials. Edouard Louis has received research grant from AstraZeneca, Schering-Plough, and Abbott; served on advisory boards at Abbott, AbbVie, Ferring, UCB, MSD, Millenium, Mitsubishi Pharma, and Takeda; and a consultant for AbbVie. Julian Panés has received consulting fees from AbbVie, Boehringer Ingelheim, BMS, Genentech, MSD, Novo-Nordisk, NSP, Pfizer, Roche, Topivert, and Tygenix. Jürgen Schölmerich has received consultancy fees from AbbVie and Falk Pharma (last 3 years). Stefan Schreiber has received consulting and speaker fees from AbbVie. Maurizio Vecchi has received financial support for research from Giuliani Pharma and Sofar and consulting fees from Nycomed, MSD, AbbVie, Hospira, and Ferring. Gionata Fiorino has received consultancy fees from MSD, AbbVie, Takeda and Janssen Pharmaceuticals. Michael A. Kamm is a consultant for AbbVie, Janssen, and Ferring and has received research support from AbbVie and Ferring. Ingrid Ordas has received grant support from AbbVie and FAES Farma and consultation fees from Prometheus and Shire. Jordi Rimola received grant support from AbbVie and Bristol Meyers Squibb; speaker fees from AbbVie, MSD, Bristol Meyers Squibb, and Genentech (Roche group); and is a consultant for AbbVie and Robarts medical trials. Maria Nachury has received consulting fees from AbbVie and Tigenix. William Sandborn has received consulting fees from ActoGeniX NV, AGI Therapeutics, Inc., Alba Therapeutics Corporation, Albireo, Alfa Wasserman, Amgen, AM-Pharma BV, Anaphore, Astellas Pharma, Athersys, Inc., Atlantic Healthcare Limited, Axcan Pharma (now Aptalis), BioBalance Corporation, Boehringer-Ingelheim Inc, Bristol Meyers Squibb, Celgene, Celek Pharmaceuticals, Cellerix SL, Cerimon Pharmaceuticals, ChemoCentryx, CoMentis, Cosmo Technologies, Coronado Biosciences, Cytokine Pharmasciences, Eagle Pharmaceuticals, Eisai Medical Research Inc., Elan Pharmaceuticals, EnGene, Inc., Eli Lilly, Enteromedics, Exagen Diagnostics, Inc., Ferring Pharmaceuticals, Flexion Therapeutics, Inc., Funxional Therapeutics Limited, Genzyme Corporation, Genentech (now Roche), Gilead Sciences, Given Imaging, Glaxo Smith Kline, Human Genome Sciences, Ironwood Pharmaceuticals (previously Microbia Inc.), Janssen (previously Centocor), KaloBios Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Lycera Corporation, Meda Pharmaceuticals (previously Alaven Pharmaceuticals), Merck Research Laboratories, MerckSerono, Millennium Pharmaceuticals (subsequently merged with Takeda), Nisshin Kyorin Pharmaceuticals Co., Ltd., Novo Nordisk A/S, NPS Pharmaceuticals, Optimer Pharmaceuticals, Orexigen Therapeutics, Inc., PDL Biopharma, Pfizer, Procter and Gamble, Prometheus Laboratories, ProtAb Limited, Purgenesis Technologies, Inc., Receptos, Relypsa, Inc., Salient Pharmaceuticals, Salix Pharmaceuticals, Inc., Santarus, Schering Plough Corporation (acquired by Merck), Shire Pharmaceuticals, Sigmoid Pharma Limited, Sirtris Pharmaceuticals, Inc. (a GSK company), S.L.A. Pharma (UK) Limited, Targacept, Teva Pharmaceuticals, Therakos, Tillotts Pharma AG (acquired by Zeria Pharmaceutical Co., Ltd), TxCell SA, UCB Pharma, Viamet Pharmaceuticals, Vascular Biogenics Limited (VBL), Warner Chilcott UK Limited, and Wyeth (now Pfizer). Jean-Frédéric Colombel is a consultant, advisory board member, or speaker for AbbVie Amgen, Bristol Meyers Squibb, Celltrion, Ferring, Genentech, Giuliani SPA, Given Imaging, Janssen and Janssen, Merck & Co., Millenium Pharmaceuticals Inc., Nutrition Science Partners Ltd., Pfizer Inc. Prometheus Laboratories, Receptos, Sanofi, Schering Plough Corporation, Takeda, Teva Pharmaceuticals, UCB Pharma, Vertex, Dr. August Wolff GmbH & Co; has received lecture fees from Bristol Meyers Squibb, and Janssen (previously Centocor) and research support from Bristol Meyers Squibb, Genentech, Glaxo Smith Kline, Janssen (previously Centocor), Millennium Pharmaceuticals (now Takeda), Novartis, Pfizer, Procter and Gamble Pharmaceuticals, Shire Pharmaceuticals, and UCB Pharma. Jacques Cosnes has received consultancy fees from AbbVie. The remaining authors disclose no conflicts.
Funding This study was conducted by the IPNIC group (see Acknowledgments). AbbVie provided funding to the IPNIC group, including honoraria for their attendance at IPNIC meetings. No payments were made to the authors for the development of this article. AbbVie participated in developing the content for the IPNIC meetings, but was not involved in the development or review of this article with the authors or the vendor. Medical writing and editing services (including for the slides at the IPNIC meetings) were provided by Margaux-Orange, and financial support for these services was provided by AbbVie.