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Accepted Manuscript Efficacy of Ustekinumab in Inducing Endoscopic Healing in Patients with Crohn’s Disease Paul Rutgeerts, Christopher Gasink, Daphne Chan, Yinghua Lang, Paul Pollack, Jean-Frederic Colombel, Douglas C. Wolf, Douglas Jacobstein, Jewel Johanns, Philippe Szapary, Omoniyi J. Adedokun, Brian G. Feagan, William J. Sandborn PII: S0016-5085(18)34655-9 DOI: 10.1053/j.gastro.2018.06.035 Reference: YGAST 61941 To appear in: Gastroenterology Accepted Date: 8 June 2018 Please cite this article as: Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel J-F, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ, Efficacy of Ustekinumab in Inducing Endoscopic Healing in Patients with Crohn’s Disease, Gastroenterology (2018), doi: 10.1053/j.gastro.2018.06.035. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. ACCEPTED MANUSCRIPT Target Journal: Gastroenterology Rutgeerts P Efficacy of Ustekinumab in Inducing Endoscopic Healing in Patients with Crohn’s Disease Short title: Ustekinumab for Endoscopic Healing in Patients with Crohn’s Disease Paul Rutgeerts,1 Christopher Gasink, 2 Daphne Chan, 2 Yinghua Lang, 2 Paul Pollack, 2 Jean- Frederic Colombel, 3 Douglas C Wolf, 4 Douglas Jacobstein, 2 Jewel Johanns, 2 Philippe Szapary,2 Omoniyi J Adedokun, 2 Brian G Feagan, 5 William J Sandborn 6 1 University Hospital Gasthuisberg, Leuven, Belgium; 2Janssen Research &Development, LLC, Spring House, PA; 3The Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY; 4Atlanta Gastroenterology Associates, Atlanta, GA; 5Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada, 6 University of California San Diego, La Jolla, CA MANUSCRIPT Grant Support: This study was funded by Janssen Research & Development, LLC (Spring House, PA). This study was designed and conducted by the UNITI-1, -2, and IM-UNITI Steering Committee, Janssen Pharmaceutical Research & Development, LLC who jointly analyzed and interpreted the data, and contributed to the manuscript: Dr. Rutgeerts prepared the first draft of the manuscript, and the UNITI-1, -2, and IM-UNITI Steering Committee made the decision to publish. Abbreviations used in this paper: CD, Crohn’s disease; CDAI, Crohn’s disease activity index; CI, confidence ACCEPTEDinterval; CRP, C-reactive protein; IBD, inflammatory bowel disease; IV, intravenous; SC, subcutaneous; SES-CD, simplified endoscopic activity scores for Crohn’s disease; TNF, tumor necrosis factor; q8w, every 8 weeks; q12w, every 12 weeks Page 1 of 40 ACCEPTED MANUSCRIPT Target Journal: Gastroenterology Rutgeerts P Address for Correspondence: Paul Rutgeerts, MD, PhD Universitaire Ziekenhuizen Leuven, Inwendige Geneeskunde, UZ Gasthuisberg; Herestraat 49 – B-3000, Leuven, Belgium; Telephone: 32-16-344225; Fax: 32-16-344419; Email: [email protected] The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and data analysis. Financial Disclosure/Potential Financial/Nonfinancial Conflicts of Interest: Author disclosures: Paul Rutgeerts has received consulting fees from AbbVie Laboratories, Janssen Research & Development, LLC, Merck Research Laboratories, MerckSerono, UCB Pharma, Millenium/Takeda, Galapagos, Pfizer, Genentech/HoffMANUSCRIPTman LaRoche, Neovacs, Bristol Myers Squibb, Robarts, Tillotts, Pfizer, and Falk Pharma; served as a Scientific Advisory Board member for AbbVie Laboratories, Janssen Research & Development, LLC, Merck Research Laboratories, MerckSerono, UCB Pharma, Millenium/Takeda, Galapagos, Pfizer, Genentech/Hoffman LaRoche, Neovacs, Bristol Myers Squibb, Robarts, Tillotts, Pfizer, and Falk Pharma; received payments for lectures/speakers bureau from AbbVie Laboratories, Janssen Research & Development, Merck Research Laboratories; and research grants from AbbVie Laboratories, Janssen Research & Development, Merck Research Laboratories. ACCEPTED Jean-Frederic Colombel has received consulting fees from AbbVie, Amgen, Boehringer- Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen Research & Development, LLC, Medimmune, Merck & Co., Pfizer, Protagonist, Second Genome, Seres, Page 2 of 40 ACCEPTED MANUSCRIPT Target Journal: Gastroenterology Rutgeerts P Shire, Takeda, Theradiag, Theravance Biopharma; served as a Scientific Advisory Board member for AbbVie, Amgen, Boehringer-Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen Research & Development, LLC, Medimmune, Merck & Co., Pfizer, Protagonist, Second Genome, Seres, Shire, Takeda, Theradiag, Theravance Biopharma; received payments for lectures/speakers bureau from AbbVie, Amgen, Boehringer-Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen Research & Development, LLC, Medimmune, Merck & Co., Pfizer, Protagonist, Second Genome, Seres, Shire, Takeda, Theradiag, Theravance Biopharma; and research grants from AbbVie, Takeda, Janssen Research & Development, LLC; and stock options from Intestinal Biotech Development, Genfit. Douglas C Wolf has received consulting fees from AbbVie, Celgene, Daiichi Sankyo, Janssen Research & Development, LLC, Prometheus, Salix, Takeda and UCB Pharma; speaker fees from AbbVie, Daiichi Sankyo, Janssen Research & DevelopmMANUSCRIPTent, LLC, Takeda, and UCB Pharma; research support from AbbVie, Celgene, Genentech, Luitpold, Janssen Research & Development, LLC, Prometheus Laboratories, Salix, Takeda, and UCB Pharma. Brian G Feagan has received consulting fees from Abbott/AbbVie, Ablynx, Actogenix, Akebia Therapeutics, Akros, Albireo Pharma, Allergan, Amgen, Applied Molecular Transport Inc., Astra Zeneca, Atlantic Pharma, Avaxia Biologics Inc., Avir Pharma, Baxter Healthcare Corp., Biogen Idec, Boehringer-Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Roche/Genentech, Galapagos, GiCare Pharma, Gilead, Given Imaging ACCEPTEDInc., GSK, Inception IBD Inc, Ironwood Pharma, /Janssen Research & Development, LLC, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nektar, Nestles, Nextbiotix, Novonordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Progenity, Protagonist, Receptos, Roche/Genentech, Salix Page 3 of 40 ACCEPTED MANUSCRIPT Target Journal: Gastroenterology Rutgeerts P Pharma, Serano, Shire, Sigmoid Pharma, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, Vivelix Pharma, VHsquared Ltd., Warner-Chilcott, Wyeth, Zealand, Zyngenia; grant/research support from AbbVie Inc., Amgen Inc., AstraZeneca/MedImmune Ltd., Atlantic Pharmaceuticals Ltd., Boehringer-Ingelheim, Celgene Corporation, Celltech, Genentech Inc/Hoffmann-La Roche Ltd., Gilead Sciences Inc., GlaxoSmithKline (GSK), Janssen Research & Development LLC., Pfizer Inc., Receptos Inc./Celgene International, Sanofi, Santarus Inc., Takeda Development Center Americas Inc., Tillotts Pharma AG, UCB; served as a Scientific Advisory Board member for Abbott/AbbVie, Allergan, Amgen, Astra Zeneca, Atlantic Pharma, Avaxia Biologics Inc., Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Ferring, Galapagos, Genentech/Roche, Janssen Research & Development, LLC, Merck, Nestles, Novartis, Novonordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Takeda, Teva, TiGenix, Tillotts Pharma AG, UCB Pharma; MANUSCRIPThas been on the Speakers Bureau for Abbott/AbbVie, Janssen Research & Development, LLC, Lilly, Takeda, Tillotts, and UCB Pharma; and is a member of the Board of Directors for Robarts Clinical Trials Inc, Western University, London. William J Sandborn reports grants, personal fees and non-financial support from Abbvie; grants and personal fees from Prometheus Laboratories, grants and personal fees from AbbVie, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Takeda, grants and personal fees fromACCEPTED Atlantic Pharmaceuticals, grants and personal fees from Janssen Research & Development, LLC, grants and personal fees from Bristol-Myers Squibb, grants and personal fees from Genentech, grants and personal fees from Nutrition Science Partners, personal fees from Kyowa Hakko Kirin, personal fees from Millennium Pharmaceuticals, personal fees from Page 4 of 40 ACCEPTED MANUSCRIPT Target Journal: Gastroenterology Rutgeerts P Celgene Cellular Therapeutics, personal fees from Santarus, personal fees from Salix Pharmaceuticals, personal fees from Catabasis Pharmaceuticals, personal fees from Vertex Pharmaceuticals, personal fees from Warner Chilcott, personal fees from Gilead Sciences, personal fees from Cosmo Pharmaceuticals, personal fees from Ferring Pharmaceuticals, personal fees from Sigmoid Biotechnologies, personal fees from Tillotts Pharma, personal fees from Am Pharma BV, personal fees from Dr. August Wolff, personal fees from Avaxia Biologics, personal fees from Zyngenia, personal fees from Ironwood Pharmaceuticals, personal fees from Index Pharmaceuticals, personal fees from Nestle, personal fees from Lexicon
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    Journal of Crohn's and Colitis, 2018, S641–S652 doi:10.1093/ecco-jcc/jjx145 Review Article Review Article Chemokines and Chemokine Receptors as Therapeutic Targets in Inflammatory Bowel Disease; Pitfalls and Promise Palak J. Trivedia,b,c,d, David H. Adamsa,b aNational Institute for Health Research (NIHR) Birmingham, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK bLiver Unit, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Birmingham, UK cDepartment of Gastroenterology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Birmingham, UK dCentre for Rare Diseases, Institute of Translational Medicine, University of Birmingham, Birmingham, UK Corresponding author: Prof. David H. Adams, MD, FRCP, FMedSci, National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre (BRC), Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK. Email: [email protected] Abstract The principal targets for anti-chemokine therapy in inflammatory bowel disease (IBD) have been the receptors CCR9 and CXCR3 and their respective ligands CCL25 and CXCL10. More recently CCR6 and its ligand CCL20 have also received attention, the expression of the latter in enterocytes being manipulated through Smad7 signalling. These pathways, selected based on their fundamental role in regulating mucosal immunity, have led to the development of several therapeutic candidates that have been tested in early phase clinical