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OP011

Comparison of adalimumab monotherapy and a combination with azathioprine for patients with Crohns disease: a prospective, multicentre, open-labelled clinical trial (DIAMOND study)

Year: 2016
Authors:

T. Matsumoto*1, S. Motoya2, K. Watanabe3, T. Hisamatsu4, H. Nakase5, N. Yoshimura6, T. Ishida7, S. Kato8, T. Nakagawa9, M. Esaki10, M. Nagahori11, T. Matsui12, Y. Naito13, T. Kanai14, Y. Suzuki15, M. Nojima16, M. Watanabe11, T. Hibi17

1Iwate Medical University, Division of Gastroenterology, Department of Medicine, Morioka, Japan, 2Sapporo Kosei General Hospital, Inflammatory Bowel Disease Centre, Sapporo, Japan, 3Osaka City General Hospital, Division of Gastroenterology, Osaka, Japan, 4Kyorin University School of Medicine, The Third Department of Internal Medicine, Tokyo, Japan, 5Kyoto University, Department of Gastroenterology and Hepatology, Endoscopic Medicine, Kyoto, Japan, 6Tokyo Yamate Medical Centre, Department of Medicine, Division of Gastroenterology, Tokyo, Japan, 7Oita Red Cross Hospital, Department of Gastroenterology, Oita, Japan, 8Saitama Medical Centre, Saitama Medical University, Department of Gastroenterology and Hepatology, Kawagoe, Japan, 9Chiba University, Department of Gastroenterology and Nephrology (K1), Graduate School of Medicine, Chiba, Japan, 10Kyushu University, Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Fukuoka, Japan, 11Tokyo Medical and Dental University, Department of Gastroenterology and Hepatology, Tokyo, Japan, 12Fukuoka University Chikushi Hospital, Department of Gastroenterology, Chikushino, Japan, 13Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Department of Molecular Gastroenterology and Hepatology, Kyoto, Japan, 14Keio University, Department of Internal Medicine, School of Medicine, Tokyo, Japan, 15Toho University Sakura Medical Centre, Department of Internal Medicine, Sakura, Japan, 16The Institute of Medical Science Hospital, The University of Tokyo, Centre for Translational Research, Tokyo, Japan, 17Kitasato University Kitasato Institute Hospital, Centre for Advanced IBD Research and Treatment, Tokyo, Japan

OP012

Risk factors for colorectal neoplasia in ulcerative colitis: results from the largest and longest-running colonoscopic surveillance programme

Year: 2016
Authors:

C. H. R. Choi*1, 2, I. Al Bakir1, 2, N. S. J. Ding1, M. Moorghen1, S. Thomas-Gibson1, J. Warusavitarne1, B. Saunders1, M. Rutter3, T. Graham2, A. Hart1

1St. Mark’s Hospital, London, United Kingdom, 2Barts Cancer Institute, Tumour Biology, London, United Kingdom, 3University Hospital of North Tees, Department of Gastroenterology, Stockton-on-Tees, Teesside, United Kingdom

OP013

Evolution of corticosteroid use in Crohns disease patients between 1991 and 2014: results from the Dutch population-based Inflammatory Bowel Disease South Limburg cohort

Year: 2016
Authors:

S. Jeuring*1, 2, V. Biemans1, L. Liu1, T. Van den Heuvel1, 2, M. Zeegers3, 4, 
W. Hameeteman1, M. Romberg-Camps5, L. Oostenbrug6, A. Masclee1, 2, D. Jonkers1, 2, M. Pierik1, 2

1Maastricht University Medical Centre, Internal Medicine - Division of Gastroenterology and Hepatology, Maastricht, Netherlands, 2Maastricht University Medical Centre, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht, Netherlands, 3Maastricht University Medical Centre, Complex Genetics - School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht, Netherlands, 4Maastricht University Medical Centre, CAPHRI - School for Public Health and Primary Care, Maastricht, Netherlands, 5Zuyderland Medical Centre, Internal Medicine and Gastroenterology-Hepatology, Sittard-Geleen, Netherlands, 6Zuyderland Medical Centre, Internal Medicine and Gastroenterology-Hepatology, Heerlen, Netherlands

OP014

A multicentre, double-blind, placebo-controlled phase 3 study of ustekinumab, a human interleukins-12/23p40 mab, in moderate-severe Crohns disease refractory to anti-tumour necrosis factor α: UNITI-1

Year: 2016
Authors:

P. Rutgeerts*1, C. Gasink2, M. Blank3, Y. Lang2, J. Johanns2, L.-L. Gao2, B. Sands4, S. Hanauer5, B. Feagan6, S. Targan7, S. Ghosh8, W. de Villiers9, J.-F. Colombel10, S. Lee11, P. Desreumaux12, E. V. Loftus, Jr13, S. Vermeire14, W. J. Sandborn15

1University Hospital Gasthuisberg, Department of Haematology, Leuven, Netherlands, 2Janssen R & D, LLC, Spring House, United States, 3Janssen Scientific Affairs, LLC., Horsham, United States, 4Mount Sinai Medical Centre, New York, New York, United States, 5Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, 6Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada, 7Cedars-Sinai Medical Centre, Division of Gastroenterology, Los Angeles, California, United States, 8University of Calgary, Department of Gastroenterology, Calgary, Canada, 9Universiteit Stellenbosch University, Stellenbosch, South Africa, 10Mount Sinai, Icahn School of 
Medicine, New York, New York, United States, 11University of Washington, Seattle, Washington, United States, 12University of Lille, Lille, France, 13Mayo Clinic Rochester, Department of Gastoenterology, Rochester, Minnesota, United States, 14University Hospitals Leuven, Department of Gastroenterology, Leuven, Belgium, 15University of California San Diego, Division of Gastroenterology, La Jolla, California, United States

OP015

Results of ANDANTE, a randomised clinical study with an anti-IL6 antibody (PF-04236921) in subjects with Crohns disease who are anti-tumour necrosis factor inadequate responders

Year: 2016
Authors:

S. Danese*1, S. Vermeire2, P. Hellstern3, R. Panaccione4, G. Rogler5, G. Fraser6, A. Kohn7, P. Desreumaux8, R.W. Leong9, G.M. Comer10, F. Cataldi10, A. Banerjee10, M.K. Maguire11, C. Li10, N. Rath11, J. Beebe10, S. Schreiber12

1Humanitas University Clinical and Research Hospital, Rozzano, Milan, Italy, 2University Hospitals Leuven, Leuven, Belgium, 3Nature Coast Clinical Research, Inverness, Florida, United States, 4University of Calgary, Calgary, Canada, 5University of Zürich, Zürich, Switzerland, 6Rabin Medical Centre and University of Tel-Aviv, Petah Tikva, Israel, 7AO San Camillo Forlanini, Rome, Italy, 8University of Lille, Inserm U995, Lille, France, 9Concord Hospital, Sydney, New South Wales, Australia, 10Pfizer Inc, Cambridge, Massachusetts, United States, 11Pfizer Inc, Collegeville, Pennsylvania, United States, 12Christian-Albrechts University, Kiel, Germany

OP016

Development and validation of diagnostic criteria for IBD-unclassified (IBDU) in children: a multicentre longitudinal study from the paediatric IBD Porto Group of ESPGHAN

Year: 2016
Authors:

L. Birimberg Schwartz1, D. Zucker2, A. Akriv2, C. Salvatore3, F. Cameron4, I. Lazowska5, L. Yianni6, P. Siba7, S. Kolacek8, C. Romano9, S. Buderus10, A. Pærregaard11, J. C. Escher12, D. Turner*13

1Shaare Zedek Medical Centre, Paediatrics, Jerusalem, Israel, 2The Hebrew University, Jerusalem, Israel, 3Sapienza University of Rome, Rome, Italy, 4Yorkhill Children’s Hospital, Glasgow, United Kingdom, 5Medical University of Warsaw, Warsaw, Poland, 6University Hospital Southampton, Hampshire, United Kingdom, 7University of Dundee, Scotland, United Kingdom, 8Zagreb University Medical School, Zagreb, Croatia, 9University of Messina, Messina, Italy, 10St Marien Hospital, Bonn, Germany, 11Hvidovre University Hospital, Copenhagen, Denmark, 12Erasmus Medical Centre, Holland, Netherlands, 13Shaare Zedek Medical Centre, Jerusalem, Israel

OP017

Multi-donor intense faecal microbiota transplantation is an effective treatment for resistant ulcerative colitis: a randomised placebo-controlled trial

Year: 2016
Authors:

S. Paramsothy*1, M. Kamm2, 3, A. Walsh4, J. van den Bogaerde5, D. Samuel6, R. Leong6, S. Connor7, W. Ng7, R. Paramsothy7, N. Kaakoush8, H. Mitchell8, W. Xuan9, E. Lin10, T. Borody10

1University of New South Wales, St Vincent’s Clinical School, Sydney, Australia, 2St Vincent’s Hospital, Melbourne, Australia, 3Imperial College London, London, United Kingdom, 4St Vincent’s Hospital, Sydney, Australia, 5Nambour General Hospital, Nambour, Australia, 6Bankstown-Lidcombe Hospital, Sydney, Australia, 7Liverpool Hopsital, Sydney, Australia, 8University of New South Wales, School of Biotechnology & Biomolecular Sciences, Sydney, Australia, 9Ingham Institute, Sydney, Australia, 10Centre for Digestive Diseases, Sydney, Australia

OP018

The impact of Crohns Disease-TReatment-with-EATing diet (CD-TREAT diet) and exclusive enteral nutrition on healthy gut bacteria metabolism

Year: 2016
Authors:

V. Svolos*1, R. Hansen2, K. Hughes1, U. Z. Ijaz3, C. Quince4, D. Gaya5, R. Russell2, K. Gerasimidis1

1Human Nutrition, School of Medicine, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, United Kingdom, 2Department of Paediatric Gastroenterology, Hepatology and Nutrition, Royal Hospital for Children, Glasgow, United Kingdom, 3School of Engineering, University of Glasgow, Glasgow, United Kingdom, 4Warwick Medical School, University of Warwick, Warwick, United Kingdom, 5Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, United Kingdom

OP019

Efficacy and safety of oral tofacitinib as induction therapy in patients with moderate-to-severe ulcerative colitis: results from 2 phase 3 randomised controlled trials

Year: 2016
Authors:

W. J. Sandborn1, B. E. Sands2, G. D’Haens*3, S. Vermeire4, S. Schreiber5, S. Danese6, J. Panés7, B. G. Feagan8, W. Reinisch9, W. Niezychowski10, G. Friedman10, N. Lawendy10, D. Yu10, D. Woodworth10, A. Mukherjee11, P. Healey11, H. Zhang10, C. Su10

1Division of Gastroenterology, University of California, San Diego, California, United States, 2Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, United States, 3Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands, 4Dept of Gastroenterology, University Hospitals Leuven, Leuven, Belgium, 5Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany, 6IBD Centre, Department of Gastroenterology, Humanitas Research Hospital, Milan, Italy, 7Hospital Clinicas de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain, 8Robarts Research Institute, London, Ontario, Canada, 9McMaster University, Hamilton, Canada, 10Pfizer Inc, Collegeville, Pennsylvania, United States, 11Pfizer Inc, Groton, Connecticut, United States

OP020

Filgotinib, a selective JAK1 inhibitor, induces clinical remission in patients with moderate-to-severe Crohns disease: interim analysis from the Phase 2 FITZROY study

Year: 2016
Authors:

S. Vermeire*1, S. Schreiber2, R. Petryka3, T. Kuehbacher4, X. Hebuterne5, X. Roblin6, M. Klopocka7, E. Goldis8, M. Wisniewska-Jarosinska9, A. Baranovsky10, R. Sike11, C. Tasset12, A. Van der Aa12, P. Harrison12

1UZ Leuven, Campus Gasthuisberg, Leuven, Belgium, 2University Medical Centre Schleswig-Holstein Kiel, Department of Internal Medicine I, Kiel, Germany, 3Vivamed, Warsaw, Poland, 4Asklepios Hospital West Hamburg, Department of Internal Medicine, Gastroenterology, Hamburg, Germany, 5Archet 2 Hospital, Department of Gastroenterology, Nice, France, 6Saint Etienne Hospital, Department of Gastroenterology, Saint Priest en Jarez, France, 7University Hospital Nr. 2 im. Biziela, Department of Gastroenterology, Bydgoszcz, Poland, 8Policlinica Algomed, Department of Gastroenterology, Timisoara, Romania, 9Saint Family Hospital Medical Centre, Department of Gastroenterology and Endoscopy, Lodz, Poland, 10City Clinical Hospital #31, St Petersburg, Russian Federation, 11Szent Margit Hospital, Department of Internal Medicine and Gastroenterology III, Budapest, Hungary, 12Galapagos NV, Department of Development, Mechelen, Belgium

Filgotinib is an oral, selective Janus kinase 1 (JAK1) inhibitor, which has demonstrated high efficacy in patients with rheumatoid arthritis. This 20-week Phase 2 study was designed to evaluate the efficacy and safety of filgotinib in patients with active Crohn’s disease.

OP021

Efficacy and safety of oral tofacitinib for maintenance therapy in patients with moderate-to-severe Crohns disease: results of a Phase 2b randomised placebo-controlled trial

Year: 2016
Authors:

G. D’Haens*1, R. Pannaccione2, P. D. R. Higgins3, J.-F. Colombel3, B. G. Feagan4, M. Moscariello5, G. Chan5, P. Healey6, W. Niezychowski5, W. Wang5, A. Marren5, E. Maller5

1Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands, 2University of Calgary, Calgary, Canada, 3University of Michigan, Ann Arbor, Michigan, United States, 4Robarts Research Institute, London, Ontario, Canada, 5Pfizer Inc, Collegeville, Pennsylvania, United States, 6Pfizer Inc, Groton, Connecticut, United States

OP022

Efficacy and safety of oral tofacitinib for induction therapy in patients with moderate-to-severe Crohns disease: results of a Phase 2b randomised placebo-controlled trial

Year: 2016
Authors:

J. Panés*1, W. J. Sandborn2, S. Schreiber3, B. E. Sands4, S. Vermeire5, G. Chan6, M. Moscariello6, W. Wang6, W. Niezychowski6, A. Marren6, P. Healey7, E. Maller6

1Hospital Clinicas de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain, 2Division of Gastroenterology, University of California, San Diego, United States, 3Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany, 4Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, United States, 5Dept of Gastroenterology, University Hospitals Leuven, Leuven, Belgium, 6Pfizer Inc, Collegeville, United States, 7Pfizer Inc, Groton, United States

OP023

Comparison between newly developed narrow band imaging and panchromoendoscopy for surveillance colonoscopy in patients with ulcerative colitis: a prospective multicentre randomised controlled trial, navigator study

Year: 2016
Authors:

K. Watanabe*1, M. Nishishita2, F. Shimamoto3, T. Fukuchi4, M. Esaki5, Y. Okamoto5, Y. Maehata5, S. Oka6, S. Nishiyama6, S. Fujii7, F. Hirai8, T. Inoue9, N. Hida10, R. Nozaki11, T. Sakurai12, K. Takeuchi13, M. Saruta14, S. Saito15, Y. Saito16, N. Ohmiya17, H. Kashida12, S. Tanaka6, T. Matsui8, Y. Suzuki18, Y. Ajioka19, H. Tajiri20

1Osaka City General Hospital, Gastroenterology, Osaka, Japan, 2Nishishita Gastrointestinal Hospital, Osaka, Japan, 3Faculty of Human Culture and Science Prefectural University of Hiroshima, Hiroshima, Japan, 4Osakafu Saiseikai Nakatsu Hospital, Gastroenterology and Hepatology, Osaka, Japan, 5Graduate School of Medical Sciences, Kyushu University, Department of Medicine and Clinical Science, Fukuoka, Japan, 6Hiroshima University Hospital, Department of Endoscopy, Hiroshima, Japan, 7Kyoto Katsura Hospital, Digestive Disease Centre, Department of Gastroenterology, Kyoto, Japan, 8Fukuoka University Chikushi Hospital, Department of Gastroenterology, Fukuoka, Japan, 9Osaka Medical College, Second Department of Internal Medicine, Osaka, Japan, 10Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Hyogo, Japan, 11Takano Hospital, Division of Gastroenterology, Coloproctology Centre, Kumamoto, Japan, 12Kinki University, Department of Gastroenterology, Osaka, Japan, 13Toho University Sakura Medical Centre, Department of Internal Medicin, Chiba, Japan, 14The Jikei University School of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokyo, Japan, 15The Jikei University School of Medicine, Department of Endoscopy, Tokyo, Japan, 16National Cancer Centre Hospital, Endoscopy Division, Tokyo, Japan, 17School of Medicine, Fujita Health University, Department of Gastroenterology, Aichi, Japan, 18Toho University Sakura Medical Centre, Department of Internal Medicine, Chiba, Japan, 19Graduate School of Medical and Dental Sciences, Niigata University, Division of Molecular and Diagnostic Pathology, Niigata, Japan, 20The Jikei University School of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Department of Endoscopy, Tokyo, Japan

OP024

Mucosal healing and dysplasia surveillance in a large referral Centre cohort of patients with Crohns disease and ulcerative colitis treated with vedolizumab

Year: 2016
Authors:

M. Noman1, M. Ferrante1, R. Bisschops1, G. De Hertogh2, K. Van Den Broeck1, K. Rans1, P. Rutgeerts1, S. Vermeire1, G. Van Assche*1

1UZ Leuven, Gastroenterology, Leuven, Belgium, 2UZ Leuven, Campus Gasthuisberg, Pathology, Leuven, Belgium

OP025

Escalation of medical therapy decreases need for repeat dilatation in Crohns anastomatic strictures

Year: 2016
Authors:

N. S. Ding*1, 2, W. Yip1, R. Choi1, B. Saunders3, S. Thomas-Gibson3, N. Arebi1, A. Humphries3, A. Hart1

1St Mark’s Hospital, IBD, London, United Kingdom, 2Imperial College London, Department of Surgery and Cancer, London, United Kingdom, 3St Mark’s Hospital, Wolfson Unit For Endoscopy, Department of Gastroenterology, Harrow, United Kingdom

OP026

The TOPPIC Trial: a randomised, double-blind parallel-group trial of mercaptopurine versus placebo to prevent recurrence of Crohns disease following surgical resection in 240 patients

Year: 2016
Authors:

I. Arnott1, C. Mowat2, H. Ennis3, C. Keerie3, S. Lewis3, N. Kennedy4, A. Cahill5, A. Morris5, M. Dunlop6, S. Bloom7, J. Lindsay8, S. Subramanian9, J. Satsangi*4, TOPPIC Trial Study Group10

1NHS Lothian, Gastroenterology, Edinburgh, United Kingdom, 2NHS Tayside, Gastroenterology, Dundee, United Kingdom, 3University of Edinburgh, Edinburgh Clinical Trials Unit, Edinburgh, United Kingdom, 4University of Edinburgh, Gastroenterology, Edinburgh, United Kingdom, 5NHS Greater Glasgow and Clyde, Gastroenterology, Glasgow, United Kingdom, 6University of Edinburgh, Institute of Genetics and Molecular Medicine, Edinburgh, United Kingdom, 7University College Hospital, Department of Gastroenterology, London, United Kingdom, 8Bart’s Health NHS Trust, Newham University Hospital, Department of Gastroenterology, London, United Kingdom, 9Royal Liverpool University Hospital, Gastroenterology, Liverpool, United Kingdom, 10Toppic Trial Study Group, UK, United Kingdom

OP027

Anti-tumour necrosis factor therapy is associated with increased risk of postoperative morbidity after surgery for ileocolonic Crohns disease: outcome analysis in a prospective nationwide cohort of 592 patients conducted by the GETAID chirurgie group

Year: 2016
Authors:

A. Brouquet*1, L. Maggiori2, P. Zerbib3, J. Lefèvre4, Q. Denost5, A. Germain6, E. Cotte7, L. Beyer-Berjot8, N. Munoz-Bongrand9, V. Desfourneaux10, A. Rahili11, J.-P. Duffas12, K. Pautrat13, C. Denet14, V. Bridoux15, G. Meurette16, J.-L. Faucheron17, J. Loriau18, F. Guillon19, E. Vicaut20, S. Benoist1, Y. Panis2

1Bicêtre Hospital - Université Paris Sud, Oncologic and Digestive Surgery, Le Kremlin-Bicêtre, France, 2Beajon Hospital, Colorectal Surgery, Clichy, France, 3CHU Lille, Digestive Surgery, Lille, France, 4Saint Antoine Hospital, Digestive Surgery, Paris, France, 5CHU Bordeaux, Digestive Surgery, Bordeaux, France, 6CHU Nancy, Digestive Surgery, Nancy, France, 7CHU Lyon-Sud, Digestive Surgery, Lyon, France, 8CHU Marseille, Digestive Surgery, Marseille, France, 9Saint Louis Hospital, Digestive Surgery, Paris, France, 10CHU Rennes, Digestive Surgery, Rennes, France, 11CHU Nice, Digestive Surgery, Nice, France, 12CHU Toulouse, Digestive Surgery, Toulouse, France, 13Lariboisière Hospital, Digestive Surgery, Paris, France, 14Montsouris insitute, Digestive Surgery, Paris, France, 15CHU Rouen, Digestive Surgery, Rouen, France, 16CHU Nantes, Digestive Surgery, Nantes, France, 17CHU Grenoble, Digestive Surgery, Grenoble, France, 18Saint-Joseph Hospital, Digestive Surgery, Paris, France, 19CHU Montpellier, Digestive Surgery, Montpellier, France, 20Fernand Widal Hospital, Clinical research, Paris, France

OP028

Pharmacokinetics and exposure-response relationships of intravenously administered ustekinumab during induction treatment in patients with Crohns disease: results from the UNITI-1 and UNITI-2 studies

Year: 2016
Authors:

O. J. Adedokun*1, Z. Xu1, C. Gasink1, J. Friedman1, P. Szapary1, Y. Lang1, J. Johanns1, L.-L. Gao1, Y. Miao1, H. Davis1, S. Hanauer2, B. Feagan3, W. Sandborn4

1Janssen R & D, LLC, Spring House, Pennsylvania, United States, 2Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, 3Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, Ontario, Canada, 4UCSD, Medicine, La Jolla, California, United States

OP029

Drug-concentration versus symptom-driven dose adaptation of Infliximab in patients with active Crohns disease: a prospective, randomised, multicentre trial (Tailorix)

Year: 2016
Authors:

G. D’Haens*1, S. Vermeire2, G. Lambrecht3, F. Baert4, P. Bossuyt5, M. Nachury6, A. Buisson7, Y. Bouhnik8, J. Filippi9, J. vande Woude10, P. Van Hootegem11, J. Moreau12, E. Louis13, D. Franchimont14, M. De Vos15, F. Mana16, L. Peyrin-Biroulet17, H. Brixi18, M. Allez19, P. Caenepeel20, A. Aubourg21, B. Oldenburg22, M. Pierik23, A. Gils24, S. Chevret25, D. Laharie26

1Academic Medical Centre, Gastroenterology, Amsterdam, Netherlands, 2University Hospitals Gasthuisberg, Gastroenterology, Leuven, Belgium, 3AZ Damiaan, Oostende, Belgium, 4AZ Delta, Roeselare, Belgium, 5Imelda GI Clinical Research Centre, Bonheiden, Belgium, 6Hopital Claude Hurriez, Lille, France, 7Hopital Estaing, Clermont-Ferrand, France, 8Hopital Beaujon, Clichy, France, 9Hospital Archet, Nice, France, 10Erasmus Medical Centre, Rotterdam, Netherlands, 11St Lukas Hospital, Bruges, Belgium, 12Hopital Rangueil, Toulouse, France, 13Hopital Sart Tilman, Liège, Belgium, 14Hopital Erasme, Brussels, Belgium, 15University of Ghent, Ghent, Belgium, 16Free University of Brussels, Brussels, Belgium, 17Hopital Brabois, Nancy, France, 18Hopital Robert Debre, Reims, France, 19Hopital St Louis, Paris, France, 20Ziekenhuis Oost Limburg, Genk, Belgium, 21Hopital Trousseau, Tours, France, 22University of Utrecht, Utrecht, Netherlands, 23University Hospital Maastricht, Maastricht, Netherlands, 24University of Leuven, Leuven, Belgium, 25Dept Biostatistique St Louis, Paris, France, 26Haut-Leveque, Pessac, France

The most potent available treatment for active Crohn’s disease (CD) is a combination of infliximab (IFX) and azathioprine, leading to disappearance of ulcerations in up to 50% of patients. Because superior outcomes have been associated with serum drug concentrations within what is considered a ‘therapeutic window’, we hypothesised that prospective therapeutic drug monitoring (TDM) would lead to higher remission rates as compared with pure symptom-based dose adaptations.

This was a prospective randomised, double-blinded, multicentre controlled trial in which biologic naïve adult patients with active CD (CDAI > 220, serum CRP > 5 mg/L, and/or faecal calprotectin > 250 µg/g and endoscopic ulcerations) received induction treatment with 3 infusions of IFX 5 mg/kg in combination with azathioprine 2–2.,5 mg/kg/day or MTX in case of intolerance. At week 14, patients were randomised to 1 of 3 different maintenance strategies: 1) dose intensification of IFX in (maximally 2) steps of 2,5 mg/kg based on clinical symptoms, biomarker analysis and serum IFX concentrations drawn before the previous infusion (group 1); 2) dose intensification of IFX from 5 to 10 mg/kg based on the same criteria (group 2), and 3) IFX dose increase to 10 mg/kg based on clinical symptoms alone (group 3). The primary endpoint of the trial was sustained steroid-free clinical remission from week 22 to -54 and absence of ulceration at 1 year based on centrally read endoscopies. Target for IFX dosing was a trough concentration > 3 ug/ml. (EUDRACT NUMBER: 2011-003038-14)

At 27 sites in Belgium, France, and the Netherlands,167 patients were screened, and 122 were randomised (71 F, median age 29.8 years). The 3 groups had comparable patient characteristics. The primary endpoint based on local endoscopy reads was attained in 21/45 (47%) in group 1, 14/37 (38%) in group 2, and 16/40 (40%) in group 3 (p = NS). The proportions of patients without ulcerations at week 54 were 36%, 43%, and 48% (p = NS) and with endoscopic remission (CDEIS < 3) 49%, 51%, and 45% (p = NS). Dose intensification was done in 51%, 65%, and 40% of the patients.

In this prospective randomised exploratory trial in patients with active CD, proactive trough-level–based dose intensification was not superior to dose intensification based on symptoms alone. Results with centrally read endoscopy are being awaited, as well as detailed pharmacokinetic, immunogenicity, and biomarker analysis. More benefit from TDM may be obtained during induction and in dose reduction efforts, which was not studied in this trial.

OP030

Factors associated with the first trough level of infliximab at week 2 that predicts short- and long-term outcomes in ulcerative colitis

Year: 2016
Authors:

T. Kobayashi*1, Y. Suzuki2, S. Motoya3, F. Hirai4, H. Ogata5, H. Ito6, N. Sato7, K. Ozaki7, M. Watanabe8, T. Hibi1

1Kitasato University Kitasato Institute Hospital, Centre for Advanced IBD Research and Treatment, Tokyo, Japan, 2Toho University Sakura Medical Centre, Department of Internal Medicine, Sakura, Japan, 3Sapporo-kosei General Hospital, Inflammatory Bowel Diseases Centre, Sapporo, Japan, 4Fukuoka University Chikushi Hospital, Department of Gastroenterology, Chikushino, Japan, 5Keio University School of Medicine, Centre for Diagnostic and Therapeutic Endoscopy, Tokyo, Japan, 6Kitano Hospital The Tazuke Kofukai Medical Research Institute, Digestive Disease Centre, Osaka, Japan, 7Mitsubishi Tanabe Pharma Corporation, Osaka, Japan, 8Tokyo Medical and Dental University, Department of Gastroenterology and Hepatology, Tokyo, Japan

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