Late‐breaking abstracts

United European Gastroenterology JournalVolume 3, Issue 6 p. 561-571 AbstractsOpen Access Late-breaking abstracts First published: 01 December 2015 https://doi.org/10.1177/2050640615616068AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat OP054-LB1 A CONTROLLED CROSS-OVER TRIAL SHOWS BENEFIT OF PRUCALOPRIDE FOR SYMPTOM CONTROL AND GASTRIC EMPTYING IN GASTROPARESIS F. Carbone1, A. Rotondo1, C. Andrews1, L. Holvoet2, L. Van Oudenhove1, T. Vanuytsel2, R. Bisschops2, P. Caenepeel2, J. Arts2, A. Papathanasopoulos1 and J. Tack1 1 TARGID, Leuven Unversity and Leuven University Hospitals 2 Gastroenterology, Leuven University Hospitals, Leuven, Belgium Contact E-mail Address: jan.tack@med.kuleuven.be Introduction: Gastroparesis is a chronic gastric disorder characterised by delayed gastric emptying without mechanical obstruction, and clinical symptoms such as post-prandial fullness, early satiety, bloating, nausea and vomiting. Prokinetics are considered the preferred treatment option for gastroparesis, but evidence of their efficacy is lacking. Prucalopride, a selective 5-hydroxytryptamine4 receptor (5-HT4 R) agonist used in the treatment of constipation, is able to enhance gastric emptying rate. Aims & Methods: In a single-center double-blind, randomized, placebo-controlled cross-over study we evaluated the efficacy of prucalopride to improve gastric emptying rate and symptoms in idiopathic or diabetic gastroparesis patients. 34 gastroparesis patients (28 idiopathic, mean age 43.5 ± 2.3, 8 men) underwent a 13 C-octanoic acid solid gastric emptying breath test, and symptom severity assessment by the Gastroparesis Cardinal Symptoms Index (GCSI) at run-in and at the end of 4 weeks blinded cross-over treatment periods with placebo or prucalopride 2 mg q.d., separated by 2 weeks wash-out. Results: Three patients were lost to follow-up. One serious adverse event occurred (small bowel volvulus in the prucalopride group), and 4 patients dropped out because of adverse events of nausea and headache (1 placebo, 3 prucalopride). Prucalopride significantly enhanced gastric half emptying time compared to placebo and to baseline (87.9 ± 8.2 vs 117.9 ± 14.4 and 139.2 ± 11.8 min, p < 0.05 and <0.005 respectively). In addition, prucalopride, compared to placebo and to baseline, also significantly improved the GCSI subscales of fullness/satiety (2.03 ± 0.27 vs 2.77 ± 0.28 and 3.07 ± 0.26, both p < 0.0005), nausea/vomiting (1.04 ± 0.23 vs 1.49 ± 0.27 and 1.77 ± 0.24, p = 0.01 and <0.0001 respectively) and bloating/distention (1.30 ± 0.25 vs 2.35 ± 0.30 and 2.89 ± 0.31, both p < 0.00001). With placebo, only the bloating/distention subscale differed significantly from baseline. Compared to both baseline or placebo, prucalopride significantly improved the overall PAGI-QOL score, and the domains of clothing and diet (all p < 0.01). Conclusion: In gastroparesis patients, 4 weeks of prucalopride treatment significantly enhances gastric half emptying time and improves symptoms and quality of life compared to placebo and to baseline. Disclosure of Interest: None declared. OP054-LB2 GASTROINTESTINAL EVENTS AND ADVERSE REACTIONS ON SELECTIVE AND NON SELECTIVE CYCLOOXYGENASE INHIBITORS IN THE LARGE RANDOMISED CONTROLLED SCOT TRIAL C. Hawkey1, J. Scheiman2, J. Dillon3, A. Lanas4, J. Moeller5, J. Hallas6, I. Ford7, N. Greenlaw7, I. Mackenzie3 and T. MacDonald3 1 University of Nottingham, Nottingham, United Kingdom 2 University of Michigan, Michigan, Canada 3 Ninewells Hospital, Dundee, United Kingdom 4 University of Zaragoza, Zaragoza, Spain 5 Odense University Hospital 6 University of Southern Denmark, Odense, Denmark 7 University of Glasgow, Glasgow, United Kingdom Contact E-mail Address: cj.hawkey@nottingham.ac.uk Introduction: Non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) are associated with adverse gastrointestinal (GI) events which may reduce with selective cyclooxygenase-2 (COX-2) inhibitors, though both may increase cardiovascular (CV) events. We compared the COX-2 inhibitor celecoxib with nsNSAIDs in a large pragmatic trial using record linkage. Aims & Methods: Patients aged ≥60 years, without CV disease, taking chronic nsNSAIDs in primary care, were randomised to celecoxib or continued nsNSAID. The primary endpoint was non-fatal myocardial infarction, biomarker positive acute coronary syndrome, stroke or CV death and the secondary (GI) endpoint adjudicated ulcer complications. Results: A total of 7297 participants (38% on ulcer healing drug) were randomised and followed for median 3 years. The CV endpoint occurred at a low rate of 0.95/100 patient years on celecoxib vs 0.86/100 on nsNSAIDs (on treatment (OT) analysis; 1.14 vs 1.10/100 by intention to treat (ITT)). There were only 15 adjudicated secondary (GI) endpoints (0.10/100 patient years on celecoxib vs 0.05 on nsNSAIDs OT, 0.09 vs 0.04 ITT). There were 218 deaths (CV: 33.3% celecoxib vs 35.3% nsNSAIDs, neoplasia: 39.2% vs 29.3%, non-malignant respiratory: 14.7% vs 12.9%) with only 2 attributed to GI bleeding (celecoxib). Serious adverse events were similar for each group (celecoxib 31.7%, ns-NSAID 32.4%) but adverse reactions (ARs) attributed to trial treatment were reported in 22.0% celecoxib vs 16.1% nsNSAIDS (p < 0.001), including 10.6% vs 9.1% GI (p = 0.04). There were more GI serious ARs on nsNSAIDs than celecoxib (1.8% vs 1.0%, p = 0.007) with 10 vs 2 reports of rectal haemorrhage and 13 vs 3 of gastritis. Haematological ARs were reported in more nsNSAID than celecoxib patients (1.3% vs 0.7%) due to to more patients with anaemia or iron deficiency anaemia (1.3% vs 0.6%). During follow-up, 50.9% patients withdrew from celecoxib compared to 30.2% from all nsNSAIDs (p < 0.001). Conclusion: Prescribing celecoxib to patients previously on nsNSAIDs did not significantly alter risk of adjudicated CV or GI endpoints. Some new ARs emerged, contributing to withdrawal, but there appeared to be fewer rectal haemorrhage and gastritis SARs and fewer ARs due to anaemia. Causes of death were similar to those seen in unselected patients and GI bleeding was an uncommon cause. Disclosure of Interest: C. Hawkey Financial support from: Univ Dundee, NIHR, HTA, Consultancy for: Bayer, InDex Pharma, Novartis/GSK, J. Scheiman: None declared, J. Dillon: None declared, A. Lanas: None declared, J. Moeller: None declared, J. Hallas: None declared, I. Ford: None declared, N. Greenlaw: None declared, I. Mackenzie: None declared, T. MacDonald Financial support from: Novartis, Pfizer, Amgen, Ipsen, Teijin, Menarini, Consultancy for: Pfizer, Novartis, Kaiser Permanente, Takeda, Servier, Shire, Astellas, Menarini, AstraZeneca, Daiicho Sankyo, Lundbeck. OP54-LB3 ENDOSCOPIC FULL THICKNESS RESECTION IN THE LOWER GASTROINTESTINAL TRACT USING AN OVER-THE-SCOPE DEVICE – PRELIMINARY RESULTS OF A PROSPECTIVE MULTICENTRE TRIAL A. R. Schmidt1, B. Schumacher2, D. Albers3, H. Neuhaus4, M. Nübel4, H. Messmann5, A. Probst5, A. Meining6, M. Birk6, H.-J. Richter-Schrag7, A. Fisher7, T. Frieling8, M. Götz9 and K. Caca10 1 Department of Gastroenterology, Klinikum Ludwigsburg, Ludwigsburg 2 Elisabeth Krankenhaus, Essen 3 Department of Gastroenterology, Elisabeth Krankenhaus, Essen 4 Evangelisches Krankenhaus Düsseldorf, Düsseldorf, 5 Klinikum Augsburg, Augsburg 6 Universitätsklinikum Ulm, Ulm 7 Klinik für Innere Medizin II, Universitätsklinikum Freiburg, Freiburg 8 Helios Klinikum Krefeld, Krefeld 9 Universitätsklinikum Tübingen, Tübingen 10 Klinikum Ludwigsburg, Ludwigsburg, Germany Contact E-mail Address: arthur.schmidt@kliniken-lb.de Introduction: The Full Thickness Resection Device (FTRD) (Ovesco, Tübingen, Germany) is a novel over-the-scope device which is approved for full-thickness resection in the lower gastrointestinal (GI) tract in Europe since September 2014. A recent retrospective study has suggested that device and technique is safe and effective. Aims & Methods: We are conducting a prospective, uncontrolled, multicenter trial at 7 academic referral centers in Germany (NCT02362126). Primary endpoints of the study are technical success and R0-resection, secondary endpoints are occurrence of adverse events. Here, we report the results of an interim analysis while the study is still recruiting. Between February 2015–August 2015, 74 patients with indication for full thickness resection in the colorectum were included in the study. Results: Indications for endoscopic full thickness resection were: recurrent, incompletely resected or untreated non-lifting adenomas (43); adenoma involving the appendix (11), T1-carcinoma (8), adenoma involving a diverticulum (2) and subepithelial tumors (10). The lesions were located as followed: coecum (19), ascending colon (15), transverse colon (13), descending colon (3), sigmoid (11), recosigmoid transition (4) and rectum (10). Reaching the target lesion with the endoscope and the mounted FTRD was possible in all patients (100%). Technical success (macroscopically complete and en bloc resection) was achieved in 64 (86.4%) patients. R0-resection rate was 80.1 %. One secondary perforation at the resection site requiring surgical therapy and two minor bleedings were observed. No other severe complications have been recorded so far. Conclusion: The interim results of this prospective study indicate that full thickness resection in the lower GI tract with the novel FTRD is feasible, effective and safe. Final results including follow up data will be expected by mid of 2016. Disclosure of Interest: A. Schmidt Lecture fee(s) from: Ovesco Endoscopy, B. Schumacher: None declared, D. Albers: None declared, H. Neuhaus: None declared, M. Nübel: None declared, H. Messmann: None declared, A. Probst: None declared, A. Meining: None declared, M. Birk: None declared, H.-J. Richter-Schrag: None declared, A. Fisher: None declared, T. Frieling: None declared, M. Götz: None declared, K. Caca Lecture fee(s) from: Ovesco Endoscopy. References References 1Schmidt A, Damm M, Caca K. Endoscopic full thickness resection using a novel over-the-scope device. Gastroenterology 2014; 47: 740– 743. Google Scholar 2Schmidt A, Bauerfeind P, Gubler C, et al. Endoscopic full thickness resection in the colorectum with a novel over-the-scope device – first experience. World J Gastroenterol 2015; 21 (31): 9273– 9285. Published online 21 August 2015. DOI: https://doi.org/10.3748/wjg.v21.i31.9273. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4541380/ CrossrefPubMedWeb of Science®Google Scholar OP054-LB4 A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PH3 STUDY OF USTEKINUMAB, A HUMAN MONOCLONAL ANTIBODY TO IL-12/23P40, IN PATIENTS WITH MODERATELY-SEVERELY ACTIVE CROHN'S DISEASE WHO ARE NAÏVE OR NOT REFRACTORY TO ANTI-TNFΑ: UNITI-2 B. Feagan1, C. Gasink2, Y. Lang2, J. R. Friedman2, J. Johanns2, L.-L. Gao2, B. Sands3, S. Hanauer4, P. Rutgeerts5, S. Targan6, S. Ghosh7, W. de Villiers8, J.-F. Colombel3, Z. Tulassay9, U. Seidler10 and W. J. Sandborn11 1 Robarts Research Institute, London, Canada 2 Janssen R&D, LLC, Spring House 3 Mt Sinai Medical Center, New York 4 Northwestern University, Chicago, United States 5 University Hospital Gasthuisberg, Leuven, Belgium 6 Cedars-Sinai Medical Center, Los Angeles, United States 7 University of Calgary, Calgary, Canada 8 University of of Cape Town, Cape Town, South Africa 9 Semmelweis University, Budapest, Hungary 10 Hannover Medical School, Hannover, Germany 11 UCSD, La Jolla, United States Contact E-mail Address: MRittenh@its.jnj.com Introduction: In the Ph 2b Crohn's Evaluation of Response to Ustekinumab anti-IL12/23 for Induction study, a single intravenous ustekinumab induction dose was effective and safe in Crohn's disease patients (pts) previously failing anti-tumor necrosis factors,1 but efficacy in pts only failing conventional therapy is unknown. We evaluated 2 intravenous ustekinumab induction dose-regimens in a Crohn's disease population not refractory to anti-tumor necrosis factors. Aims & Methods: Pts with moderate-severely active Crohn's disease (CDAI220–450) who failed conventional therapy but were not refractory to anti-tumor necrosis factors were randomized to a single dose of intravenous placebo, ustekinumab 130 mg, or weight-based tiered ustekinumab dosing ∼6 mg/kg. Primary endpoint was clinical response at Wk 6 (reduction in Crohn's Disease Activity Index score of ≥100 pts). At Wk 8, pts transitioned to IM-UNITI maintenance study or had safety follow-up through Wk 20. Results: Of 628 pts randomized, median disease duration was 6.4 years; baseline (BL) mean Crohn's Disease Activity Index was 303; 39% and 35% were receiving steroids and immunomodulators, respectively at BL; 69% were naïve to anti-tumor necrosis factors. At Wk 6, 55.5% and 51.7% in ∼6 mg/kg and 130 mg ustekinumab groups were in clinical response vs 28.7% placebo (p < 0.001). At Wk 8, 40.2% and 30.6% of pts in ∼6 mg/kg and 130 mg ustekinumab groups were in clinical remission vs 19.6% placebo (p ≤ 0.009). Both ustekinumab doses showed significant improvements vs placebo in Crohn's Disease Activity Index, Inflammatory Bowel Disease Questionnaire, C reactive protein, and fecal lactoferrin and fecal calprotectin. Proportions of adverse events, serious adverse events, and infections (including serious infections) were similar in ustekinumab and placebo groups. No malignancies, deaths, opportunistic infections or tuberculosis occurred in ustekinumab-treated pts (see table). PBO (n = 209) UST 130 mg (n = 209) UST ∼ 6 mg/kga (n = 209) Clinical responseb Wk 3 45 (21.5) 68 (32.5) p = 0.010 81 (38.8) p < 0.001 Wk 6c 60 (28.7) 108 (51.7) Delta = 23% p < 0.001 116 (55.5) Delta = 26.8% p < 0.001 Wk 8 67 (32.1) 99 (47.4) p < 0.001 121 (57.9) p < 0.001 Clinical remissiond Wk 3 24 (11.5) 33 (15.8) p = 0.199 48 (23.0) p = 0.002 Wk 6 37 (17.7) 60 (28.7) p = 0.007 73 (34.9) p < 0.001 Wk 8 41 (19.6) 64 (30.6) Delta = 11.0% p = 0.009 84 (40.2) Delta = 20.6% p < 0.001 Data are n (%); a weight-range based UST doses ∼6 mg/kg: 260 mg (weight ≤55 kg), 390 mg (weight >55 kg and ≤85 kg), 520 mg (weight >85 kg); b ≥100 pt reduction in CDAI; c primary endpoint; d CDAI < 150. Conclusion: IV UST induced clinical response and remission in pts with moderate-severe CD not previously failing anti-TNFs and was well-tolerated through induction. Disclosure of Interest: B. Feagan Other conflict with: Investigator, Janssen R&D, LLC, C. Gasink Other conflict with: Employee, Janssen R&D, LLC, Y. Lang Other conflict with: Employee, Janssen R&D, LLC, J. Friedman Other conflict with: Employee, Janssen R&D, LLC, J. Johanns Other conflict with: Employee, Janssen R&D, LLC, L.-L. Gao Other conflict with: Employee, Janssen R&D, LLC, B. Sands Other conflict with: Investigator, Janssen R&D, LLC, S. Hanauer Other conflict with: Investigator, Janssen R&D, LLC, P. Rutgeerts Other conflict with: Investigator, Janssen R&D, LLC, S. Targan Other conflict with: Investigator, Janssen R&D, LLC, S. Ghosh Other conflict with: Investigator, Janssen R&D, LLC, W. de Villiers Other conflict with: Investigator, Janssen R&D, LLC, J.-F. Colombel Other conflict with: Investigator, Janssen R&D, LLC, Z. Tulassay Other conflict with: Investigator, Janssen R&D, LLC, U. Seidler Other conflict with: Investigator, Janssen R&D, LLC, W. Sandborn Other conflict with: Investigator, Janssen R&D, LLC. References References 3Sandborn WJ, et al. N Engl J Med 2012; 367: 1519– 1528. CrossrefCASPubMedWeb of Science®Google Scholar OP054-LB5 SUSTAINED EFFICACY AFTER DUAL TOPICAL APPLICATION OF THE TOLL-LIKE RECEPTOR 9 AGONIST DIMS0150 IN CHRONIC ACTIVE ULCERATIVE COLITIS PATIENTS R. Atreya1, F. Scaldaferri2, S. Bloom3, T. E. Knittel4, V. Gerardi5, Å. Karlsson4, J. Kowalski4, M. Lukas6, R. Löfberg7, R. Petryka8, R. Schnabel9, U. Seidler10, S. Nancey11, M. Neurath1 and C. Hawkey12 1 Department of Medicine, University of Erlangen-Nuernberg, Erlangen, Germany 2 Internal Medicine Department/Gastroenterology Division, Catholic University of Rome, Rome, Italy 3 Gastroenterology, University College London Hospital, London, United Kingdom 4 R&D, Index Pharmaceuticals, Stockholm, Sweden 5 Catholic University of Rome, Rome, Italy 6 IBD Clinical and Research Centre, Prague, Prague, Czech Republic 7 Karolinska Institute and Sophiahemmet, Stockholm, Sweden 8 NZOZ Vivamed, Warsaw, Poland 9 Pannonia Maganorvosi Centrum, Budapest, Hungary 10 Dept. of Gastroenterology, Hepatology and Endocrinology, MHH, Hannover, Germany 11 Gastroenterology, Lyon-Sud Hospital, Pierre-Bénite, France 12 Department of Gastroenterology, Nottingham University Hospitals, Nottingham, United Kingdom Contact E-mail Address: thomas.knittel@indexpharma.com Introduction: In the COLLECT study the Toll-like Receptor-9 agonist DIMS0150 was evaluated for its therapeutic efficacy in ulcerative colitis patients refractory to conventional therapy. Patients were followed up to one year after administration of two single topical doses and long term efficacy and sustained clinical effects were analysed in a post-hoc analysis. Aims & Methods: The oligonucleotide DNA based ImmunoModulatory Sequence0150 was studied in a randomised, double blind, placebo-controlled, multicentre, pan-European phase III trial in 131 patients with moderate to severe ulcerative colitis. Patients were randomly assigned to receive two single doses of DNA based ImmunoModulatory Sequence0150 (30 mg) or placebo (in a 2:1 ratio) administered topically via endoscopy to the inflamed mucosa at baseline (week 0) and after 4 weeks (week 4). Efficacy was studied using the endpoints symptomatic remission (SR), absence of blood in stool and mean weekly and remission Clinical Activity Index and healing as endoscopic score of or Results: was in of the DNA based ImmunoModulatory Sequence0150 vs of the placebo patients (p = 4 weeks after a single topical administration of was achieved in of the DNA based ImmunoModulatory Sequence0150 vs of the placebo patients (p = and was in vs (p = respectively after 4 at weeks 4 and both at 4 and was achieved in of the DNA based ImmunoModulatory Sequence0150 vs of the placebo patients (p = and for weeks 4 and was vs respectively (p = The results for sustained was vs (p = for 4 and and vs for 4 and The endpoint of and achieved at both weeks 4 and 12 was in the DIMS0150 vs in the placebo patients (p = at weeks 4 and 12 was in the DNA based ImmunoModulatory Sequence0150 vs in the placebo patients (p = Conclusion: The COLLECT study that topical administration of the Toll-like Receptor-9 agonist DNA based ImmunoModulatory Sequence0150 is able to sustained clinical effects in chronic moderate to severe ulcerative colitis patients weeks after Disclosure of Interest: R. Financial support from: Index Pharmaceuticals, Consultancy for: Index Pharmaceuticals, F. Consultancy for: InDex Pharmaceuticals, S. Financial support from: Index Pharmaceuticals, T. Consultancy for: InDex Pharmaceuticals, InDex Pharmaceuticals, V. None declared, Å. Consultancy for: Index Pharmaceuticals, Index Pharmaceuticals, J. Consultancy for: Index Pharmaceuticals, M. Financial support from: Index Pharmaceuticals, R. Consultancy for: Index Pharmaceuticals, Index Pharmaceuticals, R. Financial support from: Index Pharmaceuticals, R. Financial support from: Index Pharmaceuticals, U. Seidler Financial support from: Index Pharmaceuticals, S. Financial support from: Index Pharmaceuticals, M. Consultancy for: Index Pharmaceuticals, C. Hawkey Consultancy for: Index SUSTAINED AFTER IN ULCERATIVE COLITIS C. S. N. D. E. L. and W. M. de 1 Gastroenterology & Medical Center, 2 of 3 University of Contact E-mail Address: Introduction: We to that are associated with sustained remission after for active ulcerative colitis this we analysed the and and up to 3 years Aims & Methods: and from patients and who in the trial were trial compared the efficacy of two of after bowel from a or were by and the of A was by Patients were and at 12 and by sustained remission and at year Results: At baseline, showed of groups from the and significantly of as compared to At 12 weeks were analysis showed an complete of sustained and patients that at the follow-up. was associated with at 12 weeks to a IV and including while was associated with and The of and of were to be in in patients who patients and were in placebo and only those placebo patients who at baseline had a to a IV and were able to their while in this was by a of the in all No were in of and Conclusion: In patients a low in IV and and in and is of sustained response to receive a from a IV and is by and response is associated with a of the significantly at baseline compared with Disclosure of Interest: None declared. References References N. et al. Gastroenterology 2015; CrossrefPubMedWeb of Science®Google Scholar A STUDY OF FOR M. J. R. M. M. J. E. and Z. 1 Gastroenterology, University, 2 Gastroenterology, and Hospital, 3 United States Contact E-mail Address: Introduction: is a therapy for and have the dose is unknown. Aims & Methods: We to the safety and rate of low and dose in patients who have or more of and failed to after therapy. study at two academic One site was randomized to low dose (30 and the other to dose (30 for 2 Patients in both groups inhibitor therapy for 48 to to gastric acid and were from from a stool years, mean mean clinical success in n = stool clinical success in n = using a at The primary end were safety 2 or and clinical of with at follow-up as data was compared and low dose groups by review of adverse events. were with dose (30 for 2 in Results: of the patients were similar No adverse events or serious adverse events attributed to were with the or low of in the dose was achieved in patients and in patients that low dose at follow-up (p = of was at time Clinical remission at was achieved in in the dose and in the low dose (p = of the were with a dose out of patients had of the response rate was The one patient who failed was with by Conclusion: our this study is the first randomized study of in and the effective Disclosure of Interest: None declared. – ± ± ± – n 5 8 of – ± ± ± 0.25 – n 7 9 – n 1 5 THE OF THE OF THE E. M. E. F. E. M. P. H. E. J. H. F. K. M. M. C. H. S. M. H. de and I. 1 University Medical Center, 2 Institute 3 Gastroenterology and Medical Center, 4 Gastroenterology and Hepatology 5 6 7 University Medical Center, Contact E-mail Address: Introduction: In a for with using the was in the The was by a of and of Aims & Methods: the of and of based on the of the first year of the in the target population a with a positive an for and positive and participants were using data from the for the Results: the in the The rate in the first half year of at 15 was than for and adenomas were also and but the of or was and and of the was to in 2014. in an rate of

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