Randomised clinical trial: delayed-release oral mesalazine 4.8 g day vs. 2.4 g day in endoscopic mucosal healing ASCEND I and II combined analysis
|
|
- Mercy Jefferson
- 6 years ago
- Views:
Transcription
1 Alimentary Pharmacology and Therapeutics Randomised clinical trial: delayed-release oral mesalazine 4.8 g day vs. 2.4 g day in endoscopic mucosal healing ASCEND I and II combined analysis G. R. Lichtenstein*, D. Ramsey & D. T. Rubin à *Gastroenterology Division, Department of Medicine, University of Pennsylvania School of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. Procter & Gamble Company, Mason Business Center, Mason, OH, USA. à University of Chicago Inflammatory Bowel Diseases Center, Chicago, IL, USA. Correspondence to: Dr G. R. Lichtenstein, Gastroenterology Division, Department of Medicine, University of Pennsylvania School of Medicine, Hospital of the University of Pennsylvania, 3rd Floor Ravdin Building, 34 Spruce Street, Philadelphia, PA , USA. grl@uphs.upenn.edu Publication data Submitted 3 July 21 First decision made 3 August 21 Resubmitted 6 December 21 Accepted 29 December 21 EV Pub Online 23 January 211 SUMMARY Background Recent studies have focused on the importance of mucosal healing in ulcerative colitis (UC). However, it was still unclear whether higher doses of delayed-release mesalazine (mesalamine) could provide additional benefit. Aim To examine how two doses of delayed-release mesalazine (4.8 g day and 2.4 g day) from ASCEND I and II compare in their relative ability to heal colonic mucosa over time. Methods Primary data from two prospective 6-week, double-blind, randomised studies in patients with mildly to moderately active UC were pooled and analysed retrospectively. The mucosal healing analysis focuses on moderately active UC patients (n = 391), comprising a majority of patients (84%). Additional analyses examined the relationship between mucosal healing and dose, clinical response to therapy and patient quality of life (Inflammatory Bowel Disease Questionnaire, IBDQ). Results At week 3, mucosal healing (endoscopy subscore of or 1) was achieved in 65% of moderately active UC patients on 4.8 g day and 58% of patients on 2.4 g day (P =.219). At week 6, this increased to 8% for 4.8 g day and 68% for 2.4 g day (P =.12). Healing rates with the higher dose were also greater across all extents of disease and in patients with prior steroid use. At 6 weeks, clinical response to therapy and mucosal healing were found to be well correlated (kappa =.694). Likewise, the change in IBDQ at week 6 showed a significant relationship with mucosal healing (P <.1). Conclusion Mucosal healing rates in UC achieved at 6 weeks were statistically significantly higher with delayed-release mesalazine at 4.8 g day vs. 2.4 g day (Clinicaltrials.gov: NCT577473, NCT7321). Aliment Pharmacol Ther 211; 33: doi:1.1111/j x
2 Randomised clinical trial: mucosal healing with delayed-release mesalazine INTRODUCTION Ulcerative colitis (UC) is a chronic disease characterised by diffuse mucosal inflammation limited to the colon, typically originating in the rectum and extending proximally. 1 In clinical practice, the primary goal of therapy for ulcerative colitis is the elimination of clinical symptoms such as rectal bleeding and increased stool frequency, which clearly adversely affect a patient s quality of life. Studies are now emerging that focus on the importance of more objective markers of mucosal improvement and mucosal healing. In ulcerative colitis, characteristic mucosal changes include loss of the typical vascular pattern, granularity, friability and ulceration. 1 Investigators have long felt that an effective therapy for ulcerative colitis should control symptoms in addition to restoring maintaining the integrity of the bowel mucosa. As such, mucosal healing has become increasingly common as a secondary measure of therapy success in ulcerative colitis trials, although its correlation to patient quality of life is not known. Furthermore, it is unclear whether a higher dose of mesalazine (mesalamine) (a first-line therapy in mildly to moderately active ulcerative colitis) provides incremental benefits for mucosal healing. As shown in the ASCEND I and II trials, moderately active ulcerative colitis patients taking mesalazine 4.8 g day achieved significantly higher rates of overall improvement (the primary endpoint) as compared with 2.4 g day at 6 weeks, whereas mildly active ulcerative colitis patients received the same benefit with both doses. The primary goal of this analysis is to examine the difference in effect of a higher and lower dose of delayed-release mesalazine on mucosal healing in patients with moderately active ulcerative colitis from the ASCEND I and II studies (ASCEND Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA). Although there is currently no standardised definition of mucosal healing, it is commonly defined as a sigmoidoscopy score of or 1, 2 but may also be measured differently in other trials. 3 As such, this post hoc analysis will examine the data using two definitions available. It will also aim to investigate the relationship between mucosal healing and response to therapy via clinical measures and also quality of life measures (as measured by the Inflammatory Bowel Disease Questionnaire, or IBDQ). METHODS To determine the effect of delayed-release mesalazine dosed at 4.8 g day compared with 2.4 g day on endoscopically measured mucosal healing, data from two prospective 6-week double-blind, randomised, multi-site studies conducted in patients with mildly to moderately active ulcerative colitis (ASCEND I and II; NCT and NCT7321) were pooled and analysed retrospectively. The ASCEND I and II studies were of similar design, assessing the efficacy and safety of oral delayed-release mesalazine given at doses of 4.8 g day (using 8 mg tablet, Asacol 8 [Canada and the UK], Asacol HD [US], Warner Chilcott) and 2.4 g day (using Asacol, 4 mg tablet, Warner Chilcott) in mildly to moderately active ulcerative colitis. Details of the study design, methods and results have been previously published elsewhere. 4, 5 A third study of similar design (ASCEND III) was not included in the present analysis. The authors of ASCEND III indicated that a novel technique, the contact friability test (CFT), had been incorporated in this study, but has not been performed in previous studies evaluating sigmoidoscopic improvement and mucosal healing in the modern era. This technique, which was performed using closed biopsy forceps passed through the therapeutic channel of a flexible sigmoidoscope, was included in the definition of sigmoidoscopy improvement. However, the technique may have had the effect of overestimating friability (and thus underestimating sigmoidoscopy improvement) as compared with the usual technique of assessing contact friability caused by normal passage of the flexible sigmoidoscope. For this reason, rates of sigmoidoscopy improvement reported in the ASCEND III trial cannot be compared with those reported in other ulcerative colitis studies. 6 The Mayo Score of Endoscopic Disease was used in these studies to measure mucosal healing. It is a four-point scale with scores from (endoscopically normal mucosa) to 3 (severely inflamed, spontaneously bleeding and ulcerated mucosa) (Figure 1). The mucosal healing analysis included patients with moderately active ulcerative colitis with a baseline endoscopy score of 2. Mucosal healing was defined as an endoscopy subscore of or 1, a definition that has previously been used in other ulcerative colitis clinical studies, and also an endoscopy subscore of only. 2, 3, 7 In addition, data from this population were analysed in order to determine mucosal healing rates with delayed-release oral mesalazine 4.8 g day and 2.4 g day across disease extents (proctitis, proctosigmoiditis, leftsided colitis, pancolitis), as well as for patients with mildly active ulcerative colitis with a baseline endoscopy score of 2. Finally, the relationship between mucosal healing with clinical response to therapy (overall improvement) and quality of life was examined. The Inflammatory Bowel Disease Questionnaire (IBDQ) was developed in order to examine disease- Aliment Pharmacol Ther 211; 33:
3 G. R. Lichtenstein et al. Score Endoscopy (Mayo index) Rectal bleeding Stool frequency Normal stool frequency per day PFA No friability or granularity; intact vascular pattern No blood seen Generally well 1 Erythema; diminished or absent vascular markings; mild granularity Streaks of blood with stool less than half of the time 1 to 2 stools greater than normal per day Fair 2 Marked erythema; absent vascular markings; granularity; bleeds with minimal trauma (friability); no ulcerations Obvious blood with stool most of the time 3 to 4 stools greater than normal per day Poor 3 Marked erythema; absent vascular markings; granularity; friability; spontaneous bleeding in the lumen; ulcerations Blood alone passed 5 or more stools greater than normal per day Terrible Figure 1 Clinical assessment scoring system. related dysfunction in IBD patients and to assess patient quality of life (QoL). 8 1 This questionnaire consists of 32 questions grouped into four domains (bowel symptoms, systemic symptoms, emotional function, social function). Scores range from 32 to 224, with higher scores indicating better QoL, and increase in the total IBDQ score greater than or equal to 16 points (1 2 point per question) or 32 points (1 point per question) indicate a clinically relevant improvement in QoL. Since its development in the late 198s, the IBDQ has been shown to be a valid, reliable and responsive measure of therapeutic outcome in a number of IBD studies, including large trials in ulcerative colitis 8, patients. Statistical analysis for mucosal healing Patients with moderately active ulcerative colitis fulfilling eligibility criteria to the original ASCEND I and II studies and a baseline endoscopy subscore of 2 were included in the analyses assessing mucosal healing and evaluating its relationship to clinical response to therapy and quality of life. Pooled study analyses used the Cochran-Mantel- Haenszel test stratified by study to compare treatment groups. Individual study treatment comparisons were performed using Chi-square test computed separately for each clinical study. Kappa statistics were computed to assess the level of agreement (correlation) between mucosal healing and clinical response to therapy. Logistic regression analyses were carried out to compare the relationship between mucosal healing and change from baseline IBDQ while also including term for dose in the model. RESULTS Patient characteristics Of the 448 patients with moderately active ulcerative colitis at baseline of the two original studies 391 patients 674 Aliment Pharmacol Ther 211; 33:
4 Randomised clinical trial: mucosal healing with delayed-release mesalazine Table 1 Baseline demographics and treatment history Parameter 2.4 g day (N = 235) n (%) 4.8 g day (N = 213) n (%) Mean age (years) years 214 (91) 194 (91) >64 years 21 (9) 19 (9) Gender Male 16 (45) 94 (44) Female 129 (55) 119 (56) Race Caucasian 182 (77) 158 (74) Black 23 (1) 26 (12) Hispanic 24 (1) 18 (8) Other 6 (3) 11 (5) Smoking history Never smoked 139 (59) 118 (55) Used to smoke 82 (35) 74 (35) Currently smoke 14 (6) 21 (1) Disease extent Proctitis 35 (15) 32 (15) Proctosigmoiditis 75 (32) 54 (25) Left-sided colitis 72 (31) 8 (38) Pancolitis 53 (23) 47 (22) Prior treatment Steroids (oral or IV) 8 (34) 68 (32) Immunomodulators 1 (4) 9 (4) Sulfasalazine 89 (38) 65 (31) Sulfa-free oral 5-ASAs 93 (4) 96 (45) Any oral 5-ASAs 142 () 127 () Rectal therapies 94 (4) 86 (4) Length of disease history <1 year 91 (39) 72 (34) 1 to 5 years 49 (21) 55 (26) >5 to 1 years 38 (16) 4 (19) >1 years 54 (23) 44 (21) Unknown 3 (1) 2 (1) Baseline sigmoidoscopy score (Normal) () () 1 (Mild) 26 (11) 31 (15) 2 (Moderate) 181 (77) 157 (74) 3 (Severe) 28 (12) 25 (12) qualified (endoscopy score of 2) for the analyses of mucosal healing and correlation between mucosal healing and clinical response to therapy. Baseline and demographic characteristics, disease history and disease state characterised were similar between the 2.4 g day group and the 4.8 g day groups (Table 1). Mucosal healing in moderate UC At week 3, mucosal healing was achieved by 65% of patients receiving delayed-release mesalazine 4.8 g day (8 mg tablet) compared with 58% of those receiving 2.4 g day (4 mg tablet) (P =.219). At week 6, mucosal healing rates were higher in patients receiving 4.8 g day compared with those receiving 2.4 g day (8% vs. 68%, respectively) (P =.12) (Figure 2). The mucosal healing rates for ASCEND I and ASCEND II analysed separately were found to be similar (Figure 3). At week 6, an endoscopy subscore of zero was achieved % patients with mucosal healing** % patients with mucosal healing g/day 4.8 g/day 2.4 g/day 4.8 g/day 58 n = 172 n = 156 n = 169 n = 153 Week 3 Week Figure 2 Mucosal healing at weeks 3 and 6; *P <.5 between 2.4 g day and 4.8 g day at week * 84 n = 7 n = 58 n = 69 n = 58 n = 12 n = 98 n = 1 n = 95 Week 3 Week 6 Week 3 Week 6 ASCEND I ASCEND II Figure 3 Mucosal healing at weeks 3 and 6 for ASCEND I and ASCEND II studies; *P <.5 between 2.4 g day and 4.8 g day at week * Aliment Pharmacol Ther 211; 33:
5 G. R. Lichtenstein et al g/day g/day * n = 25 n = 24 n = 51 n = 37 n = 51 n = 57 n = 42 n = 35 Proctitis Proctosigmoiditis Left-sided Pancolitis colitis Extent of disease % patients with mucosal healing Figure 4 Mucosal healing at week 6 by extent of disease; *P <.5 between 2.4 g day and 4.8 g day for left-sided disease. in 32% of patients in the 4.8 g day group compared with 24% in the 2.4 g day group (P =.125). Mucosal healing by disease extent and prior therapy Among 18 moderately active ulcerative colitis patients with left-sided colitis, mucosal healing rates were higher in those receiving 4.8 g day compared with 2.4 g day (82% vs. 63%, respectively; P=.2) (Figure 4). Mucosal healing rates were also directionally higher in patients treated with 4.8 g day in comparison to 2.4 g day across other disease extents (proctitis, proctosigmoiditis, pancolitis), but these differences were not statistically significant. Mucosal healing rates in the subgroup of moderately active ulcerative colitis patients with prior steroid therapy (oral or intravenous) were also consistent with the overall population, with higher rates in those receiving 4.8 g day compared with 2.4 g day (at week 3: 68% and 46%, respectively, P=.3; at week 6: 85% and 65%, respectively, P=.19). Mucosal healing in mild UC At week 3, mucosal healing was achieved by 79% of mildly active ulcerative colitis patients receiving delayedrelease mesalazine 4.8 g day compared with 8% of those receiving 2.4 g day (P =.8). At week 6, mucosal healing rates were 84% in patients receiving 4.8 g day compared with 88% in those receiving 2.4 g day (P =.765). At week 6, an endoscopy subscore of zero was achieved in 44% of patients in the 4.8 g day group compared with 42% in the 2.4 g day group (P =.64). Percentile No mucosal healing Mucosal healing Week 6 change from baseline IBDQ Figure 5 Relationship in the change from baseline IBDQ at 6 weeks in patients who achieved mucosal healing vs. patients who did not achieve mucosal healing. Relationship of mucosal healing with clinical response to therapy and inflammatory bowel disease questionnaire At 6 weeks, clinical responses to therapy and mucosal healing (defined as an endoscopic score of or 1) were found to be well correlated (Kappa =.694), with 67% of moderately active ulcerative colitis patients achieving both endpoints. This finding was consistent regardless of dose of 2.4 g day or 4.8 g day (Kappa =.745 and.5, respectively) and was also consistent at the 3-week time point (Kappa =.717). In a logistic regression analysis, change in Total IBDQ score at week 6 showed a significant relationship with mucosal healing (P <.1) (Figure 5). To put the results in clinical perspective, a change in the IBDQ of 16 points (1 2 point mean increase per question) multiplies the odds of mucosal healing by Likewise a change in the IBDQ of 32 points (1 point mean increase per question) multiplies the odds of mucosal healing by The results were also highly significant when examined at the individual domain level (bowel, systemic, emotional and social function) P.1. At the week 3 time point, results were significant for change in total IBDQ (P =.57), as well as for the bowel and emotional domains. The logistic regression model for mucosal healing included terms for dose and change in the IBDQ. The logistic regression analysis confirmed the effect previously mentioned at week 6 regarding dose as for patients taking 4.8 g day the odds of being mucosal healed are multiplied by relative to the 2.4 g day patients. DISCUSSION The results from this pooled analysis of the ASCEND I and ASCEND II trials demonstrated that initiation of a Percentile 676 Aliment Pharmacol Ther 211; 33:
6 Randomised clinical trial: mucosal healing with delayed-release mesalazine 4.8 g day delayed-release mesalazine dosing regimen achieves significantly higher mucosal healing rates than a 2.4 g day dosing regimen in patients with moderately active ulcerative colitis at 6 weeks. The data also demonstrated that regardless of dose and as early as 3 weeks (in the ASCEND trials, this was the first post-treatment assessment visit), delayed-release mesalazine induced endoscopically measured mucosal healing in patients with moderately active ulcerative colitis. Compared with 2.4 g day, mucosal healing rates achieved with 4.8 g day were numerically higher across all extents of disease and statistically greater among patients with left-sided disease and with prior steroid use. The higher mesalazine dose was also associated with significantly greater improvement in sigmoidoscopy at 6 weeks compared with 2.4 g day. In mildly active ulcerative colitis patients, there was no significant benefit of the higher dose, as both doses achieved high levels of mucosal healing. The ability of mesalazine to achieve mucosal healing in patients with ulcerative colitis may be an important clinical benefit as data increasingly suggest that mucosal healing is an important therapeutic endpoint for ulcerative colitis. Other studies have indicated that mucosal healing may be associated with lower long-term risk of cancer, reduced risk of relapse 17 and reduced colectomy rate in ulcerative colitis patients. 18, 19 Certain histologic findings (e.g. basal plasmacytosis) have also been found to be independently associated with a shorter time to relapse in ulcerative colitis patients. 17 Given these data and observations that endoscopic findings frequently, 2, 21 but not always 22 correlate with histologic findings, mucosal healing may be an important marker for stable disease response. A recent retrospective analysis 18 demonstrated that achievement of mucosal healing in ulcerative colitis was significantly associated with low risk of future colectomy, but did not predict disease activity, inflammatory activity, need for steroids or disease extension. Of particular interest are recent data suggesting that mucosal healing may be a strong predictor of reduced cancer risk among ulcerative colitis patients. In a case control study of patients with long-standing extensive ulcerative colitis, the degree of histologic inflammatory activity was identified as a strong predictor of colorectal cancer risk. 14 Data from a follow-up case control study determined that severe active inflammation, features indicative of previous severe inflammation (e.g. postinflammatory polyps), 23 and features indicative of chronic active colitis (e.g. shortened or tubular colon, stricture formation) are associated with a significant risk of colorectal neoplasia 23, 24 in ulcerative colitis patients. Moreover, a normal colonoscopic appearance correlated strongly with reduced risk of neoplasia, with a macroscopically normal colonoscopy returning the cancer risk to that of the general population. It is well accepted that symptom resolution is correlated with improved QoL. However, the impact of mucosal healing on QoL has not yet been established. In fact, there is an ongoing debate as to whether active disease can be present if the mucosa is healed. Discrepancies between clinical symptoms and endoscopic findings have been noted in ulcerative colitis patients 22 who may suffer from functional complaints despite complete mucosal healing. 25, 26 The results of this analysis offer new insight into this relationship, demonstrating that mucosal healing has a strong relationship with QoL increases (as measured by the IBDQ). Although further studies are needed to elucidate better the relationship between mucosal healing and the status of clinical symptoms, these findings suggest that mucosal healing is strongly related to clinical response to therapy, and impacts patient-defined improvement. In conclusion, the results from this pooled analysis indicated that 4.8 g day mesalazine provides statistically significantly higher rates of mucosal healing and sigmoidoscopic improvement within a 6-week period when compared with a 2.4 g day dosing regimen in patients with moderately active ulcerative colitis. Furthermore, mucosal healing was found to have a strong relationship with clinical response to therapy, as well as with patient quality of life. ACKNOWLEDGEMENTS Declaration of personal interests: Dr Gary R. Lichtenstein has served as a consultant for Abbott Corporation, Alaven, Centocor, Inc., Elan, Ferring, Millenium Pharmaceuticals, Procter & Gamble Pharmaceuticals/Warner Chilcott, Salix Pharmaceuticals, Schering-Plough Corporation, Shire Pharmaceuticals, UCB and Wyeth. He has done research for Bristol-Myers Squibb, Centocor, Inc., Ferring, Procter & Gamble Pharmaceuticals/Warner Chilcott, Prometheus Laboratories, Inc., Salix Pharmaceuticals, Shire Pharmaceuticals and UCB. Dr David T. Rubin has served as a consultant for Salix Pharmaceuticals, Prometheus Pharmaceuticals, Abbott Immunology, UCB Pharma, Shire, Centocor, Elan Pharmaceuticals, Takeda-Millenium, Schering-Plough Merck and Given. He has received grant support from Procter & Gamble Pharmaceuticals Warner Chilcott, Salix Pharmaceuticals, Prometheus Pharmaceuticals, Abbott Immunology (Registry) and Aliment Pharmacol Ther 211; 33:
7 G. R. Lichtenstein et al. Elan Pharmaceuticals. He is the co-founder of Cornerstones Health, Inc. (nonprofit medical education company). David Ramsey is an employee and shareholder of Procter & Gamble. Declaration of funding interests: The studies and drafting of this manuscript were funded by Warner Chilcott (formerly Procter & Gamble Pharmaceuticals). Medical writing support was provided by Erica Leung of Warner Chilcott. REFERENCES 1. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 24; 99: Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 25 8; 353: Kamm MA, Sandborn WJ, Gassull M, et al. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology 27; 132: Hanauer SB, Sandborn WJ, Kornbluth A, et al. Delayed-release oral mesalamine at 4.8g day (8mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. Am J Gastroenterol 25; 1: Hanauer SB, Sandborn WJ, Dallaire C, et al. Delayed-release oral mesalamine 4.8g day (8mg tablets) compared with 2.4g day (4mg tablets) for the treatment of mildly to moderately active ulcerative colitis: the ASCEND I trial. Can J Gastroenterol 27; 21: Sandborn WJ, Regula J, Feagan BG, et al. Delayed-release oral mesalamine 4.8g day (8mg tablet) is effective for patients with moderately active ulcerative colitis. Gastroenterology 29; 137: Sandborn WJ, Kamm MA, Lichtenstein GR, et al. MMX Multi Matrix System mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebocontrolled trials. Aliment Pharmacol Ther 27; 26: Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989; 96: Higgins PD, Schwartz M, Mapili J, Krokos I, Leung J, Zimmermann EM. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut 25; 54: Irvine EJ. Quality of life of patients with ulcerative colitis: past, present, and future. Inflamm Bowel Dis 27; 13: Irvine EJ, Feagan B, Rochon J, et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn s Relapse Prevention Trial Study Group. Gastroenterology 1994; 16: Feagan BG, Reinisch W, Rutgeerts P, et al. The effects of infliximab therapy on health-related quality of life in ulcerative colitis patients. Am J Gastroenterol 27; 12: Han SW, McColl E, Steen N, Barton JR, Welfare MR. The Inflammatory Bowel Disease Questionnaire: a valid and reliable measure in ulcerative colitis patients in the North East of England. Scand J Gastroenterol 1998; 33: Rutter MD, Saunders B, Wilkinson K, et al. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology 24; 126: Rubin DT. The changing face of colorectal cancer in inflammatory bowel disease: progress at last. Gastroenterology 26; 13: Bansal R, Itzkowitz S, Harpaz H, et al. Severity of inflammation predicts progression to colorectal neoplasia in ulcerative colitis. Am J Gastroenterol 25; 1: S-289 [Abstract #778]. 17. Bitton A, Peppercorn MA, Antonioli DA, et al. Clinical, biological, and histological parameters as predictors of relapse in ulcerative colitis. Gastroenterology 21; 12: Froslie KF, Jahnsen J, Mourn BA, et al. Mucosal healing in inflammatory bowel disease results from a Norwegian population-based cohort. Gastroenterology 27; 133: Sandborn WJ, Rutgeerts P, Feagan BG, et al. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology 29; 137: Powell-Tuck J, Day DW, Buckell NA, et al. Correlations between defined sigmoidoscopic appearances and other measures of disease activity in ulcerative colitis. Dig Dis Sci 1982; 27: Binder V. A comparison between clinical state, macroscopic and microscopic appearances of rectal mucosa and cytologic picture of mucosal exudate in ulcerative colitis. Scand J Gastroenterol 197; 5: Shen B, Achkar JP, Lashner BA, et al. Endoscopic and histologic evaluation together with symptom assessment are required to diagnose pouchitis. Gastroenterology 21; 121: Jess T, Loftus EV Jr, Velayos FS, et al. Risk of intestinal cancer in inflammatory bowel disease: a population-based study from Olmsted County, Minnestoa. Gastroenterology 26; 13: Rutter MD, Saunders BP, Wilkinson KH, et al. Cancer surveillance in longstanding ulcerative colitis: endoscopic appearances help predict cancer risk. Gut 24; 53: Mahadevan U. Mucosal healing in Crohn s disease: what you see is what you get? Gastrointest Endosc 26; 63: Lichtenstein GR, Rutgeerts P. Importance of mucosal healing in ulcerative colitis. Inflamm Bowel Dis 21; 16: Aliment Pharmacol Ther 211; 33:
As clinicians we would all agree that the goal for our
CURRENT CONTROVERSIES: PRO, CON, AND BALANCE Controversies in Mucosal Healing in Ulcerative Colitis Sunanda Kane, MD,* Frances Lu, MD, Asher Kornbluth, MD, Dahlia Awais, MD, and Peter D.R. Higgins, MD,
More informationReview article: induction therapy for patients with active ulcerative colitis
Alimentary Pharmacology & Therapeutics Review article: induction therapy for patients with active ulcerative colitis S. P. L. TRAVIS John Radcliffe Hospital and Linacre College, Oxford, UK Correspondence
More informationOnce Daily Dosing for Induction and Maintenance of Remission in Ulcerative Colitis
Once Daily Dosing for Induction and Maintenance of Remission in Ulcerative Colitis John K. Marshall MD MSc FRCPC AGAF Division of Gastroenterology McMaster University JKM 2014 Svartz N. Acta Med Scand
More informationUlcerative Colitis: Refining our Management and Incorporating Newer Concepts
Ulcerative Colitis: Refining our Management and Incorporating Newer Concepts Asher Kornbluth, MD Clinical Professor of Medicine The Henry D. Janowitz The Mt. Sinai School of Medicine Refining our Management
More informationModerately to severely active ulcerative colitis
Adalimumab in the Treatment of Moderate-to-Severe Ulcerative Colitis: ULTRA 2 Trial Results Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients
More informationMucosal healing: does it really matter?
Oxford Inflammatory Bowel Disease MasterClass Mucosal healing: does it really matter? Professor Jean-Frédéric Colombel, New York, USA Oxford Inflammatory Bowel Disease MasterClass Mucosal healing: does
More information5-aminosalicylic acid (5-ASA) is the mainstay of first-line therapy
MMX Mesalamine for Induction and Maintenance Therapy in Mild-to-Moderate Ulcerative Colitis Stephen B. Hanauer, MD 1 ; Gary R. Lichtenstein, MD 2 ; Michael A. Kamm, MD 3 ; William J. Sandborn, MD 4 ; Kirstin
More informationEarly Mucosal Healing With Infliximab Is Associated With Improved Longterm Clinical Outcomes in Ulcerative Colitis
GASTROENTEROLOGY 2011;141:1194 1201 Early Mucosal Healing With Infliximab Is Associated With Improved Longterm Clinical Outcomes in Ulcerative Colitis JEAN FRÉDÉRIC COLOMBEL,* PAUL RUTGEERTS, WALTER REINISCH,
More informationClinical Medicine Insights: Gastroenterology. Once-Daily MMX Mesalamine in the Management of Ulcerative Colitis
Clinical Medicine Insights: Gastroenterology Review Open Access Full open access to this and thousands of other papers at http://www.la-press.com. Once-Daily MMX Mesalamine in the Management of Ulcerative
More informationUlcerative colitis (UC) is a chronic disease that is commonly
ORIGINAL ARTICLE Voting with Their Feet (VWF) Endpoint: A Meta-Analysis of an Alternative Endpoint in Clinical Trials, Using 5-ASA Induction Studies in Ulcerative Colitis Sujal C. Rangwalla, DO,* Akbar
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 20 October 2010
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 20 October 2010 MEZAVANT LP 1200 mg, prolonged-release gastro-resistant tablets B/60 (CIP code: 378 689-2) Applicant
More informationClinical Study Clinical Study of the Relation between Mucosal Healing and Long-Term Outcomes in Ulcerative Colitis
Hindawi Publishing Corporation Gastroenterology Research and Practice Volume 2013, Article ID 192794, 6 pages http://dx.doi.org/10.1155/2013/192794 Clinical Study Clinical Study of the Relation between
More informationPosition of Biologics in IBD Circa 2006: Top Down vs. Step Up Therapy
Position of Biologics in IBD Circa 2006: Top Down vs. Step Up Therapy Stephen B. Hanauer, MD University of Chicago Potential Conflicts: Centocor/Schering, Abbott, UCB, Elan, Berlex, PDL Goals of Treatment
More informationNON INVASIVE MONITORING OF MUCOSAL HEALING IN IBD. THE ROLE OF BOWEL ULTRASOUND. Fabrizio Parente
NON INVASIVE MONITORING OF MUCOSAL HEALING IN IBD. THE ROLE OF BOWEL ULTRASOUND Fabrizio Parente Gastrointestinal Unit, A.Manzoni Hospital, Lecco & L.Sacco School of Medicine,University of Milan - Italy
More informationTreatment Guidelines and Clinical Practice: Optimizing Foundational Therapies for Ulcerative Colitis
O c t o b e r 2 0 0 8 w w w. c l i n i c a l a d v a n c e s. c o m V o l u m e 4, I s s u e 1 0, S u p p l e m e n t 2 2 Faculty Stephen B. Hanauer, MD Program Chair Professor of Medicine and Clinical
More informationTitle: Accuracy of calprotectin in evaluating sub- clinical inflammation in Ulcerative
PROTOCOL ACERTIVE STUDY Title: Accuracy of calprotectin in evaluating sub- clinical inflammation in Ulcerative colitis (ACERTIVE) Sponsor: Portuguese IBD Study Group (Grupo de Estudos da Doença Inflamatória
More informationTreatment of ulcerative colitis with adalimumab or infliximab: long-term follow-up of a single-centre cohort
Alimentary Pharmacology and Therapeutics Treatment of ulcerative colitis with adalimumab or infliximab: long-term follow-up of a single-centre cohort N. Gies, K. I. Kroeker, K. Wong & R. N. Fedorak Division
More informationThe quantitative validation of non-endoscopic disease activity indices in ulcerative colitis
Alimentary Pharmacology & Therapeutics The quantitative validation of non-endoscopic disease activity indices in ulcerative colitis P. D. R. HIGGINS*, J. LEUNG, M.SCHWARTZà, J.MAPILI,P.A.WREN &E.M.ZIMMERMANN*
More informationMedical Management of Inflammatory Bowel Disease
Medical Management of Inflammatory Bowel Disease John K. Marshall MD MSc FRCPC AGAF Division of Gastroenterology McMaster University John K. Marshall: Conflicts of Interest Speaker: AbbVie, Allergan, Ferring,
More informationNovel Formulations and Dosing Strategies for 5-ASA
D e c e m b e r 2 0 0 8 w w w. c l i n i c a l a d v a n c e s. c o m V o l u m e 4, I s s u e 1 2, S u p p l e m e n t 2 8 Novel Formulations and Dosing Strategies for 5-ASA A Summary of Selected Recent
More informationActivity and Endoscopic measures : Crohn s disease. Jean-Frederic COLOMBEL Justin Cote-Daigneault Icahn Medical School at Mount Sinai, New York
Activity and Endoscopic measures : Crohn s disease Jean-Frederic COLOMBEL Justin Cote-Daigneault Icahn Medical School at Mount Sinai, New York J-F Colombel has served as consultant or advisory board member
More informationClinical Trials in IBD. Bruce Yacyshyn MD Professor of Medicine Division of Digestive Diseases
Clinical Trials in IBD Bruce Yacyshyn MD Professor of Medicine Division of Digestive Diseases Objectives Today s discussion will address the following topics: Similarities and differences between Crohn
More informationUntil recently, treatment of active ulcerative colitis
ORIGINAL ARTICLE Prognostic Significance of Endoscopic Remission in Patients with Active Ulcerative Colitis Treated with Oral and Topical Mesalazine: A Prospective, Multicenter Study Gianmichele Meucci,
More informationThere is a well-established association between inflammatory
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2006;4:1346 1350 Aminosalicylate Therapy in the Prevention of Dysplasia and Colorectal Cancer in Ulcerative Colitis DAVID T. RUBIN, ANDELKA LOSAVIO, NICOLE YADRON,
More information5-ASA Therapy, Steroids and Antibiotics in Inflammatory Bowel Disease
5-ASA Therapy, Steroids and Antibiotics in Inflammatory Bowel Disease David T. Rubin, MD Associate Professor of Medicine Co-Director, Inflammatory Bowel Disease Center University it of Chicago Medical
More informationENTYVIO (VEDOLIZUMAB)
ENTYVIO (VEDOLIZUMAB) UnitedHealthcare Community Plan Medical Benefit Drug Policy Policy Number: CS2017D0053F Effective Date: July 1, 2017 Table of Contents Page INSTRUCTIONS FOR USE... 1 BENEFIT CONSIDERATIONS...
More informationAnti-tumour necrosis factor treatment of inflammatory bowel disease in liver transplant recipients
Alimentary Pharmacology and Therapeutics Anti-tumour necrosis factor treatment of inflammatory bowel disease in liver transplant recipients A. B. Mohabbat*, W. J. Sandborn, E. V. Loftus Jr, R. H. Wiesner
More informationLiterature Review: CORE I & II: COlonic RElease Budesonide for the Induction of Remission for Mild- Moderate Ulcerative Colitis
VOLUME 13, ISSUE 1, YEAR 2014 Literature Review: CORE I & II: COlonic RElease Budesonide for the Induction of Remission for Mild- Moderate Ulcerative Colitis Peter R. McNally, DO, MACG, MSRF Center for
More informationPage 1. Is the Risk This High? Dysplasia in the IBD Patient. Dysplasia in the Non IBD Patient. Increased Risk of CRC in Ulcerative Colitis
Screening for Colorectal Neoplasia in Inflammatory Bowel Disease Francis A. Farraye MD, MSc Clinical Director, Section of Gastroenterology Co-Director, Center for Digestive Disorders Boston Medical Center
More informationMonth/Year of Review: September 2012 Date of Last Review: September 2010
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationImplementation of disease and safety predictors during disease management in UC
Implementation of disease and safety predictors during disease management in UC DR ARIELLA SHITRIT DIGESTIVE DISEASES INSTITUTE SHAARE ZEDEK MEDICAL CENTER JERUSALEM Case presentation A 52 year old male
More informationOp#mizing)Management)in)IBD:) Mucosal)Healing)
Op#mizing)Management)in)IBD:) Mucosal)Healing) Vipul&Jairath&MD&PhD& Associate&Professor&of&Medicine,&Epidemiology&and& Biosta=s=cs& Western&University&&& Division&of&Gastroenterology,&& London&Health&Sciences&Network&
More informationAnti tumor necrosis factor (TNF) agents have
Achieving Clinical Response and Remission in Moderate-to-Severe Ulcerative Colitis With Golimumab Sandborn WJ, Feagan BG, Marano C, et al; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical
More informationTitle: Authors: Journal:
IMPORTANT COPYRIGHT NOTICE: This electronic article is provided to you by courtesy of Ferring Pharmaceuticals. The document is provided for personal usage only. Further reproduction and/or distribution
More informationUlcerative colitis (UC) is a chronic inflammatory
Induction and Maintenance Therapy with Vedolizumab, a Novel Biologic Therapy for Ulcerative Colitis Feagan BG, Rutgeerts P, Sands BE, et al; GEMINI 1 Study Group. Vedolizumab as induction and maintenance
More informationRecent Advances in the Management of Refractory IBD
Recent Advances in the Management of Refractory IBD Raina Shivashankar, M.D. Assistant Professor of Medicine Division of Gastroenterology and Hepatology Thomas Jefferson University Philadelphia, PA Outline
More informationClinical trial: once-daily mesalamine granules for maintenance of remission of ulcerative colitis a 6-month placebo-controlled trial
Alimentary Pharmacology and Therapeutics Clinical trial: once-daily mesalamine granules for maintenance of remission of ulcerative colitis a 6-month placebo-controlled trial G. R. Lichtenstein*, G. L.
More informationTitle: Authors: Journal:
IMPORTANT COPYRIGHT NOTICE: This electronic article is provided to you by courtesy of Ferring Pharmaceuticals. The document is provided for personal usage only. Further reproduction and/or distribution
More informationCRC and Dysplasia in IBD: Objectives of Talk. Colorectal Cancer and Dysplasia in IBD: A Case-Based Approach. Page 1
Colorectal Cancer and in IBD: A Case-Based Approach Fernando Velayos MD MPH Associate Director of Translational Research University of California, San Francisco Center for Crohn s s and Colitis CRC and
More informationHow do I choose amongst medicines for inflammatory bowel disease. Maria T. Abreu, MD
How do I choose amongst medicines for inflammatory bowel disease Maria T. Abreu, MD Overview of IBD Pathogenesis Bacterial Products Moderately Acutely Inflamed Chronic Inflammation = IBD Normal Gut Mildly
More informationUlcerative Colitis: State of the Art 2006
Ulcerative Colitis: State of the Art David T. Rubin, MD Assistant Professor of Medicine Inflammatory Bowel Disease Center University of Chicago Improving Management of Ulcerative Colitis (UC) Better classification/diagnostic
More informationTreatment Goals. Current Therapeutic Pyramids Crohn s Disease Ulcerative Colitis 11/14/10
Current Management of IBD: From Conventional Agents to Biologics Stephen B. Hanauer, M.D. University of Chicago Treatment Goals Induce and maintain response/ remission Prevent complications Improve quality
More informationBiologics in IBD. Brian P. Bosworth, MD, NYSGEF Associate Professor of Medicine Weill Cornell Medical College
Biologics in IBD Brian P. Bosworth, MD, NYSGEF Associate Professor of Medicine Weill Cornell Medical College Case 30 year old man diagnosed with ulcerative proctitis diagnosed in 2003 Had been maintained
More informationReview article: the long-term management of ulcerative colitis
Aliment Pharmacol Ther 2004; 20 (Suppl. 4): 97 101. Review article: the long-term management of ulcerative colitis S. B. HANAUER Section of Gastroenterology, University of Chicago, Chicago, IL, USA SUMMARY
More informationPersonalized Medicine in IBD: Where Are We in 2013
Personalized Medicine in IBD: Where Are We in 2013 David A. Schwartz, MD Director, Inflammatory Bowel Disease Center Associate Professor of Medicine Vanderbilt University Medical Center What is Personalized
More informationCan We Predict the Natural History of Ulcerative Colitis? Edward V Loftus, Jr, MD Professor of Medicine Mayo Clinic Rochester, Minnesota, USA
Can We Predict the Natural History of Ulcerative Colitis? Edward V Loftus, Jr, MD Professor of Medicine Mayo Clinic Rochester, Minnesota, USA Endpoints Overview Hospitalization Surgery Colorectal cancer
More informationΑναφορές εκβάσεων από τους ασθενείς (Patient Reported Outcomes): Μπορούν να αναβαθμίσουν τον τρόπο παρακολούθησης της νόσου; Γιώργος Μπάμιας
Αναφορές εκβάσεων από τους ασθενείς (Patient Reported Outcomes): Μπορούν να αναβαθμίσουν τον τρόπο παρακολούθησης της νόσου; Γιώργος Μπάμιας Σύγκρουση συμφερόντων Γιώργος Μπάμιας τιμητικές αμοιβές απο
More informationThe future of IBD therapeutic research
The future of IBD therapeutic research Jean-Frederic Colombel, MD Director Susan and Leonard Feinstein IBD Clinical Center Icahn School of Medicine, Mount Sinai Hospital New York J-F Colombel has served
More informationUpdate on Biologics in Ulcerative Colitis. Scott Plevy, MD University of North Carolina Chapel Hill, NC
Update on Biologics in Ulcerative Colitis Scott Plevy, MD University of North Carolina Chapel Hill, NC Objectives Discuss the latest advances in the pharmacologic management of ulcerative colitis Describe
More informationCASE DISCUSSION: The Patient with Dysplasia: Surgery or Active Surveillance? Noa Krugliak Cleveland, MD David T. Rubin, MD
CASE DISCUSSION: The Patient with Dysplasia: Surgery or Active Surveillance? Noa Krugliak Cleveland, MD David T. Rubin, MD Disclosure Statement NKC: No relevant conflicts to disclose. DTR: No relevant
More informationSpeaker Introduction
Speaker Introduction Stephen B. Hanauer, MD Professor of Medicine and Clinical Pharmacology University of Chicago Pritzker School of Medicine Chief of Gastroenterology, Hepatology, and Nutrition University
More informationPredicting the natural history of IBD. Séverine Vermeire, MD, PhD Department of Gastroenterology University Hospital Leuven Belgium
Predicting the natural history of IBD Séverine Vermeire, MD, PhD Department of Gastroenterology University Hospital Leuven Belgium Patient 1 Patient 2 Age 22 Frequent cramps and diarrhea for 6 months Weight
More informationTitle: Author: Journal:
IMPORTANT COPYRIGHT NOTICE: This electronic article is provided to you by courtesy of Ferring Pharmaceuticals. The document is provided for personal usage only. Further reproduction and/or distribution
More informationAzathioprine for Induction and Maintenance of Remission in Crohn s Disease
Azathioprine for Induction and Maintenance of Remission in Crohn s Disease William J. Sandborn, MD Chief, Division of Gastroenterology Director, UCSD IBD Center Objectives Azathioprine as induction and
More information5-ASA for the treatment of Crohn s disease DR. STEPHEN HANAUER FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY, CHICAGO, IL, USA
5-ASA for the treatment of Crohn s disease DR. STEPHEN HANAUER FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY, CHICAGO, IL, USA Background RCTs investigating the efficacy of aminosalicylates for
More informationEndoscopy in Inflammatory Bowel Disease DR. REENA KHANNA
Endoscopy in Inflammatory Bowel Disease DR. REENA KHANNA ASSISTANT PROFESSOR, UNIVERSITY OF WESTERN ONTARIO Background Clinical trials in ulcerative colitis and Crohn s disease require validated instruments
More informationSynopsis. Clinical Report Synopsis for Protocol Name of Company: Otsuka Pharmaceutical Development & Commercialization, Inc.
Synopsis Clinical Report Synopsis for Protocol 197-02-220 Name of Company: Otsuka Pharmaceutical Development & Commercialization, Inc. Name of Product: Tetomilast (OPC-6535) Study Title: A Phase 3, Multicenter,
More informationCCFA. Crohns Disease vs UC: What is the best treatment for me? November
CCFA Crohns Disease vs UC: What is the best treatment for me? November 8 2009 Ellen J. Scherl,, MD, FACP,AGAF Roberts Inflammatory Bowel Disease Center Weill Medical College Cornell University New York
More informationDoes Fecal Microbiota Transplantation Cause Clinical Remission in Patients with Ulcerative Colitis?
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Scholarship Student Dissertations, Theses and Papers 12-2017 Does Fecal Microbiota Transplantation
More informationPrevalence of Nonadherence With Maintenance Mesalamine in Quiescent Ulcerative Colitis
THE AMERICAN JOURNAL OF GASTROENTEROLOGY Vol. 96, No. 10, 2001 2001 by Am. Coll. of Gastroenterology ISSN 0002-9270/01/$20.00 Published by Elsevier Science Inc. PII S0002-9270(01)03245-2 Prevalence of
More informationEndpoints for Stopping Treatment in UC
Endpoints for Stopping Treatment in UC Jana G. Hashash, MD Assistant Professor of Medicine Inflammatory Bowel Disease Center Division of Gastroenterology, Hepatology, and Nutrition University of Pittsburgh
More informationIBD Updates. Themes in IBD IBD management journey. New tools for therapeutic monitoring. First-line treatment in IBD
IBD Updates Maria T. Abreu, MD University of Miami Miller School of Medicine Miami, Florida Themes in IBD 213 First-line treatment in IBD New tools for therapeutic monitoring Biologic therapy for CD and
More informationInflammatory bowel disease (IBD), which includes both Crohn s
Mucosal Healing in Inflammatory Bowel Disease A True Paradigm of Success? Maneesh Dave, MBBS, MPH, and Edward V. Loftus, Jr., MD Dr. Dave is a Fellow and Instructor of Medicine and Dr. Loftus is a Professor
More information2nd Nottingham IBD Masterclass, 2017
2nd Nottingham IBD Masterclass, 217 Positioning IL12/IL23 blockade in the Crohn s disease treatment algorithm Prof James Lindsay, Consultant Gastroenterologist, Barts Health NHS Trust Professor in Inflammatory
More informationEndoscopy in IBD. F.Hartmann K.Kasper-Kliniken (St.Marienkrankenhaus) Frankfurt/M.
F.Hartmann K.Kasper-Kliniken (St.Marienkrankenhaus) Frankfurt/M. F.Hartmann@em.uni-frankfurt.de Indications for endoscopy Diagnosis Management Surveillance Diagnosis Single most valuable tool: ileocolonoscopy
More informationENTYVIO (VEDOLIZUMAB)
ENTYVIO (VEDOLIZUMAB) UnitedHealthcare Commercial Medical Benefit Drug Policy Policy Number: 2017D0053F Effective Date: July 1, 2017 Table of Contents Page INSTRUCTIONS FOR USE... 1 BENEFIT CONSIDERATIONS...
More informationArticle: Min, T and Ford, AC (2016) Efficacy of mesalazine in IBS. Gut, 65 (1). pp ISSN
This is a repository copy of Efficacy of mesalazine in IBS. White Rose Research Online URL for this paper: http://eprints.whiterose.ac.uk/97338/ Version: Accepted Version Article: Min, T and Ford, AC (2016)
More informationPositioning Biologics in Ulcerative Colitis
Positioning Biologics in Ulcerative Colitis Bruce E. Sands, MD, MS Acting Chief, Gastrointestinal Unit Massachusetts General Hospital Associate Professor of Medicine Harvard Medical School Sequential Therapies
More informationBiologic therapy with antagonists to tumor necrosis factor
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2010;8:696 702 Reinduction With Certolizumab Pegol in Patients With Relapsed Crohn s Disease: Results From the PRECiSE 4 Study WILLIAM J. SANDBORN,* STEFAN SCHREIBER,
More informationTo help protect your privacy, PowerPoint prevented this external picture from being automatically downloaded. To download and display this picture,
To help protect your privacy, PowerPoint prevented this external picture from being automatically downloaded. To download and display this picture, click Options in the Message Bar, and then click Enable
More informationUlcerative colitis (UC) is a relatively common inflammatory
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2012;10:513 519 Efficacy of Topical 5-Aminosalicylates in Preventing Relapse of Quiescent Ulcerative Colitis: A Meta-analysis ALEXANDER C. FORD,*, KHURRAM J. KHAN,
More informationUlcerative colitis (UC) is a chronic relapsing and remitting inflammatory
TREATMENT UPDATE The Efficacy of Oral 5-ASAs in the Treatment of Active Ulcerative Colitis: A Systematic Review Sunanda V. Kane, MD, MSPH,* David J. Bjorkman, MD, MSPH, SM (Epid) *University of Chicago,
More informationFERRING PHARMACEUTICALS. Enjoy The simple COR/939/2014/CH3
Enjoy The simple pleasures of life COR/939/2014/CH3 Ulcerative colitis disrupts the simple pleasures in life Patients with ulcerative colitis may live with a considerable symptom burden despite medical
More informationOral mesalamine formulations are first-line treatments
COCHRANE REVIEW Once Daily Oral Mesalamine Compared to Conventional Dosing for Induction and Maintenance of Remission in Ulcerative Colitis: A Systematic Review and Meta-Analysis Brian G. Feagan, MD, and
More informationIntroduction. Toshifumi Hibi 1 Yuya Imai
J Gastroenterol (2017) 52:1101 1111 DOI 10.1007/s00535-017-1326-1 ORIGINAL ARTICLE ALIMENTARY TRACT Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely
More informationHow to Optimize Induction and Maintenance Responses: Definitions and Dosing Advances in Inflammatory Bowel Disease December 6, 2009
How to Optimize Induction and Maintenance Responses: Definitions and Dosing 2009 Advances in Inflammatory Bowel Disease December 6, 2009 Fernando Velayos MD MPH University of California, San Francisco
More informationAchieving Success in Ulcerative Colitis: the Role of Infliximab
Achieving Success in Ulcerative Colitis: the Role of Infliximab Dr Gill Watermeyer IBD clinic Groote Schuur Hospital 17 th August 2012 Inflammatory Bowel Disease Crohn s disease and ulcerative colitis
More informationTofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients with Ulcerative Colitis
Accepted Manuscript Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients with Ulcerative Colitis Stephen Hanauer, Remo Panaccione, Silvio Danese, Adam Cheifetz, Walter Reinisch, Peter
More informationSynopsis (C0168T37 ACT 1)
() Module 5.3 Protocol: CR004777 EudraCT No.: Not Applicable Title of the study: A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with
More informationNational Institute for Health and Care Excellence
National Institute for Health and Care Excellence 4-year surveillance (2017) Ulcerative colitis: management (2013) NICE guideline CG166 Appendix A.2: Summary of new evidence from surveillance Patient information
More informationORIGINAL ARTICLE. Abstract. Introduction
ORIGINAL ARTICLE Annals of Gastroenterology (2014) 27, 1-5 Effectiveness of adalimumab for ambulatory ulcerative colitis patients after failure of infliximab treatment: a first real-life experience in
More informationPrincipal Investigator. General Information. Certification Published on The YODA Project (
Principal Investigator First Name: William J. Last Name: Sandborn Degree: M.D. Primary Affiliation: University of California San Diego E-mail: wsandborn@ucsd.edu Phone number: 8586575284 Address: 9500
More informationThe following slides are provided as presented by the author during the live educa7onal ac7vity and are intended for reference purposes only.
The following slides are provided as presented by the author during the live educa7onal ac7vity and are intended for reference purposes only. If you have any ques7ons, please contact Imedex via email at:
More informationMucosal Healing in Crohn s Disease. Geert D Haens MD, PhD University Hospital Gasthuisberg University of Leuven Leuven, Belgium
Mucosal Healing in Crohn s Disease Geert D Haens MD, PhD University Hospital Gasthuisberg University of Leuven Leuven, Belgium Mucosal Lesions in CD: General Features CD can affect the entire GI tract
More informationLong-term outcome after infliximab for refractory ulcerative colitis
Journal of Crohn's and Colitis (2008) 2, 219 225 available at www.sciencedirect.com Long-term outcome after infliximab for refractory ulcerative colitis Marc Ferrante a, Séverine Vermeire a, Herma Fidder
More informationDiagnostic and Therapeutic Approaches to Dysplasia in Inflammatory Bowel Diseases
Diagnostic and Therapeutic Approaches to Dysplasia in Inflammatory Bowel Diseases Parakkal Deepak, M.B.B.S., M.S. Assistant Professor of Medicine Division of Gastroenterology John T. Milliken Department
More informationSeptember 12, 2015 Millie D. Long MD, MPH, FACG
Update on Biologic Therapy in 2015 September 12, 2015 Millie D. Long MD, MPH, FACG Assistant Professor of Medicine Inflammatory Bowel Disease Center University of North Carolina-Chapel Hill Outline Crohn
More informationOxford Inflammatory Bowel Disease MasterClass The mesalazine chamaeleon
Oxford Inflammatory Bowel Disease MasterClass The mesalazine chamaeleon Ailsa Hart Lead IBD Unit, St Mark s Hospital Senior Clinical lecturer Imperial College, London Oxford Inflammatory Bowel Disease
More informationMucosal Healing in Ulcerative Colitis When Zero is Better
Journal of Crohn's and Colitis, 2016, 20 25 doi:10.1093/ecco-jcc/jjv180 Advance Access publication October 5, 2015 Original Article Original Article Mucosal Healing in Ulcerative Colitis When Zero is Better
More informationRelease of 5-Aminosalicylic Acid (5-ASA) from Mesalamine Formulations at Various ph Levels
Adv Ther (2015) 32:477 484 DOI 10.1007/s12325-015-0206-4 ORIGINAL RESEARCH Release of 5-Aminosalicylic Acid (5-ASA) from Mesalamine Formulations at Various ph Levels Adeyinka Abinusawa. Srini Tenjarla
More informationENTYVIO (VEDOLIZUMAB)
ENTYVIO (VEDOLIZUMAB) UnitedHealthcare Oxford Clinical Policy Policy Number: PHARMACY 285.8 T2 Effective Date: November 1, 2017 Table of Contents Page INSTRUCTIONS FOR USE... 1 CONDITIONS OF COVERAGE...
More informationLatest Treatment Updates for Ulcerative Colitis: Evolving Treatment Goals
Latest Treatment Updates for Ulcerative Colitis: Evolving Treatment Goals Stephen Hanauer, MD Professor of Medicine Medical Director, Digestive Disease Center Northwestern Medicine Chicago, Illinois Speaker
More informationThe variable risk of colorectal cancer in patients with inflammatory bowel disease.
The variable risk of colorectal cancer in patients with inflammatory bowel disease. Lindgren, Stefan Published in: European Journal of Internal Medicine DOI: 10.1016/j.ejim.2004.12.001 Published: 2005-01-01
More informationCrohn s Disease: A New Approach to an Old Problem
Management of Postoperative Crohn s Disease: A New Approach to an Old Problem Miguel Regueiro, M.D. Associate Professor of Medicine Associate Chief for Education Clinical Head and Co-Director, IBD Center
More informationUlcerative colitis (UC) is a. The Patient with Newly Diagnosed Ulcerative Colitis: Anticipating the Questions and Individualizing the Answers
The Patient with Newly Diagnosed Ulcerative Colitis: Anticipating the Questions and Individualizing the Answers James Gregor, MD, Division of Gastroenterology, The University of Western Ontario, London,
More informationNarrow band imaging efficiency in evaluation of mucosal healing/ relapse of ulcerative colitis
Original article Narrow band imaging efficiency in evaluation of mucosal healing/ relapse of ulcerative colitis Authors Seiko Sasanuma 1, Kazuo Ohtsuka 1, 2, Shin-ei Kudo 1, Noriyuki Ogata 1, Yasuharu
More informationPresence of pseudopolyps in ulcerative colitis is associated with a higher risk for treatment escalation
ORIGINAL ARTICLE Annals of Gastroenterology (2019) 32, 1-6 Presence of pseudopolyps in ulcerative colitis is associated with a higher risk for treatment escalation Dimitrios S. Politis a, Konstantinos
More informationNew treatment options in UC. Rob Bryant IBD Consultant Royal Adelaide Hospital
New treatment options in UC Rob Bryant IBD Consultant Royal Adelaide Hospital Talk Outline 1. Raising expectations 2. Optimising UC therapy 3. Clinical trials 4. What s new on the PBS? 5. Questions 1.
More informationThe role of Surgery and Stomas in IBD
The role of Surgery and Stomas in IBD When do I need it? Can I avoid it? How do I live with it? Kyle G. Cologne, MD Assistant Professor of Surgery USC Division of Colorectal Surgery Topics Surgical Differences
More informationDENOMINATOR: All patients aged 18 and older with a diagnosis of inflammatory bowel disease
Measure #270: Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Sparing Therapy National Quality Strategy Domain: Effective Clinical Care 2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY
More information