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Introduction Ulcerative colitis (UC) patients treated with tumour necrosis factor antagonists (anti-TNFs) may require therapy changes over time, which may be considered as indicators of suboptimal therapy. Methods A multinational, multicentre, retrospective, chart review study was conducted to assess the indicators of suboptimal therapy among adult UC patients receiving their first anti-TNF [infliximab (IFX) or adalimumab (ADA)] between June 2009 and June 2013 (index therapy). The indicators of suboptimal therapy during 2 year follow up included: anti-TNF dose-escalation (assessed >4 months after index to allow for initial dose adjustments), augmentation with non-biologic therapy, UC-related surgery, discontinuation of first anti-TNF and switching to second anti-TNF. Dose escalation was defined as any increase in dose and/or frequency of the index anti-TNF agent(s). Augmentation was defined as starting a new non-biologic drug or increase in dose/frequency of the concurrent non-biological drugs with anti-TNF therapy. Discontinuation of index anti-TNF was based on entry in patients’ charts and excluded patients who discontinued anti-TNF despite it being effective during the follow-up period. Switch was defined as a subset of discontinuation patients who initiated another anti-TNF therapy over the follow-up period. The number and percentage of patients with each indicator and ≥1 indicator was summarised descriptively by country. Results The study included 538 UC patients with mean age (SD) of 42 (14) years. Forty-seven percent of patients were females and 73% reported moderate to severe UC at index. The percentages of patients on IFX and ADA as first anti-TNF were 92% and 8%, respectively. Overall, within 2 years, 61% of UC patients had ≥1 indicator of suboptimal therapy, 26% had anti-TNF dose escalation, 21% needed augmentation with non-biologic therapy, 9% underwent UC-related surgery and 29% discontinued their index anti-TNF. Of those who discontinued index anti-TNF (N = 156), 58% switched to another anti-TNF therapy. Conclusion In this large multinational cohort, more than 60% of UC patients had ≥1 indicator of suboptimal anti-TNF therapy. Predominant indicators included dose escalation and discontinuation of anti-TNF therapy. Disclosure of Interest J. Lindsay Grant/research support from: MSD, Abbvie, Hospira, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Vifor Pharma, Atlantic Health care, Actavis (Warner Chilcott), and Tillotts, Consultant for: MSD, Abbvie, Hospira, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Vifor Pharma, Atlantic Health care, Actavis (Warner Chilcott), and Tillotts, Speaker bureau with: MSD, Abbvie, Hospira, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Vifor Pharma, Atlantic Health care, Actavis (Warner Chilcott), and Tillotts, J. Gisbert Grant/research support from: MSD, Abbvie, Hospira, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma, Consultant for: MSD, Abbvie, Hospira, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma, Speaker bureau with: MSD, Abbvie, Hospira, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma, R. Mody Employee of: Takeda Pharmaceuticals International, Inc, L. Peyrin-Biroulet Consultant for: Abbvie, MSD, Jansse, Takeda, Hospira, Celltrion, Biogaran, Speaker bureau with: Abbvie, MSD, Janssen, Takeda, Mitsubishi, A. Armuzzi Grant/research support from: MSD, Consultant for: Abbvie, Hospira, Liily, MSD, Mundipharma, Pfizer, Sofar, Takeda, Speaker bureau with: Abbvie, Astra-Zeneca, Chiesi, Ferring, Hospira, MSD, Otsuka, Takeda, Zambon, B. Bokemeyer Grant/research support from: Abbvie, Ferring, UCB, Consultant for: Abbvie, MSD, Shire, Ferring, UCB, Hospira, Takeda, Movetis, Speaker bureau with: Abbvie, Ferring, MSD, Merckle, Falk, HLR, UCB, G. Nguyen Consultant for: Janssen and Abbvie, J. Siebenaler Conflict with: Employee of Mapi, a company hired to conduct the study by Takeda Pharmaceuticals International, Inc., O. Akerborg Conflict with: Employee of Mapi, a company hired to conduct the study by Takeda Pharmaceuticals International, Inc., M. Smyth Employee of: Takeda Development Centre Europe Ltd, London, UK

Introduction Crohn’s disease (CD) patients treated with tumour necrosis factor antagonists (anti-TNFs) may require therapy changes over time, which may be considered as indicators of suboptimal therapy. Methods A multi-national, multicentre, retrospective, chart review study was conducted to assess the indicators of suboptimal therapy among adult CD patients receiving their first anti-TNF [infliximab (IFX) or adalimumab (ADA)] between June 2009 and June 2011 (index therapy). The indicators of suboptimal therapy during 2 year follow up were: anti-TNF dose-escalation (assessed >4 months after index to allow for initial dose adjustments), augmentation with a non-biologic drug, discontinuation of first anti-TNF, switching to another anti-TNF and CD-related surgery. The percentages of patients with each indicator type and ≥1 indicator by country for each anti-TNF drug are summarised descriptively. Results The study included 657 CD patients with mean age (SD) of 39.2 (13.2) years, 51% females, 51% with moderate to severe CD at index, 44% and 56% on ADA and IFX, respectively and 71% on combination therapy with a non-biologic drug. Overall, 56% of CD patients had ≥1 indicator of suboptimal therapy, 20% of patients had dose escalation, 18% needed augmentation with a non-biologic, 29% discontinued first anti-TNF, and 17% underwent a CD-related surgery. Of those who discontinued (N = 183), 70% switched to another anti-TNF. Conclusion In this large multi-national cohort, over half of the CD patients had ≥1 indicator of anti-TNF suboptimal therapy. Predominant indicators included dose escalation, discontinuation and switching to another anti-TNF. Disclosure of Interest A. Armuzzi Grant/research support from: MSD, Consultant for: Abbvie, Hospira, Liily, MSD, Mundipharma, Pfizer, Sofar, Takeda, Speaker bureau with: Abbvie, Astra-Zeneca, Chiesi, Ferring, Hospira, MSD, Otsuka, Takeda, Zambon, J. Lindsay Grant/research support from: MSD, Abbvie, Hospira, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Vifor Pharma, Atlantic Health care, Actavis (Warner Chilcott), and Tillotts, Consultant for: MSD, Abbvie, Hospira, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Vifor Pharma, Atlantic Health care, Actavis (Warner Chilcott), and Tillotts, Speaker bureau with: MSD, Abbvie, Hospira, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Vifor Pharma, Atlantic Health care, Actavis (Warner Chilcott), and Tillotts, R. Mody Employee of: Takeda Pharmaceuticals International, Inc, B. Bokemeyer Grant/research support from: Abbvie, Ferring, UCB, Consultant for: Abbvie, MSD, Shire, Ferring, UCB, Hospira, Takeda, Movetis, Speaker bureau with: Abbvie, Ferring, MSD, Merckle, Falk, HLR, UCB, J. Gisbert Grant/research support from: MSD, Abbvie, Hospira, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma, Consultant for: MSD, Abbvie, Hospira, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma, Speaker bureau with: MSD, Abbvie, Hospira, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma, L. Peyrin-Biroulet Consultant for: Abbvie, MSD, Jansse, Takeda, Hospira, Celltrion, Biogaran, Speaker bureau with: Abbvie, MSD, Janssen, Takeda, Mitsubishi, G. Nguyen Consultant for: Janssen and Abbvie, J. Siebenaler Conflict with: Employee of Mapi, a company hired to conduct the study by Takeda Pharmaceuticals International, Inc., O. Akerborg Conflict with: Employee of Mapi, a company hired to conduct the study by Takeda Pharmaceuticals International, Inc., M. Smyth Employee of: Takeda Development Centre Europe Ltd, London, UK

Introduction Corticosteroids (CS) can effectively induce remission of Crohn’s disease (CD), but serious side effects prohibit long-term use. Vedolizumab (VDZ) maintenance therapy resulted in a significantly higher percentage of patients with CS-free remission at week 52 versus placebo (PBO) in the GEMINI 2 study of moderately to severely active CD. 1 Methods In GEMINI 2, patients who responded to VDZ induction therapy at week 6 were re-randomised to PBO or VDZ for 46 weeks. From week 6 onward, patients with clinical response began a CS tapering regimen. With exploratory and post hoc analyses, we characterised CS dose reductions following VDZ therapy in the population of patients on stable CS doses (≤30 mg/day prednisone or equivalent) at baseline (week 0). Median CS dose over time, change from baseline CS dose, and CS-free status at week 52 were summarised overall and by tumour necrosis factor antagonist (anti-TNF) treatment (naive or failure) history. Results At week 52, 68% of patients with baseline CS use decreased their CS dose with VDZ treatment compared with 62% with PBO ( Table ). The median CS dose in either treatment group (VDZ or PBO) at week 52 was 5 mg/day. Higher percentages of patients (overall and anti-TNF-naive) required CS doses of ≤7.5 mg/day with VDZ versus PBO at week 52 ( Table ). In anti-TNF-naive patients, the median CS dose at week 52 was 2.7 mg/day with VDZ and 5.0 mg/day with PBO. At week 52, higher percentages of VDZ-treated patients were CS- free for 90 or 180 consecutive days than PBO-treated patients. Conclusion VDZ maintenance therapy was associated with numerically higher percentages of CS-free patients at week 52 and patients who were CS-free for 90 or 180 days than PBO. Interpretation of these post hoc analyses, including the degree of dose reduction, is limited by differing initiation weeks for CS tapering per patient and small sample sizes. Reference 1 Sandborn WJ, et al . N Engl J Med . 2013; 369 :711–721; NCT00783692 . Disclosure of Interest E. Loftus Jr Grant/research support from: AbbVie, Janssen, UCB, Takeda, Pfizer, GSK, Amgen, BMS, Genentech, Robarts Clinical Trials, Gilead, Receptos, Consultant for: AbbVie, Janssen, UCB, Takeda, Immune Pharmaceuticals, Celgene, MedImmune, Theradiag, Genentech, Seres Health, Sun Pharmaceuticals, BMS, C. Siegel Grant/research support from: AbbVie, Janssen, Salix, Takeda, UCB, Consultant for: AbbVie, Amgen, Janssen, Lilly, Pfizer, Takeda, UCB, Speaker bureau with: AbbVie, Janssen, Takeda, R. Panaccione Grant/research support from: Abbott, and UCB Inc, Consultant for: Abbott, Biogen, Axcan Pharma Inc, BMS, Centocor Inc, Chemocentryx, Ferring, Genentech Inc, Lippincott Williams & Wilkins, Medscape, Osiris Therapeutics, Inc, Novartis, Genentech Inc, Elan Pharmaceuticals, Inc, UCB, W. Sandborn Grant/research support from: Janssen, AbbVie, Pfizer, Amgen, Genentech, Consultant for: Janssen, AbbVie, Pfizer, Amgen, Genentech, Takeda, Speaker bureau with: AbbVie, Takeda, M. Smyth Employee of: Takeda Development Centre Europe Ltd, London, UK, A. James Employee of: Takeda Development Centre Europe Ltd, London, UK, J. Xu Employee of: Takeda Pharmaceuticals International Co, Cambridge, Massachusetts, USA, B. Abhyankar Employee of: Takeda Development Centre Europe Ltd, London, UK

Introduction The objective of this analysis was to examine the clinical and economic impact of vedolizumab (VDZ) compared with conventional therapy (CT) in the treatment of moderately to severely active ulcerative colitis (UC) in the UK (UK). Methods A Markov decision analytic model in Microsoft Excel was used to compare VDZ with CT (aminosalicylates, corticosteroids, immunomodulators) for the treatment of UC patients in the UK. We considered three populations: the overall intent-to-treat (ITT) population; anti-tumour necrosis factor (TNF)-naive patients; and patients who previously failed anti-TNF therapy from the GEMINI 1 trial. Population characteristics, efficacy data, and UC health-state utility data were obtained from the GEMINI 1 trial. Other inputs (e.g., unit costs, adverse event disutilities, probability of surgery, mortality) were obtained from published literature. Costs are presented in 2014 British pounds. Outcomes included quality-adjusted life-years (QALY), time spent in clinical response, and time spent in clinical remission. Time horizons included 10 year (base-case) and lifetime (scenario) horizons, with costs and outcomes discounted by 3.5% per year. Incremental cost-effectiveness ratios (ICER) were presented for VDZ compared with CT. Univariate and multivariate probabilistic sensitivity analyses were conducted to assess model robustness to parameter uncertainty, and a scenario analysis was explored using efficacy data from a network meta-analysis. Results Over the base-case (10 year) time horizon, the model predicted that patients on VDZ accrued more QALY than patients on CT: 5.551 QALY vs 5.397 QALY in the ITT population (ICER=£33,297/QALY); 5.597 vs 5.403 QALY for anti-TNF-naive patients (ICER=£24,657/QALY; network meta-analysis results: utilities 5.898 for VDZ vs 5.555 for CT and ICER=£4,862/QALY); and 5.463 vs 5.373 QALY for anti-TNF-failure patients (£64,999/QALY). Patients on VDZ spent more time in clinical response (0.99 years vs 0.27 years for the ITT population) and clinical remission (0.64 years vs 0.13 years) than patients on CT. Scenario analyses with a lifetime horizon showed VDZ to be even more cost-effective (ITT population ICER=£20,599/QALY). Sensitivity analyses suggest that results are most sensitive to treatment response and transition probabilities. Conclusion Our model predicted that treatment with VDZ improves QALY, increases time in remission and response, and is a cost-effective treatment option for both anti-TNF naive and anti-TNF failure patients with moderately to severely active UC compared with CT over 10 year and lifetime horizons. Disclosure of Interest M. Wilson Conflict with: Employee of RTI Health Solutions, a company hired to conduct the study by Takeda Pharmaceuticals, M. Kerrigan Conflict with: Employee of PHMR Ltd, a company hired to conduct the study by Takeda Pharmaceuticals, M. Smyth Employee of: Takeda Development Centre Europe Ltd, London, UK, H. Chevrou-Severac Employee of: Takeda Pharmaceuticals GmbH, Zurich, Switzerland, A. Bergman Employee of: Takeda Pharmaceuticals GmbH, Zurich, Switzerland, R. Selby Employee of: Takeda UK Ltd., Bucks, UK

Introduction The objective of this analysis was to examine the clinical and economic impact of vedolizumab (VDZ) compared with infliximab (IFX), adalimumab (ADA), and golimumab (GOL) in the treatment of moderately to severely active ulcerative colitis (UC) in the UK (UK). Methods A Markov decision analytic model in Microsoft Excel was used to compare VDZ with IFX, ADA, and GOL for the treatment of UC patients in the UK. Due to a lack of data in comparable patient populations, this analysis was conducted in anti-tumour necrosis factor (TNF)-naive patients only. Efficacy data were obtained from a network meta-analysis of Phase III clinical trials, using placebo as the common comparator. Other inputs (e.g., unit costs, adverse event disutilities, probability of surgery, mortality) were obtained from published literature. Costs are presented in 2014 British pounds. Outcomes included quality-adjusted life-years (QALY), time spent in clinical response, and time spent in clinical remission. Time horizons included 10 year (base case) and lifetime (scenario) horizons, with costs and outcomes discounted by 3.5% per year. Incremental cost-effectiveness ratios (ICER) were presented for VDZ compared with other biologics. Univariate and multivariate probabilistic sensitivity analyses were conducted to assess model robustness to parameter uncertainty. Results Over the base-case (10 year) time horizon, the model predicted that anti-TNF-naive patients on VDZ accrued more QALY than patients on other biologics: 5.898 QALY vs 5.818, 5.760, and 5.790 QALY for IFX, ADA, and GOL, respectively. The incremental results over a 10 year horizon suggests that VDZ is a cost-effective treatment compared with ADA (ICER of £6,634/QALY), and VDZ is dominant compared with IFX and GOL. Patients on VDZ spent more time in clinical response (2.93 years vs 2.55 years for ADA, IFX and GOL) and clinical remission (1.38 years vs 1.08, 0.99, and 1.04 years for IFX, ADA and GOL respectively). VDZ was found to be dominant compared with all other biologics over a lifetime horizon. Sensitivity analyses suggest that results are most sensitive to treatment response and transition probabilities. However, VDZ remained cost-effective irrespective of variation in any of the input parameters. Conclusion Our model predicted that treatment with VDZ improves QALY, increases time in remission and response, and is a cost-effective treatment option for anti-TNF-naive patients with moderately to severely active UC compared with all other biologics tested. VDZ may also be a cost-saving treatment strategy as well. Disclosure of Interest M. Wilson Conflict with: Employee of RTI Health Solutions, a company hired to conduct the study by Takeda Pharmaceuticals, M. Kerrigan Conflict with: Employee of PHMR Ltd, a company hired to conduct the study by Takeda Pharmaceuticals, M. Smyth Employee of: Takeda Development Centre Europe Ltd, London, UK, H. Chevrou-Severac Employee of: Takeda Pharmaceuticals GmbH, Zurich, Switzerland, A. Bergman Employee of: Takeda Pharmaceuticals GmbH, Zurich, Switzerland, R. Selby Employee of: Takeda UK Ltd., Bucks, UK

Introduction Corticosteroids (CS) are effective for the short-term treatment of patients (pts) with ulcerative colitis (UC), but serious side effects prohibit long-term use. In the GEMINI 1 study, a higher percentage of pts with moderately to severely active UC were in CS-free remission at week (wk) 52 with vedolizumab (VDZ) treatment than with placebo (PBO). 1 Methods In GEMINI 1, pts who responded to VDZ induction therapy at wk 6 were re-randomised to PBO or VDZ for 46 wks. From wk 6 onward, pts with clinical response discontinued CS use. We characterised CS dose reductions achieved with VDZ therapy in exploratory and post hoc analyses of pts with baseline (wk 0) CS use (≤30 mg/day prednisone or equivalent). Median CS dose over time, change from baseline CS dose, and CS-free status at wk 52 were summarised overall and by anti-tumour necrosis factor (anti-TNF) treatment (naive or failure) history. Results Of pts with baseline CS use, 74% decreased their CS dose with VDZ treatment at week 52 (vs 57% with PBO) (Table). At wk 52, 56% of VDZ-treated pts were on ≤7.5 mg/day of CS ( Table ), and the median CS dose was 2.5 mg/day for VDZ-treated pts and 10.0 mg/day for PBO. Numerically higher percentages of VDZ-treated pts were CS-free for 90 and 180 consecutive days at wk 52 than PBO- treated pts. Similar trends were observed in the anti-TNF-naive and anti-TNF-failure populations. Conclusion Numerically greater reductions in CS use were achieved with VDZ maintenance therapy compared with PBO. At week 52, VDZ therapy was associated with numerically higher percentages of CS-free patients and patients who were CS-free for 90 or 180 consecutive days than PBO. Interpretation of these post hoc analyses, including the degree of dose reduction, is limited by differing initiation weeks for CS tapering per patient and small sample sizes. Reference 1 Feagan BG, et al . N Engl J Med . 2013; 369 :699–710; NCT00783718. Disclosure of Interest E. Loftus Jr Grant/research support from: from AbbVie, Janssen, UCB, Takeda, Pfizer, GlaxoSmithKline, Amgen, Bristol-Myers Squibb, Genentech, Robarts Clinical Trials, Gilead, Receptos, Consultant for: AbbVie, Janssen, UCB, Takeda, Immune Pharmaceuticals, Celgene, MedImmune, Theradiag, Genentech Inc, Seres Health, Sun Pharmaceuticals, Bristol-Myers Squibb, C. Siegel Grant/research support from: AbbVie, Janssen, Salix, Takeda, UCB, Consultant for: AbbVie, Amgen, Janssen, Lilly, Pfizer, Takeda, UCB, Speaker bureau with: AbbVie, Janssen, Takeda, R. Panaccione Grant/research support from: Abbott, and UCB Inc, Consultant for: Abbott, Biogen/IDEC, Axcan Pharma Inc, Bristol-Myers Squibb, Centocor, Inc, Chemocentryx, Ferring Pharmaceuticals Inc, Genentech Inc, Lippincott Williams & Wilkins, Medscape, Osiris Therapeutics, Inc, Novartis Pharmaceuticals, Genentech Inc, Elan Pharmaceuticals, Inc, UCB, Inc, W. Sandborn Grant/research support from: Janssen, AbbVie, Pfizer, Amgen, Genentech, Consultant for: Janssen, AbbVie, Pfizer, Amgen, Genentech, Takeda, Speaker bureau with: AbbVie, Takeda, M. Smyth Employee of: Takeda Development Centre Europe Ltd, London, UK, A. James Employee of: Takeda Development Centre Europe Ltd, London, UK, J. Xu Employee of: Takeda Pharmaceuticals International Co, Cambridge, Massachusetts, USA, B. Abhyankar Employee of: Takeda Development Centre Europe Ltd, London, UK