PTH-070 A Multinational Study to Determine Indicators of Suboptimal Therapy Among Ulcerative Colitis Patients Treated with Tumour Necrosis Factor Antagonists
Authors: J Lindsay, J Gisbert, R Mody, L Peyrin-Biroulet, A Armuzzi, B Bokemeyer, G Nguyen, J Siebenaler, Ö Åkerborg, M Smyth, A Rathmell
Journal: Gut (2016)

<h3>Introduction</h3> 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. <h3>Methods</h3> 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 &gt;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. <h3>Results</h3> 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. <h3>Conclusion</h3> 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. <h3>Disclosure of Interest</h3> 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., Ö. Åkerborg 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