TY - JOUR
T1 - Treatment patterns among patients with moderate-to-severe ulcerative colitis in the United States and Europe
AU - Armuzzi, Alessandro
AU - DiBonaventura, Marco da Costa
AU - Tarallo, Miriam
AU - Lucas, James
AU - Bluff, Daniel
AU - Hoskin, Benjamin
AU - Bargo, Danielle
AU - Cappelleri, Joseph C.
AU - Quirk, Daniel
AU - Salese, Leonardo
N1 - Funding Information:
MD, MT, DBa, JCC, DQ and LS are or were employed by Pfizer Inc during the course of the study. Giovanni Gigante, a former Pfizer employee whose contributions are disclosed in the Acknowledgements section, was employed by Pfizer Inc during the course of the study. Pfizer Inc. provided support in the form of salaries for authors MD, MT, DBa, JCC, DQ and LS (as well as for GG), but did not have any additional role in the study design, data collection and analysis, or decision to publish. JL, DBl and BH are employed by Adelphi Real World. Adelphi Real World provided support in the form of salaries for authors JL, DBl and BH, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of all of the above authors are articulated in the ?author contributions? section. The authors would like to thank Giovanni Gigante for his contribution to the study design and data interpretation. Medical writing support was provided by Helen Findlow, PhD, and Siobh?n Hoy, of CMC Connect, a division of McCann Health Medical Communications Ltd, Manchester/Glasgow, UK and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461?464). Data contained within this manuscript have been previously presented at the American College of Gastroenterology (ACG) 2018 Annual Scientific Meeting, Philadelphia, USA, and the United European Gastroenterology Week (UEGW) 2018 Annual Congress, Vienna, Austria.
Publisher Copyright:
© 2020 Armuzzi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/1
Y1 - 2020/1
N2 - Objective The aim of the present study is to examine how moderate-to-severe ulcerative colitis (UC) is currently managed in real-world clinical practice across the United States (US) and European Union Five (EU5; France, Germany, Italy, Spain, and the United Kingdom). Methods Data from the 2017 Adelphi Inflammatory Bowel-Disease Specific Programme (IBD-DSP) were used. The IBD-DSP is a database of patient chart information abstracted by selected gastroenterologists across the US and EU5. Eligible gastroenterologists who agreed to participate were asked to complete patient record forms for the next seven consecutive eligible adult patients with UC. Only charts from patients with moderate-to-severe UC were included in the analysis (defined as those with documented administration of either an immunosuppressant [IM] or a biologic). Treatment patterns were reported descriptively. Results 411 and 1191 patient charts were included in the US and EU5 (mean ages 44.2 and 39.6 years; 53.0% and 43.5% female), respectively. For those with complete treatment history, 40.7% and 52.9% used either an IM or biologic as their first treatment (with or without steroids). Usage of these therapies increased in subsequent lines. The percentage of patients treated with combination therapy (i.e., biologic therapy with a concomitant IM) in first line generally varied between 10–20% (e.g., US: adalimumab (ADA), 10.8%; infliximab (IFX), 18.2%; EU5: ADA, 12.5%; IFX, 19.9%), though increased in later lines in the EU5. Among patients currently using a biologic therapy, between 10–40% of patients used a higher than indicated dose or greater than indicated dosing frequency during maintenance (e.g., US: IFX, 37.1%; ADA, 13.4%; EU5: IFX, 39.1%; ADA, 36.1%). In both the US and EU5, the primary reason for switching therapy was efficacy-related. Conclusions In this analysis, many patients with moderate-to-severe UC use an IM or biologic as their first therapy after diagnosis. Combination therapy and dose escalation are also common, and underscore the challenges with managing this patient population.
AB - Objective The aim of the present study is to examine how moderate-to-severe ulcerative colitis (UC) is currently managed in real-world clinical practice across the United States (US) and European Union Five (EU5; France, Germany, Italy, Spain, and the United Kingdom). Methods Data from the 2017 Adelphi Inflammatory Bowel-Disease Specific Programme (IBD-DSP) were used. The IBD-DSP is a database of patient chart information abstracted by selected gastroenterologists across the US and EU5. Eligible gastroenterologists who agreed to participate were asked to complete patient record forms for the next seven consecutive eligible adult patients with UC. Only charts from patients with moderate-to-severe UC were included in the analysis (defined as those with documented administration of either an immunosuppressant [IM] or a biologic). Treatment patterns were reported descriptively. Results 411 and 1191 patient charts were included in the US and EU5 (mean ages 44.2 and 39.6 years; 53.0% and 43.5% female), respectively. For those with complete treatment history, 40.7% and 52.9% used either an IM or biologic as their first treatment (with or without steroids). Usage of these therapies increased in subsequent lines. The percentage of patients treated with combination therapy (i.e., biologic therapy with a concomitant IM) in first line generally varied between 10–20% (e.g., US: adalimumab (ADA), 10.8%; infliximab (IFX), 18.2%; EU5: ADA, 12.5%; IFX, 19.9%), though increased in later lines in the EU5. Among patients currently using a biologic therapy, between 10–40% of patients used a higher than indicated dose or greater than indicated dosing frequency during maintenance (e.g., US: IFX, 37.1%; ADA, 13.4%; EU5: IFX, 39.1%; ADA, 36.1%). In both the US and EU5, the primary reason for switching therapy was efficacy-related. Conclusions In this analysis, many patients with moderate-to-severe UC use an IM or biologic as their first therapy after diagnosis. Combination therapy and dose escalation are also common, and underscore the challenges with managing this patient population.
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U2 - 10.1371/JOURNAL.PONE.0227914
DO - 10.1371/JOURNAL.PONE.0227914
M3 - Article
C2 - 31945774
AN - SCOPUS:85078053491
VL - 15
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 1
M1 - e0227914
ER -