Treatment patterns among patients with moderate-to-severe ulcerative colitis in the United States and Europe


Autoři: Alessandro Armuzzi aff001;  Marco daCosta DiBonaventura aff002;  Miriam Tarallo aff003;  James Lucas aff004;  Daniel Bluff aff004;  Benjamin Hoskin aff004;  Danielle Bargo aff002;  Joseph C. Cappelleri aff005;  Daniel Quirk aff006;  Leonardo Salese aff006
Působiště autorů: IBD Unit, Presidio Columbus Fondazione Policlinico A. Gemelli IRCCS–Università Cattolica del Sacro Cuore, Rome, Italy aff001;  Patient Health Impact, Pfizer Inc, New York, NY, United States of America aff002;  Patient Health Impact, Pfizer Inc, Rome, Italy aff003;  Adelphi Real World, Macclesfield, SK, United Kingdom aff004;  Biostatistics, Pfizer Inc, Groton, CT, United States of America aff005;  Medical Affairs, Pfizer Inc, Collegeville, PA, United States of America aff006
Vyšlo v časopise: PLoS ONE 15(1)
Kategorie: Research Article
doi: 10.1371/journal.pone.0227914

Souhrn

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.

Klíčová slova:

Europe – European Union – Finance – Charts – Physicians – Steroid therapy – Ulcerative colitis – United States


Zdroje

1. Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology. 2011;140(6):1785–94. doi: 10.1053/j.gastro.2011.01.055 21530745

2. Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017;389(10080):1756–70. doi: 10.1016/S0140-6736(16)32126-2 27914657

3. Farthing M, Roberts SE, Samuel DG, Williams JG, Thorne K, Morrison-Rees S, et al. Survey of digestive health across Europe: Final report. Part 1: The burden of gastrointestinal diseases and the organisation and delivery of gastroenterology services across Europe. United European Gastroenterol J. 2014;2(6):539–43. doi: 10.1177/2050640614554154 25452850

4. Burisch J, Jess T, Martinato M, Lakatos PL. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013;7(4):322–37. doi: 10.1016/j.crohns.2013.01.010 23395397

5. Crohn's & Colitis Foundation of America. The facts about inflammatory bowel disease. 2014. Available from: http://www.crohnscolitisfoundation.org/assets/pdfs/ibdfactbook.pdf.

6. Fakhoury M, Negrulj R, Mooranian A, Al-Salami H. Inflammatory bowel disease: clinical aspects and treatments. J Inflamm Res. 2014;7113–20.

7. Mowat C, Cole A, Windsor A, Ahmad T, Arnott I, Driscoll R, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011;60(5):571–607. doi: 10.1136/gut.2010.224154 21464096

8. Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114(3):384–413. doi: 10.14309/ajg.0000000000000152 30840605

9. Harbord M, Eliakim R, Bettenworth D, Karmiris K, Katsanos K, Kopylov U, et al. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. part 2: current management. J Crohns Colitis. 2017;11(7):769–84. doi: 10.1093/ecco-jcc/jjx009 28513805

10. Bressler B, Marshall JK, Bernstein CN, Bitton A, Jones J, Leontiadis GI, et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology. 2015;148(5):1035–58. doi: 10.1053/j.gastro.2015.03.001 25747596

11. Loftus EV Jr, Davis KL, Wang C-C, Dastani H, Luo A. Treatment patterns, complications, and disease relapse in a real-world population of patients with moderate-to-severe ulcerative colitis initiating immunomodulator therapy. Inflamm Bowel Dis. 2014;20(8):1361–7. doi: 10.1097/MIB.0000000000000089 24918320

12. Patel H, Lissoos T, Rubin DT. Indicators of suboptimal biologic therapy over time in patients with ulcerative colitis and Crohn's disease in the United States. PLoS One. 2017;12(4):e0175099. doi: 10.1371/journal.pone.0175099 28426675

13. Rubin DT, Mody R, Davis KL, Wang CC. Real-world assessment of therapy changes, suboptimal treatment and associated costs in patients with ulcerative colitis or Crohn's disease. Aliment Pharmacol Ther. 2014;39(10):1143–55. doi: 10.1111/apt.12727 24697826

14. Anderson P, Benford M, Harris N, Karavali M, Piercy J. Real-world physician and patient behaviour across countries: Disease-Specific Programmes—a means to understand. Curr Med Res Opin. 2008;24(11):3063–72. doi: 10.1185/03007990802457040 18826746

15. Vande Casteele N, Herfarth H, Katz J, Falck-Ytter Y, Singh S. American Gastroenterological Association Institute Technical Review on the role of therapeutic drug monitoring in the management of inflammatory bowel diseases. Gastroenterology. 2017;153(3):835–57. doi: 10.1053/j.gastro.2017.07.031 28774547

16. Panaccione R, Ghosh S, Middleton S, Márquez JR, Scott BB, Flint L, et al. Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology. 2014;146(2):392–400.e3. doi: 10.1053/j.gastro.2013.10.052 24512909

17. Smith TW, DiBonaventura M, Gruben D, Bargo D, Salese L, Quirk D. Dose escalation and treatment patterns of advanced therapies used to treat ulcerative colitis: a retrospective database analysis in the United States. Am J Gastroenterol. 2018;113:S353.


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PLOS One


2020 Číslo 1