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

PLoS One. 2020 Jan 16;15(1):e0227914. doi: 10.1371/journal.pone.0227914. eCollection 2020.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab / therapeutic use*
  • Adult
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / epidemiology
  • Colitis, Ulcerative / pathology
  • Disease Management
  • Dose-Response Relationship, Drug
  • Drug Combinations
  • Europe / epidemiology
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Infliximab / therapeutic use*
  • Male
  • Middle Aged
  • United States / epidemiology

Substances

  • Drug Combinations
  • Gastrointestinal Agents
  • Infliximab
  • Adalimumab

Grants and funding

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.