Real-world Effectiveness of Advanced Therapies Among Patients With Moderate to Severe Ulcerative Colitis in the United States

Inflamm Bowel Dis. 2020 May 12;26(6):941-948. doi: 10.1093/ibd/izz204.

Abstract

Background: Ulcerative colitis (UC) treatment aims to induce response and maintain steroid-free remission. For patients with moderate to severe UC and/or nonresponse to conventional treatment, advanced therapies (immunosuppressants and biologics) are available. We assessed real-world effectiveness of advanced UC therapies.

Methods: This retrospective analysis of claims data included adult patients with UC initiating immunosuppressant or biologic therapy, with 12 months' continuous enrollment pre- and postinitiation. Patients had no prescription for biologic therapy (and/or immunosuppressant if initiating immunosuppressant) in the previous 12 months. Proportion of patients remaining steroid-free (excluding 14-week tapering period), hospitalizations, and costs in the 12 months postinitiation were assessed.

Results: In total, 3562 patients were included in the analysis. Most patients (83.0%) used steroids in the 12 months before initiating advanced therapy. Overall, 47.8% remained steroid-free after 12 months (excluding tapering). After adjusting for patient characteristics, remaining steroid-free was significantly more likely with infliximab (43.9%) than with adalimumab (39.4%; P < 0.05); golimumab (38.2%) and vedolizumab (41.4%) were not significantly different vs adalimumab. Overall, 12.2% of patients had a UC-related hospitalization within 12 months of initiation, with a mean (SD) total length of stay of 8.2 (8.9) days and no significant differences between biologic therapies. Mean, unadjusted, UC-related costs in the 12 months postinitiation were $42,579 and were similar between therapies.

Conclusions: Patients with UC initiating advanced therapy frequently continued using steroids for at least a year. Some patients experienced extended UC-related hospitalizations, with high UC-related costs overall. This suggests an ongoing challenge in managing patients with moderate to severe UC.

Keywords: biologic therapy; immunosuppressant; real-world effectiveness; ulcerative colitis.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab
  • Adult
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Biological Products / therapeutic use*
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / economics
  • Databases, Factual
  • Drug Therapy, Combination
  • Female
  • Hospitalization / economics
  • Hospitalization / statistics & numerical data*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Infliximab
  • Male
  • Middle Aged
  • Retrospective Studies
  • Severity of Illness Index
  • Treatment Outcome
  • United States

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Biological Products
  • Immunosuppressive Agents
  • golimumab
  • vedolizumab
  • Infliximab
  • Adalimumab