The impact of anti-TNFα therapy on colectomy rates and corticosteroid treatment among 3001 paediatric and adolescent patients with ulcerative colitis-a nationwide study from 1995 to 2015

Aliment Pharmacol Ther. 2019 Nov;50(10):1077-1085. doi: 10.1111/apt.15510. Epub 2019 Oct 3.

Abstract

Background: The long-term effects of anti-TNFα therapy in ulcerative colitis are debatable.

Aim: To examine whether anti-TNFα therapy changed the colectomy proportion and reduced the use of corticosteroids.

Methods: A nationwide cohort study among patients (age 0-20) diagnosed with ulcerative colitis through 1995-2015 from Danish health registries. We calculated the cumulative 5-year risk of colectomy after diagnosis and used a Cox regression model for comparison between a historical pre-anti-TNFα cohort 1 (1995-2003) and a cohort 2 for the era of anti-TNFα (2004-2015). Based on anti-TNFα users, defined as patients who had at least four anti-TNFα treatments within 4 months, we examined the subsequent need for corticosteroids.

Results: We identified 3001 patients from 1995 to 2015. The 5-year cumulative proportion of colectomy in cohort 2 was 9.7% (95% confidence interval [CI] 8.4-11.1) and 12.3% (95% CI 10.4-14.6) in cohort 1. The adjusted 5-year hazard ratio (HR) was 0.76 (95% CI 0.60-0.96) for colectomy in cohort 2 compared to cohort 1. A total of 334 patients received anti-TNFα treatments, and 16.8% (56/334) were prescribed corticosteroids in the subsequent 3-month period. Corticosteroid treatment declined with follow-up after 6 and 12 months, 5.4% and 1.2%, respectively.

Conclusion: In patient's ≤20 years, the HR for colectomy within a period of 5 years from the time of diagnosis was reduced in the era of anti-TNFα compared to a historical cohort. In patients treated with anti-TNFα, prescriptions of corticosteroids were virtually ceased after 12 months.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Antibodies, Monoclonal / therapeutic use*
  • Child
  • Child, Preschool
  • Cohort Studies
  • Colectomy / statistics & numerical data*
  • Colitis, Ulcerative / diagnosis
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / epidemiology*
  • Colitis, Ulcerative / surgery
  • Denmark / epidemiology
  • Female
  • Humans
  • Immunotherapy / methods
  • Incidence
  • Infant
  • Infant, Newborn
  • Male
  • Registries
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Tumor Necrosis Factor-alpha / immunology*
  • Young Adult

Substances

  • Adrenal Cortex Hormones
  • Antibodies, Monoclonal
  • TNF protein, human
  • Tumor Necrosis Factor-alpha