Treatment and biologic maintenance-dosing patterns among pediatric patients with ulcerative colitis or Crohn's disease

Curr Med Res Opin. 2023 Jan;39(1):63-69. doi: 10.1080/03007995.2022.2135836. Epub 2022 Nov 7.

Abstract

Objectives: To assess treatment patterns and initial and maintenance dosing of biologics over 3 years in pediatric patients with ulcerative colitis (UC) or Crohn's disease (CD), utilizing data from the ImproveCareNow registry.

Methods: Pediatric patients diagnosed with UC or CD and aged 2-17 years were included in the study. Descriptive statistics were employed to summarize baseline demographics. The proportion of patients on medication for UC or CD were analyzed at the baseline visit, 1-year, and 3-year time points (Cohort 1). Biologic maintenance dosage was calculated only for patients who had data for dose and weight at all-time points (Cohort 2).

Results: In Cohort 1 (UC = 1784; CD = 4720), baseline treatment in UC included corticosteroid, 5-ASA, and 6-MP/AZA; at 1-year and 3-year time points, treatment with 5-ASA and corticosteroid decreased, whereas 6-MP/AZA and anti-TNFs increased. In CD, baseline treatment included corticosteroid, anti-TNF, 6-MP/AZA, and methotrexate; use of corticosteroids decreased, whereas the use of methotrexate and anti-TNFs increased over 3 years. In Cohort 2 (UC = 350; CD = 1537), at first maintenance dose, UC patients on infliximab received a mean dose of 10.5 mg/kg/8 wk, adalimumab (weight < 40 kg and ≥40 kg) 1.3 mg/kg/2 wk and 0.8 mg/kg/2 wk, and vedolizumab 6.9 mg/kg/8 wks. At the first maintenance dose, CD patients on infliximab received a mean dose of 8.1 mg/kg/8 wk, adalimumab (weight < 40 kg) 1.1 mg/kg/2 wk, adalimumab (weight ≥ 40 kg) 0.8 mg/kg/2 wk, and vedolizumab 10.5 mg/kg/8 wks.

Conclusion: The use of corticosteroids was common at the initial visit in patients. Anti-TNFs remain the most used class of biologics, however, reported doses in our study were substantially higher than the standard dosing guidelines.

Keywords: Crohn’s disease; Pediatrics; bDMARDs; children; inflammatory bowel disease; ulcerative colitis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab / administration & dosage
  • Biological Factors / therapeutic use
  • Biological Products* / administration & dosage
  • Child
  • Colitis, Ulcerative* / drug therapy
  • Crohn Disease* / drug therapy
  • Humans
  • Infliximab
  • Methotrexate / administration & dosage
  • Tumor Necrosis Factor Inhibitors / administration & dosage

Substances

  • Adalimumab
  • Biological Factors
  • Biological Products
  • Infliximab
  • Methotrexate
  • Tumor Necrosis Factor Inhibitors