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Clinical Outcome Assessments in Pediatric Patients With Ulcerative Colitis and Crohn's Disease Receiving Biologics: A

Theresa Hunter1, Wendy J Komocsar2, Chunyan Liu3

  • 1Value Evidence and Outcomes, Eli Lilly and Company, Indianapolis, Indiana, USA.

Crohn'S & Colitis 360
|February 13, 2023
PubMed

Insights

Pediatric patients with ulcerative colitis (UC) and Crohn's disease (CD) showed improved disease activity and increased steroid-free remission rates one to three years after starting biologic therapy.

Area of Science:

  • Pediatric Gastroenterology
  • Inflammatory Bowel Disease Research
  • Biologics in IBD

Background:

  • Ulcerative colitis (UC) and Crohn's disease (CD) are chronic inflammatory bowel diseases affecting pediatric populations.
  • Assessing disease activity and remission in pediatric IBD is crucial for effective treatment management.
  • The ImproveCareNow (ICN) registry provides a valuable dataset for studying pediatric IBD outcomes.

Purpose of the Study:

  • To evaluate disease activity, steroid-free remission, and clinical outcomes in pediatric UC and CD patients within the ICN registry.
  • To assess the effectiveness of biologic therapies in achieving sustained remission in young patients.
  • To compare different clinical outcome measures for their agreement in assessing disease status.

Main Methods:

  • A cohort of 1887 pediatric patients (UC=350, CD=1537) aged 2-17 years were analyzed from the ICN registry.
  • Patients initiated biologic therapy between June 2013 and December 2019 with at least 12 months of follow-up.
  • Disease activity was assessed using validated pediatric indices (PUCAI, sPCDAI) and Physician Global Assessment (PGA) at multiple time points.

Main Results:

  • Both UC and CD patients demonstrated decreased disease activity scores over 1-3 years post-biologic initiation.
  • A higher proportion of pediatric patients achieved steroid-free remission and quiescent disease states at 1 and 3 years.
  • Modest correlations were observed between different disease activity assessment tools (Kappa coefficients).

Conclusions:

  • Biologic therapy is associated with significant improvements in disease activity for pediatric UC and CD patients.
  • Sustained steroid-free remission is achievable in a greater number of pediatric IBD patients over time.
  • While multiple outcome measures are used, their agreement in assessing pediatric IBD activity is only modest.
Abstract

Keywords:
Crohn’s diseasebiologicsinflammatory bowel diseasepediatricsulcerative colitis

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