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Adalimumab Biosimilars Demonstrate Long-Term Durability and Cost-Effectiveness in Paediatric Inflammatory Bowel

Silvana Ancona1,2, Katherine Armstrong2, Chiara Longo3

  • 1Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Genoa, Italy.

Biologics : Targets & Therapy
|May 5, 2025
PubMed

Insights

Adalimumab biosimilars show high durability and remission rates in pediatric Inflammatory Bowel Disease (PIBD). These treatments offer significant cost savings and a favorable safety profile for children.

Area of Science:

  • Pediatric gastroenterology
  • Immunology
  • Pharmacoeconomics

Background:

  • Adalimumab biosimilars are increasingly utilized in pediatric Inflammatory Bowel Disease (PIBD).
  • Limited real-world data exist on their long-term outcomes in this population.

Purpose of the Study:

  • To assess the durability, efficacy, safety, and cost-effectiveness of adalimumab biosimilars in PIBD.
  • To provide real-world evidence supporting their use in pediatric patients.

Main Methods:

  • A cohort of 130 PIBD patients initiating adalimumab biosimilars was studied retrospectively.
  • Data on demographics, disease characteristics, treatment, and adverse events were collected over a median follow-up of 26 months.
  • Durability was analyzed using Kaplan-Meier methods, and cost savings were estimated.

Main Results:

  • 67% of patients remained on adalimumab biosimilars, with durability probabilities of 57% at 54 months.
  • Previous exposure to the originator adalimumab was associated with a lower risk of biosimilar failure (HR 0.51).
  • High trough levels (≥11.6 μg/mL) at 6 months predicted greater durability, with estimated cost savings of €5,030 per patient/year.

Conclusions:

  • Adalimumab biosimilars demonstrate high durability and remission rates in PIBD patients.
  • These findings support their clinical effectiveness, safety, and cost-effectiveness in pediatric practice.
  • Real-world data confirm the value of biosimilars in managing pediatric Inflammatory Bowel Disease.
Abstract

Keywords:
adalimumabbiosimilarpaediatric inflammatory bowel disease

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