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Randomised clinical trial: First-line infliximab biosimilar is cost-effective compared to conventional treatment in

Stephanie A Vuijk1, Maria M E Jongsma1, Britt M Hoeven1

  • 1Department of Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands.

Alimentary Pharmacology & Therapeutics
|April 22, 2024
PubMed

Insights

First-line infliximab in pediatric Crohn's disease is more effective for achieving remission than conventional therapy. This biologic treatment is cost-effective, offering a dominant strategy for managing moderate-to-severe cases in children.

Area of Science:

  • Pediatric Gastroenterology
  • Clinical Economics
  • Immunopharmacology

Background:

  • Limited data exist on the cost-effectiveness of first-line infliximab in pediatric Crohn's disease.
  • Biologic therapies are increasingly used but are associated with significant costs.
  • Addressing this knowledge gap is crucial for guiding treatment decisions.

Purpose of the Study:

  • To evaluate the cost-effectiveness of initiating infliximab as a first-line treatment compared to conventional therapies in children with moderate-to-severe Crohn's disease.
  • To assess clinical remission rates and healthcare costs over a 2-year period.

Main Methods:

  • A randomized controlled trial (NCT02517684) included 89 newly diagnosed pediatric Crohn's disease patients.
  • Patients received either first-line infliximab induction with azathioprine maintenance or conventional induction (exclusive enteral nutrition or corticosteroids).
  • Direct healthcare costs and clinical remission (Pediatric Crohn's Disease Activity Index < 12.5) were tracked over 104 weeks.

Main Results:

  • Mean 2-year healthcare costs were similar between groups: €36,784 (infliximab) vs. €36,874 (conventional).
  • First-line infliximab showed a significantly higher odds ratio (1.56) for achieving clinical remission over 104 weeks (p=0.036).

Conclusions:

  • First-line infliximab is a dominant strategy for pediatric moderate-to-severe Crohn's disease within the first two years post-diagnosis.
  • It offers improved odds of clinical remission without increased healthcare costs compared to conventional treatment.
Abstract

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