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Analysis of the Immunogenicity from Abatacept-Treated Pediatric Patients With Polyarticular-Course Juvenile

Johanna R Mora1, Robert Wong2, Mehmooda Shaikh1

  • 1Non-clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey.

ACR Open Rheumatology
|November 18, 2021
PubMed

Insights

Anti-abatacept antibodies in children with polyarticular-course juvenile idiopathic arthritis (pJIA) showed varied incidence based on age and methotrexate (MTX) co-dosing. However, immunogenicity did not affect pharmacokinetics, safety, or efficacy.

Area of Science:

  • Pediatric Rheumatology
  • Immunology
  • Pharmacology

Background:

  • Juvenile idiopathic arthritis (JIA) is a chronic autoimmune disease affecting children.
  • Abatacept is a biologic therapy used for treating polyarticular-course JIA (pJIA).
  • Understanding anti-drug antibody formation is crucial for treatment optimization.

Purpose of the Study:

  • To analyze anti-abatacept antibody data in pediatric patients with pJIA.
  • To assess the impact of age, administration route, treatment interruption, and methotrexate (MTX) co-medication on immunogenicity.

Main Methods:

  • Analysis of immunogenicity data from 395 children with pJIA in two registrational trials.
  • Stratification by age groups (2-5 years vs. 6-17 years).
  • Comparison of intravenous (IV) and subcutaneous (SC) administration routes, and effects of drug interruption and MTX co-dosing.

Main Results:

  • Overall immunogenicity incidence ranged from 4.7% to 23.3%.
  • Higher incidence observed in younger children (2-5 years) compared to older children (6-17 years).
  • Methotrexate (MTX) co-dosing generally correlated with higher anti-abatacept antibody incidence across IV and SC routes.

Conclusions:

  • Trends in immunogenicity related to age and MTX co-dosing were observed but not conclusive due to population size limitations.
  • Drug holidays did not impact immunogenicity upon treatment resumption.
  • Anti-abatacept antibody formation did not affect abatacept's pharmacokinetics, safety, or efficacy in pJIA patients.
Abstract

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