Safety, effectiveness, and pharmacokinetics of adalimumab in children with polyarticular juvenile idiopathic arthritis aged 2 to 4 years.

Abstract

The objective of this study was to assess the safety of adalimumab in patients aged 2 to <4 years old or ≥4 years old weighing <15 kg with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). Clinical effectiveness and pharmacokinetics (PK) of adalimumab were also evaluated. This was an international, multicenter, open-label, phase 3b study in 32 patients with active JIA that were treated with adalimumab 24 mg/m(2) (maximum = 20 mg/dose) every other week up to 120 weeks, with or without concomitant methotrexate. Adverse events (AEs) were summarized for completed visits. Efficacy endpoints included American College of Rheumatology pediatric (PedACR) 30/50/70/90 responses and JIA core components. Adalimumab serum trough concentrations were measured in a subset of patients. Among the patients, 88 % were female. Baseline mean age, weight, and JIA duration were 3 years, 13 kg, and 12 months, respectively; 39 % had elevated C-reactive protein. AE incidence rates included any AEs (29/32, 91 %), serious AEs (5/32, 16 %), infectious AEs (25/32, 78 %), and serious infections (3/32, 9 %). No deaths, malignancies, or opportunistic infections were reported. Growth was not adversely impacted. At week 96, 92 % of patients achieved PedACR30, and 77 % achieved PedACR70. Improvements in JIA core components were observed. Mean steady-state serum adalimumab trough concentrations were 7-8 μg/mL at weeks 12 and 24. Adalimumab was well tolerated in JIA patients aged 2 to <4 years old or ≥4 years old weighing <15 kg. The efficacy and PK of adalimumab were comparable to those seen in older JIA patients.

• Authors: Daniel J Kingsbury, Brigitte Bader-Meunier, Gina Patel, Vipin Arora, Jasmina Kalabic, Hartmut Kupper
• Journal: Clinical rheumatology (Clin Rheumatol) Vol. 33 Issue 10 Pg. 1433-41 ( 2014) ISSN: 1434-9949 [Electronic] Germany
• PMID: 24487484 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents
• Biomarkers
• C-Reactive Protein
• Adalimumab
• Methotrexate

Topics

• Adalimumab
• Antibodies, Monoclonal, Humanized (adverse effects, pharmacokinetics, therapeutic use)
• Antirheumatic Agents (adverse effects, pharmacokinetics, therapeutic use)
• Arthritis, Juvenile (blood, drug therapy)
• Biomarkers (blood)
• C-Reactive Protein (metabolism)
• Child, Preschool
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Europe
• Female
• Humans
• International Cooperation
• Male
• Methotrexate (therapeutic use)
• Treatment Outcome
• United States