Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis.

ABSTRACT:

Objectives

To assess efficacy, pharmacokinetics (PK) and safety of intravenous (i.v.) golimumab in patients with polyarticular-course JIA (pc-JIA).

Methods

Children aged 2 to <18 years with active pc-JIA despite MTX therapy for ≥2 months received 80 mg/m2 golimumab at weeks 0, 4, then every 8 weeks through week 52 plus MTX weekly through week 28. The primary and major secondary endpoints were PK exposure and model-predicted steady-state area under the curve (AUCss) over an 8-week dosing interval at weeks 28 and 52, respectively. JIA ACR response and safety were also assessed.

Results

In total, 127 children were treated with i.v. golimumab. JIA ACR 30, 50, 70, and 90 response rates were 84%, 80%, 70% and 47%, respectively, at week 28 and were maintained through week 52

SUBMITTER: Ruperto N 

PROVIDER: S-EPMC8487314 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature