Open-Label Phase 3 Study of Intravenous Golimumab in Patients With Polyarticular Juvenile Idiopathic Arthritis

Rheumatology (Oxford). 2021 Jan 25;keab021. doi: 10.1093/rheumatology/keab021. Online ahead of print.

Abstract

Objectives: Assess efficacy, pharmacokinetics (PK), and safety of intravenous (IV) golimumab in patients with polyarticular-course juvenile idiopathic arthritis (pc-JIA).

Methods: Children aged 2 to < 18 years with active pc-JIA despite methotrexate therapy for ≥2 months received 80 mg/m2 golimumab at Weeks 0, 4, then every 8 weeks through week 52 plus methotrexate 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 American College of Rheumatology (ACR) response and safety were also assessed.

Results: In total, 127 children were treated with IV 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. Golimumab serum concentrations and AUCss were 0.40 µg/ml and 399 µg·day/ml at week 28. PK exposure was maintained at week 52. Steady-state trough golimumab concentrations and AUCss were consistent across age categories and comparable to IV golimumab dosed 2 mg/kg in adults with rheumatoid arthritis. Golimumab antibodies and neutralizing antibodies were detected via a highly sensitive drug-tolerant assay in 31% (39/125) and 19% (24/125) of patients, respectively. Median trough golimumab concentration was lower in antibody-positive vs antibody-negative patients. Serious infections were reported in 6% of patients, including 1 death due to septic shock.

Conclusion: Body surface area-based dosing of IV golimumab was well tolerated and provided adequate PK exposure for clinical efficacy in paediatric patients with active pc-JIA.ClinicalTrials.gov number NCT02277444.

Keywords: golimumab; intravenous; juvenile idiopathic arthritis; pharmacokinetics; tumour necrosis factor alpha.

Associated data

  • ClinicalTrials.gov/NCT02277444