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Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis
Nicolino Ruperto1, Hermine I Brunner2, César Pacheco-Tena3
1IRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia, PRINTO, Genoa, Italy.
Insights
Intravenous golimumab (i.v. golimumab) demonstrated good tolerability and pharmacokinetic exposure in children with polyarticular-course juvenile idiopathic arthritis (pc-JIA). This treatment maintained efficacy through 52 weeks, supporting its use in this pediatric population.
Area of Science:
- Pediatric Rheumatology
- Pharmacokinetics and Pharmacodynamics
- Immunology
Background:
- Polyarticular-course juvenile idiopathic arthritis (pc-JIA) is a chronic autoimmune condition affecting multiple joints in children.
- Effective and safe treatment options are crucial for managing pc-JIA and improving long-term outcomes in pediatric patients.
- Intravenous golimumab, a tumor necrosis factor inhibitor, has shown efficacy in adult autoimmune diseases.
Purpose of the Study:
- To evaluate the efficacy, pharmacokinetics (PK), and safety of intravenous (i.v.) golimumab in pediatric patients diagnosed with active pc-JIA.
- To assess the PK exposure, including steady-state area under the curve (AUCss), of i.v. golimumab over an 8-week dosing interval.
- To determine the achievement of JIA ACR response criteria and monitor for adverse events.
Main Methods:
- A cohort of 127 children aged 2 to <18 years with active pc-JIA received i.v. golimumab (80 mg/m2) at weeks 0, 4, and every 8 weeks through week 52.
- Methotrexate (MTX) was co-administered weekly through week 28.
- Primary and secondary endpoints focused on PK exposure (AUCss) at weeks 28 and 52, alongside JIA ACR response rates and safety assessments.
Main Results:
- High JIA ACR 30, 50, 70, and 90 response rates (84%, 80%, 70%, 47% respectively) were observed at week 28 and sustained through week 52.
- Adequate PK exposure was achieved and maintained, with steady-state trough concentrations comparable to adults with rheumatoid arthritis.
- Golimumab antibodies were detected in 31% of patients, associated with lower drug concentrations; serious infections occurred in 6%, including one fatality.
Conclusions:
- Body surface area-based dosing of i.v. golimumab is well-tolerated and provides adequate PK exposure for clinical efficacy in pediatric pc-JIA.
- The observed efficacy and PK profile support the use of i.v. golimumab in children with active pc-JIA.
- Continued monitoring for adverse events, including infections and antibody development, is warranted.
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. 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 i.v. 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 one death due to septic shock.
Conclusion:
Body surface area-based dosing of i.v. golimumab was well tolerated and provided adequate PK exposure for clinical efficacy in paediatric patients with active pc-JIA.ClinicalTrials.gov number NCT02277444.
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