Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis
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Data
2021-10-01
Autores
Ruperto, Nicolino
Brunner, Hermine I
Pacheco-Tena, César
Louw, Ingrid
Vega-Cornejo, Gabriel
Spindler, Alberto J
Kingsbury, Daniel J
Schmeling, Heinrike
Borzutzky, Arturo
Cuttica, Rubén
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Resumo
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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Golimumab, Intravenous, Juvenile idiopathic arthritis, Pharmacokinetics, Tumour necrosis factor alpha
Como citar
Rheumatology (United Kingdom), v. 60, n. 10, p. 4495-4507, 2021.