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

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dc.catalogadorjca
dc.contributor.authorRuperto, Nicolino
dc.contributor.authorBrunner, Hermine I.
dc.contributor.authorPacheco-Tena, César
dc.contributor.authorLouw, Ingrid
dc.contributor.authorVega-Cornejo, Gabriel
dc.contributor.authorSpindler, Alberto J.
dc.contributor.authorKingsbury, Daniel J.
dc.contributor.authorSchmeling, Heinrike
dc.contributor.authorBorzutzky Schachter, Arturo
dc.contributor.authorCuttica, Rubén
dc.date.accessioned2023-01-19T20:00:49Z
dc.date.available2023-01-19T20:00:49Z
dc.date.issued2021
dc.description.abstractObjectives: 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.
dc.description.funderJanssen Research & Development, LLC
dc.fechaingreso.objetodigital2023-01-19
dc.format.extent13 páginas
dc.fuente.origenWOS
dc.identifier.doi10.1093/rheumatology/keab021
dc.identifier.eissn1462-0332
dc.identifier.issn1462-0324
dc.identifier.pubmedidMEDLINE:33493312
dc.identifier.scopusidSCOPUS_ID:85110584854
dc.identifier.urihttps://doi.org/10.1093/rheumatology/keab021
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/66397
dc.identifier.wosidWOS:000753131900017
dc.information.autorucFacultad de medicina ; Borzutzky Schachter, Arturo ; 0000-0002-7904-262X ; 5897
dc.issue.numero10
dc.language.isoen
dc.nota.accesoContenido completo
dc.pagina.final4507
dc.pagina.inicio4495
dc.publisherOxford University Press
dc.revistaRheumatology
dc.rightsacceso abierto
dc.subjectGolimumab
dc.subjectIntravenous
dc.subjectJuvenile idiopathic arthritis
dc.subjectPharmacokinetics
dc.subjectTumour necrosis factor alpha
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleOpen-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis
dc.typeartículo
dc.volumen60
sipa.codpersvinculados5897
sipa.indexWoS
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