Ruperto, NicolinoBrunner, Hermine IPacheco-Tena, CésarLouw, IngridVega-Cornejo, GabrielSpindler, Alberto JKingsbury, Daniel JSchmeling, HeinrikeBorzutzky, ArturoCuttica, RubénInman, C. J.Malievskiy, VictorScott, ChristiaanKeltsev, VladimirTerreri, Maria TeresaViola, Diego OscarXavier, Ricardo MFernandes, Taciana A. Pedrosa [UNESP]Velázquez, María Del Rocío MaldonadoHenrickson, MichaelClark, Michael BBensley, Karen ALi, XiaomingLo, Kim HungLeu, Jocelyn HHsu, Chyi-HungHsia, Elizabeth CXu, ZhenhuaMartini, AlbertoLovell, Daniel JAppenzeller, SimoneOliveira, SheilaSilva, Clóvis ArthurLevy, DeborahNavarrete, CarmenAviel, Yonatan ButbulUziel, YosefAlexeeva, EkaterinaChasnyk, VladimirSpivakovsky, YuryGottlieb, BethRabinovich, EglaZeft, AndrewGriffin, ThomasDe Ranieri, DeirdreCarrasco, Ruy2022-04-292022-04-292021-10-01Rheumatology (United Kingdom), v. 60, n. 10, p. 4495-4507, 2021.1462-03321462-0324http://hdl.handle.net/11449/229170Objectives: 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 NCT022774444495-4507engGolimumabIntravenousJuvenile idiopathic arthritisPharmacokineticsTumour necrosis factor alphaArtigo10.1093/rheumatology/keab0212-s2.0-85110584854