Descrição
Made available in DSpace on 2022-04-28T17:22:32Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-10-01
Janssen Research & Development, LLC
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 >= 2months received 80 mg/m(2) 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 (AUC(ss)) 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 AUC(ss) were 0.40 mu g/ml and 399 mu g. day/ml at week 28. PK exposure was maintained at week 52. Steady-state trough golimumab concentrations and AUC(ss) were consistent across age categories and comparable to i.v. golimumab dosed 2mg/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.
IRCCS Ist Giannina Gaslini Clin Pediat & Reumatol, PRINTO, Genoa, Italy
Univ Cincinnati, Cincinnati Childrens Hosp Med Ctr, Div Rheumatol, Cincinnati, OH USA
Univ Autonoma Chihuahua, Fac Med, Circuito Univ Campus 2, Chihuahua, Mexico
Panorama Med Ctr, Cape Town, South Africa
Hosp Mexico Americano, Ctr Reumatol & Autoinmunidad CREA, Guadalajara, Jalisco, Mexico
Ctr Med Privado Reumatol, Rheumatol Sect, San Miguel De Tucuman, Tucuman, Argentina
Randall Childrens Hosp Legacy Emanuel, Portland, OR USA
Univ Calgary, Alberta Childrens Hosp, Cumming Sch Med, Dept Pediat, Calgary, AB, Canada
Pontificia Univ Catolica Chile, Sch Med, Dept Pediat Infect Dis & Immunol, Santiago, Chile
Hosp Pedro de Elizalde, Rheumatol Sect, Buenos Aires, DF, Argentina
Univ Utah, Pediat Rheumatol, Salt Lake City, UT USA
Bashkir State Med Univ Minist Healthcare Russian, Fed State Budget Educ Inst Higher Educ, Ufa, Russia
Univ Cape Town, Red Cross War Mem Childrens Hosp, Cape Town, South Africa
Univ Cape Town, Groote Schuur Hosp, Paediat Rheumatol, Cape Town, South Africa
Clin Hosp 5, Pediat Dept, Tolyatti, Russia
Univ Fed Sao Paulo, Escola Paulista Med, Pediat, Sao Paulo, Brazil
Inst CAICI, Rheumatol, Rosario, Argentina
Univ Fed Rio Grande do Sul, Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil
UNESP, Hosp Clin Botucatu Med Univ, Paediat Dept, Botucatu, SP, Brazil
Hosp Infantil Mexico Dr Federico Gomez, Med Interna & Reumatol, Mexico City, DF, Mexico
Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH 45229 USA
Janssen Res & Dev LLC, Spring House, PA USA
Janssen Res & Dev LLC, Raritan, NJ USA
Univ Genoa, Dipartimento Neurosci Riabilitaz Oftalmol Genet &, Genoa, Italy
UNESP, Hosp Clin Botucatu Med Univ, Paediat Dept, Botucatu, SP, Brazil
