> Detailanzeige

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; Inman, C J; Malievskiy, Victor; Scott, Christiaan; Keltsev, Vladimir; Terreri, Maria Teresa; Viola, Diego Oscar; Xavier, Ricardo M; Fernandes, Taciana A Pedrosa; Velázquez, María del Rocío Maldonado; Henrickson, Michael; Clark, Michael B; Bensley, Karen A; Li, Xiaoming; Lo, Kim Hung; [...]

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

Literatur-
verwaltung

Zur
Merkliste

Lösche von
Merkliste

Per Whatsapp teilen

Schließen

Merkliste



Sie können Bookmarks mittels Listen verwalten, loggen Sie sich dafür bitte in Ihr SLUB Benutzerkonto ein.
  • Medientyp: E-Artikel
  • Titel: Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis
  • Beteiligte: 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; Inman, C J; Malievskiy, Victor; Scott, Christiaan; Keltsev, Vladimir; Terreri, Maria Teresa; Viola, Diego Oscar; Xavier, Ricardo M; Fernandes, Taciana A Pedrosa; Velázquez, María del Rocío Maldonado; Henrickson, Michael; Clark, Michael B; Bensley, Karen A; Li, Xiaoming; Lo, Kim Hung; [...]
  • Erschienen: Oxford University Press (OUP), 2021
  • Erschienen in: Rheumatology
  • Sprache: Englisch
  • DOI: 10.1093/rheumatology/keab021
  • ISSN: 1462-0324; 1462-0332
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Objectives</jats:title> <jats:p>To assess efficacy, pharmacokinetics (PK) and safety of intravenous (i.v.) golimumab in patients with polyarticular-course JIA (pc-JIA).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>Children aged 2 to &amp;lt;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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>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.</jats:p> <jats:p>ClinicalTrials.gov number NCT02277444</jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang