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Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label, Phase III Study.
Brunner, Hermine I; Pacheco-Tena, César; Louw, Ingrid; Vega-Cornejo, Gabriel; Alexeeva, Ekaterina; Appenzeller, Simone; Chasnyk, Vyacheslav; Griffin, Thomas; Navarrete Suarez, Carmen; Knupp-Oliveira, Sheila; Zeft, Andrew; Butbul Aviel, Yonatan; De Ranieri, Deirdre; Gottlieb, Beth S; Levy, Deborah M; Rabinovich, C Egla; Artur Silva, Clóvis; Spivakovsky, Yury; Uziel, Yosef; Ringold, Sarah; Xu, Xie L; Leu, Jocelyn H; Lam, Edwin; Wang, Yuhua; Lovell, Daniel J; Martini, Alberto; Ruperto, Nicolino.
Affiliation
  • Brunner HI; H.I. Brunner, MD, MSc, MBA, Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA.
  • Pacheco-Tena C; C. Pacheco-Tena, MD, MSc, PhD, Investig y Biomedicina de Chihuahua, Facultad de Medicina, Universidad Autónoma de Chihuahua, Circuito Universitario Campus II, Chihuahua, México.
  • Louw I; I. Louw, MD, Panorama Medical Centre, Cape Town, South Africa.
  • Vega-Cornejo G; G. Vega-Cornejo, MD, Centro de Reumatología y Autoinmunidad (CREA)/ Hospital México Americano, Pediatric Rheumatology, Guadalajara, México.
  • Alexeeva E; E. Alexeeva, MD, PhD, National Medical Research Center for Children's Health Federal State Autonomous Institution of the Russian Federation Ministry of Health, Moscow, and I.M. Sechenov First Moscow State Medical University (Sechenovskiy University), Moscow, Russia.
  • Appenzeller S; S. Appenzeller, MD, PhD, Department of Orthopedics, Rheumatology and Traumatology, University of Campinas, UNICAMP, Campinas, Brazil.
  • Chasnyk V; V. Chasnyk, MD, GВOU VPO, Saint-Petersburg State Pediatric Medical University, St. Petersburg, Russia.
  • Griffin T; T. Griffin, MD, Division of Rheumatology, Levine Children's Specialty Center, Charlotte, North Carolina, USA.
  • Navarrete Suarez C; C. Navarrete Suarez, MD, Rheumatology, Hospital Roberto del Rio, Santiago, Chile.
  • Knupp-Oliveira S; S. Knupp-Oliveira, MD, Universidade Federal of Rio de Janeiro, Instituto de Puericultura e Pediatria Martagão Gesteira, Rio de Janeiro, Brazil.
  • Zeft A; A. Zeft, MD, Cleveland Clinic, Department of Pediatric Rheumatology and Immunology, Cleveland, Ohio, USA.
  • Butbul Aviel Y; Y. Butbul Aviel, MD, Rambam Health Care Campus, Haifa, Israel.
  • De Ranieri D; D. De Ranieri, MD, Division of Rheumatology, Comer Children's Hospital, Department of Pediatrics, University of Chicago Medicine, Chicago, now with Division of Rheumatology, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern Feinberg School of Medicine, Chicago, Illinois, USA.
  • Gottlieb BS; B.S. Gottlieb, MD, MS, Northwell Health, Cohen Children's Medical Center, Division of Pediatric Rheumatology, New Hyde Park, New York, USA.
  • Levy DM; D.M. Levy, MD, MS, The Hospital for Sick Children (SickKids), Toronto, and the University of Toronto, Toronto, Ontario, Canada.
  • Rabinovich CE; C.E. Rabinovich, MD, Duke University, Durham, North Carolina, USA.
  • Artur Silva C; C. Artur Silva, MD, Instituto da Criança e Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
  • Spivakovsky Y; Y. Spivakovsky, MD, Saratov State Medical University n.a. V.I. Razumovsky of Ministry of Health of the Russian Federation, Saratov, Russia.
  • Uziel Y; Y. Uziel, MD, Pediatric Rheumatology Unit, Department of Pediatrics, Meir Medical Center, Kfar-Saba, Tel Aviv School of Medicine, Tel Aviv University, Tel Aviv, Israel.
  • Ringold S; S. Ringold, MD, MS, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA.
  • Xu XL; X.L. Xu, PhD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA.
  • Leu JH; J.H. Leu, PharmD, PhD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA.
  • Lam E; E. Lam, PharmD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA.
  • Wang Y; Y. Wang, PhD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA.
  • Lovell DJ; D.J. Lovell, MD, MPH, Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA.
  • Martini A; A. Martini, MD, Università degli Studi di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Genova, Italy.
  • Ruperto N; N. Ruperto, MD, MPH, IRCCS Istituto Giannina Gaslini, Servizio Sperimentazioni Cliniche Pediatriche/Gaslini Trial Centre, PRINTO, Genoa, Italy.
J Rheumatol ; 2024 Aug 15.
Article in En | MEDLINE | ID: mdl-39089836
ABSTRACT

OBJECTIVE:

To report pharmacokinetics (PK), immunogenicity, clinical effect, and safety of intravenous (IV) golimumab in children with active polyarticular-course juvenile idiopathic arthritis (pcJIA) who participated in A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy (GO-VIVA)'s open-label, long-term extension (LTE) through week 252.

METHODS:

GO-VIVA participants who continued IV golimumab (80 mg/m2 every 8 weeks) after week 52 were included. PK and safety were assessed through week 244 (last dose) and week 252, respectively, and clinical response through week 116. Clinical outcomes included JIA-American College of Rheumatology (ACR) responses and clinical Juvenile Arthritis Disease Activity Score in 10 joints (cJADAS10). Binary outcomes used nonresponder imputation, and other descriptive analyses used observed data.

RESULTS:

Of 112/127 (88.2%) participants entering the LTE, 69 completed the week 252 visit. Median steady-state trough golimumab concentrations were generally maintained from week 52 through week 244 (range 0.3-0.6 µg/mL). Antigolimumab antibody rates were consistent through week 52 (39.2% [49/125]) and week 244 (44.8% [56/125]). Week 52 JIA-ACR 30/50/70/90 response rates (75.6% [96/127], 74% [94/127], 65.4% [83/127], and 48.8% [62/127], respectively) were generally maintained through week 116 (72.4% [92/127], 71.7% [91/127], 63.8% [81/127], and 50.4% [64/127], respectively), when the median cJADAS10 was 1.6 and 56.7% (72/127) of participants achieved cJADAS10 ≤ 5 (minimal disease activity). Rates (per 100 patient-years) of serious adverse events and serious infections through week 252 were 7.7 and 3.9, respectively.

CONCLUSION:

GO-VIVA LTE participants experienced adequate PK exposure and stable safety and immunogenicity. The majority of participants experienced no more than minimal residual disease activity. Data suggest IV golimumab treatment provided durable clinical response through week 116, with an acceptable risk-benefit profile.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: J Rheumatol / J. rheumatol / Journal of rheumatology Year: 2024 Document type: Article Affiliation country: United States Country of publication: Canada
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: J Rheumatol / J. rheumatol / Journal of rheumatology Year: 2024 Document type: Article Affiliation country: United States Country of publication: Canada