Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label Phase III Study

Hermine I Brunner; César Pacheco-Tena; Ingrid Louw; Gabriel Vega-Cornejo; Ekaterina Alexeeva; Simone Appenzeller; Vyacheslav Chasnyk; Thomas Griffin; Carmen Navarrete Suarez; Sheila Knupp-Oliveira; Andrew Zeft; Yonatan Butbul Aviel; Deirdre De Ranieri; Beth S Gottlieb; Deborah M Levy; C Egla Rabinovich; Clóvis Artur Silva; Yury Spivakovsky; Yosef Uziel; Sarah Ringold; Xie L Xu; Jocelyn H Leu; Edwin Lam; Yuhua Wang; Daniel J Lovell; Alberto Martini; Nicolino Ruperto; Pediatric Rheumatology Collaborative Study Group (PRCSG) and Paediatric Rheumatology International Trials Organisation (PRINTO)

doi:10.3899/jrheum.2024-0298

Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label Phase III Study

J Rheumatol. 2024 Nov 1;51(11):1125-1134. doi: 10.3899/jrheum.2024-0298.

Authors

Hermine I Brunner¹, César Pacheco-Tena², Ingrid Louw³, Gabriel Vega-Cornejo⁴, Ekaterina Alexeeva⁵, Simone Appenzeller⁶, Vyacheslav Chasnyk⁷, Thomas Griffin⁸, Carmen Navarrete Suarez⁹, Sheila Knupp-Oliveira¹⁰, Andrew Zeft¹¹, Yonatan Butbul Aviel¹², Deirdre De Ranieri¹³, Beth S Gottlieb¹⁴, Deborah M Levy¹⁵, C Egla Rabinovich¹⁶, Clóvis Artur Silva¹⁷, Yury Spivakovsky¹⁸, Yosef Uziel¹⁹, Sarah Ringold²⁰, Xie L Xu²⁰, Jocelyn H Leu²⁰, Edwin Lam²⁰, Yuhua Wang²⁰, Daniel J Lovell²¹, Alberto Martini²², Nicolino Ruperto; Pediatric Rheumatology Collaborative Study Group (PRCSG) and Paediatric Rheumatology International Trials Organisation (PRINTO)

Affiliations

¹ H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA; hermine.brunner@cchmc.org.
² C. Pacheco-Tena, MD, MSc, PhD, Investig y Biomedicina de Chihuahua, Facultad de Medicina, Universidad Autónoma de Chihuahua, Circuito Universitario Campus II, Chihuahua, México.
³ I. Louw, MD, Panorama Medical Centre, Cape Town, South Africa.
⁴ G. Vega-Cornejo, MD, Centro de Reumatología y Autoinmunidad (CREA)/Hospital México Americano, Pediatric Rheumatology, Guadalajara, México.
⁵ 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.
⁶ S. Appenzeller, MD, PhD, Department of Orthopedics, Rheumatology and Traumatology, University of Campinas, UNICAMP, Campinas, Brazil.
⁷ V. Chasnyk, MD, GВOU VPO, Saint-Petersburg State Pediatric Medical University, St. Petersburg, Russia.
⁸ T. Griffin, MD, Division of Rheumatology, Levine Children's Specialty Center, Charlotte, North Carolina, USA.
⁹ C. Navarrete Suarez, MD, Rheumatology, Hospital Roberto del Rio, Santiago, Chile.
¹⁰ S. Knupp-Oliveira, MD, Universidade Federal of Rio de Janeiro, Instituto de Puericultura e Pediatria Martagão Gesteira, Rio de Janeiro, Brazil.
¹¹ A. Zeft, MD, Cleveland Clinic, Department of Pediatric Rheumatology and Immunology, Cleveland, Ohio, USA.
¹² Y. Butbul Aviel, MD, Rambam Health Care Campus, Haifa, Israel.
¹³ 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.
¹⁴ B.S. Gottlieb, MD, MS, Northwell Health, Cohen Children's Medical Center, Division of Pediatric Rheumatology, New Hyde Park, New York, USA.
¹⁵ D.M. Levy, MD, MS, The Hospital for Sick Children (SickKids), Toronto, and the University of Toronto, Toronto, Ontario, Canada.
¹⁶ C.E. Rabinovich, MD, Duke University, Durham, North Carolina, USA.
¹⁷ C. Artur Silva, MD, Instituto da Criança e Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
¹⁸ Y. Spivakovsky, MD, Saratov State Medical University n.a. V.I. Razumovsky of Ministry of Health of the Russian Federation, Saratov, Russia.
¹⁹ 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.
²⁰ S. Ringold, MD, MS, X.L. Xu, PhD, J.H. Leu, PharmD, PhD, E. Lam, PharmD, Y. Wang, PhD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA.
²¹ H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA.
²² A. Martini, MD, Università degli Studi di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Genova, Italy.

PMID: 39089836
DOI: 10.3899/jrheum.2024-0298

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.

Keywords: biological therapy; disease-modifying antirheumatic drugs; intravenous golimumab; polyarticular-course juvenile idiopathic arthritis.

Publication types

Clinical Trial, Phase III
Multicenter Study

MeSH terms

Administration, Intravenous
Adolescent
Antibodies, Monoclonal* / administration & dosage
Antibodies, Monoclonal* / adverse effects
Antibodies, Monoclonal* / pharmacokinetics
Antibodies, Monoclonal* / therapeutic use
Antirheumatic Agents* / administration & dosage
Antirheumatic Agents* / therapeutic use
Arthritis, Juvenile* / drug therapy
Child
Child, Preschool
Female
Humans
Male
Methotrexate / administration & dosage
Methotrexate / therapeutic use
Severity of Illness Index
Treatment Outcome

Substances

golimumab
Antibodies, Monoclonal
Antirheumatic Agents
Methotrexate