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Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label Phase III Study
Indexado
WoS WOS:001348754700006
Scopus SCOPUS_ID:85208449880
DOI 10.3899/JRHEUM.2024-0298
Año 2024
Tipo artículo de investigación

Citas Totales

Autores Afiliación Chile

Instituciones Chile

% Participación
Internacional

Autores
Afiliación Extranjera

Instituciones
Extranjeras


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 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 mu g/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.

Revista



Revista ISSN
Journal Of Rheumatology 0315-162X

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Disciplinas de Investigación



WOS
Rheumatology
Scopus
Sin Disciplinas
SciELO
Sin Disciplinas

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Publicaciones WoS (Ediciones: ISSHP, ISTP, AHCI, SSCI, SCI), Scopus, SciELO Chile.

Colaboración Institucional



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Autores - Afiliación



Ord. Autor Género Institución - País
1 Brunner, Hermine Mujer UNIV CINCINNATI - Estados Unidos
University of Cincinnati - Estados Unidos
2 FUENTEALBA-PEREZ, CARLOS Mujer Univ Autonoma Chihuahua - México
Universidad Autónoma de Chihuahua, Facultad de Medicina - México
3 Louw, Ingrid Mujer Panorama Med Ctr - República de Sudáfrica
Panorama Medi-Clinic - República de Sudáfrica
4 Vega-Cornejo, Gabriel Hombre Hosp Mexico Americano - México
Hospital México Americano - México
5 Alexeeva, Ekaterina Mujer Sechenovskiy Univ - Rusia
Sechenov First Moscow State Medical University - Rusia
6 Appenzeller, Simone Mujer UNIV ESTADUAL CAMPINAS - Brasil
Universidade Estadual de Campinas - Brasil
7 Chasnyk, Vyacheslav Hombre St Petersburg State Pediat Med Univ - Rusia
Saint Petersburg State Pediatric Medical University - Rusia
8 Griffin, Thomas Hombre Levine Childrens Specialty Ctr - Estados Unidos
Levine Children's Hospital - Estados Unidos
9 Suarez, Carmen Navarrete - Hosp Salvador - Chile
Hospital de Niños Roberto del Río - Chile
10 Knupp-Oliveira, Sheila - UNIV FED RIO DE JANEIRO - Brasil
Universidade Federal do Rio de Janeiro - Brasil
11 Zeft, Andrew Hombre CLEVELAND CLIN - Estados Unidos
Cleveland Clinic Foundation - Estados Unidos
12 Aviel, Yonatan Butbul - Rambam Hlth Care Campus - Israel
13 De Ranieri, Deirdre - NORTHWESTERN UNIV - Estados Unidos
Northwestern Feinberg Sch Med - Estados Unidos
Comer Children's Hospital - Hyde Park - Estados Unidos
14 Gottlieb, Beth S. - Northwell Hlth - Estados Unidos
Cohen Children’s Medical Center - Estados Unidos
15 Levy, Deborah Mujer UNIV TORONTO - Canadá
The Hospital for Sick Children - Canadá
16 Rabinovich, C. Egla - Duke Univ - Estados Unidos
Duke University - Estados Unidos
17 Silva, Clovis Artur - UNIV SAO PAULO - Brasil
Universidade de São Paulo - Brasil
18 Spivakovsky, Yury - Saratov State Med Univ - Rusia
Ministry of Health of Russian Federation - Rusia
19 Uziel, Yosef Hombre Meir Hosp - Israel
Tel Aviv Univ - Israel
Tel Aviv University - Israel
20 Ringold, Sarah - Janssen Res & Dev LLC - Estados Unidos
Janssen Research &amp; Development - Bélgica
21 Xu, Xie L. - Janssen Res & Dev LLC - Estados Unidos
Janssen Research &amp; Development - Bélgica
22 Leu, Jocelyn H. Mujer Janssen Res & Dev LLC - Estados Unidos
Janssen Research &amp; Development - Bélgica
23 Lam, Edwin - Janssen Res & Dev LLC - Estados Unidos
Janssen Research &amp; Development - Bélgica
24 Wang, Yuhua - Janssen Res & Dev LLC - Estados Unidos
Janssen Research &amp; Development - Bélgica
25 Lovell, Daniel J. Hombre UNIV CINCINNATI - Estados Unidos
University of Cincinnati - Estados Unidos
26 Martini, Agnese Hombre Univ Studi Genova - Italia
Università degli Studi di Genova - Italia
27 Ruperto, Nicolino Hombre IRCCS Ist Giannina Gaslini - Italia
Istituto Giannina Gaslini - Italia
28 Pediat Rheumatology Collaborative Study Grp PRCSG Corporación
28 BORZUTZKY-SCHACHTER, ARTURO Hombre
29 Paediat Rheumatology Int Trials Org PRINTO Corporación
29 Cuttica, Ruben Hombre
30 Grebenkina, Liudmila -
31 Inman, Christi J. -
32 Keltsev, Vladimir Hombre
33 Kingsbury, Daniel J. -
34 Malievskiy, Victor Hombre
35 Pedrosa Fernandes, Taciana A. -
36 del Rocio Maldonado Velazquez, Maria -
37 Schmeling, Heinrike Mujer
38 Scott, Christiaan Hombre
39 Spindler, Alberto -
40 Terreri, Maria Teresa -
41 Viola, Diego Oscar -
42 Xavier, Ricardo M. -

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Financiamiento



Fuente
Janssen Research and Development
Roche
Janssen Research and Development, LLC
Holly Capasso-Harris of Certara

Muestra la fuente de financiamiento declarada en la publicación.

Agradecimientos



Agradecimiento
This study was sponsored by Janssen Research and Development, LLC.
The authors thank all PRINTO and PRCSG center personnel and all families who contributed to the study. Medical writing support was provided by Holly Capasso-Harris of Certara, under the direction of the authors and the guidance of PRINTO and PRCSG officers (NR, DJL, HIB, AM) in accordance with Good Publication Practice guidelines (Ann Intern Med 2022;175:1298-1304) and was funded by Janssen Research and Development, LLC. The authors also thank the following collaborators: Arturo Borzutzky, MD, Santiago, Chile; Ruben Cuttica, MD, Buenos Aires, Argentina; Liudmila Grebenkina, MD, Togliatti, Russia; Christi J. Inman, MD, Salt Lake City, Utah, USA; Vladimir Keltsev, MD, Togliatti, Russia (deceased); Daniel J. Kingsbury, MD, Portland, Oregon, USA; Victor Malievskiy, MD, Ufa, Russia; Taciana A. Pedrosa Fernandes, MD, Botucatu, Brazil; Maria del Rocio Maldonado Velazquez, MD, Mexico City, Mexico; Heinrike Schmeling, MD, Calgary, Canada; Christiaan Scott, MD, Cape Town, South Africa; Alberto Spindler, MD, San Miguel de Tucum\u00E1n, Argentina; Maria Teresa Terreri, MD, S\u00E3o Paulo, Brazil; Diego Oscar Viola, MD, Rosario, Argentina; Ricardo M. Xavier, MD, Porto Alegre, Brazil.
Center, Division of Pediatric Rheumatology, New Hyde Park, New York, USA; 15D.M. Levy, MD, MS, The Hospital for Sick Children (SickKids), Toronto, and the University of Toronto, Toronto, Ontario, Canada; 16C.E. Rabinovich, MD, Duke University, Durham, North Carolina, USA; 17C. Artur Silva, MD, Instituto da Crian\u00E7a e Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de S\u00E3o Paulo, S\u00E3o Paulo, Brazil; 18Y. Spivakovsky, MD, Saratov State Medical University n.a. V.I. Razumovsky of Ministry of Health of the Russian Federation, Saratov, Russia; 19Y. Uziel, MD, Pediatric Rheumatology Unit, Department of Pediatrics, Meir Medical Center, Kfar-Saba, Tel Aviv School of Medicine, Tel Aviv University, Tel Aviv, Israel; 20S. 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; 21A. Martini, MD, Universit\u00E0 degli Studi di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Genova, Italy; 22N. Ruperto, MD, MPH, IRCCS Istituto Giannina Gaslini, Servizio Sperimentazioni Cliniche Pediatriche/Gaslini Trial Centre, PRINTO, Genoa, Italy. HIB works as a full-time public employee at the Cincinnati Children\u2019s Hospital, which has received contributions from the following industries in the past 3 years: BMS, Eli Lilly, GSK, F. Hoffmann-La Roche, Janssen, Novartis, and Pfizer. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment to third parties. HIB has also received consulting fees from AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, EMD Serono, Genzyme, GSK, F. Hoffmann-La Roche, Janssen, Merck, Novartis, R-Pharm, and Sanofi, and has served on speakers\u2019 bureaus for Novartis, Roche, and GSK. CPT has received speaker fees from AbbVie, Boehringer Ingelheim, BMS, Eli Lilly, Janssen, Novartis, and Pfizer, and has served as a principal investigator for AbbVie, AstraZeneca, Biogen, Boehringer Ingelheim, Eli Lilly, Janssen, and UCB. IL has served as a consultant/advisory board member for AbbVie, Janssen, Lilly, and Pfizer. EA has received grant/research support from AbbVie, Amgen, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche, and Sanofi, and has been a speaker for AbbVie, BMS, MSD, Novartis, Pfizer, and Roche. SA has received consulting fees from AstraZeneca and GSK, and served as a principal investigator in clinical trials for BMS, Celgene, Eli Lilly, Janssen, Novartis, and Roche. AZ owns stock in Merck, OPKO Health, and Teva. DML has received consulting fees from Janssen and has served as a principal investigator for AstraZeneca, BMS, Roche, and Sobi. CER has received grant/research support (paid to institution) from AbbVie and UCB. YU has received speaker fees from AbbVie, Novartis, and Pfizer. SR, XLX, JHL, EL, and YW are employees of Janssen Research and Development, LLC, a wholly owned subsidiary of Johnson & Johnson, and may own stock or stock options in Johnson & Johnson. DJL has received grant/research support from BMS, Janssen Research and Development LLC, and Roche Laboratories; consulting fees from AstraZeneca, GSK, Novartis, Pfizer (consultant and advisory board member), and United Bioscience Corporation; and served on speakers\u2019 bureaus for Novartis and Pfizer (all above are paid to institution). AM has received consulting fees from AbbVie, Boehringer Ingelheim, Eli Lilly, EMD Serono, Idorsia, Janssen, Novartis, and Pfizer. NR received honoraria for scientific consultancies or speaker bureau participation in the past 2 years from AbbVie, Aclaris, Amgen, AstraZeneca, Aurinia, Boehringer Ingelheim, BMS, Eli Lilly, Galapagos, Guidepoint, Janssen, Novartis, Pfizer, and Sanofi. The remaining authors declare no conflicts of interest relevant to this article. Address correspondence to Dr. H.I. Brunner, Cincinnati Children\u2019s Hospital Medical Center, Division of Rheumatology, 3333 Burnet Avenue, Cincinnati, OH 45229, USA. Email: hermine.brunner@cchmc.org. Accepted for publication July 16, 2024.
The authors thank all PRINTO and PRCSG center personnel and all families who contributed to the study. Medical writing support was provided by Holly Capasso-Harris of Certara, under the direction of the authors and the guidance of PRINTO and PRCSG officers (NR, DJL, HIB, AM) in accordance with Good Publication Practice guidelines (Ann Intern Med 2022;175:1298-1304) and was funded by Janssen Research and Development, LLC. The authors also thank the following collaborators: Arturo Borzutzky, MD, Santiago, Chile; Ruben Cuttica, MD, Buenos Aires, Argentina; Liudmila Grebenkina, MD, Togliatti, Russia; Christi J. Inman, MD, Salt Lake City, Utah, USA; Vladimir Keltsev, MD, Togliatti, Russia (deceased); Daniel J. Kingsbury, MD, Portland, Oregon, USA; Victor Malievskiy, MD, Ufa, Russia; Taciana A. Pedrosa Fernandes, MD, Botucatu, Brazil; Maria del Rocio Maldonado Velazquez, MD, Mexico City, Mexico; Heinrike Schmeling, MD, Calgary, Canada; Christiaan Scott, MD, Cape Town, South Africa; Alberto Spindler, MD, San Miguel de Tucum\u00E1n, Argentina; Maria Teresa Terreri, MD, S\u00E3o Paulo, Brazil; Diego Oscar Viola, MD, Rosario, Argentina; Ricardo M. Xavier, MD, Porto Alegre, Brazil.

Muestra la fuente de financiamiento declarada en la publicación.