Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial

Annals of the Rheumatic Diseases
Hermine I BrunnerPaediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group

Abstract

This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA). In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m2of body surface area; maximum: 50 mg/dose) every 4 weeks together with weekly methotrexate during Part 1 (weeks 0-16). Patients with at least 30% improvement per American College of Rheumatology Criteria for JIA (JIA ACR30) in Part 1 entered the double-blinded Part 2 (weeks 16-48) after 1:1 randomisation to continue golimumab or start placebo. In Part 3, golimumab was continued or could be restarted as in Part 1. The primary outcome was JIA flares in Part 2; secondary outcomes included JIA ACR50/70/90 responses, clinical remission, PK and safety. Among 173 patients with polyJIA enrolled, 89.0% (154/173) had a JIA ACR30 response and 79.2%/65.9%/36.4% demonstrated JIA ACR50/70/90 responses in Part 1. At week 48, the primary endpoint was not met as treatment groups had comparable JIA flare rates (golimumab vs placebo: 32/78=41% vs 36/76=47%; p=0.41), and rates of clinical remission were comparable (golimumab vs placebo: 10/78=1...Continue Reading

References

Jul 1, 1997·Arthritis and Rheumatism·E H GianniniA Martini
Aug 18, 2004·Current Opinion in Rheumatology·Nicolino Ruperto, Alberto Martini
Jul 18, 2008·Lancet·Nicolino RupertoUNKNOWN Pediatric Rheumatology Collaborative Study Group
Aug 22, 2008·The New England Journal of Medicine·Daniel J LovellUNKNOWN Pediatric Rheumatology International Trials Organisation
May 1, 2009·Arthritis and Rheumatism·Alessandro ConsolaroUNKNOWN Paediatric Rheumatology International Trials Organisation
Mar 26, 2010·BMC Medicine·Kenneth F SchulzUNKNOWN CONSORT Group
Jul 1, 2011·Arthritis Care & Research·Carol A WallaceUNKNOWN Paediatric Rheumatology International Trials Organisation
Jan 11, 2012·Arthritis and Rheumatism·Alessandro ConsolaroUNKNOWN Paediatric Rheumatology International Trials Organization
Dec 21, 2012·The New England Journal of Medicine·Nicolino RupertoUNKNOWN PRCSG
May 20, 2014·Annals of the Rheumatic Diseases·Hermine I BrunnerUNKNOWN Pediatric Rheumatology Collaborative Study Group (PRCSG)
Jan 7, 2015·Nature Reviews. Rheumatology·Claas HinzeDirk Foell

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Citations

Feb 27, 2018·Arthritis & Rheumatology·Hermine I BrunnerUNKNOWN Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group
Oct 1, 2018·Annals of the Rheumatic Diseases·Nicolino RupertoUNKNOWN Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group
Jun 7, 2019·Current Opinion in Rheumatology·Gabriella GiancaneUNKNOWN Paediatric Rheumatology International Trials Organisation (PRINTO)
Jul 18, 2019·Arthritis & Rheumatology·Laura E SchanbergYukiko Kimura
Mar 3, 2020·Expert Opinion on Biological Therapy·Rolando CimazGiulia Calabrese
May 27, 2017·Annals of the Rheumatic Diseases·Roberta A Berard, Ronald M Laxer
Jul 10, 2019·Arthritis Research & Therapy·Gabriella GiancaneAngelo Ravelli
Aug 20, 2019·Arthritis Care & Research·Hermine I BrunnerUNKNOWN Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group
May 23, 2017·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·James E Frampton
Jan 20, 2019·Pediatric Rheumatology Online Journal·Arnold NagyBernadett Mosdósi
May 18, 2019·Zeitschrift für Rheumatologie·Gerd Horneff
May 28, 2019·Arthritis Research & Therapy·Ivan FoeldvariUNKNOWN Paediatric Rheumatology International Trials Organisation (PRINTO)
Jul 14, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Pavine L C LefevreNiels Vande Casteele
Dec 29, 2020·Human Vaccines & Immunotherapeutics·Ana Teresa MeloJoão Eurico Fonseca
Jan 26, 2021·Rheumatology·Nicolino RupertoUNKNOWN Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (
Mar 9, 2021·Current Rheumatology Reports·Gabriella GiancaneNicolino Ruperto
Dec 18, 2018·Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver·Pablo OliveraLaurent Peyrin-Biroulet
Jun 21, 2021·Clinical Pharmacology and Therapeutics·Mara L Becker, Walter K Kraft
Jul 14, 2021·Current Rheumatology Reports·Hemalatha SrinivasaluChristopher Redmond
May 17, 2021·Joint, Bone, Spine : Revue Du Rhumatisme·Jérémie SellamChristophe Richez
Sep 19, 2020·Current Rheumatology Reviews·Ioanna G SaougouAlexandros A Drosos

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Methods Mentioned

BETA
ESR

Clinical Trials Mentioned

NCT01230827

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