PT  - JOURNAL ARTICLE
AU  - Hermine I Brunner
AU  - Nicolino Ruperto
AU  - Nikolay Tzaribachev
AU  - Gerd Horneff
AU  - Vyacheslav G Chasnyk
AU  - Violeta Panaviene
AU  - Carlos Abud-Mendoza
AU  - Andreas Reiff
AU  - Ekaterina Alexeeva
AU  - Nadina Rubio-Pérez
AU  - Vladimir Keltsev
AU  - Daniel J Kingsbury
AU  - Maria del Rocio Maldonado Velázquez
AU  - Irina Nikishina
AU  - Earl D Silverman
AU  - Rik Joos
AU  - Elzbieta Smolewska
AU  - Márcia Bandeira
AU  - Kirsten Minden
AU  - Annet van Royen-Kerkhof
AU  - Wolfgang Emminger
AU  - Ivan Foeldvari
AU  - Bernard R Lauwerys
AU  - Flavio Sztajnbok
AU  - Keith E Gilmer
AU  - Zhenhua Xu
AU  - Jocelyn H Leu
AU  - Lilianne Kim
AU  - Sarah L Lamberth
AU  - Matthew J Loza
AU  - Daniel J Lovell
AU  - Alberto Martini
ED  - ,
TI  - Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial
AID  - 10.1136/annrheumdis-2016-210456
DP  - 2018 Jan 01
TA  - Annals of the Rheumatic Diseases
PG  - 21--29
VI  - 77
IP  - 1
4099  - http://ard.bmj.com/content/77/1/21.short
4100  - http://ard.bmj.com/content/77/1/21.full
SO  - Ann Rheum Dis2018 Jan 01; 77
AB  - Objective This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA).Methods In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m2 of 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.Results 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=12.8% vs 9/76=11.8%). Adverse event and serious adverse event rates were similar in the treatment groups during Part 2. Injection site reactions occurred with <1% of all injections. PK analysis confirmed adequate golimumab dosing for polyJIA.Conclusion Although the primary endpoint was not met, golimumab resulted in rapid, clinically meaningful, improvement in children with active polyJIA. Golimumab was well tolerated, and no unexpected safety events occurred.Clinical Trial Registration NCT01230827; Results.