RT Journal Article
SR Electronic
T1 Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 21
OP 29
DO 10.1136/annrheumdis-2016-210456
VO 77
IS 1
A1 Hermine I Brunner
A1 Nicolino Ruperto
A1 Nikolay Tzaribachev
A1 Gerd Horneff
A1 Vyacheslav G Chasnyk
A1 Violeta Panaviene
A1 Carlos Abud-Mendoza
A1 Andreas Reiff
A1 Ekaterina Alexeeva
A1 Nadina Rubio-Pérez
A1 Vladimir Keltsev
A1 Daniel J Kingsbury
A1 Maria del Rocio Maldonado Velázquez
A1 Irina Nikishina
A1 Earl D Silverman
A1 Rik Joos
A1 Elzbieta Smolewska
A1 Márcia Bandeira
A1 Kirsten Minden
A1 Annet van Royen-Kerkhof
A1 Wolfgang Emminger
A1 Ivan Foeldvari
A1 Bernard R Lauwerys
A1 Flavio Sztajnbok
A1 Keith E Gilmer
A1 Zhenhua Xu
A1 Jocelyn H Leu
A1 Lilianne Kim
A1 Sarah L Lamberth
A1 Matthew J Loza
A1 Daniel J Lovell
A1 Alberto Martini
A1 ,
YR 2018
UL http://ard.bmj.com/content/77/1/21.abstract
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.