Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial.
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Brunner Hermine I, Ruperto Nicolino, Tzaribachev Nikolay, Horneff Gerd, Chasnyk Vyacheslav G, Panaviene Violeta, Abud-Mendoza Carlos, Reiff Andreas, Alexeeva Ekaterina, Rubio-Pérez Nadina, Keltsev Vladimir, Kingsbury Daniel J, Del Rocio Maldonado Velázquez Maria, Nikishina Irina, Silverman Earl D, Joos Rik, Smolewska Elzbieta, Bandeira Márcia, Minden Kirsten, van Royen-Kerkhof Annet, Emminger Wolfgang, Foeldvari Ivan, Lauwerys Bernard R, Sztajnbok Flavio, Gilmer Keith E, Xu Zhenhua, Leu Jocelyn H, Kim Lilianne, Lamberth Sarah L, Loza Matthew J, Lovell Daniel J, Martini Alberto, Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)
Аннотация
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.