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

abstract

  • 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%25 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%25 (154/173) had a JIA ACR30 response and 79.2%25/65.9%25/36.4%25 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%25 vs 36/76=47%25; p=0.41), and rates of clinical remission were comparable (golimumab vs placebo: 10/78=12.8%25 vs 9/76=11.8%25). Adverse event and serious adverse event rates were similar in the treatment groups during Part 2. Injection site reactions occurred with <1%25 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. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved.

publication date

  • 2018-01-01