Abstract | OBJECTIVE: METHODS: In patients with systemic JIA, ages 4-20 years, the efficacy of rilonacept was evaluated using 30%, 50%, and 70% levels of improvement according to the adapted American College of Rheumatology (ACR) Pediatric 30, 50, and 70 response criteria, respectively. Efficacy and safety were evaluated during 23 months of open-label treatment (3 phases) after a 4-week, double-blind, placebo-controlled phase. Following double-blind treatment with 2.2 mg/kg or 4.4 mg/kg of rilonacept, patients were eligible to receive open-label treatment at their prior dose, with adjustments. Reductions in the median daily dose of oral prednisone and improvements in laboratory parameters of disease activity (i.e., decreased levels of D-dimer and myeloid-related proteins [MRPs]) were also evaluated. RESULTS: Twenty-four patients entered the double-blind study and 23 entered the open-label period. Patients were predominantly white and female, and had a median age of 14.0 years at baseline. No significant differences in efficacy were observed between the rilonacept- and placebo-treated patients during the double-blind phase, but fever and rash completely resolved by month 3 in all patients during the open-label treatment period and did not recur. Adapted ACR Pediatric 30, 50, and 70 response rates at 3 months from the start of the study were 78.3%, 60.9%, and 34.8%, respectively; these responses were generally maintained over the study duration. Levels of D-dimer and MRP-8/MRP-14 dramatically improved during the study, and in 22 of 23 patients, the prednisone dose was decreased or prednisone therapy was discontinued. No serious treatment-related adverse events were observed. CONCLUSION: Sustained improvements in clinical and laboratory measures of the articular and systemic manifestations of systemic JIA were achieved in >50% of rilonacept-treated patients over 2 years. Treatment with rilonacept had a substantial steroid-sparing effect and was generally well-tolerated.
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Authors | Daniel J Lovell, Edward H Giannini, Andreas O Reiff, Yukiko Kimura, Suzanne Li, Philip J Hashkes, Carol A Wallace, Karen B Onel, Dirk Foell, Richard Wu, Stephanie Biedermann, Jennifer D Hamilton, Allen R Radin |
Journal | Arthritis and rheumatism
(Arthritis Rheum)
Vol. 65
Issue 9
Pg. 2486-96
(Sep 2013)
ISSN: 1529-0131 [Electronic] United States |
PMID | 23754188
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 by the American College of Rheumatology. |
Chemical References |
- Antirheumatic Agents
- Recombinant Fusion Proteins
- rilonacept
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Topics |
- Adolescent
- Antirheumatic Agents
(adverse effects, therapeutic use)
- Arthritis, Juvenile
(drug therapy)
- Child
- Child, Preschool
- Double-Blind Method
- Female
- Humans
- Male
- Recombinant Fusion Proteins
(adverse effects, therapeutic use)
- Treatment Outcome
- Young Adult
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