A randomized, placebo-controlled, double-masked clinical trial of etanercept for the treatment of uveitis associated with juvenile idiopathic arthritis
| Autor: | Scott M. Whitcup, Jonghyeon Kim, Eric B. Suhler, Janine A. Smith, Susan F Smith, Darby J. S. Thompson, Karyl S. Barron, Grace Clarke, Michael R. Robinson |
|---|---|
| Rok vydání: | 2005 |
| Předmět: |
Male
musculoskeletal diseases medicine.medical_specialty Adolescent Immunology Arthritis Pilot Projects Placebo Receptors Tumor Necrosis Factor Etanercept law.invention Placebos Uveitis Double-Blind Method Rheumatology Randomized controlled trial law Internal medicine medicine Humans Immunology and Allergy Pharmacology (medical) Child skin and connective tissue diseases Tumor Necrosis Factor-alpha business.industry medicine.disease Arthritis Juvenile Surgery Clinical trial Regimen Treatment Outcome Antirheumatic Agents Child Preschool Immunoglobulin G Female business Juvenile rheumatoid arthritis Follow-Up Studies medicine.drug |
| Zdroj: | Arthritis & Rheumatism. 53:18-23 |
| ISSN: | 1529-0131 0004-3591 |
| Popis: | Objective To investigate the safety and efficacy of etanercept in the treatment of uveitis associated with juvenile idiopathic arthritis (JIA). Methods Children who met the American College of Rheumatology diagnostic criteria for JIA with active uveitis, who had anterior chamber cells of ≥1+ or requiring topical corticosteroid ≥3 times daily, and who were on a stable regimen for arthritis treatment were eligible. Study participants received etanercept (0.4 mg/kg) or placebo administered subcutaneously twice weekly for 6 months. All participants received open-label etanercept for an additional 6 months. Results Five patients received placebo and 7 received etanercept. Three of the 7 patients treated with etanercept and 2 of the 5 placebo-treated patients were considered ophthalmic successes (P = 1.0). One patient in each treatment group was considered a treatment failure. Three of the 7 etanercept-treated and 2 of the 5 placebo-treated patients were neither successes nor failures by our definition. There were no serious adverse events for any patient during the entire study period. Reports of minor infections were comparable in each treatment group, 71% for etanercept and 60% for placebo (P = 0.58). Conclusion In this small pilot study there was no apparent difference in the anterior segment inflammation between patients treated with etanercept and placebo. The stringent criteria used to measure ophthalmic success of treatment and the small patient population limit the implications of our findings. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text