Document Detail


Safety and Efficacy of Etanercept in a Cohort of Patients with Juvenile Idiopathic Arthritis Under 4 Years of Age.
MedLine Citation:
PMID:  22589254     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate safety, tolerability, and efficacy of etanercept in a cohort of patients with juvenile idiopathic arthritis (JIA) under 4 years of age. METHODS: Data were collected at every visit during treatment with etanercept in 25 children who began treatment at a mean age of 3 years (range 18-48 months). Safety endpoints included the incidence of any adverse events. Efficacy endpoints included the American College of Rheumatology (ACR) Pediatric 30, 50, and 70 criteria for improvement. RESULTS: Data from 25 patients with JIA treated with etanercept for a mean period of 23 months were analyzed. All patients received concomitant medications: 24 methotrexate, 3 cyclosporin A, and 10 corticosteroids. After the first 6 months of treatment, 15 (71.4%) patients achieved an ACR Pedi30 response and at the last observation 20 (80%) achieved ACR Pedi30. ACR Pedi50 and 70 responses were, respectively, 62% and 43% at 6 months and 72% and 64% at the last followup. Five patients (20%) discontinued etanercept for lack of efficacy. Two (8%) developed adverse events, both primary varicella zoster virus (VZV) infections (both not vaccinated). One was hospitalized because of a necrotizing fasciitis secondary to VZV infection. No cases of tuberculosis, opportunistic infections, or malignancies were reported. CONCLUSION: In our cohort of patients etanercept proved to be safe and efficacious in the majority of children. The response in toddlers was similar to that in older children. We observed only 1 case of severe infection that required hospitalization and stopped treatment temporarily.
Authors:
Claudia Bracaglia; Paola S Buonuomo; Alberto E Tozzi; Manuela Pardeo; Rebecca Nicolai; Andrea Campana; Antonella Insalaco; Elisabetta Cortis; Fabrizio De Benedetti
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-5-15
Journal Detail:
Title:  The Journal of rheumatology     Volume:  -     ISSN:  0315-162X     ISO Abbreviation:  -     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-5-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7501984     Medline TA:  J Rheumatol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
From the Division of Rheumatology, Department of Pediatric Medicine; and Division of Epidemiology, Ospedale Pediatrico Bambino Gesù IRCCS, Rome, Italy.
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