ReviewsDosing Regimen Determination for Juvenile Idiopathic Arthritis: A Review of Studies During Drug Development1
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INTRODUCTION
Juvenile idiopathic arthritis (JIA), previously known as juvenile rheumatoid arthritis (JRA), is defined by the International League of Associations for Rheumatology classification system as a group of heterogeneous arthritis that start before the age of 16 years, are of unknown cause, and persist for more than 6 weeks.1,2 It is the most common childhood arthritis with the prevalence estimated to vary from eight cases to as high as 400 cases per 100,000 children in developed countries.3 JIA is
SUMMARY
This review summarizes the pediatric clinical development programs of 14 drugs and biologics investigated for JIA indication. Five non-selective NSAIDs have been approved by FDA for the treatment of JIA (naproxen, tolmetin, oxaprozin, meloxicam, and etodolac). As rofecoxib was withdrawn from markets in 2004, celecoxib is the only FDA approved COX-2 selective inhibitor currently on the market with JIA indication. The proposed dosing regimens were based on the evaluation of PK, safety, and
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2015, Endocrinology (United States)Dosing of biologics in juvenile idiopathic arthritis: Is the sky the limit?
2013, Journal of RheumatologyJuvenile idiopathic arthritis: Diagnosis and management
2013, Journal of Clinical Outcomes Management
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Opinions expressed in this manuscript are those of the authors’ and do not reflect the views or policies of the US Food and Drug Administration.