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Juvenile Arthritis News
Senate holds hearing on biosimilar agents with FDA's CDER director, some senators call for action
The Subcommittee on Primary Health and Retirement Security met on Thursday, September 17 for a hearing on the implementation of biosimilar agents with Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA, and among other questions about interchangeability and safety, some senators questioned the lack of action in the issuance of guidance documents.
Patients with JIA treated with Enbrel may be at higher risk for infections
Patients with juvenile idiopathic arthritis who were treated with Enbrel may be at a higher risk for medically significant infections compared to patients only treated with methotrexate, according to the results of a recently published study.
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No correlation found with BMD, leptin in patients with JIA treated with glucocorticoids
A cohort of patients with juvenile idiopathic arthritis with low-dose exposure to glucocorticoids had normal body composition, and while patients with low BMD tended to have higher serum leptin levels, a significant association was not seen, according to a recently published report.
Patients with entheses-related, undifferentiated JIA had lower PROs than children with other forms of JIA
Lower patient-reported outcomes were observed in patients with entheses-related and undifferentiated juvenile idiopathic arthritis compared to oligoarticular and polyarticular rheumatoid factor-negative and other forms of juvenile idiopathic arthritis, according to recently published data.
Recent articles about biosimilars hold readers’ interest
While no biosimilars indicated for rheumatic diseases in the U.S. have been approved by the FDA, reader interest in the topic has been high as results from clinical trials and other clinical data are revealed.
Physicians support proposed biosimilar naming convention
In agreement with the FDA’s recent draft guidance on nonproprietary naming of biological products, six physician groups collectively sent a letter to CMS Acting Administrator Andrew Slavitt on Tuesday urging CMS to adopt unique billing codes for biosimilars, according to a press release.
Interventions increase vaccination rates for pediatric rheumatology patients
Simple practice-level interventions increased the pneumococcal vaccination coverage rate of pediatric patients with systemic lupus erythematosus and others on immunosuppressive therapy, according to research in Pediatrics.
FDA issues draft guidance on nonproprietary naming of biologics, biosimilars
The FDA announced the availability of a draft guidance describing its proposal on the nonproprietary naming of biological products.
Genetic overlap among pediatric autoimmune diseases may point to shared therapies
Genetic analysis of pediatric patients with 10 clinically distinct pediatric autoimmune diseases revealed overlapping genome-wide signals shared by at least two of the diseases, according to the results of a study.
Australia approves Hospira’s Inflectra biosimilar to Remicade
Hospira announced that the Australian Therapeutic Goods Administration has approved Inflectra, its biosimilar to Remicade, for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn's disease, adult and pediatric ulcerative colitis and plaque psoriasis, and today, it was added to the country’s Pharmaceutical Benefits Scheme, according to a press release.
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