On February 10, the National Institutes of Health (NIH) reported details of a new study showing that the rheumatoid arthritis drug Kineret (anakinra) is effective for stopping the progression of organ damage in individuals with neonatal-onset multisystem inflammatory disease (NOMID).
The new study, performed by scientists at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), was published online in Arthritis & Rheumatism. The study evaluated 26 NOMID patients who ranged from 10 months of age to 42 years. The patients were treated daily with 1 to 5 mg of Kineret per kg of body weight for at least 36 months. The researchers found that increasing the dose of Kineret could help to control organ inflammation, which can lead to organ damage.
Analysis:
[s2If !is_user_logged_in()] Subscribe today for access to our proprietary analysis and adverse event data for this item![s2If current_user_can(access_s2member_level1)]Neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological cutaneous articular syndrome (CINCA), is a rare, systemic, congenital, inflammatory disorder that affects numerous organs and body systems. Symptoms of NOMID include fever, joint disease, rash, central nervous system disease, meningitis, mental retardation, and vision and hearing loss.
Prolonged inflammation of organs can lead to irreversible organ damage. The researchers in the study found that higher doses of Kineret could help to control organ inflammation. Lead study author Dr. Raphaela Goldbach-Mansky states:
Without Kineret, people with NOMID are at risk of progressive organ damage that results in hearing and vision loss, cognitive impairment and, in many cases, early death. As many as 20 percent of children with this genetic disorder do not live to adulthood. This study shows that treatment over five years is safe and effective, and can prevent organ damage.
Marketed by Swedish Orphan Biovitrum, Kineret was approved on November 14, 2001 to treat the symptoms and progression of structural damage associated with moderately to severely active rheumatoid arthritis. Kineret is typically administered via subcutaneous injection.
Using data from AERS, from 01/01/2004 to 9/30/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 1,086 patients who experienced a serious adverse event where Kineret was identified as a suspect drug causing the event and 858 patients who experienced a serious adverse event where Kineret was identified as the primary suspect. The most commonly reported side effects were injection site pain, injection site reaction and injection site erythema (redness).
From 01/01/2004 to 9/30/2011, there were 50 reported patient deaths and 275 reports of patient hospitalization where Kineret was identified as the primary suspect.
