Guilt by association - what is the true risk of malignancy in children treated with etanercept for JIA?
Summary of "Guilt by association - what is the true risk of malignancy in children treated with etanercept for JIA?"
Recently, the Food and Drug Administration placed a "black box" label on etanercept, and other tumor necrosis factor inhibitors used to treat childhood arthritis, warning of the risk of malignancies. The Food and Drug Administration made their decision based on a review of 48 cases of malignancies identified worldwide in children treated with tumor necrosis factor inhibitors for inflammatory bowel disease, sarcoidosis, and juvenile idiopathic arthritis. Recently, an article in Pediatric Rheumatology demonstrated that there may not be an increased risk of cancer in children with juvenile idiopathic arthritis treated specifically with the tumor necrosis factor receptor fusion protein, etanercept. There are many confounding issues regarding whether or not etanercept increases the risk of malignancy, specifically lymphomas, above the background rate of cancer in children with juvenile idiopathic arthritis who are not being treated with biologic agents. Whether or not it was appropriate for the Food and Drug Administration to lump cancer patients with underlying granulomatous diseases (inflammatory bowel disease and sarcoidosis) with children with juvenile idiopathic arthritis is explored herein. Moreover, the amalgamation of etanercept with anti-tumor necrosis factor monoclonal antibodies (adalimumab and infliximab) is another point of contention. What is clear is that there is much that is currently unknown to be able to convincingly demonstrate a substantial risk of cancer in children with juvenile idiopathic arthritis treated with etanercept. Conversely, there is ample evidence demonstrating remarkable benefit of etanercept in treating juvenile idiopathic arthritis. Physicians treating childhood arthritis should weigh these potential risks and benefits with patients and their families discussing the current limitations in available data regarding the risk of cancer in children treated with etanercept for juvenile idiopathic arthritis.
This article was published in the following journal.
Name: Pediatric rheumatology online journal
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/20712883
- DOI: http://dx.doi.org/10.1186/1546-0096-8-23
Medical and Biotech [MESH] Definitions
Early Intervention (education)
Procedures and programs that facilitate the development or skill acquisition in infants and young children who have disabilities, who are at risk for developing disabilities, or who are gifted. It includes programs that are designed to prevent handicapping conditions in infants and young children and family-centered programs designed to affect the functioning of infants and children with special needs. (From Journal of Early Intervention, Editorial, 1989, vol. 13, no. 1, p. 3; A Discursive Dictionary of Health Care, prepared for the U.S. House of Representatives Committee on Interstate and Foreign Commerce, 1976)
Risk Reduction Behavior
Reduction of high-risk choices and adoption of low-risk quantity and frequency alternatives.
Heat Stress Disorders
A group of conditions due to overexposure to or overexertion in excess environmental temperature. It includes heat cramps, which are non-emergent and treated by salt replacement; HEAT EXHAUSTION, which is more serious, treated with fluid and salt replacement; and HEAT STROKE, a condition most commonly affecting extremes of age, especially the elderly, accompanied by convulsions, delusions, or coma and treated with cooling the body and replacement of fluids and salts. (From Segen, Dictionary of Modern Medicine, 1992)
A system of therapeutics founded by Samuel Hahnemann (1755-1843), based on the Law of Similars where "like cures like". Diseases are treated by highly diluted substances that cause, in healthy persons, symptoms like those of the disease to be treated. The dilutions are repeated so many times that there is less than one molecule per dose and it is suggested that benefit is from the energetic life force of the original substance.
The process of minimizing risk to an organization by developing systems to identify and analyze potential hazards to prevent accidents, injuries, and other adverse occurrences, and by attempting to handle events and incidents which do occur in such a manner that their effect and cost are minimized. Effective risk management has its greatest benefits in application to insurance in order to avert or minimize financial liability. (From Slee & Slee: Health care terms, 2d ed)
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