Navigation Links
TNF blockers may increase the risk of malignancy in children
Date:7/29/2010

The Food and Drug Administration (FDA) received reports of malignancies in children using tumor necrosis factor a (TNF) blockers, raising concerns of an associated risk and prompting an investigation. Researchers from the FDA set out to identify all reports of malignancy in children using infliximab, etanercept, and adalimumab and their report is published in the August issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.

The FDA has approved 3 TNF blockers for use in children: Etanercept to treat juvenile idiopathic arthritis (JIA); infliximab to treat Crohn's disease; and adalimumab to treat JIA. Data suggest that certain adult populations may be at an increased risk of malignancy with TNF blocker therapy. The immunosuppressive properties of TNF blockers may also increase the risk of malignancy in children, but to what extent is unclear.

Cancer is very rare in children. According to the National Cancer Institute's Surveillance, Epidemiology, and End-Results (SEER) database, the U.S. annual incidence rate for all cancers in children ages 0󈝿 years was 16.8/100,000 compared with the rate of 469.7/100,000 for all cancers in adults, age adjusted to the year 2000 U.S. population. When 48 incidences of malignancy were identified among pediatric patients treated with TNF blockers, there was cause for concern. Study leader Peter Diak, Pharm.D., explains. "The number and rare types of malignances reported in these cases are worrisome given the underreporting of adverse events in the Adverse Event Reporting System (AERS) database, the long latency period of malignancy, and the relatively small number of pediatric patients treated with TNF blockers."

The study team searched the AERS database for all reports of malignancy in children using infliximab, etanercept, and adalimumab who initiated therapy between the ages of 0 and 18 years. The 48 cases identified included 31 following infliximab use, 15 following etanercept use, and 2 following adalimumab use. The reporting rates for infliximab and etanercept were compared with the background cancer rate in the general pediatric population. Reporting rates were not calculated for adalimumab because only 2 cases were reported, and previous use of other TNF blockers was reported in both cases. Most of the children evaluated received TNF blocker therapy for a prolonged perioda median of 30 monthssuggesting these cases were not preexisting malignancies that were misdiagnosed as a rheumatic condition.

The analysis showed the reporting rate for U.S. cases of malignancy in children for infliximab was 66 per 100,000 patient years, 4 times the estimated background rate for the general U.S. pediatric population. For lymphomas in children, the reporting rate was 44 per 100,000 patient years, 18 times the background rate. If cases of hepatosplenic T cell lymphoma are excluded from the calculation, the reporting rate for lymphomas with infliximab drops to 22 per 100,000 patient years but still exceeds the background rate by 9 times. For etanercept, the reporting rate for U.S. cases of malignancy in children was 22 per 100,000 patient years and approximated the background rate. However, for lymphomas, the reporting rate with etanercept was 11 per 100,000 patient years, 5 times the background rate for lymphomas in children.

The team concludes that the risk of malignancy should be considered prior to initiating TNF blockers in children, particularly as some of the reported cases involved types of cancers not commonly seen in children and that are usually associated with immunosuppression. Further, they suggest that the true incidence rate for these events in the pediatric population may be even higher due to substantial under-reporting to FDA's MedWatch program. Another concern is that the latency period of malignancy indicates there may be an extensive interval between the onset of TNF blocker treatment and the diagnosis of malignancy. Dr. Diak comments, "The number of reported cases of malignancy in children using TNF blockers is likely to increase as the usage and duration of therapy with TNF blockers increases."

He cautions, however, that the cases were confounded by the potential underlying risk of malignancy in patients with autoimmune disease and the use of concomitant immunosuppressants, preventing a clear causal relationship from being established.

The paper is accompanied by an editorial which points out that while the study raises a key concern, it is important to recognize that 25 of the 48 cases of malignancies occurred in children with inflammatory bowel disease who were also receiving immunosuppressants and thus the study findings are not directly relevant to children with JIA. The editorial, written by Thomas Lehman, M.D., from the Hospital for Special Surgery and Weill Medical College at Cornell University in New York, also highlights that there is no convincing evidence that the use of TNF blockers in children with JIA is associated with an increased risk of malignancy beyond that due to the disease alone or the disease when treated with methotrexate.


'/>"/>

Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell
Source:Eurekalert

Related medicine news :

1. Study finds beta blockers alone more effective for first variceal bleeding
2. Beta Blockers May Slow Spread of Breast Cancer
3. Beta-blockers help reduce metastasis and improve survival in breast cancer patients
4. Small increases in vaccine cost can cause large gaps in protection
5. Use of decision-aid program increases safety for women experiencing abuse, researchers find
6. Wood smoke exposure multiplies damage from smoking, increases risk of COPD
7. Mayo Clinic Proceedings: Sexual abuse survivors have increased of psychiatric disorders
8. Women with gestational diabetes have increased risk of recurrence in subsequent pregnancies
9. The Laser Warehouse Increases its Inventory of Used Cosmetic Lasers to Meet Growing Demand
10. Clothing4all WOWs Yet Again With Customer Appreciation and Increased Sales
11. Legalizing marijuana in California would lower the price of the drug and increase use, study finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... , ... June 25, 2016 , ... On Friday, June ... a Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments ... of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott ...
(Date:6/24/2016)... ... 24, 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. ... the benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has ... , Sickle Cell Disease (SCD) is a disorder of the red blood cells, which ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of ... AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
(Date:6/24/2016)... ... ... National recruitment firm Slone Partners is pleased to announce the ... as Vice President of North American Capital Sales at HTG Molecular . ... team in the commercialization of the HTG EdgeSeq system and associated reagents in North ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , Belgium , June 24, ... VNRX), today announced the appointment of Dr. ... Directors as a Non-Executive Director, effective June 23, ... Audit, Compensation and Nominations and Governance Committees.  As ... Futcher will provide independent expertise and strategic counsel ...
(Date:6/23/2016)... 23, 2016 Any dentist who has made an ... current process. Many of them do not even offer this ... and high laboratory costs involved. And those who ARE able ... such a high cost that the majority of today,s patients ... Parsa Zadeh , founder of Dental Evolutions Inc. and ...
(Date:6/23/2016)... , June 23, 2016 Research and ... Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data derived ... Assessment of major trends with potential impact on the market ... of market segmentation which comprises of sub markets, regional and ...
Breaking Medicine Technology: