The Food and Drug Administration (FDA) is requiring the manufacturers of tumor necrosis factor (TNF) blockers to update the boxed warning and prescribing information to alert health care professionals of an increased risk of malignancies in pediatric patients treated with TNF blockers*.  The FDA’s safety review and analysis is based on 48 cases of malignancies – including lymphoma and other cancers – in children and adolescents treated with TNF inhibitors. This is an ongoing investigation by the FDA, and the Arthritis Foundation expects more information from the FDA in the future.

TNF blockers, also known as biologic response modifiers, are approved for the treatment of one or more immune system diseases, including juvenile idiopathic arthritis (JIA, formerly known as juvenile rheumatoid arthritis, or JRA), rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease.

TNF therapies are improving the lives of millions of Americans and they are important treatment options for people with inflammatory forms of arthritis, such as JIA.  The Arthritis Foundation concurs that additional data and further analysis are needed, however, to determine whether malignancies are a direct result of TNF blocker use. Whether treated with biologics or not, some types of arthritis may increase the risk for developing cancer. Other drug and non-drug factors that may contribute to this risk include suppression of the immune system, use of multiple immunosuppressive therapies, long-term drug treatment and higher dosages.

The Arthritis Foundation believes the FDA’s decision will help to inform healthcare professionals and their patients about the potential risks associated with this class of drugs.  If there is an increased risk of cancer in JIA patients treated with TNF blockers, it appears to be small, particularly when compared to the risk of disability from untreated juvenile arthritis.

Therefore, the Arthritis Foundation urges adult patients and parents of children being treated with TNF blockers to:

• consult their prescribing physician to discuss their individual situation before altering treatment or taking any action on their own;
• work closely with their physicians to understand risks and benefits clearly before choosing a treatment plan; and
• be alert to the warning signs and symptoms of malignancies, and undergo cancer screenings appropriate for their age and gender.

The concern about adverse side effects with TNF blockers further emphasizes the need for a national registry for patients with JIA as well as a network of collaborating treatment centers to ensure that full information can be acquired about the risks and benefits of arthritis therapies.  The Arthritis Foundation is working toward this goal through its support for the Childhood Arthritis & Rheumatology Research Alliance (CARRA). CARRA is a North American organization of pediatric rheumatologists who have joined together to answer critical clinical research questions and determine the best possible treatment options for childhood arthritis and other childhood rheumatic diseases.

For more information about arthritis and treatment options, visit the Arthritis Foundation Web site at www.arthritis.org.

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* The FDA’s analysis on pediatric malignancies included TNF inhibitors Remicade and Enbrel.  It did not include Humira, which rarely is used to treat children, nor Cimzia or Simponi, which are not yet approved for use in children.