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Tumor Necrosis Factor Inhibitors

Tumor necrosis factors (TNF) are a type of protein that facilitates apoptosis, the death of cells as part of normal biological growth and functioning. Although tumor necrosis factors are created by certain cells within the body, in some instances they can cause inflammatory problems related to the immune system.

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Drugs called TNF inhibitors can be used to counteract some symptoms of inflammatory problems, but the drugs have also been linked to increased risk of certain forms of cancer. Several companies have issued recalls for TNF blockers.

TNF Inhibitors and autoimmune conditions

The most common form of TNF (sometimes called TNF alpha) has been associated with the following autoimmune conditions.

Condition Description
Inflammatory bowel diseases (IBDs) Crohn’s disease and ulcerative colitis are two of the most prominent forms of IBD, a chronic inflammatory condition which impacts up to 1.4 million Americans. Crohn’s disease specifically affects the gastrointestinal tract, while ulcerative colitis is located in the colon and large intestine. 1
Rheumatoid Arthritis Commonly found in small joints of the hands and feet, rheumatoid arthritis occurs when the immune system assaults joint linings. This inflammatory condition can cause swelling, stiffness, pain, bone erosion, deformity of the joints and ultimately loss of function. Women are more prone to developing rheumatoid arthritis than men. 2
Ankylosing spondylitis Another form of chronic arthritis is ankylosing spondylitis, which is located in the spine and typically develops in young adults (ages 17 – 45). The condition can sometimes spread to other joints, and over long periods of time may cause bones to calcify (fuse together). 3
Plaque psoriasis The most common form of psoriasis, plaque psoriasis is characterized by scaly epidermal patches due to the rapid growth of skin cells. The fast skin growth is believed to be caused by an improperly functioning autoimmune system, possibly caused by TNF. For severe forms of psoriasis, doctors may prescribe an anti-TNF drug. 4
Psoriatic arthritis Up to 30% of people who have psoriasis also may develop psoriatic arthritis, in which the inflammation causing psoriasis also spreads to the patient’s joints. The inflammation may be mild or severe, and treatments can involve TNF blockers. 5

Tumor Necrosis Factor Inhibitor Drugs

To combat immune system conditions triggered by TNF, various companies have produced a variety of TNF inhibitors. These drugs work by suppressing the TNF proteins to help relieve symptoms related to chronic inflammatory problems, such as Crohn’s disease, various forms of psoriasis and rheumatoid arthritis. Although TNF inhibitors may relieve certain symptoms related to these conditions, they are not cures.

Currently, there are five FDA-approved TNF inhibitors on the market: 6

  • Remicade (infliximab) – approved in 1998
  • Enbrel (etanercept) – approved in 1998
  • Humira (adalimumab) – approved in 2002
  • Cimzia (certolizumab pegol) – approved in 2008
  • Simponi and Simponi Aria (golimumab) – approved in 2009 and 2013, respectively

TNF Inhibitor Side Effects and Cancer Risks

Common side effects of TNF inhibitors include:

  • Skin reactions that create a burning or itchy sensation near the site of the injection
  • Greater potential for infections, including severe illnesses such as tuberculosis or bacterial infections like Legionella and Listeria 7

In some cases, taking TNF inhibitors may increase the risk for developing skin cancer, also known as melanoma. An April 2013 study showed that patients who took TNF blockers to treat rheumatoid arthritis have as much as a 50% greater chance of developing invasive melanomas than patients who did not take the drugs. 8 Another study that examined the FDA Adverse Event Reporting System (FAERS) found “a significant association” connecting TNF inhibitors to malignant melanomas. 9

Additionally, there have been reports of a rare and often fatal form of cancer, Hepatosplenic T-Cell Lymphoma (HSTCL), connected to TNF inhibitors. In April 2011, the FDA issued a warning indicating that teenagers and young adults especially may have an increased risk of developing HSTCL when taking TNF inhibitors for inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis. ((U.S. Food and Drug Administration.10

Several TNF drugs now include warnings specifically about melanoma and other potentially dangerous aftereffects on their labels.

TNF Inhibitor Recalls

Although no recalls have been issued due to the potentially deadly consequences of taking TNF inhibitors, several recalls of TNF inhibitors have occurred for other reasons.

If you or a loved one has suffered from adverse effects of TNF inhibitors, you should seek legal advice to identify your options.

  1. Crohn’s & Colitis Foundation of America. What Are Crohn’s & Colitis? (n.d.). Accessed Aug. 4, 2014. from http://www.crohnscolitisfoundation.org/
  2. National Institute on Arthritis and Musculoskeletal and Skin Diseases. Handout on Health: Rheumatoid Arthritis. (April 2013). Accessed Aug. 4, 2014. from http://www.niams.nih.gov
  3. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Questions and Answers about Ankylosing Spondylitis. (January 2013). Accessed Aug. 4, 2014. from http://www.niams.nih.gov
  4. Berman, Kevin. Psoriasis. (Updated Nov. 20, 2012). MedlinePlus. Accessed Aug. 5, 2014. from http://www.nlm.nih.gov
  5. Starkebaum, Gordon A. Psoriatic arthritis. (Updated April 20, 2013.) MedlinePlus. Accessed Aug. 5, 2014. From http://www.nlm.nih.gov
  6. U.S. Food and Drug Administration. Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria. (Sept. 7, 2011). Accessed Aug. 4, 2014. from https://www.fda.gov/
  7. U.S. Food and Drug Administration. Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria. (Sept. 7, 2011). Accessed Aug. 4, 2014. from https://www.fda.gov/
  8. Raaschou, Pauline. Rheumatoid arthritis, anti-tumour necrosis factor therapy, and risk of malignant melanoma. (April 8, 2013.) Accessed Aug. 4, 2014. from https://www.bmj.com/
  9. Nardone, B. et al. Melanoma associated with tumour necrosis factor-α inhibitors: a Research on Adverse Drug events And Reports (RADAR) project. (May 2014). British Journal of Dermatology. Accessed Aug. 4, 2014.
  10. U.S. Food and Drug Administration. Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine. (April 14, 2011). Accessed Aug. 4, 2014. from https://www.fda.gov/