FDA Approved Rheumatoid Arthritis Drug Has Serious Side Effects

The rheumatoid arthritis drug, Tofacitinib, recently received FDA approval for treatment of the disease. The drug was created in a joint partnership between Pfizer and a team of researchers led by Dr. John J. Shea, a senior NIH Researcher, and his team of scientists.

Dr. John J. Shea, M.D., scientific director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases Organization (NIAMS), is a senior researcher with the National Institutes Of Health (NIH), as well as being the scientist that first discovered the enzyme Janus kinase 3 (JAK3) and cloned the human form of the gene for the first time.

This discovery happened in 1993 and was an extremely important finding, as Dr. O Shea and his fellow researchers established the JAK3 link to auto inflammatory diseases, such as rheumatoid arthritis.

Scientists at the pharmaceutical company Pfizer, had previously been investigating drugs that target autoimmunity and transplant rejection, and when Dr. O Shea learned of these inquiries, subsequent discussions between the two parties led to the creation of an innovative public/private agreement between the National Institutes of Health and Pfizer, through a cooperative research and development agreement. Since that time a cooperative research team was formed, working together towards the universal goal of the partnership, an autoimmune suppressive drug allowing treatment for rheumatoid arthritis.

The drug developed by this research team and approved by the FDA to treat rheumatoid arthritis is named Tofacitinib. Pfizer has also been investigating the use of this drug for psoriasis, inflammatory bowel disease, and other immunological diseases, as well as for the prevention of organ transplant rejection.

Tofacitinib inhibits the Janus kinase 3 enzyme, interfering with the signaling pathway that transmits information to the cell nucleus, which influences DNA transcription of the cell.

Phase 2 clinical trials in RA patients that had not been responsive to the drug DMARD showed promising results, and when combined with the drug methotrexate, showed an even more marked improvement for the treatment of rheumatoid arthritis.

The bad news is, phase 2 studies on covered several unpleasant side effects, in which four patients died, but only one of the deaths was attributed to tofacitinib.

The 2 side effects discovered in the phase 2 studies were increase serum blood cholesterol levels, doubling the LDL cholesterol level, and 25% higher for the HDL cholesterol level with a medium dose. Additionally the drug was found to increase a granulocyte disorder called neutropenia.

This is extremely bad news for rheumatoid arthritis sufferers with the con-competent autoimmune deficiency disorder, like the HIV/AIDS virus and here’s why.

Neutropenia presents itself as an unusually low number of neutrophils, which which make up between 50 to 70% of your white blood cells, and are the primary defense against infections in your blood system. As these white blood cells destroy bacteria and infection in your blood, neutropenia will make immune deficient patients more susceptible to bacterial infections, and this condition may then become life threatening in nature.

Once again this is bad news for people with an autoimmune deficiency, because generally neutropenia goes undetected, and is only discovered when a patient develops severe infections or neutropenia sepsis. Common symptoms of neutropenia sepsis include fever and frequent infections resulting in mouth ulcers, diarrhea, a burning sensation upon urination, unusual redness, pain and swelling around the wound, and a sore throat.

The dietary restrictions for patients developing neutropenia are somewhat strict, especially for HIV-positive individuals, who, if they are trying to take better care of themselves, are already eating most of these restricted items. The recommended guidelines include:

  • Avoid raw vegetables and fruit.
  • Avoid fast food and take-out foods and fountain drinks.
  • Avoid aged cheese.
  • Cook all produce to well done. Eggs must be hard-boiled.
  • Avoid deli meats.
  • No raw nuts, nuts roasted in the shell, or freshly ground nut butters of any kind, even from a health food store.
  • No well water.
  • No yogurt.

It would appear that the risks of this new drug therapy for rheumatoid arthritis outweigh the benefits, in my minds eye anyway, as there are other treatment options for pain and joint therapy which have no side effects or only limited side effects compared to Tofacitinib.

Article by Jim Donahue