FDA Approves Tofacitinib for Rheumatoid Arthritis

first oral rheumatoid arthritis medication approved neck pain causes

Xelijanz from Pfizer is the first approved oral medication for RA, but it has some serious side-effects.

A new drug, tofacitinib, is the first oral medication for Rheumatoid arthritis to be approved by the US Food and Drug Administration. Tofacitinib will offer another option for those with moderate to severe active RA that has not responded to methotrexate treatment. Two new studies of the drug appear to show that the oral medication is helpful in quelling the immune system response that causes joint damage in the disease and which can cause neck pain, pinched nerves, cervical spine subluxation and spinal cord compression where severe.

Selective Immunosuppression for Rheumatoid Arthritis Treatment

Tofacitinib is to be marketed under the brand name Xelijanz by Pfizer and works by interrupting the signals prompting cytokine activity and autoimmune attack on joint tissue. The drug is a selective Janus kinase (JAK) inhibitor, meaning that it does not have a blanket immunosuppressive activity but, instead, targets specific cytokine signalling pathways to provide relief from the joint condition.

RA Drug Approved Ahead of Schedule

The FDA Arthritis Advisory Committee voted 8-2 to recommend approval of tofacitinib, the first oral RA medication, back in May 2012 with full approval granted ahead of the scheduled date of November 21st, 2012. Seven clinical trials have explored the safety and efficacy of tofacitinib, all looking at adult patients with moderate to severe active Rheumatoid arthritis. Patients were treated with oral tofacitinib, or given a placebo, with evidence suggesting the medication improves clinical response and physical functioning.

Serious Risks Associated with Xelijanz


There were safety considerations with the medication, however, including the risk of serious infections increasing when using tofacitinib. Opportunistic infections, tuberculosis, cancers and lymphoma all had an associated increase risk with the newly approved oral drug for Rheumatoid arthritis. Common adverse reactions to tofacitinib included upper respiratory tract infections, headache, diarrhoea, and inflammation of the nasal passages and upper pharynx. Cholesterol increases, decreases in blood counts and altered liver enzyme tests are also associated with use of the drug.

Ensuring Awareness in RA Patients and Physicians

When such a drug is approved it is done so with a risk evaluation and mitigation strategy (REMS). The FDA ensures that patients receive a medication guide alongside their drugs that informs them of risks and actions to take if concerned about side-effects of tofacitinib. REMS also provides healthcare workers with information about the serious risks associated with Xelijanz. A post-marketing study will be conducted to investigate the long-term effects of Xelijanz on cancer, heart disease and serious infections, based on two doses of the drug compared to RA patients taking a different medication.

Long-Term Effects of Xelijanz Unknown

It remains to be seen if tofacitinib will prove popular for patients with Rheumatoid arthritis for whom methotrexate is ineffective at relieving neck pain and other symptoms of the disease. As with all newly approved medications there are concerns that long-term effects will prove significantly disadvantageous, skewing the risk/benefit analysis. Younger patients with RA face a lifetime of such immunosuppressive medications and it has been repeatedly found that preventing joint degeneration is preferable to trying to encourage healing at a later date. The first approved oral medication for Rheumatoid arthritis will certainly appear attractive but it is vital that patients understand the risks associated with tofacitinib.

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