March 2013

In this issue we have a last minute announcement about Dr. Howard speaking on Arthritis. This is a free event this Wednesday evening, March 6th. See details below. Additionally, is information about a new drug available for patients with rheumatoid arthritis.

As always, we thank you for allowing us to be part of your health care.

Your Staff at Arthritis Health


Free Talk on Arthritis by Dr. Howard

A novel medication, Xeljanz (tofacintanib citrate) was approved by the FDA in November 2012. Xeljanz is the first oral DMARD approved for rheumatoid arthritis in 10 years. It’s also the first in a new class of medicines known as JAK (Janus kinase) inhibitors.

Xeljanz can be used as monotherapy (alone), or combined with methotrexate or other non-biologic DMARDs. The standard dosing is 5mg pill twice a day.

How Does Xeljanz Work?
Xeljanz works by inhibiting the JAK pathway – a signaling pathway inside cells that plays a significant role in inflammation associated with rheumatoid arthritis. JAKs are intracellular enzymes that transmit signals which arise from cytokines or growth factor-receptor interactions on the cell membrane.

Xeljanz is considered a small-molecule medication, not a biologic drug. Biologics, such as Enbrel (etanercept), Remicade (infliximab), Humira (adalimumab), Cimzia (certolizumab pegol), Simponi (golimumab), Orencia (abatacept), Actemra (tocilizumab), and Rituxan (rituximab) block pro-inflammatory cytokines from outside the cell. Xeljanz is a small molecule that alters chemical actions within cells reducing cytokine production.

How Did Xeljanz Perform in Clinical Trials?
More than 5,000 rheumatoid arthritis patients were involved in clinical trials for Xeljanz, producing one of the largest clinical databases for any rheumatoid arthritis drug ever submitted to the FDA for review, according to Pfizer.

There were two clinical trials which assessed the optimal dose range of Xeljanz, Clinical trials showed that Xeljanz 5 mg twice a day significantly reduced the signs and symptoms of rheumatoid arthritis and improved physical function (the ability to perform usual daily activities).

How Is Xeljanz Administered?
Xeljanz is taken orally, 5 mg twice daily. It may be taken with or without food. A 10 mg dose of Xeljanz was tested in clinical trials, but the FDA did not elect to approve the higher dose at this time.

What Common Side Effects Have Been Associated With Xeljanz?
The most common adverse effects associated with Xeljanz, which occurred during the first 3 months of use in clinical trials, were upper respiratory tract infections, headache, diarrhea, and nasopharyngitis.

Are There Any Warnings and Precautions Associated With Xeljanz?
Xeljanz carries a black boxed warning: serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungi, viral, and other opportunistic infections, have occurred in patients receiving Xeljanz; We test all patients before starting a biologic DMARD or this unique oral agent for TB and valley fever and monitor periodically during treatment.

The advantage of Xeljanz is that it is an oral agent that acts similarly to the injectable or infusible biologic agents. Where this will fit in will be determined over time as we gain more experience with this agent. If you have questions, please ask us at your next appointment or you can receive more information at the following sites:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm327152.htm

http://www.xeljanz.com

http://www.arthritistoday.org/news/tofacitinib-xeljanz-approved223.php

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