The Food and Drug Administration (FDA) recently approved the biologic drug sarilumab (Kevzara) for the treatment ofrheumatoid arthritis(RA). Sarilumab blocks a protein called interleukin-6 (IL-6), which plays a key role in many inflammatory diseases, including RA. It’s the secondIL-6 inhibitorto receive FDA approval for RA; the other, tocilizumab (Actemra), got the nod in 2010.
IL-6 blockers historically have not been used as first-line treatments for RA (because they were developed later). They’re usually tried after other treatments such as methotrexate and anti-tumor necrosis factor (anti-TNF) drugs have failed to relieve symptoms and/or adequately control disease activity.
There are five anti-TNFs, which are administered in different ways and in different doses.
“If a patient doesn’t respond to one anti-TNF, most rheumatologists will try a second,” says Rayford June, MD, a rheumatologist at the Penn Medical Center in Hershey, Pennsylvania. Instead of cycling through even more anti-TNFs, some doctors now turn to other biologic medications, including IL-6 blockers, he adds.
他说:“尽管类风湿关节炎的治疗取得了进展，但药物的反应往往是不完整的，当我们讨论患者的缓解时，往往[他们]没有保持持续缓解，所以需要更多的治疗选择。”
Sarilumab performed well in clinical trials. Compared to people who received a placebo, patients taking sarilumab were twice as likely to have a 20 percent improvement after 24 weeks in measures such as pain and the number of tender and swollen joints. They were also five times more likely to be in remission at six months and had less disease progression after a year of treatment.
Sarilumab is very similar to tocilizumab, the other IL-6 inhibitor on the market. Donald Miller, PharmD, a professor of pharmacy practice at North Dakota State University, says the two drugs are essentially the same, targeting identical IL-6 receptors.
Sarilumab’s price is similar to tocilizumab, too, but while still very expensive (with an annual price tag of $39,000), it’s 30 percent lower than the cost of the two most commonly prescribed anti-TNFs, according to pharmaceutical industry data.
Dr. June says he might consider sarilumab for patients who haven’t responded to TNF blockers, but other doctors may stick with tocilizumab, which has been around longer and is better known.
Both have the samepotential side effects as other biologics, which interfere with the immune system and can lead to serious infections, among other things.
Dr. June cautions that safety data for new biologic drugs lags behind data about effectiveness; patients should understand the potential side effects.
Linda Rath for the Arthritis Foundation
Is this an IV therapy drug, like Rituxin, Remicade, Orencia, etc
Is this injectable or pill form?
I have been on Actemra infusions since their FDA approval. My question is, what is the true definition of remission for an RA patient?
My labs all come back pretty good, but I continue to have pain and stiffness, along with mobility issues.
How many of us can afford $39,000 a year for one medication that may show a possible 20% improvement in 6 months ?
I did see on their website they have a copay assistance card for up to $15,000 with $0 copay.