Biologic Drug (Cimzia) for Rheumatoid Arthritis Has Been Approved By FDA

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Wanted to get this up before I head to work, so I’m re-posting part of an article that appears on ArthritisToday.com:

The U.S. Food and Drug Administration has given its nod to certolizumab pegol (Cimzia), a drug previously approved to treat Crohn’s disease, to also treat moderate to severe rheumatoid arthritis.

Certolizumab pegol belongs to a class of biologic drugs that block an inflammatory protein called tumor necrosis factor alpha, or TNF-alpha. Other drugs in this category include etanercept (Enbrel), infliximab (Remicade), adalimumab (Humira) and golimumab (Simponi), which was approved last month.

Cimzia’s molecule is slightly different from the other drugs in its class, however, because it is pegylated, or coated, a process that, in theory, should help it slip by the body’s immune system more easily and may make it less likely to cause an infusion reaction.

Pegylation may also help the drug work more quickly. According to UCB, the Belgian company that makes certolizumab pegol, when used in conjunction with methotrexate, patients in clinical trials for Cimzia reported a reduction in symptoms as early as the first week.

Certolizumab pegol is administered with at-home injections, which can be given every two or four weeks.

Cimzia Website

FDA Urges Stronger Warnings For TNF Blockers

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Don’t mean to scare anyone, but we all know the TNF inhibitors do come with some potentially worrisome side effects. Just wanted to put the news out there so you are informed.

From the NY Times:

WASHINGTON (AP) — The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections.

The drugs — Enbrel, Remicade , Humira and Cimzia — work by suppressing the immune system to keep it from attacking the body. For patients with rheumatoid arthritis, the treatment provides relief from swollen and painful joints, but it is “a double-edged sword,” said Dr. Jeffrey Siegel of the drug agency. That is because the drugs also lower the body’s defenses to infections.

Dr. Siegel, who heads the office that oversees arthritis drugs, said the agency became concerned after discovering that doctors seemed to be overlooking a kind of fungal infection called histoplasmosis . Of 240 cases reported to the agency in which patients taking one of the four drugs developed this infection, 45 died. That is about 20 percent.

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