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dr.nick.riviera · Joined: 15 Apr 2008 Posts: 15

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html

FDA News

FOR IMMEDIATE RELEASE
April 22, 2008

FDA Approves Cimzia to Treat Crohn's Disease

A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide.

Crohn's disease is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs.

"Crohn's is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA's Center for Drug Evaluation and Research. "This drug works to reduce the signs and symptoms of Crohn's, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals."

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

The most common side effects of Cimzia are headache, upper respiratory infections, abdominal pain, injection site reactions and nausea.

Patients taking Cimzia are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because Cimzia affects the immune system, it can lower the body's ability to fight infections, such as tuberculosis and other opportunistic infections. Cimzia is a blocker of TNF (tumor necrosis factor) and may cause lymphomas (a form of cancer) and other malignancies. Although an increased risk of tumors was not seen in studies of Cimzia, the modest size and relatively short duration of the controlled studies prevents any firm conclusion. Post-marketing studies and clinical trials will be required to obtain long-term safety data.

Patients taking Cimzia should be educated about how to identify an infection and be instructed to contact their health care professional at the first sign of infection while on Cimzia. In cases of serious infections, the drug should be discontinued immediately.

Cimzia is manufactured by UCB, Inc., Smyrna, GA.

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"Hi ev-ery-body, I am doctor Nick Riviera!"

Reef08 · Joined: 28 Jan 2008 Posts: 11

I agree with you, but what is the alternative here? I personally have not been able to find a doc who prescribes the Anti-MAP protocol. Even if I were to take it, the chance of it working is low according to the clinical trials. And there's nothing preventing re-infection. If it's in the water, I'll be exposed to it again for sure.

dr.nick.riviera · Joined: 15 Apr 2008 Posts: 15

I agree that there aren't many alternatives. But I wouldn't say the odds of success are low with anti-MAP therapy. While anti-MAP is not always perfect, it has achieved some comparable results to biologics. The recent Lancent study using Remicade and other immune suppressants achieved a remission rate of 62% at the end of one year. But compare that to six trials using antimicrobials - either rifabutin and clarithromycin alone or sometimes with clofazimine or once with azithromycin - where a success rate of between 44%-89% (mean 52.4%) was achieved, and the difference is not that great. Certainly, it is something to always try before a major surgery.

That said, more needs to be done. Maybe an overall approach would be to target the bacteria while also trying to reduce the inflammation through the elimination of certain foods like gluten which, along with other supplements, may allow the leaky gut to heal itself. Maybe some of the anti-MAP trials have not had as good as results as others because a focus on healing the gut through the elimination of the inflammation was missing?

But, like you said, there is always the chance of re-exposure via water, which, seemingly, is difficult to avoid. So maybe our only hope lies with a vaccine that would help to attenuate pre-existing infection and confer protection against future exposure(s).
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"Hi ev-ery-body, I am doctor Nick Riviera!"

Exploited · Joined: 24 Jan 2008 Posts: 42

The phrase that really alarmed me was "relatively short duration of the controlled studies prevents any firm conclusion. Post-marketing studies and clinical trials will be required to obtain long-term safety data"

In other words, we aren't sure if its safe, but we will release it anyways and let the public be our guinea pigs.

Those crazy bastards almost killed me, the only reason I plan to ever go back to my GI is to give him another clean blood test and call him a fucking Quack!