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Ingredients for new MS drugs associated with serious brain disease

Brenda Goodman
Health Day Reporter

Wednesday, April 24 (HealthDay News)-The active ingredient in a drug that is expected to become a popular treatment Multiple sclerosis Rare but sometimes associated with four European cases of fatal brain disease Progressive multifocal leukoencephalopathy (PML).

material, Dimethyl fumarateUsed in a drug called Fumaderm, approved in Germany in 1994 for the treatment of skin conditions psoriasis..It is called another but closely related drug TecfideraJust approved for treatment by the U.S. Food and Drug Administration in March Multiple sclerosis (((MS).It is known as fumaric acid ester and is commonly used as a food additive and has been used therapeutically. psoriasis 30 years in Germany.

According to the report published in the April 25 issue of New England Journal of MedicineHowever, three patients who were taking Humaderm to treat them psoriasis Developed PML. One other patient developed a brain condition after taking another drug from a dispensing pharmacy that also contained dimethyl fumarate.

In the letter in response to the report, Biogen, the company that makes both Drug, Fumaderm also contains three other fumaric acid esters, while techfidera contains only dimethyl fumarate, which may be safer.

The company also said no patients were taking Techfidera. Clinical trial Developed PML (known at the time as BG-12). Tecfidera is a pill, not an injection, Clinical trialAnalysts predicted it would soon become a top seller Treatment of multiple sclerosis..

But the German doctor who treated one of psoriasis Patients who have had PML still believe that there is a source of concern.

Dr. Holg Schultz, Neurologist At Rheinisch-Westfaelische Technische Hochschule Aachen, a research university in Aachen, the two drugs are virtually identical when broken down in the body.

“The problem is that the study with BG-12 covered two years, but not more,” Schulz said, requiring long-term treatment with drugs to surface PML. I think it could be.

“By presenting our case, we want to raise awareness that all forms of treatment with fumaric acid can carry the risk of developing PML,” Schulz said.

In their response, Biogen said that when Tecfidera received FDA approval, patients were followed for an average of only two years. MSMany patients in these trials have not reported PML and are currently taking the drug for 5 years. The company added that in the 20 years that German patients have been using Fumaderm, only three case reports of PML have occurred, and these cases contain additional risk factors for the disease. ..

PML is usually caused by the harmless JC virus, which is dormant in the body.About half of Multiple sclerosis Patients have antibodies to the JC virus in their blood, suggesting current or previous infections.When the immune system is depleted due to the following diseases cancer Or AIDS Or when suppressed by certain drugs, the virus can flare and destroy nerve cells in the brain.

Ironically, PML is very similar Multiple sclerosis, But as it causes it progresses more rapidly Weaknesses, paralysis, confusion, amnesia And Vision loss Or a speech. Prompt treatment can stop the injury, but the patient can be permanently disabled.

PML is rare, but Genentech psoriasis processing Raptiva It withdrew from the market in 2009 after reporting four cases of patients taking biopharmaceuticals. Biological drugs are biological drugs used to prevent certain diseases, such as diseases in which the immune system is dysfunctional.

Another biopharmacy, Thai Sabri, Treatment of multiple sclerosis Crohn’s diseaseWas shelved in 2005 for about a year after three patients involved in clinical trials of the drug developed PML. Tysabri returned to the market in 2006 with the introduction of strict new safeguards.For example, before starting the drug, the patient MRI Of their brain. They may also have a blood test to check for antibodies to the JC virus. It will also be monitored by your doctor every 3-6 months while taking Biogen medications.

No such precautions are recommended for Tecfidera, which is currently welcomed as a less toxic alternative to other treatments.Other multiple sclerosis drugs are known to be the cause influenza-Like a symptomatism Chest pain,and heart, liver And Eye problems..

In clinical trials, the main side effects reported with Tecfidera were relatively mild, including hot flushes, stomach upset, and decreased white blood cell count.

“Our main reason [psoriasis] Patient developed PML after extended treatment with Humaderm for 3 years Lymphocytopenia [low white blood cell counts]”Mr. Schultz said. New England Journal of Medicine In 2012, I believe that 4% to 5% of patients will develop this type of severe lymphocytopenia and are at risk of developing PML as well. “



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Dr. Robert Fox is a neurologist at the Multiple Sclerosis Melen Center in Cleveland Clinic, Ohio, and was a member of the Steering Committee in one of the studies that tested medication.

He called the new PML case report “a very important addition to understanding this class of treatment.” Fox, who was also a paid Biogen consultant in the past, said, “There were no cases of PML in patients treated with Tecfidera, but there are good reasons to apply the lessons learned here to Tecfidera. I think. “

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References

Source: Jorg Schulz, MD, Neurologist, Rheinisch-Westfaelische Technische Hochschule Aachen, Aachen, Germany. Dr. Robert Fox, MD, Neurologist at Melen Multiple Sclerosis Center, Cleveland Clinic, Ohio. April 25, 2013, New England Journal of Medicine

Ingredients for new MS drugs associated with serious brain disease

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