Author Topic: 22 cases if listeriosis (3 of them fatal) linked to Lemtrada in MS patients  (Read 145 times)

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Offline agate

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From MedPage Today, April 13, 2017:

Case Report: MS Drug Tied to Listeriosis

Condition may mimic infusion-related reaction

by Kate Kneisel
Contributing Writer, MedPage Today
April 12, 2017

Treatment with alemtuzumab (Lemtrada) was linked with listeria infections in a multiple sclerosis (MS) patient, and symptoms mimicked those of an infusion-related reaction, according to a case history.

The female MS patient developed pyrexia, nausea, and abdominal discomfort a few hours after the third and final infusion of a second alemtuzumab cycle, reported Trygve Holm°y, MD, of the University of Oslo, and colleagues.

"An infusion-related reaction was suspected," they wrote in BMJ Neurology." The patient had however eaten soft cheese and raw sausage 3 days prior to treatment, and L.monocytogenes septicaemia was diagnosed based on positive blood cultures."

Even when preceded by 1,000 mg methylprednisolone, alemtuzumab may induce a rapid and transient increase in pro-inflammatory cytokines and acute phase proteins, including c-reactive protein which can rise to septic levels, the authors noted.

"The present case history highlights that a serious infection can be difficult to distinguish from noninfectious infusion-related reactions caused by cytokine release, which may occur up to 24 hours after alemtuzumab infusion," they said.

They pointed out that, as of January 2017, at least 16 of these types of cases have occurred in 11,500 MS patients treated with alemtuzumab, according to data from drugmaker Sanofi Genzyme, suggesting an overall risk of listeriosis in the range of 0.1%. The current case is the 22nd one, and of those, three have been fatal, they said.

These cases of listeria infections in this patient population is concerning, said Dennis Bourdette MD, of Oregon Health and Science University in Portland, to MedPage Today.

"Alemtuzumab causes profound, long-lasting immunosuppression, and should only be administered to multiple sclerosis patients with aggressive disease unresponsive to less dangerous therapies," he said.

"It also should be administered by physicians who are fully aware of the short-term and long-term risks," emphasized Bourdette, was not involved in the case report.

The patient was a woman in her early 50s with MS for whom alemtuzumab was the fourth disease-modifying treatment over 2 years. Her immediate reaction to the first cycle of treatment was limited to transient bradycardia.

In July 2016, several hours after the last infusion of her second treatment cycle (12 mg alemtuzumab preceded by 1,000 mg methylprednisolone, 12 mg cetirizine, and 1,000 mg paracetamol for 3 consecutive days), the patient developed nausea and fever up to 40░C (104░F).

She reported no neck stiffness, in contrast to most previous reports of cases that included signs of meningitis with headache, the authors wrote.

The patient was clinically dehydrated but had normal blood pressure. Her C-reactive protein was 180, lymphocytes were below the detection limit but the number of granulocytes was normal, and there were no new neurological symptoms.
Listeriosis is caused by Gram positive bacteria Listeria monocytogenes, usually found in unpasteurized dairy products, raw fish and meat, or pasteurized products contaminated after production, like soft cheeses.

The incubation period of L. monocytogenes varies between 1 to 70 days, and corticosteroids (now routinely administered prior to alemtuzumab infusions) can prolong their persistence after food exposure, researchers noted. The mortality of septicemia, meningitis, and encephalitis caused by Listeria monocytogenes is 20%-40%.

While the patient had consumed the foods mentioned above, "no such foods were eaten during the treatment cycle," the authors said, concluding that the infection was likely contracted before treatment.

Based on this and other case reports of consumption of raw milk a few days before the first infusion, researchers said they now advise patients to avoid eating such food items the last weeks prior to alemtuzumab infusion, rather than only after treatment as currently recommended in the European Summary of Product Characteristics (SPC).

Elisabeth Lucassen MD, of Penn State Hershey Neurology, told MedPage Today that she has had several patients develop thrush in the week or two following an alemtuzumab infusion.

Lucassen, who was not involved in the study, agreed that patients and prescribing physicians need to be counseled on avoiding certain foods "in the weeks prior to the treatment, as many would probably expect that exposure after the treatment would be more the concern."

However, given that outbreaks of listeria infections have been linked deli meats, hot dogs, soft cheeses, celery, sprouts, and ice cream, "exposure to L.monocytogenes might therefore be difficult to avoid," the researchers noted.

Bourdette said that "specific recommendations [about certain foods] should be provided by the manufacturer of alemtuzumab, and incorporated into their risk reduction program. "In the U.S., general recommendations regarding not eating undercooked meat or foods that may carry listeria are buried in the package insert."
Holm°y and co-authors disclosed no relevant relationships with industry.


Holm°y and co-authors disclosed no relevant relationships with industry.

Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.


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