DIR Return Create A Forum - Home
---------------------------------------------------------
MS Speaks
HTML https://msspeaks.createaforum.com
---------------------------------------------------------
*****************************************************
DIR Return to: LEMTRADA (Campath, alemtuzumab)
*****************************************************
#Post#: 1641--------------------------------------------------
22 cases if listeriosis (3 of them fatal) linked to Lemtrada in
MS patients
By: agate Date: April 13, 2017, 6:36 pm
---------------------------------------------------------
From MedPage Today, April 13, 2017:
[quote]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 Holmøy, 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."
Holmøy and co-authors disclosed no relevant relationships with
industry.
____________________
Holmøy 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[/quote]
HTML https://www.medpagetoday.com/Neurology/MultipleSclerosis/64515?xid=nl_mpt_DHE_2017-04-13&eun=g345846d0r&pos=1
HTML https://www.medpagetoday.com/Neurology/MultipleSclerosis/64515?xid=nl_mpt_DHE_2017-04-13&eun=g345846d0r&pos=1
*****************************************************