Frontiers in Neurology,
Год журнала:
2021,
Номер
12
Опубликована: Авг. 5, 2021
The
non-interventional
long-Term
study
foR
obsErvAtion
of
Treatment
with
alemtuzumab
in
active
relapsing–remitting
MS
(TREAT-MS)
collects
the
so
far
largest
real-life
cohort
regarding
utilization,
long-term
effectiveness,
and
safety
alemtuzumab,
a
humanized
monoclonal
antibody
directed
against
cell
surface
glycoprotein
CD52,
adult
patients
multiple
sclerosis
(RRMS).
An
interim
analysis
baseline
parameters
at
inclusion
real-world
about
Germany
including
previous
(MS)
medication
activity,
severity,
duration,
as
well
comorbidities
was
performed.
Of
883
patients,
71.6%
were
women.
Mean
age
35.7
±
9.2
years,
time
since
first
symptoms
(=disease
duration)
is
8.0
6.8
Expanded
Disability
Status
Scale
(EDSS)
2.7
1.8
points
(range,
0.0–7.5
points).
number
relapses
12
24
months
prior
to
1.6
1.2
2.2
1.8,
respectively.
14.4%
treatment
naive,
while
for
majority,
wide
spectrum
disease-modifying
treatments
(DMTs)
sequences
documented.
Overall,
interferon
beta
(IFN-beta)
reported
most
frequently
(52.4%),
followed
by
fingolimod
(35.2%),
natalizumab
(34.9%),
glatiramer
acetate
(28.9%).
Patients
longer
disease
duration
higher
EDSS
had
DMTs.
Compared
pivotal
phase
2/3
studies,
RRMS
starting
conditions.
There
variety
different
before
final
switch
alemtuzumab.
In
future,
linking
these
or
other
characteristics
effectiveness
outcomes
might
be
useful
support
decisions.
Registered
Paul-Ehrlich-Institut
under
NIS
281.
Journal of Neurology,
Год журнала:
2022,
Номер
269(10), С. 5382 - 5394
Опубликована: Май 24, 2022
Abstract
Multiple
sclerosis
(MS)
is
a
chronic
and
progressive
neurological
disease
that
characterized
by
neuroinflammation,
demyelination
neurodegeneration
occurring
from
the
earliest
phases
of
may
be
underestimated.
MS
patients
accumulate
disability
through
relapse-associated
worsening
or
progression
independent
relapse
activity.
Early
intervention
with
high-efficacy
disease-modifying
therapies
(HE-DMTs)
represent
best
window
opportunity
to
delay
irreversible
central
nervous
system
damage
MS-related
hindering
underlying
heterogeneous
pathophysiological
processes
contributing
progression.
In
line
this,
growing
evidence
suggests
early
use
HE-DMTs
associated
significant
greater
reduction
not
only
inflammatory
activity
(clinical
relapses
new
lesion
formation
at
magnetic
resonance
imaging)
but
also
progression,
in
terms
accumulation
clinical
compared
delayed
HE-DMT
escalation
strategy.
These
beneficial
effects
seem
acceptable
long-term
safety
risks,
thus
configuring
this
treatment
approach
as
most
positive
benefit/risk
profile.
Accordingly,
it
should
mandatory
treat
people
case
prognostic
factors
suggestive
aggressive
disease,
advisable
offer
an
after
diagnosis,
taking
into
account
drug
profile,
severity,
and/or
radiological
activity,
patient-related
factors,
including
possible
comorbidities,
family
planning,
patients’
preference
agreement
EAN/ECTRIMS
AAN
guidelines.
Barriers
for
include
concerns
safety,
challenges
management
initiation
monitoring,
negative
preferences,
restricted
access
according
guidelines
regulatory
rules,
sustainability.
However,
these
barriers
do
apply
each
none
appear
insuperable.
CNS Drugs,
Год журнала:
2021,
Номер
35(8), С. 861 - 880
Опубликована: Июль 28, 2021
In
this
narrative
review,
we
analyze
pre-registration
and
post-marketing
data
concerning
hepatotoxicity
of
all
disease-modifying
therapies
(DMTs)
available
for
the
treatment
relapsing-remitting
multiple
sclerosis,
including
beta
interferon,
glatiramer
acetate,
fingolimod,
teriflunomide,
dimethyl
fumarate,
cladribine,
natalizumab,
alemtuzumab,
ocrelizumab.
We
review
proposed
causal
mechanisms
described
in
literature
also
address
issues
like
use
DMTs
patients
with
viral
hepatitis
or
liver
cirrhosis.
Most
emerged
phase
by
reports
to
national
pharmacovigilance
agencies
published
case
series.
Serious
adverse
events
are
rare,
but
exact
incidence
is
largely
unknown,
as
predictive
factors.
Unfortunately,
none
currently
sclerosis
free
potential
hepatic
toxic
effects.
Cases
acute
failure
have
been
reported
beta-interferon,
ocrelizumab
different
(idiosyncratic
reaction,
autoimmune
hepatitis,
reactivation).
Patients
should
be
informed
about
possible
side
effects
their
treatment.
cases
injury
idiosyncratic
unpredictable.
The
specific
monitoring
schedule
each
DMT
has
reviewed
clinician
ready
recognize
clinical
symptoms
suggestive
injury.
Not
indicated
cirrhotic
patients.
For
some
DMTs,
screening
B
virus
C
required
before
starting
a
antiviral
prophylaxis
established.
Beta
alemtuzumab
relatively
contraindicated
due
risk
disease
exacerbation.
Frontiers in Neurology,
Год журнала:
2023,
Номер
14
Опубликована: Сен. 21, 2023
Alemtuzumab
(ALZ)
is
a
pulsed
immune
reconstitution
therapy
for
multiple
sclerosis
(MS).To
assess
basic
characteristics,
therapeutic
effects,
and
prognostic
biomarkers
on
clinical
imaging
parameters
of
disease
activity
relapsing-remitting
MS
(RRMS)
patients
selected
ALZ,
in
real-world
long-term
setting.Fifty-one
RRMS
[female
=
31;
mean
age
36
(standard
deviation
7.1)
years;
median
expanded
disability
status
scale
(EDSS)
2
(interquartile
range
(IQR)
1.5)]
initiating
ALZ
treatment,
were
consecutively
included.
Patients
assessed
at
baseline
thereafter
annually
5
years
with
measures,
symbol
digit
modality
test
(SDMT),
magnetic
resonance
(MRI).
Concentrations
glial
fibrillary
acidic
protein
(GFAP),
reflecting
astrogliosis,
neurofilament
light
(NfL),
axonal
damage,
measured
cerebrospinal
fluid
(CSF)
serum
samples
collected
after
CSF,
serum.
Control
subjects
symptomatic
controls
(SCs,
n
27),
who
examined
without
evidence
neurological
disease.While
the
annualized
relapse
rate
was
significantly
reduced
from
each
year
follow-up,
essentially
maintained
EDSS
1.5
IQR
between
1.13
2.25.
New
MRI
recorded
26
(53%)
over
years.
The
proportion
achieved
no
(NEDA-3),
6-months
confirmed
worsening
(CDW),
improvement
(CDI)
33,
31,
31%,
respectively.
SDMT
score
(p
<
0.001),
but
unchanged
SCs.
treatment
did
not
change
GFAP
levels,
whereas
there
significant
decrease
CSF
NfL
levels
follow-up
[CSF
month
24:
456
pg./mL
(IQR
285.4)
0.05);
6.7
pg/mL
4.7)
0.01);
60:
7.2
0.01)],
compared
to
[CSF:
1014
2832.5);
8.6
17.4)].In
this
mono-center
population,
we
observed
progression-free
survival
69%,
cumulative
NEDA-3
33%,
five-year
follow-up.
This
confirms
as
an
effective
that
reduces
neuro
loss,
therefore
has
potential
reduce
disability.
appear
affect
astrogliosis.
Frontiers in Immunology,
Год журнала:
2025,
Номер
15
Опубликована: Янв. 8, 2025
Pediatric-Onset
Multiple
Sclerosis
(POMS)
is
characterized
by
both
white
and
grey
matter
inflammation,
as
well
a
higher
risk
of
long-term
physical
cognitive
disability.
The
peculiar
immunopathogenic
mechanisms
POMS
suggests
that
the
use
induction
therapies,
including
alemtuzumab
(ALTZ),
might
be
promising
approach,
at
least
for
postpuberal
(>
11
yo)
POMS.
Although
no
data
on
therapies
in
are
available
from
clinical
trials
currently,
case
series
or
reports
effect
(ALTZ)
have
been
recently
published.
In
this
review
we
briefly
revised
features
POMS,
how
ALTZ
impact
them,
reporting
its
efficacy
observed
different
cohorts.
Frontiers in Neuroscience,
Год журнала:
2025,
Номер
19
Опубликована: Фев. 27, 2025
Immune
reconstitution
therapies
(IRT)
are
highly
effective
for
multiple
sclerosis
(MS).
Among
IRT,
we
can
distinguish
partially
selective
such
as
cladribine
in
tablets
(CLAD)
and
non-selective
therapies,
which
include
alemtuzumab
(ALEM).
Today,
it
is
known
that
these
controlling
the
relapse
activity
of
disease
progression
clinical
disability,
has
been
proven
both
trials
real
world
evidence
(RWE).
However,
there
a
lack
data
assessing
effect
IRT
on
neurodegenerative
process,
intensified
patients
with
MS.
The
aim
study
was
to
assess
treatment
degree
pattern
brain
atrophy
MS
during
3
years
observation.
Patients
relapsing-remitting
(RRMS)
treated
CLAD
ALEM
were
retrospectively
recruited
study.
Demographic,
clinical,
magnetic
resonance
imaging
(MRI)
collected
at
4
time
points:
before
one,
two,
three
after
treatment.
MRI
examinations
analyzed
volumetrically
using
Freesurfer
software.
Global
regional
changes
assessed
by
calculating
percentage
volume
between
points.
Results
drug
groups
compared
each
other.
After
follow-up,
statistically
significant
differences
observed
hippocampus
[p
<
0.01]
amygdala
0.01].
Ventral
diencephalon
noted
groups.
On
other
hand,
groups,
no
white
grey
matter
noted.
In
addition,
an
increase
thalamus
observed.
studied
shown
slow
down
process
similar
extent.
These
may
play
neuroprotective
role
increasing
hippocampus.
limited
small
number
Therefore,
further
studies
needed
fully
processes
RRMS.
Current Opinion in Neurology,
Год журнала:
2021,
Номер
34(3), С. 303 - 311
Опубликована: Март 11, 2021
The
fact
that
multiple
sclerosis
(MS)
predominantly
affects
women
has
been
recognized
for
many
years.
As
the
age
at
diagnosis
is
decreasing,
and
treatment
options
are
becoming
more
complex,
increasing
numbers
of
facing
decisions
about
use
disease
modifying
therapy
(DMT)
in
around
pregnancy.New
data
rapidly
available,
particularly
regarding
safety
therapies
both
pregnancy
breastfeeding.
Effective
suppression
relapses
key
to
ensuring
good
outcomes
longer
term
woman,
however
this
must
be
balanced
against
individual
risk
relapse
risks
fetus.
Women
should
advised
it
possible
breastfeed
while
taking
selected
DMT.In
review,
we
discuss
evidence
surrounding
DMTs
breastfeeding,
knowledge
suggest
approaches
family
planning
with
MS.