Real-world pharmacovigilance of ofatumumab in multiple sclerosis: a comprehensive FAERS data analysis
Frontiers in Pharmacology,
Год журнала:
2025,
Номер
15
Опубликована: Янв. 23, 2025
Background
Ofatumumab,
a
fully
human
monoclonal
antibody
targeting
CD20,
is
approved
for
the
treatment
of
relapsing
multiple
sclerosis.
Comprehensive
real-world
safety
data
are
crucial
informing
clinical
practice.
Methods
The
FDA
Adverse
Event
Reporting
System
database
was
utilized
to
perform
disproportionality
analysis,
covering
reports
from
Q3
2020
Q2
2024,
in
which
ofatumumab
identified
as
primary
suspected
drug.
Statistical
approaches
used
included
Odds
Ratio,
Proportional
Bayesian
Confidence
Propagation
Neural
Network,
and
Multi-item
Gamma
Poisson
Shrinker.
timing
adverse
events
assessed
using
Weibull
distribution
model
highlight
temporal
risk
patterns.
Results
Known
reactions,
such
injection
site
reactions
upper
respiratory
tract
infections,
displayed
positive
signals.
Additionally,
novel
off-label
events,
including
brain
fog,
muscle
spasms,
mood
alterations,
were
identified,
marking
first
evidence
these
potential
risks.
Temporal
analysis
revealed
that
most
occurred
within
month
treatment,
indicating
an
early
phase.
Subgroup
demonstrated
notable
differences
event
profiles
by
gender
age,
with
males
more
prone
hyperhidrosis
older
patients
susceptible
neurological
symptoms.
Conclusion
This
provides
important
insights,
confirming
known
identifying
additional
Early
tailored
monitoring
protocols
during
initial
phase,
regular
psychiatric
assessments,
recommended
optimize
patient
outcomes.
Prospective
studies
validate
results
explore
underlying
mechanisms.
Язык: Английский
ESCLEROSIS MULTIPLE Y ENFERMEDADES REUMATOLOGICAS: Behçet, Sarcoidosis, Sjögren.
Neurology Perspectives,
Год журнала:
2025,
Номер
unknown, С. 100198 - 100198
Опубликована: Май 1, 2025
Systematic review and meta-analysis of preclinical studies
Nature Reviews Methods Primers,
Год журнала:
2024,
Номер
4(1)
Опубликована: Окт. 3, 2024
Язык: Английский
Future perspectives in myasthenia gravis (Review)
Deleted Journal,
Год журнала:
2023,
Номер
3(1)
Опубликована: Май 30, 2023
Myasthenia
gravis
(MG)
is
a
rare,
highly
polygenic
autoimmune
disease
mainly
caused
by
target‑specific
pathogenic
antibodies,
and
its
fluctuating
course
through
the
patient's
life,
often
entails
hospitalizations
difficulties
in
everyday
life.
The
pathophysiology
of
MG
complex
with
number
contributing
factors,
involving
genetic,
epigenetic
environmental
factors
are
responsible
for
limited
immune
tolerance.
This
heterogenic
appears
to
have
common
genetic
background
other
diseases
single
nucleotide
polymorphisms
(SNPs)
been
found
be
associated
different
forms
genome‑wide
association
studies;
i.e,
cholinergic
receptor
nicotinic
alpha
1
subunit
(CHRNA1)
that
encodes
α
acetylcholine
includes
SNP
allele
MG.
Additionally,
specific
genes
or
even
genomic
regions
can
differentiated
set
including
methylations,
non‑coding
RNAs
histone
modifications.
role
epigenetics
has
reported
monozygotic
twin
studies,
where
combination
methylations
numerous
small
changes
gene
expression
shown
contribute
development
disease,
demonstrating
stronger
predisposition
Establishing
realm
further
promote
basic
research
novel
therapeutic
approaches
used
overcome
limitations
current
clinical
practices.
Язык: Английский