Six Injections of Modified Adjuvanted PQ Grass Is Effective and Well‐Tolerated in a Pivotal Phase III Trial
Allergy,
Journal Year:
2025,
Volume and Issue:
unknown
Published: Feb. 4, 2025
ABSTRACT
Background
PQ
Grass
27600
SU
(PQ
Grass)
cumulative
dose
is
a
pre‐seasonal,
six‐injection,
aluminium‐free,
modified
subcutaneous
immunotherapy
product
under
development
for
the
treatment
of
allergic
rhinitis
(AR).
A
pivotal
Phase
III
randomised
double‐blind,
placebo‐controlled
clinical
trial
was
performed
to
evaluate
efficacy
and
safety
in
subjects
with
seasonal
AR.
Methods
An
adaptive
group
sequential
PQGrass306
(G306)
one
pre‐defined
interim
analysis
designed,
using
2
parallel
groups
applying
1:1
active
versus
placebo
randomisation
patients
aged
18–65.
The
primary
endpoint
EAACI
(European
Academy
Allergy
Clinical
Immunology)
Combined
Symptom
Medication
Score
(EAACI‐CSMS
0–6
)
averaged
over
peak
grass
pollen
season
(GPS).
Results
858
were
screened
555
randomised.
Based
on
results
analysis,
stopped
success
showing
superiority
favour
Grass.
EAACI‐CSMS
(peak
GPS)
demonstrated
highly
significant
clinically
meaningful
point
difference
−0.27
points
(95%
CI:
−0.42
−0.12),
corresponding
relative
−20.3%
(
p
=
0.0005).
Highly
consistent
beneficial
obtained
all
key
secondary
endpoints.
Significant
induction
blocking
IgG4
IgA
antibody
subclasses
occurred.
well
tolerated,
no
unexpected
signals
Conclusions
This
effect
as
supportive
profile.
Language: Английский
IgE‐Mediated Activation of Mast Cells and Basophils in Health and Disease
Nicolas Charles,
No information about this author
Ulrich Blank
No information about this author
Immunological Reviews,
Journal Year:
2025,
Volume and Issue:
331(1)
Published: March 31, 2025
Type
2-mediated
immune
responses
protect
the
body
against
environmental
threats
at
barrier
surfaces,
such
as
large
parasites
and
toxins,
facilitate
repair
of
inflammatory
tissue
damage.
However,
maladaptive
to
typically
nonpathogenic
substances,
commonly
known
allergens,
can
lead
development
allergic
diseases.
2
immunity
involves
a
series
prototype
TH2
cytokines
(IL-4,
IL-5,
IL-13)
alarmins
(IL-33,
TSLP)
that
promote
generation
adaptive
CD4+
helper
cells
humoral
products
allergen-specific
IgE.
Mast
basophils
are
integral
players
in
this
network,
serving
primary
effectors
IgE-mediated
responses.
These
bind
IgE
via
high-affinity
receptors
(FcεRI)
expressed
on
their
surface
and,
upon
activation
by
release
variety
mediators
regulate
responses,
attract
modulate
other
cells,
contribute
repair.
Here,
we
review
biology
effector
mechanisms
these
focusing
primarily
role
mediating
both
physiological
pathological
contexts.
Language: Английский