Six Injections of Modified Adjuvanted PQ Grass Is Effective and Well‐Tolerated in a Pivotal Phase III Trial
Allergy,
Год журнала:
2025,
Номер
unknown
Опубликована: Фев. 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.
Язык: Английский
TAPAS—A Prospective, Multicentre, Long-Term Cohort Study in Children, Adolescents and Adults with Seasonal Allergic Rhinitis—Design and Early Results
Journal of Clinical Medicine,
Год журнала:
2025,
Номер
14(8), С. 2609 - 2609
Опубликована: Апрель 10, 2025
Background/Objectives:
The
guideline
on
allergen-specific
immunotherapy
of
the
European
Academy
Allergy
and
Clinical
Immunology
recommends
subcutaneous
for
treatment
allergic
rhinitis
in
children
adults
with
moderate
to
severe
symptoms.
five
years
cohort
study
described
below
was
designed
2020
demonstrate
non-inferiority
terms
safety,
tolerability
efficacy
a
paediatric
population
compared
adult
patients
treated
microcrystalline
tyrosine-adsorbed
allergoids
their
tree
grass
pollen
allergy
perennial
setting.
Here,
we
present
preliminary
findings
from
first
year.
Methods:
Combined
Symptom
Medication
Score
chosen
as
primary
endpoint
this
therapy.
Secondary
endpoints
include
Rhinoconjunctivitis
Quality
Life
Questionnaire,
retrospective
score,
Asthma
Control
Test
Rhinitis
Test,
well
an
analysis
adverse
drug
reactions.
Results:
A
total
number
320
were
enrolled
into
study,
129
these
age
group
between
5
17
191
group.
Mean
values
did
not
differ
significantly
minors
season
after
induction.
score
showed
strong
significant
reduction
rhinoconjunctivitis
asthma
Treatment
tolerated,
more
than
80%
reporting
no
Conclusions:
validity
approach
has
been
confirmed
by
interim
initial
course
therapy
Язык: Английский