Key
Takeaways
-
A
large
real-life
study
affirmed
the
benefit
of
mepolizumab
in
adults
with
severe
chronic
rhinosinusitis
with
nasal
polyps. -
The
study
provided
what
might
be
the
first
data
on
disease
control
rates,
which
reached
42%
at
12
months
and
appeared
likely
to
improve
further,
as
20%
of
patients
were
on
their
way
to
remission. -
Longer-term
studies
are
needed
to
determine
whether
improvements
continue
beyond
12
months.
Mepolizumab
(Nucala)
improved
outcomes
for
adults
with
severe
chronic
rhinosinusitis
with
nasal
polyps
(CRSwNP)
and
put
about
one
in
five
on
the
way
to
remission,
a
real-life
study
from
Italy
showed.
The
nasal
polyp
score
dropped
from
a
median
of
6
at
baseline
to
3
at
12
months
on
the
0-8
point
scale
(P<0.0001),
with
reductions
that
grew
over
time,
reported
researchers
led
by
Eugenio
De
Corso,
MD,
PhD,
of
the
University
of
Perugia,
in
Lancet
Respiratory
Medicine.
Health-related
quality
of
life
as
measured
by
the
sino-nasal
outcome
test-22
(SNOT-22;
0-110
point
scale,
with
higher
scores
worse)
gradually
improved
over
12
months
from
a
median
59
at
baseline
to
21
at
12
months
(P<0.0001).
“The
progressive
nature
of
improvement
observed
over
time
suggests
that
clinical
benefits
could
continue
to
increase
beyond
the
earlier
phases
of
treatment,”
the
researchers
wrote.
Disease
control
was
achieved
by
42%
of
patients
at
12
months,
and
appeared
likely
to
improve
further
as
20%
of
patients
were
on
their
way
to
remission
(they
met
remission
criteria
but
had
not
yet
completed
the
12-month
duration
required
by
its
definition).
“Remission
is
now
a
recognized
and
achievable
therapeutic
goal
in
CRSwNP,”
De
Corso
and
team
noted,
but
this
might
be
the
first
time
this
measure
has
been
reported
with
mepolizumab.
“Longer-term
studies
are
needed
to
determine
whether
improvements
in
disease
control
and
remission
continue
beyond
12
months
or
plateau
thereafter,”
they
wrote.
Even
so,
“these
findings
contribute
to
the
currently
limited
real-world
evidence
on
the
12-month
effectiveness
of
mepolizumab
in
severe
CRSwNP,
offering
novel
insights
for
clinical
decision-making,”
they
concluded.
In
the
phase
III
SYNAPSE
trial
that
led
to
mepolizumab’s
indication
in
CRSwNP,
the
median
change
in
nasal
polyp
score
from
baseline
to
12
months
was
1
point
with
the
anti-interleukin-5
monoclonal
antibody
compared
with
0
in
the
placebo
group.
Nearly
22%
of
patients
had
at
least
a
3-point
improvement
in
that
score.
Prior
real-world
studies
have
affirmed
benefit
but
largely
involved
single-center
cohorts
or
small
sample
sizes,
“failing
to
reflect
the
heterogeneity
of
the
broader
CRSwNP
patient
population
in
real
life,”
De
Corso
and
colleagues
noted.
This
phase
IV
study
included
621
consecutive
patients
across
25
Italian
tertiary
referral
rhinology
clinics
experienced
in
the
management
of
severe,
uncontrolled
CRSwNP
and
biologic
therapies.
Eligible
patients
started
mepolizumab
100
mg
every
4
weeks,
and
had
not
received
any
other
biologic
therapy
within
the
prior
3
months.
Median
age
was
59
years,
57%
were
men,
52%
had
comorbid
asthma,
and
29%
had
non-steroidal
anti-inflammatory
drug-exacerbated
respiratory
disease.
Among
the
18%
of
patients
who
received
prior
biologic
therapy
before
switching
to
mepolizumab,
57%
had
received
dupilumab
(Dupixent).
While
20%
had
never
undergone
surgery
for
their
rhinosinusitis,
38%
had
one
prior
surgery,
22%
had
undergone
two,
and
19%
had
undergone
at
least
three.
In
terms
of
secondary
endpoints,
all
major
symptoms
and
olfaction
improved.
However,
38%
of
patients
with
data
on
olfaction
remained
unable
to
smell
at
12
months.
Comorbid
asthma
was
associated
with
greater
or
more
rapid
improvements
in
SNOT-22
scores
and
self-reported
symptoms.
Patients
with
no
prior
biologic
treatment
had
greater
improvements
in
SNOT-22
scores
compared
with
bio-experienced
patients.
“This
finding
could
be
related
to
the
greater
clinical
complexity
typically
observed
in
patients
switching
from
other
biological
therapies
who
did
not
respond
adequately
to
the
previous
biological
therapy,”
the
researchers
suggested.
While
there
are
no
validated
biomarkers
for
predicting
mepolizumab
response,
the
study
linked
better
baseline
olfactory
function
with
higher
likelihood
of
achievement
of
disease
control
across
all
timepoints,
while
less
severe
baseline
nasal
polyp
score
significantly
predicted
progression
towards
remission
at
12
months.
Asthma
and
baseline
blood
eosinophil
count
did
not
predict
control
or
remission.
Limitations
included
the
potential
for
some
degree
of
selection
bias
inherent
to
observational
real-world
studies
and
an
inability
to
attribute
the
effects
specifically
to
mepolizumab
due
to
lack
of
a
control
group.
Also,
“caution
is
warranted
when
generalizing
these
findings
to
non-European
patients,
as
the
study
population
was
exclusively
Italian,”
De
Corso
and
team
noted.
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