Page 77 - Portuguese Journal - SPORL - Vol 61. Nº1

a budget limit of $25,000 per QALY provided to had a considerable impact on symptom
the patient . The same conclusion was drawn
32
in a different study, which demonstrated with
95% confidence that FESS was a more cost- study to up to 52 weeks, a mean difference
effective alternative when the budget limit
was $20,000 33.
In a more recent study, Scangas et al.
conducted a cost-effectiveness analysis in
which they compared FESS to the use of
dupilumab using the economic Markov 10
states model. In this analysis, a cohort of 197
patients with CRSwNP who underwent FESS
was compared to 293 patients with CRSwNP
in the RCTs LIBERTY SINUS 24 and LIBERTY
SINUS 52 who underwent treatment with
14
dupilumab . Using a time perspective of 36
34
years, Scangas et al. reported that surgical
intervention achieved a total of 9.80 QALYs
costing $50,436,99, whereas treatment with
dupilumab achieved a total of 8.95 QALYs
costing $536,420,22 . This led the authors to
34
conclude that treatment with dupilumab was
not only extremely expensive but was also less
effective than FESS. They showed through
unidirectional sensitivity analysis that for an
annual cost of dupilumab above $855, FESS
was more cost-effective regardless of the
number of required revision surgeries .
34
Discussion
CRSwNP is a chronic disease that affects a
significant number of patients with high
associated comorbidity and heterogeneous
features. The disease remains uncontrolled in
a large number of patients, despite the use of
topical and/or oral glucocorticoids or surgical
treatment. In this meta-analysis, the efficacy
of the different monoclonal antibodies used
for the control of refractory disease was
compared to that of conventional therapies.
The most effective antibody was dupilumab.
With regard to the impact on the quality of
life, this antibody achieved a reduction of -19.61
(P<0.00001) points in the SNOT-22 at 24 weeks,
compared to the use of placebo. Considering
that the SNOT-22 scale has a minimum
clinically significant difference of 9 points ,
11
we concluded that this monoclonal antibody
improvement and the patients’ quality of life.
With the extension of the LIBERTY SINUS 52
14
of -22.38 (P<0.00001) points was obtained in
the SNOT-22, i.e., an even better result in the
long term. With regard to the extension of
the disease, a difference between the group
that discontinued treatment at 24 weeks
(-1.80 [P<0.00001] points in the NPS and -7.00
[P<0.00001] points in the Lund-Mackay Score)
and the group that continued the treatment
up to 52 weeks (-2.34 [P<0.00001] points in the
NPS) was also observed, which indicates that
the maximum potential of the monoclonal
therapy has not yet been reached. The
reduction obtained in disease extension was
limited, with persistence of polyps, which
means that complete remission of polyps
was not achieved. Moreover, in patients who
discontinued the treatment in the LIBERTY
SINUS 24 (14) after 24 weeks, there was a
gradual reoccurrence/worsening of symptoms.
This reflects a need for the provision of chronic
treatment with monoclonal antibodies in a
continuous or intermittent manner to ensure
successful outcomes over time.
The use of the remaining monoclonal
antibodies also led to improvements, albeit less
significant. This may be because the amount
of medication, sample size , and duration of
the intervention in the studies on omalizumab,
mepolizumab, and benralizumab were
considerably lower than those in the study
on dupilumab. Therefore, further studies with
larger samples and longer follow-up periods
are necessary to better characterize the
impact of these new therapies on CRSwNP.
With regard to the impact on the quality
of life of omalizumab, mepolizumab, and
benralizumab, there were significant
reductions in the SNOT-22 compared to
the use of placebo, but not as marked as
with dupilumab. However, in the case of
benralizumab, the SNOT-22 was below the
minimum clinically significant difference; in
addition, the results for disease extension were
modest despite being significant, with only a
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