Page 78 - Portuguese Journal - SPORL - Vol 61. Nº1

mean difference of -0.60 (P<0.00001) points in therapeutic tool for the control of CRSwNP.
the NPS compared to the use of placebo. The
use of omalizumab and mepolizumab led to
a mean difference of -1.37 (P=0.004) and -0.85
(P<0.00001) points in the NPS, respectively,
compared to the use of placebo. Although
they were more effective than benralizumab,
the impact was still not very significant
considering the minimum score for inclusion
in the study (bilateral NPS ≥5, with a score ≥ 2 for
each nostril). The results of the analysis of the
Lund-Mackay Score were not evaluated in the
studies on mepolizumab. Although the results
of the use of omalizumab and benralizumab
were not statistically significant, they showed
a trend towards a reduction in the Lund
Mackay Score, with a mean difference of -4.7
(P=0.06) and -1.37 (P=0.12) points in the case of
omalizumab and benralizumab, respectively,
compared to the use of placebo.
A recently published study on this topic
presented the same conclusions regarding
dupilumab being the best choice for the
control of CRSwNP. In that study, the authors
also reported that omalizumab was the second
best agent for the control of the disease and
mepolizumab was the monoclonal antibody
with the most adverse effects. 36
The present study has some limitations,
one being the fact that it appears that the
maximum potential of monoclonal therapy
has not been reached yet, which reflects the
need for further studies with longer follow-
up periods to obtain data on the therapeutic
peak level and potential late adverse effects.
In addition, it is not known how a change in
the type of baseline inflammatory pattern
may impact the individual and multiple
body systems, and what adverse effects may
subsequently appear.
Indications for biologicals and cost-
effectiveness analysis of dupilumab
Among the antibodies studied in the
RCTs included herein, only benralizumab
does not have a formal indication from
the Food and Drug Administration 23 and
European Medicines Agency as a potential
24
78 Portuguese Journal of Otorhinolaryngology - Head and Neck Surgery
All the other monoclonal antibodies, namely
dupilumab, omalizumab, and mepolizumab
are currently indicated by the Food and Drug
Administration 25-27 and European Medicines
Agency 28-30 for the treatment of severe
uncontrolled CRSwNP despite the use of
systemic glucocorticoids and/or surgery.
In an ideal world, health would not have an
idealized value; however, one must consider
the price of treatments. Thus, each therapy
has an associated value, which is defined
as its quality divided by its cost . By using
3
the Quality Adjusted Life Year (QALY), which
equates to a person living one year in perfect
health with the implementation of the
novel therapy under study, it is possible to
quantify the benefit of a given intervention
through the number of QALYs it adds and
estimate the value of the treatment using
the cost inherent to each QALY added to the
patient’s life . The results obtained in the
3,31
review highlight the economic implications
of the use of these new medications. There
is no doubt that there is a high economic
burden associated with CRSwNP and one,
therefore, questions, whether society is ready
to support the development of new biological
medications when the therapeutic effects are
achieved, remain fairly limited in comparison
to the “conventional” medical and surgical
treatments.
Criteria for the use of monoclonal antibodies
in CRSwNP
With the knowledge of the cost involved
in biological therapies and their innovative
potential to control CRSwNP, it becomes
imperative to define those patients who could
benefit the most from these therapies.
In 2019, the European Forum for Research
and Education in Allergy and Airway Diseases
(EUFOREA) organized a meeting of the
35
multidisciplinary board of specialists to discuss
the positioning of biologics in CRSwNP. In
this meeting, the consensus reached was
that for a patient to have an indication for
biological therapy, he/she would need to have