Page 73 - Portuguese Journal - SPORL - Vol 61. Nº1

responses via the synthesis of IgE and related interval) with relapse
cell types. They share a common receptor,
IL-4Rα, and act as two essential mediators
in Th2 cell differentiation. Dupilumab is a
monoclonal antibody against IL-4Rα and there
are great expectations regarding its effect on
the control of the inflammatory process that
underlies CRSwNP (8).
Materials and Methods
This systematic review and meta-analysis
were conducted in 2022 (the last date of the
search was February, 2), using the PRISMA
2020 checklist (Preferred Reporting Items for
Systematic Reviews and Meta-Analysis) and
PubMed database. In addition, the included
randomized clinical trials (RCTs) were
searched on the website www.clinicaltrials.
gov. Only articles written in Portuguese and
English were included. Because this was
a systematic review, there was no need to
obtain approval from the ethics committee. A
protocol was written, submitted, and approved
in PROSPERO (CRD42022308005).
In this review, articles published between 2011
and 2021 were considered. The bibliographic
search was performed by three independent
researchers using a sequence of terms
(rhinosinusitis OR "chronic rhinosinusitis"
OR "nasal polyps" OR "nasal polyposis") AND
("monoclonal antibodies" OR biologics OR
humanized) AND (treatment OR therapy OR
management). The selection of the studies
was performed by three researchers and
started with a simple reading of the titles
and abstracts. Subsequently, in the first step,
those articles that did not address the topic of
biological therapies in CRSwNP were excluded
and in the second step, all articles that were
not RCTs were excluded. Subsequently, the
full texts of the RCTs were reviewed and
checked to ensure that they met the following
inclusion criteria:
• Population aged 18 years and over
• Presence of CRSwNP
• Refractoriness to treatment with glu-
cocorticoids and/or previous surgery for
nasal polyps (more than a three-month
• Bilateral nasal polyp score (NPS) ≥5,
with a score ≥ 2 for each nostril.
Concurrently, exclusion criteria were also
established, namely:
• Patients with cystic fibrosis, allergic
fungal rhinosinusitis, ciliary dyskinesia,
antrochoanal polyps, and nasal polyps
associated with malignant sinonasal
conditions.
The Cochrane risk-of-bias tool was used to
assess the risk of bias (9).
Data extraction and review were performed by
three researchers and any disagreement was
resolved by discussion . At this stage, data were
extracted on the population of each study and
group (control vs placebo), treatment duration,
treatment used, and respective protocol, as well
as the means and standard deviations (for both
groups) of the parameters used in the meta-
analysis. The parameters evaluated in the meta-
analysis included analysis of health-related quality
of life, measured using the Sinonasal Outcome
Test-22 (SNOT-22 test) (10), with a scale 0-110,
and minimum clinically significant difference
of 9 (11), in which “higher means worse”; and
of disease extension, measured using the
Nasal Polyp Score (NPS) (12), an endoscopic
visual scale scoring from 0 to 8, in which, for
each nostril: 0 = without polyps and 4 = large
polyps; and the Lund Mackay Score (13), a scale
scoring from 0 to 24, in which “higher means
worse”, which uses CT of the paranasal sinuses
to assess the extension of CRS. These results
were analyzed using the Review Manager 5.4.1
softwar e in the form of tables comparing the
different parameters using continuous data.
Inverse variance was used as the statistical
method, random effects were used as the
analysis model, and the mean difference was
used as a measure of effect. The confidence
interval (CI) was set at 95% and heterogeneity
was measured for all comparisons. The results
were considered significant when P<0.05. The
safety of the trials was analyzed according to
the reported adverse events, their severity,
and their association with the intervention
compared to the placebo.
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