Page 74 - Portuguese Journal - SPORL - Vol 61. Nº1

To perform the cost-benefit analysis of monoclonal antibodies was evaluated using
the biological medications, a review of the SNOT-22, NPS, and Lund Mackay Score
the pertinent literature was conducted in instruments. The results are summarized in
PubMed using the terms “biologics”, “cost- Table 2.
effectiveness”, “dupilumab”, “monoclonal
antibodies”, “chronic rhinosinusitis”, and Dupilumab
“nasal polyps”. In addition, other articles were The effects of dupilumab were analyzed in
identified through a review of the lists of the following studies: Bachert 2016, LIBERTY
bibliographic references. SINUS 24, and LIBERTY SINUS 52 (14,16).
The parameters SNOT-22, NPS, and Lund-
Results Mackay Score were evaluated at 24 weeks in
This systematic review included ten studies, all three studies, while the SNOT-22 and NPS
with the risk of bias being deemed “low” or were additionally assessed at 52 weeks in the
“unclear” for most parameters. The risk of bias LIBERTY SINUS 52.
graph (Figure 1) shows the assessment of the With regard to the impact on the quality of life,
review regarding each risk of bias parameter the use of dupilumab led to a mean difference
and the percentage refers to all the included of -19.61 (95% CI: -22.53, -16.69; P<0.00001) points
studies. Figure 1 also shows the summary of in the SNOT-22 at 24 weeks in the three studies
the risk of bias with the assessment of each and of -22.38 (95% CI: -27.10, -17.66; P<0.00001)
risk of bias parameter for each included study. points at 52 weeks in the LIBERTY SINUS 52,
Figure 2 presents the flow chart of the study. compared to the use of the placebo.
The search in PubMed yielded 1330 articles. With regard to the extension of the disease,
Two additional articles from other sources the use of dupilumab led to a mean difference
were also included. Of the 1332 articles, four of -1.80 (95% CI: -2.25, -1.35, P<0.00001) points
were duplicates and after a simple reading in the NPS and -7.00 (95% CI: -9.61, -4.39;
of the titles and abstracts, 1118 were excluded P<0.00001) points in the Lund-Mackay Score
in the first phase, while 189 articles were at 24 weeks in the three studies, and to a
excluded in the second phase. Twelve of mean difference of -2.34 (95% CI: -2.77, -1.91;
the 21 articles whose full text was read were P<0.00001) points in the NPS at 52 weeks in
excluded, either because they did not meet the LIBERTY SINUS 52, compared to the use of
the inclusion/exclusion criteria or because the placebo.
they addressed the same study. A total of
nine articles were finally selected, with seven Omalizumab
articles addressing one study per article and The effects of omalizumab were evaluated
two articles addressing two studies per article in the studies of Gevaert 2013, POLYP 1, and
[LIBERTY SINUS 24 and LIBERTY SINUS 52 POLYP 2 (15,17), with the SNOT-22 being used
are two different trials addressed in the same for evaluation in the studies POLYP 1 and
articles (14) as are POLYP 1 and POLYP 2 (15)], POLYP 2, the NPS in the studies Gevaert 2013,
,
which makes a final total of 11 studies used in POLYP 1, and POLYP 2, and the Lund-Mackay
the meta-analysis. The inclusion criteria for Score in the Gevaert 2013 study.
the studies in the meta-analysis are described With regard to the impact on the quality of life,
in Table 1. the use of omalizumab led to a mean difference
Several monoclonal antibodies were tested in of -15.62 (95% CI: -19.79, -11.45; P<0.00001) points
these 11 RCTs, namely: dupilumab, the focus in the SNOT-22 in the POLYP1 and POLYP2
of three RCTs (14,16); omalizumab, the focus studies, compared to the use of placebo.
of three RCTs (15,17); mepolizumab, the focus With regard to the extension of the disease, the
of three 3 RCTs (18–20), and benralizumab, the use of omalizumab led to a mean difference of
focus of two RCTs (21,22). The efficacy of these -1.37 (95% CI: -2.30, -0.44; P=0.004) points in the

74 Portuguese Journal of Otorhinolaryngology - Head and Neck Surgery