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. 2024 Sep 23;14(9):1014.
doi: 10.3390/jpm14091014.

Sinonasal Outcomes Obtained after 2 Years of Treatment with Benralizumab in Patients with Severe Eosinophilic Asthma and CRSwNP: A "Real-Life" Observational Study

Eugenio De Corso  1 , Dario Antonio Mele  1   2 , Angela Rizzi  3 , Camilla Spanu  2 , Marco Corbò  2 , Serena Pisciottano  2 , Rodolfo Francesco Mastrapasqua  4 , Silvia Baroni  5 , Davide Paolo Porru  2 , Gabriele De Maio  2 , Alberta Rizzuti  2 , Giuseppe Alberto Di Bella  2 , Augusta Ortolan  6 , Matteo Bonini  7 , Francesca Cefaloni  7 , Cristina Boccabella  7 , Francesco Lombardi  7 , Raffaella Chini  3 , Cristiano Caruso  3 , Marco Panfili  8 , Jacopo Galli  1   2
Affiliations

Sinonasal Outcomes Obtained after 2 Years of Treatment with Benralizumab in Patients with Severe Eosinophilic Asthma and CRSwNP: A "Real-Life" Observational Study

Eugenio De Corso et al. J Pers Med. .

Abstract

Background/objectives: Benralizumab is a monoclonal antibody that targets the interleukin-5 receptor (IL-5Rα), leading to the rapid depletion of blood eosinophils. RCTs have demonstrated efficacy in patients with severe eosinophilic asthma (SEA). The aim of this study was to assess the efficacy of benralizumab on sinonasal outcomes in a real-life setting in patients with SEA and concomitant chronic rhinosinusitis with nasal polyps (CRSwNP).

Methods: We included 25 patients (mean age: 57.47 years, range: 35-77, F/M = 12:13) who were prescribed 30 mg benralizumab every month for the first three administrations and then every 2 months. The primary endpoint was to evaluate changes in the SinoNasal Outcome Test-22 (SNOT-22) and nasal polyp score (NPS) over a 24-month treatment period. Secondary endpoints included measuring the effects on nasal obstruction and impaired sense of smell.

Results: The mean NPS score decreased significantly from 5.11 ± 1.84 at baseline to 2.37 ± 1.96 at 24 months. The mean SNOT-22 decreased from 57 ± 15.30 at baseline to 26 ± 16.73 at 24 months. The SSIT-16 mean score improved with an increase in olfactory performance from 5.23 ± 2.58 at baseline to 7 ± 3.65 at 24 months. Moreover, 8/25 patients (32%) required rescue treatment with systemic steroids and 2 patients required endoscopic sinus surgery.

Conclusions: While the improvement may not seem optimal at 12 months, a progressive enhancement was noted during the second year of treatment. Despite our data showing an improvement in quality of life and a reduction in the size of nasal polyps, no significant improvement in olfactory sensitivity was observed. In addition, in several patients, rescue treatments were required to maintain control of nasal and sinus symptoms. A careful risk-benefit assessment is therefore needed when deciding to continue treatment, weighing the potential for further improvement against the risks of complications. Such decisions should always be made in the context of a multidisciplinary team.

Keywords: CRSwNP; IL5; benralizumab; biologics; functional endoscopic sinus surgery; intranasal corticosteroids; non-steroidal anti-inflammatory drugs; systemic corticosteroids.

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Conflict of interest statement

EDC has received lecture fees and participated in expert board meetings for GSK, Novartis, Sanofi, and AstraZeneca. CC has received lecture fees and participated in expert board meetings for GSK, Novartis, and Sanofi. MB has received research grants and advisory board/speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Grifols, Glaxo Smith Kline, Lusofarmaco. Menarini, Omron, and Sanofi. All other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Nasal polyp endoscopic score (NPS) (a) and Sino-nasal Outcome Test−22 (SNOT−22) (b) fluctuation over time.
Figure 2
Figure 2
VAS nasal obstruction (a), rhinorrhea (b), facial pain (c), and sleep disturbance (d) fluctuations over time.
Figure 2
Figure 2
VAS nasal obstruction (a), rhinorrhea (b), facial pain (c), and sleep disturbance (d) fluctuations over time.
Figure 3
Figure 3
Sniffin Sticks (a) and VAS olfaction (b) fluctuations over time.
See this image and copyright information in PMC

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