Mepolizumab improves sino-nasal symptoms and asthma control in severe eosinophilic asthma patients with chronic rhinosinusitis and nasal polyps: a 12-month real-life study

Aikaterini Detoraki, Eugenio Tremante, Maria D'Amato, Cecilia Calabrese, Claudia Casella, Mauro Maniscalco, Remo Poto, Raffaele Brancaccio, Matilde Boccia, Maria Martino, Clara Imperatore, Giuseppe Spadaro, Aikaterini Detoraki, Eugenio Tremante, Maria D'Amato, Cecilia Calabrese, Claudia Casella, Mauro Maniscalco, Remo Poto, Raffaele Brancaccio, Matilde Boccia, Maria Martino, Clara Imperatore, Giuseppe Spadaro

Abstract

Background: Severe eosinophilic asthma is frequently associated to chronic rhinosinusitis and nasal polyposis (CRSwNP) that contribute to poor asthma control. Mepolizumab is an anti-IL-5 monoclonal antibody, approved for the treatment of severe eosinophilic asthma. A limited number of studies have assessed the efficacy of mepolizumab on CRSwNP in severe asthmatics. We aim to evaluate the efficacy of mepolizumab on sino-nasal symptoms, polyp growth and asthma control in severe eosinophilic asthma patients with CRSwNP in real life.

Methods: In this study 44 severe eosinophilic asthma patients with CRSwNP were treated with mepolizumab (100 mg q4w) for 1 year. The following outcomes were assessed before (T0), after 6 (T6) and 12 months (T12) of treatment: sino/nasal outcome test (SNOT-22), Total Endoscopic Nasal Polyp Score (TENPS), %FEV1 (FEV1/FEV1 predicted) and Asthma control test (ACT). Blood eosinophil count, exhaled nitric oxide (FENO) and prednisone intake were measured. In a subgroup of patients, nasal cytology was performed before (T0), after 6 (T6) and after 12 months (T12) of treatment with mepolizumab.

Results: We reported a significant reduction of SNOT-22 [from 51.5 ± 21.2 at baseline (T0) to 31.70 ± 17.36 at T6 and 29.7 ± 21.5 at T12 (T0-T12 p < 0.001)] and a decrease of TENPS (from 2.88 ± 3.07 to 1.70 ± 2.37 and 1.77 ± 2.56 at T0, T6 and T12, respectively, T0-T12 p = 0.99). A significant improvement of %FEV1, ACT and a decrease in blood eosinophils and mean prednisone intake were also reported. No statistically significant decreasing trend was measured for FENO. Nasal cytology findings suggest a significant reduction of eosinophil percentage following mepolizumab treatment (from 16.8 ± 7.2% to 3.6 ± 6.2% and 0.8 ± 2.4% at T0, T6 and T12 respectively, T0 to T12: p < 0.001).

Conclusions: Mepolizumab improves sino-nasal and asthma symptoms and reduces polyp growth in patients with severe eosinophilic asthma and concomitant CRSwNP in real life.The reviews of this paper are available via the supplemental material section.

Keywords: biologics; chronic rhinosinusitis; mepolizumab; nasal polyposis; personalized therapy; severe eosinophilic asthma.

Conflict of interest statement

Conflict of interest statement: The authors declare that there is no conflict of interest.

Figures

Figure 1.
Figure 1.
(a) Sino-Nasal Outcome Test (SNOT-22) score at baseline (T0), at 6 (T6) and 12 months (T12) of treatment with mepolizumab (Bars represent 95% CIs). **p < 0.01 versus T0. (b)Total endoscopic nasal polyp score (TENPS) measured at T0, T6 and T12 (Bars represent 95% CIs). (c) Asthma Control Test (ACT) at T0, T6 and T12 (Bars represent 95% CIs). (d) Mean % Forced Expiratory Volume at T0, T6 and T12 (Bars represent 95% CIs). (e) Peripheral eosinophil reduction (cells/μl) observed at T6 and T12 after treatment (Bars represent 95% CIs). (f) Prednisone intake (mg/day) at T0, T6 and T12 (Bars represent 95% CIs).
Figure 2.
Figure 2.
(a) Relation between the improvement in SNOT-22 and ACT score at T0, T6 and T12. (b) Mean asthma exacerbation at T0, T6 and T12. Bars represent 95% CIs. **p < 0.01 versus T0.
Figure 3.
Figure 3.
(a) Detection of percentage of nasal cellular components (neutrophils, eosinophils, lymphocytes, mast cells) at T0, T6 and T12. (b) Nasal cytology shows many eosinophils (E) with abundant degranulation (ED) in A (T0); in B (T6) only one eosinophil surrounded by nude nuclei (NN), neutrophils (N), and muciparous cells (CM); in C (T12): many ciliate cells (C), absence of eosinophils.

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