Efficacy of anti-IL-5 therapy with mepolizumab for severe bronchial asthma and concomitant inflammatory nasal diseases in real clinical practice

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Abstract

BACKGROUND: T2 inflammation underlies nonallergic eosinophilic severe bronchial asthma and chronic rhinosinusitis with nasal polyposis. Existing targeted anti-IL-5 drugs can improve the clinical and functional parameters in patients with a combination of severe asthma and CRSwNP.

AIM: To evaluate mepolizumab efficacy in patients with nonallergic severe asthma and concomitant inflammatory nasal diseases in real clinical practice.

MATERIALS AND METHODS: The study was conducted without a control group, by comparing related populations (before–after analysis) and based on the Sverdlovsk regional register of adult patients with severe asthma and concomitant inflammatory nasal diseases. The primary endpoints were asthma control achievement (ACT questionnaire) and a decrease in the proportion of patients with uncontrolled severe asthma. The number of asthma exacerbations, emergency calls and hospitalizations, quality of life according to the AQLQ questionnaire, peripheral blood eosinophil level, and respiratory function (the volume of forced exhalation in the first second, the forced vital capacity of the lungs, as well as the ratio of these parameters) were also assessed. The dynamics of nasal symptoms was assessed using the SNOT-22 questionnaire and visual analog scale.

RESULTS: During 12 months of therapy with mepolizumab, the ACT score increased from 9 (Q1–Q3, 7–11) to 22 (Q1–Q3, 21–24) points (p <0.001). The proportion of patients with uncontrolled asthma decreased from 100% to 10% (p <0.001). The number of asthma exacerbations decreased from 3.18±2.8 per patient per year to 0 (p <0.001), and that of hospitalizations decreased from 0.57±0.9 per patient per year to 0 (p=0.007). The quality of life according to the AQLQ increased from 3.48±1.05 (95% CI, 2.73–4.24) to 5.59±0.88 points (95% CI, 4.96–6.22) (p <0.001). The number of blood eosinophils decreased from 442 (Q1–Q3, 336–853) to 90 (Q1–Q3, 73–117) cells/µL (p <0.001). There was increase in FEV1 from 63.9%±24.2% (95% CI, 46.6–81.2) to 80.5%±18.3% (95% CI, 67.4–93.6) (p=0.015). Decreases in the SNOT-22 questionnaire score by 33 points, from 45±30 to 22±15 (p=0.006), and in the visual analog scale score by 5 points, from 8 (Q1–Q3, 5–8) to 3 (Q1–Q3, 3–5) (p=0.017), were also noted.

CONCLUSIONS: Based on the study results, there were asthma control improvement, a decrease in asthma exacerbations, and quality of life improvement according to the AQLQ. A statistically significant decrease in the number of peripheral blood eosinophils and respiratory function improvement were also revealed. In patients with concomitant inflammatory nasal diseases, significant improvement in nasal breathing was noted, which was confirmed by the scores of the SNOT-22 questionnaire and visual analog scale.

About the authors

Veronika V. Naumova

Ural State Medical University

Author for correspondence.
Email: nika.naumova@gmail.com
ORCID iD: 0000-0002-3028-2657
SPIN-code: 8210-6478
ResearcherId: AAI-1588-2020

MD, Cand. Sci. (Med.), assistant of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology

Russian Federation, 3, Repina str., Ekaterinburg, 620028

Evgeny K. Beltyukov

Ural State Medical University

Email: asthma@mail.ru
ORCID iD: 0000-0003-2485-2243
SPIN-code: 6987-1057
ResearcherId: AAI-1608-2020

MD, Dr. Sci. (Med.), Professor, Professor of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology

Russian Federation, 3, Repina str., Ekaterinburg, 620028

Darina V. Kiseleva

Ural State Medical University

Email: darinakiseljova@mail.ru
ORCID iD: 0000-0002-7847-5415
SPIN-code: 9446-7866

MD, Assistant of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology

Russian Federation, 3, Repina str., Ekaterinburg, 620028

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Supplementary files

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2. Fig. 1. Primary results of the study: а ― changes of AАT scores (ptotal <0.001; рААТ baseline - ААТ 4 month = 0.020; рААТ baseline - ААТ 12 month = 0.006); b ― asthma control level trend (ptotal <0.001; pcontrol baseline - control 4 month = 0.043; pcontrol baseline - control 12 month = 0.004). Note: AAT ― aspartate aminotransferase, BА ― bronchial asthma.

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3. Fig. 2. Additional research results: а ― trend of SABA demand (рtotal <0.001; pSABA baseline - SABA 4 month = 0.035; pSABA baseline - SABA 12 month = 0.002); b ― trend of use mode of systemic corticosteroids (pSGCS mode baseline - SGCS mode 12 month = 0.032). Note: SABA ― short-acting β2-agonists, SGCS ― systemic corticosteroids.

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4. Fig. 3. Additional research results: а ― asthma exacerbations trend, hospitalizations and emergency medicine services (EMS) calls due to asthma exacerbations; b ― blood eosinophilic level trend (ptotal <0.001; pEosinophils baseline - Eosinophils 4 month = 0.007; pEosinophils baseline - Eosinophils 12 month = 0.008); с ― FEV1 trend, % (p=0.015). Note: BA ― bronchial asthma; EMC ― emergency medical care; FEV1 ― volume of forced exhalation in the first second.

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5. Fig. 4. Additional study results: а ― trend of quality of life according to AQLQ (ptotal <0.001; pAQLQ 12 month - AQLQ 4 month = 0.005; pAQLQ 12 month - AQLQ baseline <0.001; pAQLQ 4 month - AQLQ baseline = 0.005); b ― trend of SNOT-22 scores (ptotal = 0.006; рSNOT 12 month - SNOT baseline = 0.037; рSNOT 4 month - SNOT baseline = 0.037); с ― VAS scores trend (р=0.017).

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6. Fig. 5. Trend of basic therapy volume in patients with severe asthma receiving mepolizumab. Note: IGCS ― inhaled glucocorticosteroids, SGCS ― systemic corticosteroids, LRA ― leukotriene receptor antagonist, LAMA ― long-acting muscarinic antagonist.

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