One year of mepolizumab. Efficacy and safety in real-life in Italy

Bagnasco, Diego; Caminati, Marco; Menzella, Francesco; Milanese, Manlio; Rolla, Giovanni; Lombardi, Carlo; Bucca, Caterina; Heffler, Enrico; Paoletti, Giovanni; Testino, Elisa; Manfredi, Andrea; Caruso, Cristiano; Guida, Giuseppe; Senna, Gianenrico; Bonavia, Marco; Riccio, Anna Maria; Canonica, Giorgio Walter; Passalacqua, Giovanni

doi:10.1016/j.pupt.2019.101836

Cited by 66 publications

(78 citation statements)

References 36 publications

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“…The results show a clear improvement for the patients, which is reflected in a reduction of the number of exacerbations, improved clinical control, and a reduction in the use of OCS. The data are very similar to those in the literature, both in the controlled clinical trials (5-9) and in the real-life studies carried out with the drug (11,(15)(16)(17)(18). In this way, the type of patients included in our series are very similar to those already published, both in existence of associated comorbidities and in the presence of secondary effects attributed to the administration of the drug.…”

Section: Discussionsupporting

confidence: 87%

“…In some patients, with high levels of eosinophils in blood and sputum, the use of a drug ( Mepolizumab) is indicated whose function is to block interleukin 5 (IL-5), and, in this way, avoid the mobility and the passage of the eosinophils towards the airways (3,4). The experience with Mepolizumab comes from diverse published clinical trials (5)(6)(7)(8)(9) as well as the clinical use in different countries (10,11). The drug has demonstrated efficacy in reducing exacerbations and the need for OCS, and also in improving the healthrelated quality of life (HRQoL) (12,13).…”

Section: Introductionmentioning

confidence: 99%

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Clinical Experience in the Treatment of Severe Eosinophilic Asthma With Mepolizumab

Rodríguez

Valverde

Álvarez

et al. 2020

Preprint

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Introduction: Severe eosinophilic asthma is an incapacitating disease requiring the patient to take many drugs, amongst which are oral corticoids (OCS), for its control. Mepolizumab is a monoclonal antibody capable of blocking the binding of Interleukin 5 (IL-5) to the eosinophils, and, in this way reducing the exacerbations, symptoms and need for OCS. Our objective was to evaluate the experience with this drug on patients being treated for severe asthma in real-life conditions. Methods: Retrospective, multicentric study carried out in eight hospitals in the Principality of Asturias, in which the demographic, clinical, analytical, lung function and ACT (Asthma Control Questionnaire) data of the patients with severe eosinophilic asthma being treated with Mepolizumab for three years were collected. Results: Sixty-nine patients (72% women) were included, with a mean age of 56±13 years. The eosinophil blood count before treatment was 856 cels/mm3 (SD 754), decreasing after 6 months to 101 cels/mm3 (SD 98). Annual exacerbations decreased from 4.7 (SD 3.7) to 1.3 (SD 2.5) (p=0.001), while the FEV1% increased from 68% (SD 20) to 76% (SD 21) (<0.001). At the onset 25 patients (36%) were using OCS ( 18 mg/day of prednisone) and after treatment this decreased to 13 (19%) ( 9mg/day of prednisone) ( p=0.000), with complete withdrawal in 12 (48%). The response to Mepolizumab was positive in 56 patients (81%), and no adverse effects were observed. Conclusions: Mepolizumab has demonstrated to be efficacious and safe in real life in the treatment of patients with badly controlled eosinophilic asthma.

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Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Clinical Experience in the Treatment of Severe Eosinophilic Asthma With Mepolizumab

Rodríguez

Valverde

Álvarez

et al. 2020

Preprint

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“…The general characteristics and their changes over 12 months of treatment are described elsewhere. 7 To assess this, the percentage change (12 months-baseline) was calculated for: OCS dose, asthma control test (ACT) score, FEV1, exacerbation rate, and In total, 138 patients (78 female, 60 male, mean age 58 ± 10 years; age range 21-81) were observed. Of them, 27 were allergic (all to mite, and 18 also to pollen allergens).…”

Section: The Importance Of Being Not Significant: Blood Eosinophils Amentioning

confidence: 99%

The importance of being not significant: Blood eosinophils and clinical responses do not correlate in severe asthma patients treated with mepolizumab in real life

Bagnasco

Massolo

Bonavia³

et al. 2020

Allergy

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“…Многоцентровой ретроспективный анализ, проведенный в 11 итальянских клиниках и включивший 138 больных, получавших МЕПО в течение не менее 12 месяцев, продемонстрировал снижение количества обострений с 3,8 в год до 0,7 (-81%; р < 0,0001), средняя суточная доза СГКС у стероид-зависимых больных была снижена с 10,1 ± 9,4 мг до 2,0 ± 4,2 мг/день (р < 0,0001), на фоне падения уровня Эф с 822 ± 491/мкл в начале исследования до 117 ± 96/мкл (р < 0,0001) после 12 месяцев терапии [41]. Испанские исследователи оценили эффективность МЗБ у 25 больных, 15 их которых на регулярной основе получали СГС [42].…”

Section: клинические исследования мзб при баunclassified

Successful management of severe bronchial asthma: the right choice of biologic therapy in properly selected patients

Фассахов

2019

Medicinskij sovet

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Severe asthma along with the impact on the quality of life of those suffering from this disease leads to significant medical and social damage. Studies of the last decade indicate the leading role of eosinophilic inflammation of the bronchi as the basis of the pathogenesis of the T2 phenotype of bronchial asthma, which led to the development of targeted therapy. The most effective in this direction were preparations of humanized monoclonal antibodies directed against the main pro-inflammatory cytokines involved in respiratory tract inflammation in bronchial asthma, one of the most significant among which is interleukin 5. Refinement of the definition of severe asthma, selection of these patients among patients with difficult to treat bronchial asthma allows to clearly determine the contingent with a predicted positive effect these highly effective drugs precision therapy. On clinical examples, the difference between difficult to treat and severe bronchial asthma is discussed. The stages of clinical trials of the preparation of monoclonal antibodies against interleukin 5 Mepolizumab are analyzed in detail, the search for effective prognostic biological markers available in normal practice, allowing to select patients suitable for the treatment of patients with severe eosinophilic bronchial asthma. The effectiveness of the approach based on the allocation of two threshold values of the number of eosinophils in the peripheral blood is convincingly confirmed by the results indicating a significant reduction in the number of exacerbations, improved of lung function and an increase of the quality of life in patients, including with steroiddependent bronchial asthma, obtained not only in randomized clinical studies, but also in studies in real clinical practice.

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One year of mepolizumab. Efficacy and safety in real-life in Italy

Cited by 66 publications

References 36 publications

Clinical Experience in the Treatment of Severe Eosinophilic Asthma With Mepolizumab

Clinical Experience in the Treatment of Severe Eosinophilic Asthma With Mepolizumab

The importance of being not significant: Blood eosinophils and clinical responses do not correlate in severe asthma patients treated with mepolizumab in real life

Successful management of severe bronchial asthma: the right choice of biologic therapy in properly selected patients

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