Mepolizumab for severe eosinophilic asthma: a real-world snapshot on clinical markers and timing of response

Caminati, Marco; Cegolon﻿﻿, Luca; Vianello, Andrea; Bianchi, Fulvia Chieco; Festi, Giuliana; Marchi, Maria Rita; Micheletto, Claudio; Mazza, Francesco; Tognella, Silvia; Senna, Gianenrico

doi:10.1080/17476348.2019.1676734

Cited by 28 publications

(36 citation statements)

References 25 publications

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“…Our study contributes to the topic, confirming that mepolizumab is very effective in reducing respiratory symptoms, the number and severity of exacerbations, and OCS intake, enabling significant health gains in patients with severe eosinophilic asthma. Moreover, our data further underline the rapidity of action of mepolizumab: its positive effects on respiratory parameters, such as ACT, CaNO, and FEV1, were already significant after the first dose, as previously described [14], and were maintained throughout the observation time. These data are interesting and suggest that these parameters could be early predictors of sustained response to mepolizumab.…”

Section: Discussionsupporting

confidence: 86%

A Comprehensive Evaluation of Mepolizumab Effectiveness in a Real-Life Setting

Cameli

Bergantini

d’Alessandro

et al. 2020

Int Arch Allergy Immunol

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Introduction: Interleukin-5 (IL-5) is the principal cytokine regulating eosinophil growth, differentiation, activation, and expression. It is a specific target of mepolizumab, an anti-IL-5 monoclonal antibody used in the treatment of severe eosinophilic asthma. This new drug can improve symptoms, reduce asthma exacerbations and steroid use. Few data are available on its efficacy for nasal symptoms. Objective: To describe the all-round clinical impact of mepolizumab in a real-life setting, evaluating the efficacy and safety of the drug in severe eosinophilic asthma patients. Population and Methods: We retrospectively collected the clinical and functional data on 27 patients (16 males) affected with severe eosinophilic asthma, diagnosed at the Siena Regional Referral Centre and monitored for 6 months. Clinical, immunological, and functional data at baseline and follow-up were entered in a database together with comorbidities, number of exacerbations, steroid treatment, multiple-flow exhaled nitric oxide, and validated questionnaires. Results: A significant reduction in asthma exacerbations was observed in all patients after 6 months of the biological therapy (p = 0.0009), and 4/6 patients discontinued chronic oral steroids. A significant improvement in ACT, FEV1, SNOT22, and alveolar nitric oxide was observed after 1 month of mepolizumab (p = 0.003, p = 0.007, p = 0.047, and p = 0.019, respectively) and maintained after 6 months of treatment. After 6 months, FeNO 50 was reduced as well (p = 0.030). Mepolizumab was very well tolerated, and no major side effects were observed. Conclusions: Our study suggests that mepolizumab is effective in improving control of asthma, lung function parameters, exhaled biomarkers, and nasal symptoms in patients with severe eosinophilic asthma.

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Section: Discussionsupporting

confidence: 86%

A Comprehensive Evaluation of Mepolizumab Effectiveness in a Real-Life Setting

Cameli

Bergantini

d’Alessandro

et al. 2020

Int Arch Allergy Immunol

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“…There also appears to be an over-representation of late-onset, eosinophilic asthma with nasal polyposis in the nATU population compared with the MUSCA trial (38.7% of patients in the nATU versus 17-21% in MUSCA) [15]. Nonetheless, disease severity in this study was similar to that of a real-world study of patients receiving omalizumab [20] and other early access programmes, including the omalizumab and dupilumab ATUs in France [21,22].…”

Section: Discussionsupporting

confidence: 56%

Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme

et al. 2020

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BackgroundMepolizumab was available in France as part of an early access programme for patients with severe eosinophilic asthma (nominative autorisation temporaire d'utilisation [temporary use authorisation] (nATU)) before its commercialisation. This study aimed to characterise patients who received mepolizumab in the nATU.MethodsThis retrospective, observational study analysed data from the hospital medical records of patients up to 24 months after treatment initiation. Study objectives were to describe patient baseline characteristics, the evolution of disease severity and treatment modifications during follow-up; safety was also investigated.FindingsOverall, 146 patients who received ≥1 dose of mepolizumab were included. At inclusion, patients had a mean age of 58.2 years with a mean severe asthma duration of 13.4 years, and 37.0% had respiratory allergies. Patients experienced, on average, 5.8 exacerbations per patient per year at baseline, 0.6 and 0.5 of which required hospitalisation and emergency department visits, respectively. These values improved to 0.6, 0.1 and 0.1 exacerbations per patient per year, respectively, at 24 months of follow-up. Most patients (92.8%) were using oral corticosteroids at baseline, compared with 34.7% by 24 months of follow-up. Moreover, mean blood eosinophil counts improved from 722 cells·µL−1 at baseline to 92 cells·µL−1 at 24 months of follow-up; lung function and asthma control followed a similar trend.InterpretationResults confirm findings from clinical trials, demonstrating that mepolizumab is associated with important improvements in several clinically meaningful outcomes and has a favourable safety profile in a population with severe eosinophilic asthma, outside of the controlled environment of a clinical trial.

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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 the Sposato et al study (17), where they retrospectively included 134 asthma patients treated with Mepolizumab, the OCS were withdrawn in 45.6% of the patients, with similar values to those observed in our study. These figures are slightly higher in the study by Caminati et al (18) where OCS were removed in 56% of the patients. The withdrawal or reduction of OCS is one of the main objectives in the treatment of asthmatic patients in advanced stages.…”

Section: Discussionmentioning

confidence: 60%

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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Mepolizumab for severe eosinophilic asthma: a real-world snapshot on clinical markers and timing of response

Cited by 28 publications

References 25 publications

A Comprehensive Evaluation of Mepolizumab Effectiveness in a Real-Life Setting

A Comprehensive Evaluation of Mepolizumab Effectiveness in a Real-Life Setting

Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme

Clinical Experience in the Treatment of Severe Eosinophilic Asthma With Mepolizumab

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