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Clinical Application of Biological Therapies in Severe Asthma

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A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Pulmonology".

Deadline for manuscript submissions: closed (10 May 2023) | Viewed by 11699

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Special Issue Editors

Dr. Giulia Scioscia

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Department of Medical and Surgical Sciences, Institute of Respiratory Disease, University of Foggia, University Hospital Policlinico Riunti Foggia, 71121 Foggia, Italy
Interests: asthma; biologic therapy in severe asthma; COPD; non-cystic fibrosis bronchiectasis; microRNAs in respiratory diseases

Prof. Dr. Donato Lacedonia

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Department of Medical and Surgical Sciences, Institute of Respiratory Diseases, Policlinico Universitario "Riuniti" di Foggia, University of Foggia, 71122 Foggia, Italy
Interests: interstitial lung diseases; idhiopatic pulmonary fibrosis; microRNAs in respiratory diseases; COPD; asthma
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Prof. Dr. Maria Pia Foschino Barbaro

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Department of Medical and Surgical Sciences, Institute of Respiratory Diseases, University Hospital Policlinico "Riuniti" di Foggia, University of Foggia, 71122 Foggia, Italy
Interests: asthma; non-invasive biomarkers in respiratory diseases; COPD

Special Issue Information

Dear Colleagues,

Severe asthma (SA) is a complex heterogeneous condition that affects 5 to 10% of patients with asthma. Different SA phenotypes with multiple underlying endotypes have been described over the last 20 years, with severe eosinophilic asthma (SEA) being recognized as one of the most frequent, severe, and difficult-to-treat asthma subtypes. The management of severe asthma is a major unmet medical need in respiratory medicine. Most severe asthmatic patients are not clinically controlled, despite optimised treatment being available and maximal treatment being required to achieve asthma control. Major advances have been made in the past few years in the management of severe asthma as a result of the development of targeted biological therapies. These biological treatments affect crucial points of bronchial inflammation. IgE (Omalizumab), interleukin 5 (Mepolizumab and Reslizumab), interleukin 5 receptor alpha (Benralizumab) and interleukin 4/13 receptor (Dupilumab) are some of the mechanisms that have been explored. Under investigation and expected to be commercialized in the near future is the monoclonal antibody blocking the thymic stromal lymphopoietin (Tezepelumab). The principal objective of biological therapy in severe asthma is to ensure disease control, in terms of annual exacerbations, and promote the use of systemic corticosteroids taken either daily or in cycles in the acute phase of the disease. During the time course of the disease, in type 2 inflammation, other comorbidities could emerge, such as rhinosinusitis with nasal polyposis and/or atopic dermatitis. The indications for these therapies overlap, which has created a new challenge for physicians who need to decide which drug to prescribe for which patient. The absence of randomised head-to-head trials has meant the absence of coherent national and international guidelines to help navigate this process. This Special Issue will focus on the treatment of patients with a severe form of asthma secondary to type 2 inflammation and its comorbidities. The Special Issue will comprise a combination of original research articles and review papers.

Topics will include:

Biological therapies in severe asthma: characteristics associated with responses to each biologic therapy;
Biological therapies for comorbidities of severe asthma;
The role of biomarkers in making decisions between different biologics;
Switching biological therapies for uncontrolled severe asthma.

Dr. Giulia Scioscia
Prof. Dr. Donato Lacedonia
Prof. Dr. Maria Pia Foschino Barbaro
Guest Editors

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Keywords

severe asthma
eosinophilic asthma
T2 inflammation
biological therapies
switching

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Research

17 pages, 2365 KiB

Open AccessArticle

Benralizumab Effectiveness in Severe Eosinophilic Asthma with Co-Presence of Bronchiectasis: A Real-World Multicentre Observational Study

by Raffaele Campisi, Santi Nolasco, Corrado Pelaia, Pietro Impellizzeri, Maria D’Amato, Andrea Portacci, Luisa Ricciardi, Giulia Scioscia, Nunzio Crimi, Nicola Scichilone, Maria Pia Foschino Barbaro, Girolamo Pelaia, Giovanna Elisiana Carpagnano, Alessandro Vatrella and Claudia Crimi

J. Clin. Med. 2023, 12(12), 3953; https://doi.org/10.3390/jcm12123953 - 9 Jun 2023

Cited by 13 | Viewed by 3710

Abstract

Introduction: The co-presence of bronchiectasis (BE) in severe eosinophilic asthma (SEA) is common. Data about the effectiveness of benralizumab in patients with SEA and BE (SEA + BE) are lacking. Aim: The aim of this study was to evaluate the effectiveness of benralizumab and remission rates in patients with SEA compared to SEA + BE, also according to BE severity. Methods: We conducted a multicentre observational study, including patients with SEA who underwent chest high-resolution computed tomography at baseline. The Bronchiectasis Severity Index (BSI) was used to assess BE severity. Clinical and functional characteristics were collected at baseline and after 6 and 12 months of treatment. Results: We included 74 patients with SEA treated with benralizumab, of which 35 (47.2%) showed the co-presence of bronchiectasis (SEA + BE) with a median BSI of 9 (7–11). Overall, benralizumab significantly improved the annual exacerbation rate (p < 0.0001), oral corticosteroids (OCS) consumption (p < 0.0001) and lung function (p < 0.01). After 12 months, significant differences were found between SEA and SEA + BE cohorts in the number of exacerbation-free patients [64.1% vs. 20%, OR 0.14 (95% CI 0.05–0.40), p < 0.0001], the proportion of OCS withdrawal [−92.6% vs. −48.6, p = 0.0003], and the daily dose of OCS [−5 mg (0 to −12.5) vs. −12.5 mg (−7.5 to −20), p = 0.0112]. Remission (zero exacerbations + zero OCS) was achieved more frequently in the SEA cohort [66.7% vs. 14.3%, OR 0.08 (95% CI 0.03–0.27), p < 0.0001]. Changes in FEV₁% and FEF_25–75% were inversely correlated with BSI (r = −0.36, p = 0.0448 and r = −0.41, p = 0.0191, respectively). Conclusions: These data suggest that benralizumab exerts beneficial effects in SEA with or without BE, although the former achieved less OCS sparing and fewer respiratory-function improvements. Full article

(This article belongs to the Special Issue Clinical Application of Biological Therapies in Severe Asthma)

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12 pages, 1314 KiB

Open AccessArticle

A Real-World Study of Achievement Rate and Predictive Factors of Clinical and Deep Remission to Biologics in Patients with Severe Asthma

by Keiji Oishi, Kazuki Hamada, Yoriyuki Murata, Kazuki Matsuda, Syuichiro Ohata, Yoshikazu Yamaji, Maki Asami-Noyama, Nobutaka Edakuni, Tomoyuki Kakugawa, Tsunahiko Hirano and Kazuto Matsunaga

J. Clin. Med. 2023, 12(8), 2900; https://doi.org/10.3390/jcm12082900 - 16 Apr 2023

Cited by 22 | Viewed by 4832

Abstract

Background: Recent advances in biologics have provided new insights into the clinical course of asthma, including disease modification, clinical remission (CR), and deep remission (DR). However, the extent to which biologics achieve CR and DR in severe asthma patients is poorly understood. Methods: To assess the achievement rate and predictors of CR and DR using long-term biologics, we retrospectively evaluated 54 severe asthma patients recently started on biologics. “CR” denotes the achievement of all three criteria: (1) absence of asthma symptoms, (2) no asthma exacerbations, and (3) no use of oral corticosteroids. DR denoted CR plus (4) normalized pulmonary function and (5) suppressed type 2 inflammation. Results: CR and DR achievement rates were 68.5% and 31.5%, respectively. Compared with the non-deep remission group, the DR group had higher adult-onset asthma rates (94.1% vs. 70.3%, p = 0.078), shorter asthma duration (5 vs. 19 years, p = 0.006), and higher FEV₁ (91.5% vs. 71.5%, p < 0.001). There were no significant differences in the Asthma Control Questionnaire scores, exacerbation frequency, or type 2 inflammation at baseline between groups. Asthma duration combined with FEV₁ can stratify the achievement rates of CR and DR. Conclusions: the early introduction of biologics in severe asthma patients may help achieve CR and DR. Full article

(This article belongs to the Special Issue Clinical Application of Biological Therapies in Severe Asthma)

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11 pages, 956 KiB

Open AccessEditor’s ChoiceArticle

Effectiveness of Benralizumab in OCS-Dependent Severe Asthma: The Impact of 2 Years of Therapy in a Real-Life Setting

by Carolina Vitale, Angelantonio Maglio, Corrado Pelaia, Maria D’Amato, Luigi Ciampo, Giulia Pelaia, Antonio Molino and Alessandro Vatrella

J. Clin. Med. 2023, 12(3), 985; https://doi.org/10.3390/jcm12030985 - 27 Jan 2023

Cited by 8 | Viewed by 2432

Abstract

Patients with severe OCS-dependent asthma can be considered a subgroup of asthma patients with severe disease and great risk of complications, related to chronic OCS use. The introduction of biological drugs has represented a turning point in the therapeutic strategy for severe asthma, offering a valid alternative to OCS. Benralizumab, like other anti-IL-5 agents, has been shown to reduce exacerbations and OCS intake/dosage and improve symptom control and lung function. While these findings have also been confirmed in real-life studies, data on long-term efficacy are still limited. Methods: In this retrospective study, we evaluated the effects of 2 years of treatment with benralizumab on 44 patients with OCS-dependent severe asthma by analyzing clinical, biological and functional data. Results: After 2 years of benralizumab, 59.4% discontinued OCS and patients who continued to use OCS had their mean dose reduced by approximately 85% from baseline. Meanwhile, 85% of patients had their asthma well-controlled (ACT score > 20) and had no exacerbations, and 41.6% had normal lung function. Conclusions: Our findings support the long-term effectiveness of benralizumab in severe OCS-dependent asthma in a real-life setting, suggesting potential reductive effects on costs and complications such as adverse pharmacological events. Full article

(This article belongs to the Special Issue Clinical Application of Biological Therapies in Severe Asthma)

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