Oral CorticoSteroid sparing with biologics in severe asthma: A remark of the Severe Asthma Network in Italy (SANI)

Canonica, Giorgio Walter; Blasi, Francesco; Paggiaro, Pierluigi; Senna, Gianenrico; Passalacqua, Giovanni; Spanevello, Antonio; Aliberti, Stefano; Bagnasco, Diego; Bonavia, Marco; Bonini, Matteo; Brussino, Luisa; Bucca, Caterina; Caiaffa, Maria Filomena; Calabrese, Cecilia; Camiciottoli, Gianna; Caminati, Marco; Carpagnano, Giovanna Elisiana; Centanni, Stefano; Conte, Maria Elisabetta; Corsico, Angelo Guido; Cosmi, Lorenzo; Costantino, Maria Teresa; Crimi, Nunzio; D’Alò, S.; D’Amato, Maria; Giacco, Stefano Del; Farsi, Alessandro; Favero, Elisabetta; Barbaro, Maria Pia Foschino; Guarnieri, Gabriella; Guida, Giuseppe; Latorre, Manuela; Cicero, Salvatore Lo; Lombardi, Carlo; Macchia, Luigi; Mazza, Francesco; Menzella, Francesco; Milanese, Manlio; Montagni, Marcello; Montuschi, Paolo; Nucera, Eleonora; Parente, Roberta; Pelaia, Girolamo; Pini, Laura; Puggioni, Francesca; Ricciardi, Luisa; Ricciardolo, Fabio Luigi Massimo; Richeldi, Luca; Ridolo, Erminia; Rolla, Giovanni; Santus, Pierachille; Scichilone, Nicola; Spadaro, Giuseppe; Vianello, Andrea; Viviano, Vittorio; Yacoub, Mona‐Rita; Zappa, Maria Cristina; Heffler, Enrico; Sani,

doi:10.1016/j.waojou.2020.100464

Cited by 42 publications

(30 citation statements)

References 44 publications

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“…Biological drugs have been recognized as a breakthrough in the treatment of severe refractory asthma, with very evident results in terms of reducing exacerbations, improving quality of life and reducing the use of oral corticosteroids (OCS) [1,2]. This also has an impact on the OCS-related complications with a consequent reduction in the related economic costs, thanks to the significant steroid-sparing effect of biologics [2][3][4]. In the field of severe eosinophilic asthma (SEA), two important pharmacological options have been available for a few years, namely mepolizumab and benralizumab, and more recently also dupilumab has become usable [5].…”

Section: Introductionmentioning

confidence: 99%

Real world effectiveness of benralizumab on respiratory function and asthma control

Menzella¹,

Fontana²,

Galeone³

et al. 2021

Multidis Res Med

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Background: Biological drugs have been recognized as a breakthrough in the treatment of severe refractory asthma. This retrospective real-life observational study aims to evaluate the effect of add-on benralizumab on lung function, exacerbation rate, oral corticosteroids (OCS) reduction and asthma control questionnaire (ACQ) score after 52 weeks.Methods: In this observational study, a cohort of 18 patients with severe eosinophilic asthma (SEA) according to the ERS / ATS and GINA 2020 classifications, with reference to the Pulmonology Unit of the Azienda USL - IRCCS, Reggio Emilia, Italy, were enrolled from 1 September 2019 to 31 August 2020. For each patient, the following data were collected: demographic data (age, sex, age of onset of asthma, history of smoking and atopy); comorbidity; clinical data (lung function, exacerbations, emergency room visits and hospitalizations); asthma control questionnaire (ACQ); biomarkers (blood eosinophil count and total serum IgE); asthma control drugs as high-dose inhaled corticosteroids / long-acting beta-adrenoceptor agonists (ICS / LABA), long-acting muscarinic antagonists (LAMA), leukotriene receptor antagonists (LTRA), theophylline, OCS. The benralizumab 30 mg treatment schedule was based on the currently recommended dosing regimen.Results: After end-of-treatment (EOT), a complete weaning of all patients from OCS was confirmed. After 26 weeks, the number of exacerbations decreased from 2.90 to 0.05 (p<0.0001), hospitalizations and ACQ score decreased from 3.37 to 0.97 (p<0.0001). At EOT, the number of exacerbations was unchanged, while no hospitalizations had occurred. Overall, lung function markedly improved over the study period. After 52 weeks, the increase in FEV1 from baseline was 26.8% (p=0.0002). The subset of patients with nasal polyposis (NP) had an increase of nearly 50% (1008 ml) and patients with blood eosinophils count (BEC) greater than 500 cells/μl showed an increase of 68% (1081 ml) in FEV1 at EOT.Conclusions: The notable improvement in respiratory function is a significant result in this study and it is much higher than what has emerged to date. This result, together with the OCS sparing effect and the excellent clinical control of asthma, makes benralizumab a reliable and safe therapeutic option for SEA.

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Section: Introductionmentioning

confidence: 99%

Real world effectiveness of benralizumab on respiratory function and asthma control

Menzella¹,

Fontana²,

Galeone³

et al. 2021

Multidis Res Med

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“…Asthma is considered as severe when high numbers of exacerbations occur despite the maximal inhalation therapy by one half of the participants (55%) with minimal consideration of the OCS use (2% of responders) or hospitalization (5%). According to the Severe Asthma Network Italy Register (SANI), about two thirds of the Italian severe asthmatics (64%) are treated with OCS [ 11 ]. Further, the daily dose is higher than 10 mg prednisolone on average [ 11 ] despite the fact that ≤ 2.5 mg per day has been recently recommended [ 12 ].…”

Section: Discussionmentioning

confidence: 99%

“…According to the Severe Asthma Network Italy Register (SANI), about two thirds of the Italian severe asthmatics (64%) are treated with OCS [ 11 ]. Further, the daily dose is higher than 10 mg prednisolone on average [ 11 ] despite the fact that ≤ 2.5 mg per day has been recently recommended [ 12 ]. The reduction of OCS is considered a benefit of biological treatment by a minority of the responders, while exacerbation reduction and quality of life improvements are favored targets of treatment.…”

Section: Discussionmentioning

confidence: 99%

Management of patients with severe asthma: results from a survey among allergists and clinical immunologists of the Central Italy Inter-Regional Section of SIAAIC

et al. 2021

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Background Asthma, and severe asthma in particular, is often managed within a specialized field with allergists and clinical immunologists playing a leading role. In this respect, the National Scientific Society SIAAIC (Società Italiana di Allergologia, Asma ed Immunologia Clinica), structured in Regional and Inter-Regional sections, interviewed a large number of specialists involved in the management of this respiratory disease. Methods A survey entitled “Management of patients with asthma and severe asthma” based on 17 questions was conducted through the SIAAIC newsletter in 2019 thanks to the collaboration between GlaxoSmithKline S.p.A. and the Inter-Regional Section of SIAAIC of Central Italy. Results Fifty-nine allergists and clinical immunologists participated to the survey, and 40 of them completed the entire questionnaire. Almost all of the specialists (88%) reported that asthma control was achieved in above 50% of their patients, even if only one third (32%) actually used validated clinical tools such as asthma control test (ACT). Poor adherence to inhaled therapy was recognized as the main cause of asthma control failure by 60% of respondents, and 2–5 min on average is dedicated to the patient inhaler technique training by two-thirds of the experts (65%). Maintenance and as-needed therapy (SMART/MART) is considered an appropriate approach in only a minority of the patients (25%) by one half of the respondents (52%). A high number of exacerbations despite the maximum inhalation therapy were recognized as highly suspicious of severe asthma. Patients eligible for biological therapies are 3–5% of the patients, and almost all the responders (95%) agreed that patients affected by severe asthma need to be managed in specialized centers with dedicated settings. Biological drugs are generally prescribed after 3–6 months from the initial access to the center, and once started, the follow-up is initially programmed monthly, and then every 3–6 months after the first year of treatment (96% of responders). After phenotyping and severity assessment, comorbidities (urticaria, chronic rhinosinusitis with or without nasal polyps, vasculitis, etc.) are the drivers of choice among the different biological drugs. In the management of severe asthma, general practitioners (GPs) should play a central role in selecting patients and referring them to specialized centers while Scientific Societies should train GPs to appropriately recognize difficult asthma and promote public disease awareness campaigns. Conclusions This survey which collects the point of view of allergists and clinical immunologists from Central Italy highlights that asthma control is still not measured with validated instruments. There is a general consensus that severe asthma should be managed only in dedicated centers and to this aim it is essential to encourage patient selection from a primary care setting and develop disease awareness campaigns for patients.

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“…An ad hoc CRF on the Web platform, REDCap, has been created. A similar database has been adopted by the Severe Asthma Network Italy (SANI), which is an ongoing project (16)(17)(18)(19)(20)(21)(22)(23)(24). Each center that participates in the MANI study will have a username and password, which allows access to a reserved area of the Web application.…”

Section: Methodsmentioning

confidence: 99%

Mild/Moderate Asthma Network in Italy (MANI): a long-term observational study

et al. 2021

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Oral CorticoSteroid sparing with biologics in severe asthma: A remark of the Severe Asthma Network in Italy (SANI)

Cited by 42 publications

References 44 publications

Real world effectiveness of benralizumab on respiratory function and asthma control

Real world effectiveness of benralizumab on respiratory function and asthma control

Management of patients with severe asthma: results from a survey among allergists and clinical immunologists of the Central Italy Inter-Regional Section of SIAAIC

Mild/Moderate Asthma Network in Italy (MANI): a long-term observational study

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