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  1. Article: Baseline Characteristics of Patients Enrolled in Clinical Trials of Biologics for Severe Asthma as Potential Predictors of Outcomes.

    Menzella, Francesco

    Journal of clinical medicine

    2023  Volume 12, Issue 4

    Abstract: 1) Background: Over the past 20 years, monoclonal antibodies have been developed for the treatment of severe asthma, with numerous randomised controlled trials (RCTs) conducted to define their safety and efficacy. The growing availability of biologics, ... ...

    Abstract (1) Background: Over the past 20 years, monoclonal antibodies have been developed for the treatment of severe asthma, with numerous randomised controlled trials (RCTs) conducted to define their safety and efficacy. The growing availability of biologics, which until now have only been available for T2-high asthma, has been further enriched by the arrival of tezepelumab. (2) Methods: This review aims to evaluate the baseline characteristics of patients enrolled in RCTs of biologics for severe asthma to understand how they could potentially predict outcomes and how they can help differentiate between available options. (3) Results: The studies reviewed demonstrated that all biologic agents are effective in improving asthma control, especially with regard to reducing exacerbation rates and OCS use. As we have seen, in this regard, there are few data on omalizumab and none yet on tezepelumab. In analysing exacerbations and average doses of OCSs, pivotal studies on benralizumab have enrolled more seriously ill patients. Secondary outcomes, such as improvement in lung function and quality of life, showed better results-especially for dupilumab and tezepelumab. (4) Conclusion: Biologics are all effective, albeit with important differences. What fundamentally guides the choice is the patient's clinical history, the endotype represented by biomarkers (especially blood eosinophils), and comorbidities (especially nasal polyposis).
    Language English
    Publishing date 2023-02-15
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2662592-1
    ISSN 2077-0383
    ISSN 2077-0383
    DOI 10.3390/jcm12041546
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Home-based treatment of biologics for asthma: who, what, where, when and why.

    Menzella, Francesco / Fontana, Matteo / Ruggiero, Patrizia / Livrieri, Francesco / Facciolongo, Nicola

    Expert review of respiratory medicine

    2022  Volume 16, Issue 4, Page(s) 419–428

    Abstract: Introduction: The advent of biologic therapies for severe asthma has profoundly changed the management of this pathology. The introduction of home administration is therefore an important innovation to optimize the patients' management, even if there ... ...

    Abstract Introduction: The advent of biologic therapies for severe asthma has profoundly changed the management of this pathology. The introduction of home administration is therefore an important innovation to optimize the patients' management, even if there are many aspects that need to be clarified and pointed out.
    Areas covered: This review summarizes the path that led to the possibility of self-administration of biologics, and what the pandemic has changed in the management of these patients.
    Expert opinion: The growing understanding of asthma phenotypes and endotypes is enabling the careful selection of patients suitable for biologics. In this context, the availability of reliable and simple self-injection devices is important in implementing self-administration. The transition to self-injection is also possible thanks to the high safety profile of biologics. With attention, most patients may potentially be suitable for self-administration. The transition process from hospital to home administration can therefore be carried out correctly by clinicians with adequate expertise in the field of severe asthma and biologic therapies, with the support of other health professionals, pharmacists, and general practitioners. Home administration is probably the best way to guarantee high adherence and high-level satisfaction of patients, even in the long term.
    MeSH term(s) Anti-Asthmatic Agents/adverse effects ; Asthma/drug therapy ; Biological Products/adverse effects ; Humans ; Phenotype
    Chemical Substances Anti-Asthmatic Agents ; Biological Products
    Language English
    Publishing date 2022-03-29
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2479146-5
    ISSN 1747-6356 ; 1747-6348
    ISSN (online) 1747-6356
    ISSN 1747-6348
    DOI 10.1080/17476348.2022.2057301
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  3. Article ; Online: Safety of dupilumab in T2 airways conditions: focus on eosinophilia across trials and real-life evidence.

    Caminati, Marco / Micheletto, Claudio / Norelli, Francesca / Olivieri, Bianca / Ottaviano, Giancarlo / Padoan, Roberto / Piacentini, Giorgio / Schiappoli, Michele / Senna, Gianenrico / Menzella, Francesco

    Expert opinion on biological therapy

    2024  Volume 24, Issue 1-2, Page(s) 15–23

    Abstract: Introduction: Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha subunit, effectively blocks both IL-4 and IL-13 mediated pathways. Its introduction has represented a significant advancement in the treatment of severe asthma and other ... ...

    Abstract Introduction: Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha subunit, effectively blocks both IL-4 and IL-13 mediated pathways. Its introduction has represented a significant advancement in the treatment of severe asthma and other Type 2 (T2) conditions, including nasal polyps, atopic dermatitis, and eosinophilic esophagitis. To date, Dupilumab has demonstrated optimal efficacy and safety profile.
    Areas covered: The safety profile of dupilumab has been extensively studied, especially for its effects on blood eosinophil count. Transient eosinophil increase during treatment is typically insignificant from a clinical point of view and related to its mechanism of action. Rare cases of hyper-eosinophilia associated with clinical conditions like eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES) have been reported. Those cases are often related to the drug's steroid-sparing effect or the natural trajectory of the underlying disease rather than a direct cause-effect relationship with dupilumab.
    Expert opinion: The management of hyper-eosinophilia during dupilumab treatment requires comprehensive diagnostic work-up and strict follow-up monitoring for early detection of systemic disease progression in order to avoid unnecessary discontinuation of an effective treatment. This approach highlights the importance of a personalized treatment.
    MeSH term(s) Humans ; Churg-Strauss Syndrome/drug therapy ; Granulomatosis with Polyangiitis/drug therapy ; Antibodies, Monoclonal, Humanized/adverse effects ; Eosinophilia/drug therapy ; Interleukin-4 Receptor alpha Subunit
    Chemical Substances dupilumab (420K487FSG) ; Antibodies, Monoclonal, Humanized ; Interleukin-4 Receptor alpha Subunit
    Language English
    Publishing date 2024-01-30
    Publishing country England
    Document type Journal Article
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2024.2304556
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Tezepelumab: patient selection and place in therapy in severe asthma.

    Menzella, Francesco / Munari, Sara / Corsi, Lorenzo / Tonin, Silvia / Cestaro, Walter / Ballarin, Andrea / Floriani, Ariel / Dartora, Cristina / Senna, Gianenrico

    The Journal of international medical research

    2024  Volume 52, Issue 4, Page(s) 3000605241246740

    Abstract: Asthma is a disease characterised by heterogeneous and multifaceted airway inflammation. Despite the availability of effective treatments, a substantial percentage of patients with the type 2 (T2)-high, but mainly the T2-low, phenotype complain of ... ...

    Abstract Asthma is a disease characterised by heterogeneous and multifaceted airway inflammation. Despite the availability of effective treatments, a substantial percentage of patients with the type 2 (T2)-high, but mainly the T2-low, phenotype complain of persistent symptoms, airflow limitation, and poor response to treatments. Currently available biologicals target T2 cytokines, but no monoclonal antibodies or other specific therapeutic options are available for non-T2 asthma. However, targeted therapy against alarmins is radically changing this perspective. The development of alarmin-targeted therapies, of which tezepelumab (TZP) is the first example, may offer broad action on inflammatory pathways as well as an enhanced therapeutic effect on epithelial dysfunction. In this regard, TZP demonstrated positive results not only in patients with severe T2 asthma but also those with non-allergic, non-eosinophilic disease. Therefore, it is necessary to identify clinical features of patients who can benefit from an upstream targeted therapy such as anti-thymic stromal lymphopoietin. The aims of this narrative review are to understand the role of alarmins in asthma pathogenesis and epithelial dysfunction, examine the rationale underlying the indication of TZP treatment in severe asthma, summarise the results of clinical studies, and recognise the specific characteristics of patients potentially eligible for TZP treatment.
    MeSH term(s) Humans ; Asthma/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Patient Selection ; Anti-Asthmatic Agents/therapeutic use ; Severity of Illness Index ; Cytokines/metabolism ; Cytokines/antagonists & inhibitors ; Thymic Stromal Lymphopoietin
    Chemical Substances tezepelumab (RJ1IW3B4QX) ; Antibodies, Monoclonal, Humanized ; Anti-Asthmatic Agents ; Cytokines ; Thymic Stromal Lymphopoietin (GT0IL38SP4)
    Language English
    Publishing date 2024-04-26
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 184023-x
    ISSN 1473-2300 ; 0300-0605 ; 0142-2596
    ISSN (online) 1473-2300
    ISSN 0300-0605 ; 0142-2596
    DOI 10.1177/03000605241246740
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Omalizumab for the treatment of patients with severe allergic asthma with immunoglobulin E levels above >1500 IU/mL.

    Menzella, Francesco / Just, Jocelyne / Sauerbeck, Inessa Schwab / Mailaender, Claudia / Saccheri, Fabiana / Thonnelier, Celine / Jaumont, Xavier / Mala, Laurence

    The World Allergy Organization journal

    2023  Volume 16, Issue 6, Page(s) 100787

    Abstract: Immunoglobulin E (IgE) plays a critical role in the allergen-initiated inflammatory pathway and thus serves as a viable therapeutic target in allergic or IgE-mediated diseases such as asthma. Omalizumab, ... ...

    Abstract Immunoglobulin E (IgE) plays a critical role in the allergen-initiated inflammatory pathway and thus serves as a viable therapeutic target in allergic or IgE-mediated diseases such as asthma. Omalizumab, an
    Language English
    Publishing date 2023-06-10
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2581968-9
    ISSN 1939-4551
    ISSN 1939-4551
    DOI 10.1016/j.waojou.2023.100787
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  6. Article ; Online: Oscillometry in severe asthma: the state of the art and future perspectives.

    Menzella, Francesco / Antonicelli, Leonardo / Cottini, Marcello / Imeri, Gianluca / Corsi, Lorenzo / Di Marco, Fabiano

    Expert review of respiratory medicine

    2023  Volume 17, Issue 7, Page(s) 563–575

    Abstract: Introduction: Approximately 3-10% of people with asthma have severe asthma (SA). Patients with SA have greater impairment in daily life and much higher costs. Even if asthma affects the entire bronchial tree, small airways have been recognized as the ... ...

    Abstract Introduction: Approximately 3-10% of people with asthma have severe asthma (SA). Patients with SA have greater impairment in daily life and much higher costs. Even if asthma affects the entire bronchial tree, small airways have been recognized as the major site of airflow limitation. There are several tools for studying small airway dysfunction (SAD), but certainly the most interesting is oscillometry. Despite several studies, the clinical usefulness of oscillometry in asthma is still in question. This paper aims to provide evidence supporting the use of oscillometry to improve the management of SA in clinical practice.
    Areas covered: In the ATLANTIS study, SAD was strongly evident across all severity. Various tools are available for evaluation of SAD, and certainly an integrated use of these can provide complete and detailed information. However, the most suitable method is oscillometry, implemented for clinical routine by using either small pressure impulses or small pressure sinusoidal waves.
    Expert opinion: Oscillometry, despite its different technological implementations is the best tool for determining the impact of SAD on asthma and its control. Oscillometry will also be increasingly useful for choosing the appropriate drug, and there is ample room for a more widespread diffusion in clinical practice.
    MeSH term(s) Humans ; Oscillometry/methods ; Spirometry/methods ; Asthma/diagnosis ; Asthma/therapy ; Lung
    Language English
    Publishing date 2023-07-20
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2479146-5
    ISSN 1747-6356 ; 1747-6348
    ISSN (online) 1747-6356
    ISSN 1747-6348
    DOI 10.1080/17476348.2023.2237872
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  7. Article: Pneumonia and Invasive Pneumococcal Diseases: The Role of Pneumococcal Conjugate Vaccine in the Era of Multi-Drug Resistance.

    Scelfo, Chiara / Menzella, Francesco / Fontana, Matteo / Ghidoni, Giulia / Galeone, Carla / Facciolongo, Nicola Cosimo

    Vaccines

    2021  Volume 9, Issue 5

    Abstract: Streptococcus ... ...

    Abstract Streptococcus pneumoniae
    Language English
    Publishing date 2021-04-22
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2703319-3
    ISSN 2076-393X
    ISSN 2076-393X
    DOI 10.3390/vaccines9050420
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  8. Article: Pharmacologicaltreatment of COVID-19: lights and shadows.

    Menzella, Francesco / Biava, Mirella / Barbieri, Chiara / Livrieri, Francesco / Facciolongo, Nicola

    Drugs in context

    2020  Volume 9

    Abstract: At the end of December 2019, a novel coronavirus, the severe acute respiratory syndrome coronavirus 2, caused an outbreak of pneumonia spreading from Wuhan, Hubei province, to the whole country of China and then the entire world, forcing the World Health ...

    Abstract At the end of December 2019, a novel coronavirus, the severe acute respiratory syndrome coronavirus 2, caused an outbreak of pneumonia spreading from Wuhan, Hubei province, to the whole country of China and then the entire world, forcing the World Health Organization to make the assessment that the coronavirus disease (COVID-19) can be characterized as a pandemic, the first ever caused by a coronavirus. To date, clinical evidence and guidelines based on reliable data and randomized clinical trials for the treatment of COVID-19 are lacking. In the absence of definitive management protocols, many treatments for COVID-19 are currently being evaluated and tested worldwide. Some of these options were soon abandoned due to ineffectiveness, while others showed promising results. The basic treatments are mainly represented by antiviral drugs, even if the evidence is not satisfactory. Among the antivirals, the most promising appears to be remdesivir. Corticosteroids and tocilizumab seem to guarantee positive results in selected patients so far, although the timing of starting therapy and the most appropriate therapeutic schemes remain to be clarified. Efficacy of the other drugs is still uncertain, and they are currently used as a cocktail of treatments in the absence of definitive guidelines. What will represent the real solution to the enormous problem taking place worldwide is the identification of a safe and effective vaccine, for which enormous efforts and investments are underway.
    Keywords covid19
    Language English
    Publishing date 2020-05-19
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2719560-0
    ISSN 1740-4398 ; 1745-1981
    ISSN (online) 1740-4398
    ISSN 1745-1981
    DOI 10.7573/dic.2020-4-6
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  9. Article ; Online: The role of systemic corticosteroids in severe asthma and new evidence in their management and tapering.

    Menzella, Francesco / Ghidoni, Giulia / Fontana, Matteo / Capobelli, Silvia / Livrieri, Francesco / Castagnetti, Claudia / Facciolongo, Nicola

    Expert review of clinical immunology

    2021  Volume 17, Issue 12, Page(s) 1283–1299

    Abstract: Introduction: Based on the latest literature evidence, between 30% and 60% of adults with severe refractory asthma (SRA) are systemic corticosteroid (SCS) dependent. There are numerous therapeutic options in asthma, which are often not effective in ... ...

    Abstract Introduction: Based on the latest literature evidence, between 30% and 60% of adults with severe refractory asthma (SRA) are systemic corticosteroid (SCS) dependent. There are numerous therapeutic options in asthma, which are often not effective in severe forms. In these cases, SCS should be considered, but it is increasingly recognized that their regular use is often associated with significant and potentially serious adverse events.
    Areas covered: The aim of this article is to provide an update about the recent and significant literature on SCS and to establish their role in the management of SRA. We summarized the most important and recent evidence and we provided useful indications for clinicians.
    Expert opinion: There is now strong evidence supporting the increased risk of comorbidities and complications with long-term SCS therapies, regardless of the dose. New evidence on SCS tapering and withdrawal will allow to define protocols to address SCS management with greater safety and effectiveness, after starting efficient steroid-sparing strategies. In the next 5years, it will be necessary to implement corrective actions to address these unmet needs, to reduce the inappropriate use of SCS by maximizing the application of more innovative and effective therapies.
    MeSH term(s) Administration, Inhalation ; Adrenal Cortex Hormones/therapeutic use ; Adult ; Anti-Asthmatic Agents/therapeutic use ; Asthma/drug therapy ; Humans
    Chemical Substances Adrenal Cortex Hormones ; Anti-Asthmatic Agents
    Language English
    Publishing date 2021-11-16
    Publishing country England
    Document type Journal Article
    ZDB-ID 2274260-8
    ISSN 1744-8409 ; 1744-666X
    ISSN (online) 1744-8409
    ISSN 1744-666X
    DOI 10.1080/1744666X.2021.2004123
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    Zs.A 6661: Show issues Location:
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  10. Article ; Online: Expert consensus on the role of OM-85 in the management of recurrent respiratory infections: A Delphi study.

    Esposito, Susanna / Cassano, Michele / Cutrera, Renato / Menzella, Francesco / Varricchio, Alfonso / Uberti, Marzio

    Human vaccines & immunotherapeutics

    2022  Volume 18, Issue 6, Page(s) 2106720

    Abstract: Recurrent infections of upper and lower respiratory tract have an important clinical and economic impact, which can be reduced through appropriate preventive measures, including the use of immunomodulating agents, such as OM-85, which proved to be ... ...

    Abstract Recurrent infections of upper and lower respiratory tract have an important clinical and economic impact, which can be reduced through appropriate preventive measures, including the use of immunomodulating agents, such as OM-85, which proved to be effective and safe in both adults and children. Although OM-85 can be useful for the prevention of respiratory tract infections, it is still underused in clinical practice. In order to evaluate the level of awareness of the disease burden of recurrent respiratory infections in adults and children and to assess the level of agreement on the prophylactic and therapeutic approach to the disease, including the use of immunomodulants, a Delphi study was performed. A board of six experts in the field of respiratory infections was appointed to elaborate a series of statements covering four main topics (disease, prevention, OM-85, and future strategies), which were thereafter voted by a panel of 30 experts. Results showed that prevention is unanimously recognized as the most important intervention to reduce disease burden, and the use of immunomodulation to improve the effectiveness of vaccination is gaining increasing favor among clinicians. In this respect, OM-85 is recognized as the most studied immunomodulating agent currently available, whose efficacy and safety make it a valuable tool to optimize the management of recurrent respiratory infections in both adults and children. In particular, the combined use of OM-85 and influenza vaccine was recognized as an effective and safe approach to improve the current prevention strategies in order to reduce the burden of recurrent respiratory infections.
    Language English
    Publishing date 2022-08-19
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2664176-8
    ISSN 2164-554X ; 2164-5515
    ISSN (online) 2164-554X
    ISSN 2164-5515
    DOI 10.1080/21645515.2022.2106720
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