Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI).

Background: This study aimed to evaluate the impact of severe asthma (SA) treatments after 12 months in achieving clinical remission (CR) within the context of the Severe Asthma Network in Italy (SANI) using the recent SANI definition of CR on treatment.

Methods: CR has been defined by SANI as complete, partial, and no CR. Complete CR is defined by the absence of oral corticosteroids (OCS), no symptoms, no exacerbations, and stable lung function, and partial CR requires the absence of OCS and the fulfillment of 2 out of the other 3 criteria.

Allergen immunotherapy in Italy: How, when, and why-A real-world study conducted through a patient association.

Background: Allergen immunotherapy (AIT) is the only treatment that modifies the natural course of allergies. However, AIT is only used in some eligible patients, is frequently underused, and only a few studies investigated this aspects. Understanding AIT utilization patterns might disclose information about why it is underused, thus providing valuable insights on how to broaden the positive impact it can have on the population.

Determination of the Bioavailability of 3 Intranasal Formulations of Azelastine Hydrochloride in Healthy Male Volunteers.

The primary objective of the study was to determine the bioavailability of 2 new formulations of azelastine (AZE) hydrochloride (0.10% and 0.15% AZE) containing sorbitol and sucralose compared with the commercially available 0.

Background therapy in severe asthma on monoclonal antibody treatment in real life.

Background: Global Initiative for Asthma (GINA) recently recommends clinicians to reduce inhaled corticosteroid doses in patients with severe asthma who respond positively to monoclonal antibodies (MAbs).

Objective: As we operated this reduction even before the document, we analysed our cohort of subjects on treatment with a MAbs for at least 24 months.

Methods: Data stored in our electronic archive and at the 6-month follow-up (FU) were registered and patients' adherence to asthma therapy was derived by electronic pharmacy claim database.

Costs of Oral Corticosteroid Use in Patients with Severe Asthma With/Without Chronic Rhinosinusitis with Nasal Polyps: Data from the Italian SANI Registry.

Introduction: The burden of severe asthma on patients, especially on those with concomitant chronic rhinosinusitis with nasal polyps (CRSwNP), is substantial. Treatment intensification with oral corticosteroids is a common strategy for managing severe asthma exacerbations; however, prolonged exposure to systemic corticosteroids is associated with multisystem toxicity. This study aimed to quantify the association between oral corticosteroid use and annual asthma-related costs in patients with severe asthma with or without CRSwNP.

Chronic spontaneous urticaria remission definition and therapy stepping down: World Allergy Organization position paper.

Background: There is no global agreement on the definition of chronic spontaneous urticaria (CSU) remission.

Objective: Our aim was to generate a consensus for clinical definitions of CSU-related terms focused on remission.

Methods: The World Allergy Organization Urticaria Committee systematically reviewed current available longitudinal articles.

Long-term dupilumab efficacy in type 2 asthma regardless of baseline characteristics.

https://bit.ly/3XSwX62.

Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Azelastine Hydrochloride in Children with Perennial Allergic Rhinitis.

Introduction: Allergic rhinitis (AR) affects up to 40% of the pediatric population. The US practice parameter recommends the use of intranasal antihistamines (INAH) or INCS as first-line therapy for the treatment of AR. Although not directly targeted to children, the recent US practice parameters proposed INAH as first-line therapy whereas the ARIA guidelines did not.

A 300 IR 5-grass pollen sublingual immunotherapy tablet-specific systematic review and meta-analysis confirms its clinical benefits for patients with allergic rhinoconjunctivitis with or without asthma.

Background: In the realm of allergen immunotherapy (AIT), the quality of evidence varies across different products, making it unjustifiable to extend overall conclusions to all AIT products, as highlighted by WAO and EAACI.

Objective: To confirm the efficacy of the 300 IR 5-grass pollen sublingual AIT (SLIT)-tablet through a specific meta-analysis of randomized controlled trials (RCTs) involving patients with allergic rhino-conjunctivitis (ARC) with/without mild/intermittent asthma.

Methods: Data from published RCTs on the 300 IR 5-grass SLIT-tablet were gathered from electronic databases (MEDLINE, ISI Web of Science, LILACS, the Cochrane Library and ClinicalTrial.

Clinical characteristics, use and switch of drugs for obstructive airway diseases among patients with COPD experiencing an exacerbation: a retrospective analysis of Italian administrative healthcare data.

Background: Chronic obstructive pulmonary disease (COPD) represents an important health challenge, despite being preventable and manageable thanks to up-to-date recommendations. In Italy, the pharmaceutical care of COPD patients is still ill-timed and inaccurate. This study aimed to describe the treatment of COPD patients in Italy and possible switches following an exacerbation.

Dupilumab and House Dust Mite Immunotherapy in Patients with Atopic Dermatitis: A Preliminary Study.

Background: Severe atopic dermatitis (AD) is a complex disease requiring systemic treatment. This study aimed to assess the effectiveness of combined therapy consisting of dupilumab and sublingual dust mite allergen immunotherapy (SLIT-HDM) in patients with severe AD and HDM allergies.

Methods: Patients diagnosed with severe AD were included in this randomised, placebo-controlled, double-blind 12-month trial; they received SLIT for HDMs and/or dupilumab for 12 months and were compared with patients on cyclosporine.

Twenty-five years: The fexofenadine clinical experience.

Allergic rhinitis (AR) and urticaria affect a sizable portion of the population worldwide, resulting in reduced quality-of-life and productivity and increased healthcare costs. Fexofenadine (FEX) is a non-sedating second-generation H antihistamine with pronounced efficacy and a very good safety profile, used for the treatment of allergic diseases. In addition to its antihistaminic properties, FEX also has anti-inflammatory effects.

Real-world evidence of allergen immunotherapy.

Purpose Of Review: The full understanding of the long-term effectiveness and safety of allergen immunotherapy (AIT) for allergic respiratory diseases cannot be achieved through randomized controlled trials (RCTs) alone. However, real-world studies designed as registries can complement RCTs.

Recent Findings: The significance of registries is highlighted by their potential to reassess contraindications and collect data on adult and pediatric patients with multiple comorbidities who are often excluded from RCTs.

RIAIT (Italian Registry of Allergen Immunotherapy): Protocol for a New Tool in a New Vision of Disease-Modifying Therapy for Allergists.

Randomized controlled trials have demonstrated responses to clinical parameters, but a significant proportion of allergy patients in real-life settings would have been excluded from such studies. Therefore, real-world research is needed, and there is a growing body of information on allergen immunotherapy's long-term effectiveness and safety. Real-world evidence can be a valuable instrument to better understand the patient's journey and the effectiveness and safety of therapies.

Sublingually administered bacterial lysates: rationale, mechanisms of action and clinical outcomes.

This review discusses available evidence on the mechanisms of action of bacterial lysates, and the clinical effects of their sublingual administration. Bacterial lysates act through many immunological effects, including dendritic cell activation, modification of circulating lymphocyte subsets and antibody production. The production of salivary IgA was repeatedly shown to be induced by the sublingual administration of a prototype bacterial lysate containing soluble and corpuscular antigens.

Asthma severity: the patient's point of view.

Objective: Initiated by the Severe Asthma Network Italy (SANI), this study aims to explore asthma patients' perceptions of disease severity, differentiating between mild and severe asthma. The objective is to identify factors influencing tailored treatment strategies for varying disease severities and to provide insights into asthma care in Italy.

Methods: Conducted between November 2020 and January 2021, a survey using Computer-Assisted Personal Interviewing (CAPI) collected data from 308 Italian adults, representing the population.

SANI clinical remission definition: a useful tool in severe asthma management.

In the field of severe asthma, the concept of disease control has recently been integrated by the one of clinical remission. With this new concept, we move on to analyze the efficacy of therapy on multiple parameters simultaneously, starting with the mandatory discontinuation of the systemic glucocorticoids, to which is added the effect on exacerbations, respiratory function, and symptoms control. The Italian severe asthma registry SANI (Severe Asthma Network Italy) drafted criteria for the definition of disease remission, allowing patients to be classified into two groups, partial and complete remission.

Real-world biologics response and super-response in the International Severe Asthma Registry cohort.

Background: Biologic asthma therapies reduce exacerbations and long-term oral corticosteroids (LTOCS) use in randomized controlled trials (RCTs); however, there are limited data on outcomes among patients ineligible for RCTs. Hence, we investigated responsiveness to biologics in a real-world population of adults with severe asthma.

Methods: Adults in the International Severe Asthma Registry (ISAR) with ≥24 weeks of follow-up were grouped into those who did, or did not, initiate biologics (anti-IgE, anti-IL5/IL5R, anti-IL4/13).

Asthma remission one, none and one-hundred thousand: the relevance of the patient's view.

Objective: Achieving remission in severe asthma holds paramount importance in elevating patient quality of life and reducing both individual and societal burdens associated with this chronic condition. This study centers on identifying pivotal patient-relevant endpoints through standardized, reproducible methods, while also developing a patient-centric definition of remission, essential for effective disease management.

Methods: A discrete choice experiment (DCE) was conducted to assess patients' perceptions on the four primary criteria for defining severe asthma remission, as outlined by the SANI survey.

New evidence in food allergies treatment.

Purpose Of Review: To acknowledge, the newly available treatments for food allergy described in the latest scientific literature, such as oral immunotherapy (OIT), biologics and the combination of them in managing patients with IgE-mediated food allergies.

Recent Findings: Recent studies suggest that OIT and biologics, alone or together, can have a role as disease-modifying treatments for food allergies. The FDA has recently approved omalizumab as a treatment for food allergy.

Relevance of individual bronchial symptoms for asthma diagnosis and control in patients with rhinitis: A MASK-air study.

Rationale: It is unclear how each individual asthma symptom is associated with asthma diagnosis or control.

Objectives: To assess the performance of individual asthma symptoms in the identification of patients with asthma and their association with asthma control.

Methods: In this cross-sectional study, we assessed real-world data using the MASK-air app.