Criteria to evaluate efficacy of biologics in asthma: a Global Asthma Association survey.

BACKGROUND: Currently, there are no universally accepted criteria to measure the response to biologics available as treatment for severe asthma. This survey aims to establish consensus criteria to use for the evaluation of response to biologics after 4 months of treatment. METHOD: Using Delphi methodology, a questionnaire including 10 items was validated by 13 international experts in asthma. The electronic survey circulated within the Interasma Scientific Network platform. For each item, five answers were proposed graduated from 'no importance' to 'very high importance' and by a score (A = 2 points; B = 4 points; C = 6 points; D = 8 points; E = 10 points). The final criteria were selected if the median score for the item was ≥7 and > 60% of responses according 'high importance' and 'very high importance'. All selected criteria were validated by the experts. RESULTS: Four criteria were identified: reduce daily systemic corticosteroids dose by ≥50%; decrease the number of asthma exacerbations requiring systemic corticosteroids by ≥50%; have no/minimal side effects; and obtain asthma control according validated questionnaires. The consensual decision was that ≥3 criteria define a good response to biologics. CONCLUSIONS: Specific criteria were defined by an international panel of experts and could be used as tool in clinical practice.

Allergen immunotherapy in asthma: current evidence.

Background: Allergic asthma is the predominant phenotype in clinical practice. Allergen immunotherapy is the only curative and specific approach for the treatment of allergies with clinical benefits for several years after its discontinuation. Despite advances, the use of allergen immunotherapy in allergic asthma is still suboptimal and controversial.Objective: The purpose of this article is to review the published data about the impact of allergen immunotherapy with the most commonly used allergen extracts on allergic asthma outcomes, including both clinical parameters and patients' subjective experience (quality of life).Methods: As data sources several databases were used, including PubMed, Scopus, Web of Science (2002-2019) and search in English and Spanish languages was performed using the following terms: "allergen immunotherapy" and "asthma" in combination with "house dust mite", "birch pollen", "grass pollen", "olive tree pollen", "molds", "pets" and "asthma quality of life". Randomised control trials and meta-analysis from reviewed publications were selected.Results: Emerging data relating to the positive impact on asthma outcomes of allergen immunotherapy allows the addition of this treatment as a therapeutic option in mild to moderate asthmatics sensitized to house dust mite and pollens. Limited data are available for patients sensitized to molds and pets, as well in severe allergic asthma population.Conclusion: Allergen immunotherapy remains a potential therapeutic option for some patients with allergic asthma. Further research is needed to define the optimal period of treatment, the possible therapeutic role in the treatment of severe allergic asthma, and the cost-effectiveness of allergen immunotherapy in asthmatic patients.

Impact of Air Pollution on Asthma Outcomes.

Asthma is a chronic respiratory disease characterized by variable airflow obstruction, bronchial hyperresponsiveness, and airway inflammation. Evidence suggests that air pollution has a negative impact on asthma outcomes in both adult and pediatric populations. The aim of this review is to summarize the current knowledge on the effect of various outdoor and indoor pollutants on asthma outcomes, their burden on its management, as well as to highlight the measures that could result in improved asthma outcomes. Traffic-related air pollution, nitrogen dioxide and second-hand smoking (SHS) exposures represent significant risk factors for asthma development in children. Nevertheless, a causal relation between air pollution and development of adult asthma is not clearly established. Exposure to outdoor pollutants can induce asthma symptoms, exacerbations and decreases in lung function. Active tobacco smoking is associated with poorer asthma control, while exposure to SHS increases the risk of asthma exacerbations, respiratory symptoms and healthcare utilization. Other indoor pollutants such as heating sources and molds can also negatively impact the course of asthma. Global measures, that aim to reduce exposure to air pollutants, are highly needed in order to improve the outcomes and management of adult and pediatric asthma in addition to the existing guidelines.

Beliefs and preferences regarding biological treatments for severe asthma.

BACKGROUND: Severe asthma is a serious condition with a significant burden on patients' morbidity, mortality, and quality of life. Some biological therapies targeting the IgE and interleukin-5 (IL5) mediated pathways are now available. Due to the lack of direct comparison studies, the choice of which medication to use varies. We aimed to explore the beliefs and practices in the use of biological therapies in severe asthma, hypothesizing that differences will occur depending on the prescribers' specialty and experience. METHODS: We conducted an online survey composed of 35 questions in English. The survey was circulated via the INterasma Scientific Network (INESNET) platform as well as through social media. Responses from allergists and pulmonologists, both those with experience of prescribing omalizumab with (OMA/IL5) and without (OMA) experience with anti-IL5 drugs, were compared. RESULTS: Two hundred eighty-five (285) valid questionnaires from 37 countries were analyzed. Seventy-on percent (71%) of respondents prescribed biologics instead of oral glucocorticoids and believed that their side effects are inferior to those of Prednisone 5 mg daily. Agreement with ATS/ERS guidelines for identifying severe asthma patients was less than 50%. Specifically, significant differences were found comparing responses between allergists and pulmonologists (Chi-square test, p < 0.05) and between OMA/IL5 and OMA groups (p < 0.05). CONCLUSIONS: Uncertainties and inconsistencies regarding the use of biological medications have been shown. The accuracy of prescribers to correctly identify asthma severity, according to guidelines criteria, is quite poor. Although a substantial majority of prescribers believe that biological drugs are safer than low dose long-term treatment with oral steroids, and that they must be used instead of oral steroids, every effort should be made to further increase awareness. Efficacy as disease modifiers, biomarkers for selecting responsive patients, timing for outcomes evaluation, and checks need to be addressed by further research. Practices and beliefs regarding the use of asthma biologics differ between the prescriber's specialty and experience; however, the latter seems more significant in determining beliefs and behavior. Tailored educational measures are needed to ensure research results are better integrated in daily practice.

Determinants and Factors of Satisfaction with Sublingual Immunotherapy in Patients with Allergic Rhinitis.

INTRODUCTION: Allergen specific immunotherapy provides effective treatment of allergic rhinitis. Despite its efficacy, it can be signifi-cantly compromised by a possible treatment dissatisfaction of patients. AIM: To explore determinants and factors of satisfaction with sublingual immunotherapy in patients with allergic rhinitis. MATERIALS AND METHODS: A total number of 191 patients with allergic rhinitis who completed a three-year course of sublingual im-munotherapy were included in the study. Of these, 76 had house dust mite (HDM) allergy - 42 men (55.26%) and 115 had grass pollen allergy - 63 men (54.78%) (mean age 27.3 years, SD: 6.14). The patients assessed their satisfaction using a visual analog scale. Health- Related Quality of Life was assessed by Rhinoconjunctivitis Quality of Life questionnaire. A visual analog scale was used to determine severity of the allergic rhinitis. RESULTS: The mean overall satisfaction, compared with that in previous therapy, increased significantly from 4.80 (SD 2.16) to 7.47 (SD 2.05) in the grass pollen allergy group and from 3.42 (SD 2.31) to 7.61 (SD 2.38) in the patients with HDM SLIT (p< 0.001). No relation between satisfaction and sex, type of immunotherapy extracts and duration of the disease was established. A strong correlation was found between satisfaction with treatment and quality of life (R=0.62) and severity of allergic rhinitis (R=0.69) after a three-year course. CONCLUSION: The results of this real-life study demonstrated that most patients with allergic rhinitis appeared to be satisfied with a three-year course of sublingual immunotherapy. The study provided evidence that reduction in severity of symptoms and improvement in quality of life could determine satisfaction with treatment.

Progress in Occupational Asthma.

Occupational asthma (OA) represents one of the major public health problems due to its high prevalence, important social and economic burden. The aim of this review is to summarize current data about clinical phenotypes, biomarkers, diagnosis and management of OA, a subtype of work-related asthma. Most studies have identified two phenotypes of OA. One is sensitizer-induced asthma, occuring after a latency period and caused by hypersensitivity to high- or low-molecular weight agents. The other is irritant-induced asthma, which can occur after one or more exposures to high concentrations of irritants without latency period. More than 400 agents causing OA have been identified and its list is growing fast. The best diagnostic approach for OA is a combination of clinical history and objective tests. An important tool is a specific inhalation challenge. Additional tests include assessments of bronchial hyperresponsiveness to methacholine/histamine in patients without airflow limitations, monitoring peak expiratory flow at- and off-work, sputum eosinophil count, exhaled nitric oxide measurement, skin prick tests with occupational allergens and serum specific IgE. Treatment of OA implies avoidance of exposure, pharmacotherapy and education. OA is a heterogeneous disease. Mechanisms of its different phenotypes, their diagnosis, role of new biomarkers and treatment require further investigation.

How to apply the personalized medicine in obesity-associated asthma?

INTRODUCTION: Obesity-associated asthma (OA) is frequently severe, with an increased rate of hospitalizations, numerous comorbidities and low response to corticosteroids. Despite progress in applying for personalized medicine in asthma, no specific recommendations exist for the management of OA. AREAS COVERED: The aim of this review is to summarize recent data about the relationship obesity-asthma, describe clinical characteristics, potential mechanisms involved and possible therapeutic interventions to improve OA outcomes. Extensive research in the PubMed was performed using the following terms: "asthma and obesity" and "obese asthma" in combination with "phenotypes", "airway inflammation", "biomarkers", "lung function", "weight loss", "lifestyle interventions", "therapies" Currently two phenotypes are described. Early-onset atopic asthma is conventional allergic asthma aggravated by the pro-inflammatory properties of adipose tissue in excess, while late-onset non-atopic asthma is due to airway dysfunction as a consequence of the chronic lung compression caused by the obese chest walls. Previous data showed that different therapeutic strategies used in weight loss have a positive impact on OA outcomes. EXPERT OPINION: The presence of a multidisciplinary team (chest physician, nutritionist, exercise physiologist, physiotherapist, psychologist, bariatric surgeon) and the collaboration between different specialists are mandatory to optimize the management and to apply the personalized medicine in OA.

Beta-blockers in asthma: myth and reality.

Introduction: Patients with asthma often have important co-morbidities which reduce the likelihood of gaining optimal asthma control. Beta2-blockers are commonly prescribed for the treatment of different clinical indications, including coronary artery disease, cardiac arrhythmia, arterial hypertension, heart failure and glaucoma. Areas covered: The aim of this reviw is to summarize current evidence on the effect of systemic and local ß-blockers on asthma outcomes based on their pharmacologic properties,and to help clinicians when prescribing for patients with asthma and co-morbidities. Current data suggest that risk of asthma worsening from systemic and local use of non-selective ß-blockers outweighs any potential benefits for their clinical indications. Recent studies confirm that topical and systemic prescription of cardio-selective ß-blockers is not associated with a significant increased risk of moderate or severe asthma exacerbations. Expert opinion: Non-selective ß-blockers should not be prescribed for the management of comorbidities in patients with asthma while cardio-selective ß-blockers, preferably in low doses, may be used when strongly indicated and other therapeutic options are not available. More prospective real-life studies are needed to evaluate the risk of long-term use of ß-blockers in patients with asthma.

Adherence to treatment in allergic respiratory diseases.

Introduction: Asthma and allergic rhinitis (AR) are chronic conditions in which management needs adherence to prescribed drugs. Despite the benefits of regular maintenance of asthma and AR therapy, low adherence is a frequent issue in clinical practice. Areas covered: The aim of this review is to provide a targeted analysis of the more recent literature on adherence in asthma and AR, focused on the following areas: adherence extent, barriers and consequences, effects of educational interventions and use of new technologies to improve the level of adherence. Expert commentary: Despite the extent, reasons and effects of this problem being well known, non-adherence in asthma and allergic AR remains worryingly high. Poor adherence leads to unsatisfactory health outcomes, with a negative impact on patients and society. Recent literature suggests that successful programs to improve adherence should include a combination of strategies. The new technologies represent a promising tool to improve adherence.

Current opinions for the management of asthma associated with ear, nose and throat comorbidities.

Ear, nose and throat (ENT) comorbidities are common in patients with asthma and are frequently associated with poorer asthma outcomes. All these comorbidities are "treatable traits" in asthma. Identification and management of these disorders may spare medication usage and contribute to improved asthma control and quality of life, and a decrease in exacerbation rates.This review summarises recent data about the prevalence, clinical impact and treatment effects of ENT comorbidities in asthma including allergic rhinitis, chronic rhinosinusitis with and without nasal polyposis, aspirin-exacerbated respiratory disease, obstructive sleep apnoea and vocal cord dysfunction.Many of these comorbidities are possible to be managed by the pulmonologist, but the collaboration with the ENT specialist is essential for patients with chronic rhinosinusitis or vocal cord dysfunction. Further rigorous research is needed to study the efficacy of comorbidity treatment to improve asthma outcomes, in particular with the development of biotherapies in severe asthma that can also be beneficial in some ENT diseases.

A Three-Year Course of House Dust Mite Sublingual Immunotherapy Appears Effective in Controlling the Symptoms of Allergic Rhinitis.

Background Allergic rhinitis is the most common allergic disorder. Although the management of the disease is successful in many patients, based on guidelines, some of them remain with symptoms uncontrolled with pharmacotherapy. Presently, there is no substantiated information on the control of allergic rhinitis in patients who underwent sublingual immunotherapy. Objective The purpose of this prospective follow-up study was to assess the control of allergic rhinitis in adults after a three-year course of house dust mite sublingual immunotherapy. Methods This prospective real-life study was designed to include adults with moderate to severe allergic rhinitis sensitized to house dust mite who underwent a three-year course of sublingual immunotherapy. Control of symptoms was assessed by Rhinitis Control Assessment Test (RCAT) after three years of house dust mite sublingual immunotherapy. Additionally, patients assessed their symptoms by utilizing a visual analog scale. Results A total number of 86 consecutively enrolled patients (46 (53.49%) men; mean age 26.10 years (SD = 5.85)) with moderate to severe allergic rhinitis and clinically relevant sensitization to house dust mite were evaluated. When assessed by RCAT on the third year, 74 (86.05%) had well-controlled symptoms and 20 (27.03%) of them were completely controlled. A significant reduction in visual analog scale scores-from 7.52 cm at baseline to 2.31 cm-was established ( P < 0.0001). There was a strong negative correlation between RCAT scores and visual analog scale (r = -0.65; P < 0.01). Conclusion This study provided evidence that a three-year course of house dust mite sublingual immunotherapy appears effective in controlling the symptoms of allergic rhinitis.

Quality of life improvement after a three-year course of sublingual immunotherapy in patients with house dust mite and grass pollen induced allergic rhinitis: results from real-life.

BACKGROUND: Along with its high prevalence, the burden of allergic rhinitis rests upon the serious impact on quality of life of patients. Allergic rhinitis is associated with impairments in daily activities, work and school performance, and practical problems. Patients suffer from sleep disorders and emotional problems. Тhe advantages of sublingual immunotherapy on quality of life have only recently begun to emerge. The objective of this prospective real-life study was to evaluate the effect of a three-year course of sublingual immunotherapy with house dust mite (HDM) and grass pollen extracts on quality of life in adults with allergic rhinitis. METHODS: A total number of 191 adult patients [105 (54,979%) men; mean age 27.3 years (SD-6.14)] with moderate to severe allergic rhinitis and clinically relevant sensitization to house dust mites or grass pollen were prospectively evaluated in the course of management of their disease. Health-related quality of life was assessed by Rhinoconjunctivitis Quality of Life Questionnaire at baseline and after three-year course of sublingual immunotherapy. RESULTS: The mean overall Qol score assessed at baseline and at the end of the third year of treatment decreased significantly in patients treated with HDM extract (from 2.95 to 0.76) as well as with Grass pollen extract (from 2.83 to 1.22) (р < 0.001). The improvements in treated with HDM extract were as followed: activities - 3.52 to 0.68; sleep- 2.48 to 0.31; general problems - 1.79 to 0.49; practical problems - 3.57 to 0.68; nasal symptoms - 3.91 to 0.74; eye symptoms - 2.92 to 0.39; emotions - 3.03 to 0.39. The improvements in grass pollen group were: activities - 3.68 to 1.69; sleep- 1.85 to 0.84; general problems - 1.74 to 0.97; practical problems - 3.52 to 1.37; nasal symptoms - 3.72 to 1.57; eye symptoms - 3.58 to 1.3; emotions - 2.48 to 1.19. CONCLUSION: Our study conducted in real life provided evidence that a three-year course of SLIT with HDM extract as well as with grass pollen extract significantly increased QoL in patients with allergic rhinitis.