SQ HDM SLIT-tablet (ALK) in treatment of asthma – Post hoc results from a randomised trial

SummaryIntroductionIn a double-blind, placebo-controlled trial (EudraCT identifier: 2006-001795-20), the standardised quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) was investigated.MethodThe trial included 604 subjects, ≥14 years, with mild-moderate HDM allergic asthma. Subjects were randomised 1:1:1:1 to 1, 3 or 6 SQ-HDM or placebo once daily. The primary endpoint was reduction in inhaled corticosteroid (ICS) after one year. ICS reduction, asthma quality of life questionnaire (AQLQ) and asthma control questionnaire (ACQ) score was analysed post hoc in a subgroup with daily ICS use of 400–800 μg and ACQ score of 1–1.5, corresponding to partly contr…

Personalized medicine for allergy treatment: Allergen immunotherapy still a unique and unmatched model

International audience; The introduction of personalized medicine (PM) has been a milestone in the history of medical therapy, because it has revolutionized the previous approach of treating the disease with that of treating the patient. It is known today that diseases can occur in different genetic variants, making specific treatments of proven efficacy necessary for a given endotype. Allergic diseases are particularly suitable for PM, because they meet the therapeutic success requirements, including a known molecular mechanism of the disease, a diagnostic tool for such disease, and a treatment blocking the mechanism. The stakes of PM in allergic patients are molecular diagnostics, to dete…

WITHDRAWN: Scaling up strategies of the Chronic Respiratory Disease programme of the European Innovation Partnership on Active and Healthy Ageing (Action Plan B3 – Area 5)

Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma

Long-term oral corticosteroid (OCS) use in patients with severe asthma is associated with significant adverse effects.This 40-week, randomised, double-blind trial evaluated the OCS-sparing potential of tralokinumab in patients with severe, uncontrolled asthma requiring maintenance OCS treatment plus inhaled corticosteroids/long-acting β2-agonists. Overall, 140 patients were randomised to tralokinumab 300 mg or placebo (n=70 in each group) administered subcutaneously every 2 weeks. The primary end-point was percentage change from baseline in average OCS dose at week 40, while maintaining asthma control. Secondary end-points included proportion of patients with a prescribed maintenance OCS do…

ARIA‐EAACI care pathways for allergen immunotherapy in respiratory allergy

Funding Information: BSreports personal fees from Allergopharma, during the conduct of the study; grants from National Health Programm, grant, personal fees from Polpharma, ASTRA, personal fees from Mylan, Adamed, patient ombudsman, national Centre for Research and Development, Polish Allergology Society. Funding Information: NGP reports personal fees from Novartis, Nutricia, HAL, MENARINI/FAES FARMA, SANOFI, MYLAN/MEDA, BIOMAY, AstraZeneca, GSK, MSD, ASIT BIOTECH, Boehringer Ingelheim, grants from Gerolymatos International SA, Capricare. Funding Information: CA reports grants from Allergopharma, grants from Idorsia, Swiss National Science Foundation, Christine Kühne‐Center for Allergy Rese…

Reductions in Inflammatory Biomarkers in Patients with Oral Corticosteroid-Dependent Asthma Treated with Tezepelumab

Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement

Background Exacerbations are a key outcome in clinical research, providing patient-relevant information about symptomatic control, health state and disease progression. Generally considered as an episode of (sub)acute deterioration of respiratory symptoms, a precise, clinically useful definition is needed for use in clinical trials. Aim and methods Focussing on moderate exacerbations, this opinion piece reviews landmark trials and current guidelines to provide a practical definition of a moderate exacerbation. Specifically, we adapt the ATS/ERS consensus statement of terminology Reddel et al. (2009) [1] which provides a conceptual (or 'theoretical') definition for moderate exacerbations, to…

Severe Chronic Allergic (and Related) Diseases: A Uniform Approach – A MeDALL – GA<sup>2</sup>LEN – ARIA Position Paper

Concepts of disease severity, activity, control and responsiveness to treatment are linked but different. Severity refers to the loss of function of the organs induced by the disease process or to the occurrence of severe acute exacerbations. Severity may vary over time and needs regular follow-up. Control is the degree to which therapy goals are currently met. These concepts have evolved over time for asthma in guidelines, task forces or consensus meetings. The aim of this paper is to generalize the approach of the uniform definition of severe asthma presented to WHO for chronic allergic and associated diseases (rhinitis, chronic rhinosinusitis, chronic urticaria and atopic dermatitis) in …

ARIA���EAACI statement on asthma and COVID���19 (June 2, 2020)

Artículo con numerosos autores sólo se mencionan el primero y el de la UAM

ARIA digital anamorphosis: Digital transformation of health and care in airway diseases from research to practice: Review

Submitted by (omml@ubi.pt) on 2021-07-05T10:37:14Z No. of bitstreams: 1 2021_Bousquet J_A_Anamorphosis.pdf: 1897974 bytes, checksum: 918eb581ab4e940b055ef8514f960e28 (MD5) Approved for entry into archive by Pessoa (pfep@ubi.pt) on 2021-07-05T11:16:44Z (GMT) No. of bitstreams: 1 2021_Bousquet J_A_Anamorphosis.pdf: 1897974 bytes, checksum: 918eb581ab4e940b055ef8514f960e28 (MD5) Approved for entry into archive by Pessoa (pfep@ubi.pt) on 2021-07-05T11:20:07Z (GMT) No. of bitstreams: 1 2021_Bousquet J_A_Anamorphosis.pdf: 1897974 bytes, checksum: 918eb581ab4e940b055ef8514f960e28 (MD5) Made available in DSpace on 2021-07-05T11:20:07Z (GMT). No. of bitstreams: 1 2021_Bousquet J_A_Anamorphosis.pdf: …

Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations

This randomised, double-blind, 6-month study compared budesonide/formoterol for maintenance and relief with salmeterol/fluticasone and a fixed maintenance dose of budesonide/formoterol, both with terbutaline for relief. Following a 2-week run-in, 3335 symptomatic adults and adolescents (mean FEV1 73% predicted, mean inhaled corticosteroid dose 745 μg/day) received budesonide/formoterol 160/4.5 μg one inhalation bid plus additional inhalations as needed, salmeterol/fluticasone 25/125 μg two inhalations bid plus as-needed terbutaline or budesonide/formoterol 320/9 μg one inhalation bid plus as-needed terbutaline. Budesonide/formoterol for maintenance and relief prolonged the time to first sev…

Le comprimé d’immunothérapie sublinguale acariens SQ est efficace dans le traitement de l’asthme allergique ; résultats de l’essai de phase III MITRA

Introduction Les allergenes d’acariens domestiques sont associes a une pathologie respiratoire persistante. La rhinite allergique et l’asthme allergique (AA) coexistent frequemment. L’immunotherapie a le potentiel de modifier la cause de la maladie sous-jacente. Nous rapportons ici l’efficacite du comprime acarien d’immunotherapie sublinguale (ITSL) SQ-HDM (ALK, Danemark) sur le controle de l’asthme allergique aux acariens (AAA). Methodes L’essai europeen randomise en double aveugle controle par placebo MITRA (EudraCT 2010-018621-19) a inclus 834 sujets de 13 pays, ayant a l’inclusion un asthme allergique depuis plus d’un an, des tests de sensibilisation aux acariens positifs et un asthme m…

Correlation between work impairment, scores of rhinitis severity and asthma using the MASK-air ® App

Background: In allergic rhinitis, a relevant outcome providing information on the effectiveness of interventions is needed. In MASK-air (Mobile Airways Sentinel Network), a visual analogue scale (VAS) for work is used as a relevant outcome. This study aimed to assess the performance of the work VAS work by comparing VAS work with other VAS measurements and symptom-medication scores obtained concurrently. Methods: All consecutive MASK-air users in 23 countries from 1 June 2016 to 31 October 2018 were included (14 189 users; 205 904 days). Geolocalized users self-assessed daily symptom control using the touchscreen functionality on their smart phone to click on VAS scores (ranging from 0 to 1…

Management of anaphylaxis due to COVID-19 vaccines in the elderly

Submitted by (omml@ubi.pt) on 2021-07-05T10:47:24Z No. of bitstreams: 1 2021_Bousquet J_A_COVID anaphylaxis.pdf: 12561118 bytes, checksum: 2f801ee76ad2cb3cbdaa02ffabea8e09 (MD5) Approved for entry into archive by Pessoa (pfep@ubi.pt) on 2021-07-05T10:49:11Z (GMT) No. of bitstreams: 1 2021_Bousquet J_A_COVID anaphylaxis.pdf: 12561118 bytes, checksum: 2f801ee76ad2cb3cbdaa02ffabea8e09 (MD5) Rejected by Pessoa (pfep@ubi.pt), reason: Rever os nomes dos autores. Depois da correção é só voltar a submeter. on 2021-07-05T10:54:19Z (GMT) Submitted by (omml@ubi.pt) on 2021-07-05T11:52:24Z No. of bitstreams: 1 2021_Bousquet J_A_COVID anaphylaxis.pdf: 12561118 bytes, checksum: 2f801ee76ad2cb3cbdaa02ffab…

Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy

Patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) often continue to experience symptoms despite receiving standard-of-care therapy with H1-antihistamines along with 1 or more add-on therapies.We sought to evaluate the safety and efficacy of 24 weeks of treatment with omalizumab in patients with persistent CIU/CSU despite treatment with H₁-antihistamines at up to 4 times the approved dose plus H₂-antihistamines, leukotriene receptor antagonists, or both.In this phase III study patients were randomized to receive 6 subcutaneous injections at 4-week intervals of either 300 mg of omalizumab or placebo, followed by a 16-week observation period. The primary object…

Allergic Rhinitis and its Impact on Asthma (ARIA) Phase 4 (2018): Change management in allergic rhinitis and asthma multimorbidity using mobile technology

Allergic Rhinitis and its Impact on Asthma (ARIA) has evolved from a guideline by using the best approach to integrated care pathways using mobile technology in patients with allergic rhinitis (AR) and asthma multimorbidity. The proposed next phase of ARIA is change management, with the aim of providing an active and healthy life to patients with rhinitis and to those with asthma multimorbidity across the lifecycle irrespective of their sex or socioeconomic status to reduce health and social inequities incurred by the disease. ARIA has followed the 8-step model of Kotter to assess and implement the effect of rhinitis on asthma multimorbidity and to propose multimorbid guidelines. A second c…

Allergy immunotherapy across the life cycle to promote active and healthy ageing: from research to policies: An AIRWAYS Integrated Care Pathways (ICPs) programme item (Action Plan B3 of the European Innovation Partnership on active and healthy ageing) and the Global Alliance against Chronic Respiratory Diseases (GARD), a World Health Organization GARD research demonstration project.

Allergic diseases often occur early in life and persist throughout life. This life-course perspective should be considered in allergen immunotherapy. In particular it is essential to understand whether this al treatment may be used in old age adults. The current paper was developed by a working group of AIRWAYS integrated care pathways for airways diseases, the model of chronic respiratory diseases of the European Innovation Partnership on active and healthy ageing (DG CONNECT and DG Santé). It considered (1) the political background, (2) the rationale for allergen immunotherapy across the life cycle, (3) the unmet needs for the treatment, in particular in preschool children and old age adu…

The effect of budesonide/formoterol maintenance and reliever therapy on the risk of severe asthma exacerbations following episodes of high reliever use: an exploratory analysis of two randomised, controlled studies with comparisons to standard therapy.

Abstract Background Divergent strategies have emerged for the management of severe asthma. One strategy utilises high and fixed doses of maintenance treatment, usually inhaled corticosteroid/long-acting β2-agonist (ICS/LABA), supplemented by a short-acting β2-agonist (SABA) as needed. Alternatively, budesonide/formoterol is used as both maintenance and reliever therapy. The latter is superior to fixed-dose treatment in reducing severe exacerbations while achieving similar or better asthma control in other regards. Exacerbations may be reduced by the use of budesonide/formoterol as reliever medication during periods of unstable asthma. We examined the risk of a severe exacerbation in the per…

Efficacy of a House Dust Mite Sublingual Allergen Immunotherapy Tablet in Adults With Allergic Asthma: A Randomized Clinical Trial.

Importance The house dust mite (HDM) sublingual allergen immunotherapy (SLIT) tablet is a potential novel treatment option for HDM allergy–related asthma. Objectives To evaluate the efficacy and adverse events of the HDM SLIT tablet vs placebo for asthma exacerbations during an inhaled corticosteroid (ICS) reduction period. Design, Settings, and Participants Double-blind, randomized, placebo-controlled trial conducted between August 2011 and April 2013 in 109 European trial sites. The trial included 834 adults with HDM allergy–related asthma not well controlled by ICS or combination products, and with HDM allergy–related rhinitis. Key exclusion criteria were FEV 1 less than 70% of predicted…

Cabbage and fermented vegetables: from death rate heterogeneity in countries to candidates for mitigation strategies of severe COVID-19

International audience; Large differences in COVID-19 death rates exist between countries and between regions of the same country. Some very low death rate countries such as Eastern Asia, Central Europe, or the Balkans have a common feature of eating large quantities of fermented foods. Although biases exist when examining ecological studies, fermented vegetables or cabbage have been associated with low death rates in European countries. SARS-CoV-2 binds to its receptor, the angiotensin-converting enzyme 2 (ACE2). As a result of SARS-CoV-2 binding, ACE2 downregulation enhances the angiotensin II receptor type 1 (AT1 R) axis associated with oxidative stress. This leads to insulin resistance …