SQ HDM sublingual immunotherapy tablet for the treatment of HDM allergic rhinitis and asthma improves subjective sleepiness and insomnia: an exploratory analysis of the real-life CARIOCA study.

BACKGROUND AND OBJECTIVE: There are still gaps in the knowledge regarding the effectiveness of house dust mite (HDM) sublingual immunotherapy (SLIT) on allergic rhinitis (AR) and asthma (AA)-associated sleep disorders. A non-interventional study was conducted to assess the effect of the Standardized quality (SQ) HDM SLIT-tablet on safety and symptoms in adults with HDM respiratory allergies. The aim was to describe the status of insomnia and daytime sleepiness in AR and/or AA patients treated with the SQ HDM SLIT-tablet. METHODS: This was a 12-month multicenter, longitudinal and prospective study. Participants started the SQ HDM SLIT-tablet for moderate-to-severe HDM AR, persistent despite the use of symptom-relieving medication; or HDM AA not well controlled by inhaled corticosteroids and associated with mild-to-severe HDM AR. Sleep symptoms were measured using the Insomnia Severity Index (ISI) questionnaire and the Epworth Sleepiness Scale (ESS). RESULTS: A total of 1,526 adult patients were enrolled and 1,483 were included in the analysis. At baseline, 41.5% of patients reported sleep disorders: 77.0% of them had insomnia and 28.9% suffered from excessive daytime sleepiness. Insomnia was significantly more frequent among patients with uncontrolled AR (83.1%) than those with controlled AR (52.6%) (p<0.0001). Over time, 48.3% and 59.7% of patients reported an improvement greater than the minimal clinically important difference on the ISI and ESS scales respectively. CONCLUSION: In patients with HDM AR and/or asthma associated sleep disorders, an improvement in subjective insomnia and sleepiness was observed after one year of treatment with the SQ HDM SLIT-tablet in a real-life setting.

Update about Oralair® as a treatment for grass pollen allergic rhinitis.

Sublingual immunotherapy (SLIT) is a well-tolerated, safe, and effective approach to treating allergic rhinitis (AR). Oralair® is a five-grass pollen SLIT tablet containing natural pollen allergens from five of the major grass species responsible for seasonal AR due to grass pollen allergy. Recommended use is in a pre-coseasonal regimen, starting daily treatment approximately 4 months before the start of the pollen season, with treatment then continued daily throughout the season; treatment should continue for 3-5 y. Clinical efficacy and safety of Oralair® in patients with grass pollen-induced AR has been demonstrated in a comprehensive clinical development program of randomized controlled trials. Effectiveness has been substantiated in subsequent observational studies with sustained efficacy following treatment cessation and a favorable level of adherence, quality of life, benefit, and satisfaction for the patients. Supportive evidence for a benefit in reducing the risk or delaying the development of allergic asthma is emerging.

Essential oils: what is the clinical tolerance in asthmatic patients?

Essential oils in air-spray form are being more and more used for several purposes, even by allergic and asthmatic patients. Available data on the potentially dangerous effects of volatile organic compounds and terpenes contained in essential oils are scarce, and sometimes difficult to compare. Through the present work, we evaluated the clinical tolerance of asthmatic patients exposed to compounds emitted by an essential oils spray, and compared previous and new data available in the scientific literature, focusing on the aspects that may influence clinical results.

[Anaphylaxis and COVID-19 vaccines]. / L'anaphylaxie et les vaccins COVID-19.

Vaccines against COVID-19 are an essential global intervention to control the current pandemic situation. Anaphylactic reactions have rapidly been reported after SARS-CoV2 RNA vaccines. This risk is now measured at 2.5-11/1,000,000 in the context of vaccine safety surveillance programs and only one case was documented to be due to polyethylene glycol. Suggestions for its role are indirect. The COVID-19 vaccination is rolling out vastly and surveillance programs are key to monitor severe adverse reactions, such as anaphylaxis. It is important to restore confidence about vaccination with COVID-19 mRNA and other vaccines and current data confirm their safety with no greater mortality than previous vaccines. Anaphylaxis is a complication that should be recognized immediately, be treated with epinephrine and which is not limiting and allows re-vaccination of some patients with pre-medication. It is important to recognize populations at risk such as women, patients with a history of allergies and anaphylaxis and to recognize the rare patients who have mast cell activating diseases. Anaphylaxis due to vaccine is extremely rare and specific cases should receive individualized investigation and care, highlighting the key role of allergists in the vaccination programmes.

[The allergist facing the COVID-19 pandemic: What impact and what precautions should be taken?] / L'allergologue face à l'épidémie de COVID-19 : quel impact et quelles précautions prendre ?

In the unusual health environment of the COVID 19 pandemic, allergists must adapt their exercise and their office or clinic, by strengthening hygiene and distancing precautions. In case of sanitary containment telehealth can, in many cases, replace face-to-face visits. Nevertheless, each practitioner must define the contingency planning and the priorities according to his own practice and the epidemic context.

Action Plan to Ensure Global Availability of Adrenaline Autoinjectors.

Adrenaline (epinephrine) is the first-line treatment for anaphylaxis and, therefore, is listed as an essential medication for the treatment of anaphylaxis by the World Health Organization (WHO). However, the availability of adrenaline autoinjectors (AAI) for use as first-aid treatment is limited to only 32% of all the world's 195 countries, most of which are high-income countries. The key issues leading to the lack of availability of AAIs include cost, national regulations, lack of regional evidence on the value of epinephrine, and limited accurate data about the epidemiology of anaphylaxis. For these reasons, regional and international allergy academies support initiatives to narrow these gaps. Our WHO Collaborating Centre is deeply involved in this process. This document aims to serve as a baseline to ensure the following: (1) adequate access to affordable autoinjectors for all patients/societies; and (2) the development of disease-/patient-specific approaches. Therefore, we propose a 5-step action plan that aims to gather accurate epidemiological data on anaphylaxis and autoinjector consumption, confirm partnerships, strengthen awareness, and include AAIs in the WHO Model List of Essential Medicines. These aspects should be considered in combination. A prioritized research agenda should encapsulate all these steps within the framework a global initiative against anaphylaxis. More than calling for universal availability of autoinjectors for optimal management of anaphylaxis, we propose an action plan as the baseline for a global initiative against anaphylaxis. We strongly believe that combined efforts will ensure a strong public health and societal approach that will lead to optimal care of allergic patients and best practices in allergology.

Contraindications to immunotherapy: a global approach.

BACKGROUND: Recommendations on contraindications to allergen immunotherapy (AIT) have been independently developed by National and International Societies/Academies. AIT contraindications are mainly based on case reports, case-series, or experts' opinion, while evidence-based information is limited. The aim of the present review was to describe existing guidelines on contraindications to AIT and to highlight differences between them. MAIN BODY: An extended review of the literature regarding contraindications to AIT for respiratory allergy and venom hypersensitivity was performed. Furthermore, Societies and Academies registered in the World Allergy Organization and EAACI databases, were asked for additional information. Only AIT guidelines published under official auspicies were included. A large heterogeneity among the various recommendations on contraindications was registered. Common contraindications to most of the guidelines were: lack of adherence, pregnancy before the start of AIT, the use of beta-blockers, certain age groups, uncontrolled asthma, autoimmune diseases and malignancies. CONCLUSION: As new data arise, revisions might soon be needed allowing AIT in the cases of patients treated with ACE inhibitors and beta-blockers, in elderly patients and in patients with concomitant autoimmune diseases and neoplasias in remission. The decision to prescribe AIT is always tailor-made, balancing risk vs benefit. Creating globally accepted guidelines would help Allergologists in their decision making.

Epidemiological Data on Anaphylaxis in French Emergency Departments.

BACKGROUND: Although anaphylaxis has been considered a priority public health issue in the world allergy community, epidemiological data on morbidity and mortality remain suboptimal. We performed the first multicenter epidemiological study in French emergency departments (EDs). The study covered 7 EDs over a period of 1 year. The objectives were to identify areas that are amenable to change and to support ongoing national and international efforts for better diagnosis, management, and prevention of anaphylaxis. METHODS: Ours was a descriptive study based on data routinely reported to French institutional administrative databases from 7 French public health institutions in the Lorraine region between January and December 2015. Data were collected based on the anaphylaxisrelated codes of the International Classification of Diseases (ICD)-10, and cases were clinically validated as anaphylaxis. RESULTS: Of the 202 079 admissions to the EDs, 4817 had anaphylaxis-related codes; of these, 323 were clinically validated as anaphylaxis. Although 45.8% were severe, adrenaline was prescribed in only 32.4% of cases. Of the 323 cases, 57.9% were subsequently referred for an allergy work-up or evaluation (after or during hospitalization), and 17.3% were prescribed autoinjectable epinephrine. CONCLUSION: Our results highlight an urgent need for improved public health initiatives with respect to recognition and treatment of anaphylaxis. We flag key problems that should be managed in the coming years through implementation of national and international actions.

Prevalence of self-reported drug hypersensitivity reactions among Lithuanian children and adults.

INTRODUCTION AND OBJECTIVES: Drug hypersensitivity reactions (DHRs) are the adverse effects of drugs that, when taken at doses generally tolerated by normal subjects, clinically resemble allergy. We aimed to assess the prevalence of self-reported DHRs among Lithuanian children and adults and to identify possible risk factors. MATERIALS AND METHODS: A cross-sectional survey of a population visiting their general practitioners in Vilnius and Kaunas regions of Lithuania was performed. Thirty-five questions on drug allergy symptoms, in addition, food, pollen allergy and family history were included. RESULTS: 3222 (60.0%) children and 2148 (40.0%) adults were included in the study. 7.9% of children and 13.8% of adults reported a DHR for at least one drug (p<0.001). 69.8% of children and 47.3% of adults, who indicated DHRs, had skin symptoms. Rate of anaphylaxis was similar in both groups (about 10%). 4.5% of children and 7.3% of adults had DHRs induced by antibiotics and this was the most implicated group of drugs. Significant self-reported risk factors for DHRs were family history of DHRs (OR=6.007, 95%CI 4.756-7.587), pollen allergy (OR=2.0, 95%CI 1.573-2.544), food allergy (OR=1.92, 95%CI 1.505-2.448), female gender (OR=1.439, 95%CI 1.187-1.744) and age (OR=1.017 in favour of adults, 95%CI 1.013-1.021). CONCLUSIONS: The prevalence of self-reported DHRs in Lithuania is higher among adults than children. Drug-induced skin reactions were the predominant symptom in both groups. Besides female gender and age, a positive family history of DHR and presence of pollen or food allergy may be associated with DHR.

[Omalizumab and allergen immunotherapy: A clinical report and review of the literature]. / Omalizumab et immunothérapie allergénique : cas clinique et revue de la littérature.

INTRODUCTION: Several authors have proposed combined omalizumab and allergen immunotherapy (AIT) in patients suffering from severe allergic asthma to both increase disease control and decrease the severity through targeting the main allergen responsible for the respiratory symptoms. OBSERVATION: In a female pediatric patient suffering from severe asthma, followed-up at the University Hospital of Montpellier (France), we prescribed an AIT to Alternaria after obtaining symptom control with omalizumab. The patient showed an overall improvement in symptoms after AIT was administered and the disease remained controlled long after cessation of omalizumab. CONCLUSIONS: There are only a few publications evaluating the efficacy of the association of these two biotherapies in the management of severe allergic asthma. In addition there is, as yet, no common protocol for the administration of the two prescriptions. This approach to treatment would benefit from standardization in order to optimize the management of severe allergic asthma.

MASK 2017: ARIA digitally-enabled, integrated, person-centred care for rhinitis and asthma multimorbidity using real-world-evidence.

mHealth, such as apps running on consumer smart devices is becoming increasingly popular and has the potential to profoundly affect healthcare and health outcomes. However, it may be disruptive and results achieved are not always reaching the goals. Allergic Rhinitis and its Impact on Asthma (ARIA) has evolved from a guideline using the best evidence-based approach to care pathways suited to real-life using mobile technology in allergic rhinitis (AR) and asthma multimorbidity. Patients largely use over-the-counter medications dispensed in pharmacies. Shared decision making centered around the patient and based on self-management should be the norm. Mobile Airways Sentinel networK (MASK), the Phase 3 ARIA initiative, is based on the freely available MASK app (the Allergy Diary, Android and iOS platforms). MASK is available in 16 languages and deployed in 23 countries. The present paper provides an overview of the methods used in MASK and the key results obtained to date. These include a novel phenotypic characterization of the patients, confirmation of the impact of allergic rhinitis on work productivity and treatment patterns in real life. Most patients appear to self-medicate, are often non-adherent and do not follow guidelines. Moreover, the Allergy Diary is able to distinguish between AR medications. The potential usefulness of MASK will be further explored by POLLAR (Impact of Air Pollution on Asthma and Rhinitis), a new Horizon 2020 project using the Allergy Diary.

Geolocation with respect to personal privacy for the Allergy Diary app - a MASK study.

BACKGROUND: Collecting data on the localization of users is a key issue for the MASK (Mobile Airways Sentinel networK: the Allergy Diary) App. Data anonymization is a method of sanitization for privacy. The European Commission's Article 29 Working Party stated that geolocation information is personal data.To assess geolocation using the MASK method and to compare two anonymization methods in the MASK database to find an optimal privacy method. METHODS: Geolocation was studied for all people who used the Allergy Diary App from December 2015 to November 2017 and who reported medical outcomes. Two different anonymization methods have been evaluated: Noise addition (randomization) and k-anonymity (generalization). RESULTS: Ninety-three thousand one hundred and sixteen days of VAS were collected from 8535 users and 54,500 (58.5%) were geolocalized, corresponding to 5428 users. Noise addition was found to be less accurate than k-anonymity using MASK data to protect the users' life privacy. DISCUSSION: k-anonymity is an acceptable method for the anonymization of MASK data and results can be used for other databases.

Daily allergic multimorbidity in rhinitis using mobile technology: A novel concept of the MASK study.

BACKGROUND: Multimorbidity in allergic airway diseases is well known, but no data exist about the daily dynamics of symptoms and their impact on work. To better understand this, we aimed to assess the presence and control of daily allergic multimorbidity (asthma, conjunctivitis, rhinitis) and its impact on work productivity using a mobile technology, the Allergy Diary. METHODS: We undertook a 1-year prospective observational study in which 4 210 users and 32 585 days were monitored in 19 countries. Five visual analogue scales (VAS) assessed the daily burden of the disease (i.e., global evaluation, nose, eyes, asthma and work). Visual analogue scale levels <20/100 were categorized as "Low" burden and VAS levels ≥50/100 as "High" burden. RESULTS: Visual analogue scales global measured levels assessing the global control of the allergic disease were significantly associated with allergic multimorbidity. Eight hypothesis-driven patterns were defined based on "Low" and "High" VAS levels. There were <0.2% days of Rhinitis Low and Asthma High or Conjunctivitis High patterns. There were 5.9% days with a Rhinitis High-Asthma Low pattern. There were 1.7% days with a Rhinitis High-Asthma High-Conjunctivitis Low pattern. A novel Rhinitis High-Asthma High-Conjunctivitis High pattern was identified in 2.9% days and had the greatest impact on uncontrolled VAS global measured and impaired work productivity. Work productivity was significantly correlated with VAS global measured levels. CONCLUSIONS: In a novel approach examining daily symptoms with mobile technology, we found considerable intra-individual variability of allergic multimorbidity including a previously unrecognized extreme pattern of uncontrolled multimorbidity.

Treatment of allergic rhinitis using mobile technology with real-world data: The MASK observational pilot study.

BACKGROUND: Large observational implementation studies are needed to triangulate the findings from randomized control trials as they reflect "real-world" everyday practice. In a pilot study, we attempted to provide additional and complementary insights on the real-life treatment of allergic rhinitis (AR) using mobile technology. METHODS: A mobile phone app (Allergy Diary, freely available in Google Play and Apple App stores) collects the data of daily visual analog scales (VAS) for (i) overall allergic symptoms, (ii) nasal, ocular, and asthma symptoms, (iii) work, as well as (iv) medication use using a treatment scroll list including all medications (prescribed and over the counter (OTC)) for rhinitis customized for 15 countries. RESULTS: A total of 2871 users filled in 17 091 days of VAS in 2015 and 2016. Medications were reported for 9634 days. The assessment of days appeared to be more informative than the course of the treatment as, in real life, patients do not necessarily use treatment on a daily basis; rather, they appear to increase treatment use with the loss of symptom control. The Allergy Diary allowed differentiation between treatments within or between classes (intranasal corticosteroid use containing medications and oral H1-antihistamines). The control of days differed between no [best control], single, or multiple treatments (worst control). CONCLUSIONS: This study confirms the usefulness of the Allergy Diary in accessing and assessing everyday use and practice in AR. This pilot observational study uses a very simple assessment (VAS) on a mobile phone, shows novel findings, and generates new hypotheses.

Current practice of allergy diagnosis and the potential impact of regulation in Europe.

In the European Union (EU), the regulatory framework regarding diagnostic allergen extracts is currently in the process of being implemented at the national level. Due to these regulations, the initial and periodic renewal expenses for the registration of diagnostic allergen extracts may render extract production unprofitable. Consequently, many extracts may be at risk of removal from the market. The current survey, which was conducted by a task force of the European Academy of Allergy and Clinical Immunology, aimed to assess the current practice of allergy diagnosis in Europe. This survey revealed that skin tests continue to be the main diagnostic procedure and are used as the first option in almost two-third of all types of allergic diseases and in 90% of individuals suffering from respiratory allergies. Therefore, there is a need to ensure the availability of high-quality allergen extracts to maintain the common diagnostic procedures used by EU professionals. To reach this goal, it is necessary to align efforts and establish active partnerships between manufacturers, relevant scientific societies, consumer organizations and authorities to maintain the availability of these diagnostic tools.