Shared Decision-Making in Allergen Immunotherapy (AIT) Options Using a Questionnaire for Respiratory Allergic Patients: A Delphi Consensus Study.

Purpose: The objective of this study was to develop and validate a questionnaire, through a Delphi consensus, to be used by allergists in their routine clinical practice to assess the preferences of patients starting allergen immunotherapy (AIT) treatment using an objective approach. Patients and Methods: A Delphi consensus-driven process was used. The scientific committee, composed of 15 allergists, led the study and participated in the preparation of the questionnaire. Two-hundred panelists from different Spanish regions were invited to complete a 16-item questionnaire on a nine-point Likert scale covering six topic blocks. Consensus was achieved if ≥66.6% of panelists reached agreement or disagreement. Results: Of the 200 experts invited to participate in the Delphi process, a total of 195 (97.5%) answered the questionnaire. The panel experts reached a consensus on "agreement" on a total of 12 of the 16 (75.0%) items, covering a total of six categories: (a) patient knowledge (2 questions), (b) barriers to patient adherence (3 questions), (c) patient behavior (4 questions), (d) future actions (3 questions), (e) treatment costs (2 questions), and (f) final patient preferences (2 questions). Conclusion: This Delphi consensus study validated a set of twelve recommended questions for patients objectively assessing their preferences and suitability for the most common AIT options available. The questionnaire intends to assist allergists in making an objective, unconditioned decision regarding the best AIT option for each patient, after informing them about the different routes.

First-in-human phase 2 trial with mite allergoids coupled to mannan in subcutaneous and sublingual immunotherapy.

BACKGROUND: Polymerized allergens conjugated to non-oxidized mannan (PM-allergoids) are novel vaccines targeting dendritic cells (DCs). Previous experimental data indicate that PM-allergoids are readily taken up by DCs and induce Treg cells. This first-in-human study was aimed to evaluate safety and to find the optimal dose of house dust mite PM-allergoid (PM-HDM) administered subcutaneously (SC) or sublingually (SL). METHODS: In a randomized, double-blind, double-dummy, placebo-controlled trial, 196 subjects received placebo or PM-HDM at 500, 1000, 3000, or 5000 mannan-conjugated therapeutic units (mTU)/mL in 9-arm groups for 4 months. All subjects received 5 SC doses (0.5 ml each) every 30 days plus 0.2 ml SL daily. The primary efficacy outcome was the improvement of titrated nasal provocation tests (NPT) with D. pteronyssinus at baseline and at the end of the study. All adverse events and reactions were recorded and assessed. Secondary outcomes were the combination of symptom and medication scores (CSMS) and serological markers. RESULTS: No moderate or severe adverse reactions were reported. Subjects improving the NPT after treatment ranged from 45% to 62% in active SC, 44% to 61% in active SL and 16% in placebo groups. Statistical differences between placebo and active groups were all significant above 500 mTU, being the highest with 3000 mTU SL (p = 0.004) and 5000 mTU SC (p = 0.011). CSMS improvement over placebo reached 70% (p < 0.001) in active 3000 mTU SC and 40% (p = 0.015) in 5000 mTU SL groups. CONCLUSIONS: PM-HDM immunotherapy was safe and successful in achieving primary and secondary clinical outcomes in SC and SL at either 3000 or 5000 mTU/ml.

Allergic rhinitis causes loss of smell in children: The OLFAPEDRIAL study.

BACKGROUND: The objective of the OLFAPEDRIAL study was to assess the olfactory dysfunction in allergic paediatric population, which has been scarcely studied. METHODS: Observational, cross-sectional and multicentre study evaluated the sense of smell in untreated allergic rhinitis (AR) paediatric patients aged 6-12 years. RESULTS: Forty-four per cent (551 of 1260) of children with AR reported smell dysfunction, with both loss of smell frequency (52.1%, p < 0.001) and intensity (0.75 ± 0.84, p < 0.0001) being more frequent in patients with persistent than intermittent AR (38.0% and 0.51 ± 0.73, respectively). In addition, both loss of smell frequency and intensity increased according to disease severity (m-ARIA classification) but always being significantly higher in persistent (p < 0.0001) than in intermittent AR. CONCLUSIONS: Children with allergic rhinitis present a mild-moderate loss of smell frequency and intensity which is clearly related to the disease duration and severity. The loss of smell can be considered, as in adults, a clinical marker of disease severity.

Analysis of comorbidities and therapeutic approach for allergic rhinitis in a pediatric population in Spain.

BACKGROUND: Allergic rhinitis (AR) is the most common chronic disease in children. The main objective of this study was to analyze the comorbidities and therapeutic approaches for AR in a Spanish pediatric population. METHODS: Children aged 6 to 12 years with AR were included in an observational, cross-sectional, multicenter study. RESULTS: 1,275 children were recruited from 271 centers. AR was intermittent in 59.5% of cases, persistent in 40.5%, seasonal in 60.7%, and perennial in 39.3% of patients. The most frequent comorbidities were conjunctivitis (53.6%), asthma (49.5%), atopic dermatitis (40%), rhinosinusitis(26.1%), otitis media (23.8%), and adenoid hypertrophy (17.3%). Overall, patients with persistent, moderate or severe, AR were more likely to present comobidities, except for food allergy and urticaria. The most common drugs used for treatment of AR were oral antihistamines(76%), nasal corticosteroids(49%) and a combination of both (45%). Antihistamines and nasal corticosteroids were used on demand (<18 days) in 38 and 41% of patients, respectively; for 18-30 days in 22 and 27%; for 1-3 months in 31 and 29%; and for more than 3 months in 8 and 3%, respectively. Eye drops were used in 32% and specific immunotherapy in 21% of patients. CONCLUSION: Comorbidities are frequent in children with AR, supporting the notion of allergy as a systemic disease. Severity and duration of AR were significantly associated with presence of most of comorbidities. The most common drugs used for AR treatment were oral antihistamines, followed by nasal corticosteroids and a combination of both used on demand.

Bilastine for the treatment of urticaria.

INTRODUCTION: Urticaria is a highly prevalent disease among people. First-choice treatment continues to be centred on the second-generation H1 antihistamines, including a wide group of drugs with a better therapeutic index (or risk:benefit ratio) than the classic ones, even in the high, off-label dosage occasionally required in chronic urticaria. Bilastine is a newly registered H1-antihistamine for treatment of allergic rhinoconjunctivitis and urticaria. With established antihistaminic and antiallergic properties, it is widely reviewed in the medical literature; however, to our knowledge, a specific review of bilastine's role in the treatment of urticaria was lacking. AREAS COVERED: This article reviews the medical literature on the effectiveness and safety of bilastine in urticarial syndromes, either spontaneous or inducible, by means of a Medline search from 1990 to present, completed with some nonpublished data provided by the manufacturer. EXPERT OPINION: Once-daily treatment with bilastine 20 mg is effective in managing symptoms and improving patient's quality of life in chronic urticaria, with at least comparable efficacy to levocetirizine. As far as studies in healthy volunteers, clinical assays, and recent clinical experience can establish, bilastine's safety profile is adequate, appearing to be entirely free from cardiovascular effects, and not impairing psychomotor performance or actual driving, even at twice the therapeutic dose.

Aeroallergen sensitization influences quality of life and comorbidities in patients with nasal polyposis.

BACKGROUND: Nasal polyposis (NP) is a chronic inflammatory disease of unknown etiology that impairs quality of life (QoL). The role of atopy in NP is not established. The aim of this study was to describe the clinical characteristics and QoL in a broad sample of patients with NP and to evaluate the influence of allergy on this disease. METHODS: A multicenter, observational, cross-sectional study was conducted in 67 allergy units in Spain. NP and nonsteroidal anti-inflammatory drug (NSAID) hypersensitivity were diagnosed following EP(3)OS guidelines. Rhinitis and asthma were classified following Allergic Rhinitis and Its Impact on Asthma and the Global Initiative for Asthma guidelines, respectively. Skin tests with a battery of aeroallergens were performed on all patients. A visual analog scale (VAS) and Short-Form 12 (SF-12) and 31-item Rhinosinusitis Outcome Measure (RSOM 31) questionnaires were completed by all the patients. RESULTS: Of the 671 patients included, 611 were evaluable. Mean age was 46 years and 50% of patients were men. Also, 50% were atopic. Asthma was present in 66% of patients and NSAID hypersensitivity was present in 26%. The most frequent symptoms were nasal congestion and rhinorrhea. Mean value of VAS was 58.6. Global health and bodily pain were the items most frequently identified in the SF-12 questionnaire and nasal and ocular symptoms in the RSOM-31 questionnaire. There was a good correlation between VAS score and QoL (p < 0.0001). Rhinitis was more severe in nonallergic patients. Asthma was more frequent in atopic patients, whereas ASA triad was more frequent in nonatopic patients. Atopic patients showed higher VAS scores and worse QoL. CONCLUSION: Atopic NP patients showed worse QoL, higher incidence of asthma and a less severe form of rhinitis than non-atopic patients.

Epidemiology of allergic rhinitis caused by grass pollen or house-dust mites in Spain.

BACKGROUND: Although the prevalence of allergic rhinitis (AR) is increasing, relatively little is known about patient characteristics in Spain. The aim of this study was to investigate the clinical profile and therapeutic strategies in patients attending Spanish specialists for AR caused by grass pollen or house-dust mites (HDMs). METHODS: This was a multicenter cross-sectional epidemiological study of consecutive patients aged ≥5 years with confirmed diagnosis of AR caused by grass pollen or HDMs attending allergy specialists throughout Spain. Demographic and clinical data and information on treatment were collected. RESULTS: Data from 1043 patients were analyzed (524 with grass pollen allergy and 519 with HDM allergy; mean age, 27.1 years). Three-quarters had persistent AR as per the Allergic Rhinitis and Its Impact on Asthma (ARIA) definition, with disease duration of >2 years in 94.3% of those with pollen allergy and 85.5% of those with HDM allergy. Approximately 38% had concurrent asthma. Over one-half of the patients were considered to have gotten worse since the first onset of symptoms. In total, 51.5% did not achieve good disease control with pharmacotherapy and 47.7% were treated with immunotherapy (52.2% of HDM allergic patients and 43.2% of grass pollen-allergic patients). CONCLUSION: The duration of AR in patients attended for the first time by specialists is long and, in general, the disease does not improve over time and is often not well controlled with pharmacologic interventions. Less than one-half of patients receive allergen-specific immunotherapy that is more often prescribed in HDM allergy.

Validation of ARIA (Allergic Rhinitis and its Impact on Asthma) classification in a pediatric population: the PEDRIAL study.

Allergic rhinitis (AR) is the commonest chronic disease in children. Allergic Rhinitis and its Impact on Asthma (ARIA) classification based on symptom duration (intermittent vs. persistent) and severity (mild vs. moderate/severe) has not been yet validated in children. Thus our objective was to validate ARIA classification in children, after determining the severity and duration of AR in a pediatric population, using ARIA definitions. Children aged 6-12 with a diagnosis of AR were included in an observational, cross-sectional, multicenter study. Patients were classified according to ARIA guidelines. AR symptoms were assessed using the Total Four Symptoms Score (T4SS). Severity was also evaluated by the patient using a visual analogue scale (VAS). Comparisons were made by means of a statistical analysis. One thousand two hundred and seventy-five children from 271 centers were included. Among them, 59.5% had intermittent and 40.5% persistent AR, while 60.7% seasonal and 39.3% perennial according to dated classification, with significant differences existing between one classification and another; 89.7% had moderate/severe rhinitis. Significantly higher T4SS and VAS scores were obtained in moderate/severe compared to mild AR. In our experience, the current ARIA classification can be considered a valid tool also in children from 6- to 12-yr old.

Validation of ARIA duration and severity classifications in Spanish allergic rhinitis patients - The ADRIAL cohort study.

INTRODUCTION: Allergic rhinitis (AR) is an increasingly prevalent worldwide disease, which has an important impact on quality of life and generates high social and health care costs. The ARIA classification, that considers both the duration and severity of AR, seems more appropriate than previous classifications of AR, but few studies exist on the validation of the severity criteria proposed by the ARIA classification. OBJECTIVES: To assess the ARIA duration and severity classification of AR in a large sample population of patients, by investigating whether different degrees of severity correlate with differences in symptom score, quality of life or the patient's self evaluation of impairment. This study also assesses the relationship between AR severity and co morbidities. MATERIAL AND METHODS: An observational, cross-sectional, multicentre study conducted in Spain. AR was classified based on the ARIA criteria, and compared to the classical classification based on allergen exposure. Rhinitis was evaluated by the Total 4-Symptom Score (T4SS) scale, quality of life was measured using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and disease severity through a Visual Analogue Scale (VAS, 0-100 mm). Comorbidities were evaluated based both on the duration and severity of the symptoms of rhinitis. RESULTS: AR patients, (n = 3,529; mean age 37.5 +/= 13.4 years; 52.3% women) were included in the study. AR patients were classified as intermittent (51.5%) and persistent (48.5%) based on the ARIA classification, and as seasonal (61.2%), perennial (35.1%), and occupational (3.7%) based on the allergen exposure classification. Significantly higher T4SS, RQLQ and VAS scores were obtained in moderate/severe compared to mild AR. The incidence of asthma was significantly higher in patients with persistent and moderate/severe AR compared to intermittent and mild AR. Asthma was the only co morbidity to reach statistical significance. CONCLUSION: ARIA classification of severity reflects two different statuses of AR in terms of symptoms and quality of life. Asthma was the only concomitant pathology in which incidence was related to ARIA categories in terms of duration or severity.