Impact of house dust mite-driven asthma on children's school performance and activity.

Evidence regarding asthma's impact on children's daily lives is limited. This prospective and cross-sectional, observational, multicenter study assessed school/work and activity impairment in children and adolescents with allergic asthma and their caregivers and allergen immunotherapy (AIT) effects. Included patients were schooled children and adolescents (5 to 17 years) with allergic asthma due to house dust mites (HDM). Impairment of school/work (i.e., absenteeism and presenteeism) and activity was measured in patients and their caregivers using the Work Productivity Impairment Questionnaire plus Classroom Impairment Questions: Allergy Specific (WPAI + CIQ:AS). HDM allergic patients with school impairment received subcutaneous AIT with a MicroCrystalline Tyrosine-associated allergoid. WPAI + CIQ:AS and effectiveness variables were compared between baseline and 1-year post-AIT. Of the 113 patients included, 59 (52.2%) and 51 (45.1%) showed school and activity impairment, respectively, missing a mean (SD) of 37.6 (24.4) % and 42.6 (25.6) % of school and activity time, respectively. Twenty-six (23%) caregivers reported activity impairment and, of the 79 (69.9%) employed, 30 (38%) reported work impairment. Of the 65 patients with school/activities impairment, 41 (63.1%) received AIT, of which 21 (51.2%) completed 1 year of treatment. Effectiveness variables and WPAI + CIQ:AS significantly improved: Mean (SD) school impairment decreased from 39.7 (26.7) to 2.1 (7.1) % (p < 0.001) and activity impairment from 46.2 (34.6) to 1.4 (3.6) % (p < 0.001). CONCLUSION: Allergic asthma due to HDMs results in school/work and activity impairment in children and adolescents and their caregivers. One year of AIT provided clinical benefits and reduced school and activity impairment. WHAT IS KNOWN: • Allergic asthma impairs children's school performance and daily activities. • Allergen immunotherapy modifies allergic disease course and ameliorates its symptoms. WHAT IS NEW: • Asthma symptoms due to allergy to house dust mites impair children's school attendance and productivity and daily activity and their caregivers' work performance and daily lives. • Allergen immunotherapy with a house dust mite MicroCrystalline Tyrosine (MCT)-associated allergoid seems to provide clinical benefits, associated with decreased school and activity impairment, supporting it as an effective treatment option.

Role of C-reactive protein as a biomarker for prediction of the severity of pulmonary exacerbations in patients with cystic fibrosis.

BACKGROUND: Pulmonary exacerbation is one of the main risk factors for death in patients with cystic fibrosis. Several biomarkers have proven useful in the diagnosis and treatment of pulmonary exacerbations, although none has been associated with severity. The objective of the present study was to investigate whether C-reactive protein (CRP) level was associated with the severity of pulmonary exacerbation requiring admission to hospital in patients with cystic fibrosis. METHODS: We designed a severity index for exacerbations based on 4 clinical parameters and determined whether there was an association between CRP levels and severity of the exacerbation. We also investigated the association between CRP and baseline functional and clinical variables. RESULTS: Twenty-seven patients with cystic fibrosis required 62 admissions to hospital. CRP levels were not significantly associated with the severity index, although they were associated with specific patient characteristics: colonization by Pseudomonas aeruginosa, allergic bronchopulmonary aspergillosis, treatment with oral corticosteroids, and number of severe exacerbations treated with intravenous antibiotics during the previous year. CONCLUSIONS: CRP level is not associated with the severity of pulmonary exacerbations, but it is associated with specific clinical characteristics. This simple scoring system (severity index) could prove very useful for evaluating the severity of exacerbations.

Effectiveness and safety of a microcrystalline tyrosine-adjuvanted Dermatophagoides pteronyssinus allergoid immunotherapy in adult patients with allergic asthma and rhinitis: A real-life prospective observational study.

INTRODUCTION: Although clinical trials have shown the efficacy and safety of allergen-specific immunotherapy (AIT) in the treatment of allergic asthma, there is a need for real-life studies. We aimed to assess the effectiveness and safety of a microcrystalline tyrosine-adjuvanted Dermatophagoides pteronyssinus allergoid (Acarovac Plus®) in patients with house dust mite (HDM)-induced allergic asthma in a real-life study. METHODS: A subanalysis of a multicenter, prospective, observational, real-life study. Patients with rhinitis and allergic asthma caused by HDMs were assessed before AIT with Acarovac Plus® and at 6 and 12 months after this treatment. Assessment parameters were percentage of days with asthma symptoms, percentage of days on asthma medication, classification of asthma according to Spanish guidelines for the management of asthma, asthma-related quality of life (quality of life in adults with asthma questionnaire [QLAAQ]), perception of symptoms (visual analog scale [VAS]), and treatment satisfaction (treatment satisfaction questionnaire for medication [TSQM]). Safety was assessed by the number and severity of adverse reactions. RESULTS: This subanalysis included 55 patients. Treatment with Acarovac Plus® showed significant differences in the analyzed variables when the baseline visit was compared with the 12-month visit: reduction of the mean (SD) percentage of days with asthma symptoms (23.9 [9.2] vs. 5.1 [12.8]; p = .002), of the mean [SD] percentage of days on asthma medication (67.6 [42.9] vs. 45.1 [46.8]; p = .002), and of the percentage of patients with persistent asthma (78.2% vs. 38.9%; p = .009). Acarovac Plus® significantly improved asthma-related quality of life, as shown by a decrease of 1.39 points in QLAAQ score at 12 months (p < .001), and in the subjective perception of symptoms on the VAS (-3.50, p < .0001). Patients showed high treatment satisfaction according to the TSQM, and it was well tolerated. No serious adverse events were reported. CONCLUSIONS: Acarovac Plus® was effective and safe for the treatment of patients with HDM-induced allergic asthma in a real-life study.

Diagnosis and treatment of grass pollen-induced allergic rhinitis in specialized current clinical practice in Spain.

Allergic rhinitis (AR) is the leading cause of consultation at the allergy specialist's office, but detailed, reliable, and validated clinical data on this condition are limited. This study was designed to define the clinical features, diagnostic methods, and therapeutic approaches of patients with AR induced by grass pollen in Spain. Two hundred twelve specialists participated in a multicenter, observational, epidemiologic, questionnaire-based study. Each investigator had to recruit at least two patients consulting for the first time and with a diagnosis of AR induced by grass pollen. Five hundred twenty-four patients (52% men; mean age, 29.3 years) with grass pollen-induced rhinitis (mean disease duration, 8.7 years) were recruited. Just 18.4% of patients reported that their symptom status had improved since the beginning of the condition, 89.4% had moderate-severe rhinitis (Allergic Rhinitis and Its Impact on Asthma classification) and 35.1% had concomitant bronchial asthma. For 52.1% of patients, control of symptoms with previous drug treatment was poor. Most of the patients were polysensitized to other pollens (sensitization to olive tree pollen, 57.1%). Oral antihistamines (97.3%) and nasal corticosteroids (82.3%) were the most frequently prescribed drugs and 43.1% of patients received specific immunotherapy. The clinical profile for the majority of Spanish patients consulting an allergy specialist for AR induced by grass pollen corresponds to a young adult with a lengthy moderate-severe rhinitis, often accompanied by bronchial asthma. Their symptoms progressively worsen and rhinitis is poorly controlled by symptomatic treatment. Oral antihistamines and nasal corticosteroids are the most frequently used therapeutic approaches and less than one-half receive specific immunotherapy.

Immunological parameters as biomarkers of response to MicroCrystalline Tyrosine-adjuvanted mite immunotherapy.

BACKGROUND: Despite the effectiveness of allergen immunotherapy (AIT), some patients are unresponsive for reasons still unknown; yet validated response biomarkers remain unavailable. OBJECTIVE: To analyze immunological parameters as biomarkers to monitor and predict clinical response to a MicroCrystalline Tyrosine-adjuvanted house dust mite (HDM) AIT in patients with allergic rhinitis (AR). METHODS: Observational, prospective, multicenter study including adult patients (aged 18-65 years) with AR, with and without asthma, sensitized to the HDM Dermatophagoides pteronyssinus (DP) and prescribed Acarovac Plus® DP 100% in the routine practice. Serum concentrations of total IgE, specific IgE, specific IgG4, IL-4, IL-5, IL-10, IL-13, and IFN-γ were compared between baseline and 12 months after AIT. The relationship between patients' baseline immunological profiles and classification as low, high, and non-responders and between their sensitization profile to DP allergens and effectiveness were analyzed. RESULTS: Of 141 patients recruited, 118 (mean [SD] age of 33.6 [9.5] years) were evaluable. One year after treatment, Der p 1-specific IgE, DP-specific IgG4, and IL-10 increased by a mean (SD) of 3.4 (13.6) kU/L (p = 0.016), 0.43 (0.55) mg/L (p < 0.0001), and 1.35 (7.56) pg/mL (p = 0.033), respectively. Non-responders showed increased baseline levels of IL-13 compared to high responders (p = 0.037). Changes in effectiveness variables between baseline and after AIT were similar regardless of the sensitization profile. CONCLUSION: Non-responsive patients to AIT showed increased baseline IL-13 concentrations, suggesting its value as prognostic biomarker. DP-specific AIT increased Der p 1-specific IgE, DP-specific IgG4, and IL-10 concentrations in patients with AR. All patients benefited from treatment regardless of their sensitization profile to major DP allergens.

Real-life effect of a microcrystalline tyrosine adjuvanted mite immunotherapy in patients with allergic rhinitis.

Aim: Evaluate the effectiveness and safety of immunotherapy with Acarovac Plus® in a 1-year prospective multicentered real-life study. Methods: A total of 118 adults with allergic rhinitis sensitized to Dermatophagoides received subcutaneous immunotherapy with Acarovac Plus. Treatment outcomes were evaluated at baseline, 6 months and 1 year after treatment initiation. Primary end point was the evolution of the combined symptom and medication score. Secondary end points included other effectiveness outcomes and measurement of product tolerability. Results: Acarovac Plus induced significant improvements in primary and secondary end points after 6 months compared with baseline. These differences persisted after 1 year of treatment (p < 0.001; baseline vs 1 year): combined symptom and medication score (1.60 vs 0.79). No serious adverse events were recorded. Conclusion: Acarovac Plus for 1 year was effective and well tolerated in a real-life setting.

Safety and effectiveness of a microcrystalline tyrosine-associated mite extract immunotherapy for allergic rhinitis.

Aim: To assess the safety and effectiveness of an allergen immunotherapy (AIT) with a microcrystalline tyrosine-associated mite allergoid in real-world patients with allergic rhinitis (AR). Materials & methods: Retrospective, multicenter study assessing the safety of AIT in patients aged 5 to 65 years with AR, with or without asthma, sensitized to mites. Secondary objective was effectiveness, measured as unscheduled visits to healthcare centers and emergency rooms, rhinitis and asthma evolution, medication use and patients' and physicians' disease perception 12 months before and after treatment. Results: The 306 patients evaluated, with a mean (standard deviation) age of 29.68 (14.66) years, received different treatment compositions and regimens, and 25 (8.2%) experienced nonserious adverse reactions. Unscheduled visits to the specialist and emergency room admissions significantly decreased after immunotherapy (mean [standard deviation] 2.11 [1.95] and 0.3 [0.93] vs 0.66 [1.09] and 0.02 [0.2], before and after treatment, respectively). Rhinitis and asthma classification ('AR and its impact on asthma' and 'Guía Española para el Manejo del Asma', respectively) significantly changed (p < 0.0001 for all classifications), showing symptom reduction after AIT. Median (interquartile range)-combined rhinitis and combined asthma medication scores significantly decreased (4.0 [1.33, 7.0] vs 0.25 [0, 10.0]; p < 0.0001 and 6.94 [1.5, 6.0] vs 0.67 [0, 4.67]; p < 0.0001) within 12 months before and after starting AIT, respectively. Conclusion: AIT with microcrystalline tyrosine-associated mite allergoid appears to be safe and effective in treating rhinitis caused by mites.

Is faster safer? Cluster versus short conventional subcutaneous allergen immunotherapy.

AIM: Few studies have compared cluster immunotherapy and conventional administration regimens. The aim of this study was to establish the safety profile of these different regimens in patients with allergic respiratory diseases who received index-of-reactivity (IR)-standardized allergen extracts by the subcutaneous route. MATERIALS & METHODS: The safety of subcutaneous immunotherapy (SCIT), administered by means of a 4-week cluster titration schedule (cluster-SCIT) or by an 8-week short conventional titration schedule (SC-SCIT), both with a target dose of 8 IR, was assessed in a retrospective, observational, multicenter study. RESULTS: A total of 658 patients (339 cluster-SCIT and 319 SC-SCIT) were recruited from 92 sites in Spain. Injection site reactions occurred in 25.1 and 27.3% of patients treated with cluster-SCIT and SC-SCIT, respectively. Systemic reactions (European Academy of Allergy and Clinical Immunology criteria) were reported for 0.2% of doses and 1.5% of patients with cluster-SCIT, and 0.7% of doses and 4.4% of patients with SC-SCIT. Most reactions were mild and there were no grade 3 or 4 systemic reactions. No life-threatening systemic reactions, anaphylactic shock, or adverse events leading to therapy discontinuation were reported. CONCLUSION: The safety profile of the cluster regimen supports the use of accelerated SCIT schedules with IR-standardized allergen extracts compared with short conventional schedules, particularly if similar extracts and application methods are used.

Diagnosis and treatment of allergic rhinitis due to house-dust mites in Spain.

BACKGROUND: The prevalence of allergic rhinitis due to house-dust mites (HDMs) is high and increasing. Treatment guidelines and consensus statements are available, but few data exist on how these are followed in clinical practice in Spain. This study was designed to collect data on diagnosis and treatment of allergic rhinitis due to HDMs and adherence to guidelines in Spanish specialized clinical practice. METHODS: In this observational study, patients referred to specialists for a first consultation were collected. Diagnosis of allergic rhinitis due to HDMs was confirmed by skin-prick tests and measurement of specific immunoglobulin E levels. Variables included patient demographics, diagnosis, and treatment. Moreover, investigators answered a questionnaire on their attitudes to allergic rhinitis treatment. RESULTS: Two hundred forty-seven clinicians collected evaluable data from 519 patients (mean age, 24.8 years; SD, 11.9 years; 54% women) with confirmed allergic rhinitis (86.2% with moderate or severe disease and 70.5% with persistent disease; 40% with concomitant asthma) caused by Dermatophagoides. In 85.6% of patients, symptoms had not improved since diagnosis and good disease control was only being achieved in 43.4%. At the study visit, pharmacologic treatment was prescribed in 98.3% and allergen immunotherapy was prescribed in 52.2% of patients. CONCLUSION: When patients with HDM-induced allergic rhinitis are referred to an allergy specialist in Spain, they have moderate-to-severe persistent disease and are generally not achieving good control with symptomatic treatment. Allergen immunotherapy is prescribed in approximately one-half of patients. In this representative sample of Spanish allergy specialists, the level of adherence to clinical guidelines in these patients is encouraging.

Safety evaluation of rapid build-up schedules with IR-standardized allergen extracts for subcutaneous immunotherapy of allergic respiratory diseases.

INTRODUCTION: The conventional schedule used in specific subcutaneous immunotherapy (SCIT) is a slow treatment that often leads to poor compliance or discontinuation of treatment. These disadvantages have led to design administration schedules that shorten the build-up phase without increasing the adverse reactions rate. AREAS COVERED: This report reviews the available scientific documentation of the safety profile of build-up schedules for SCIT with Alustal Rapid® (a suspension of standardized allergen extracts adsorbed on aluminum hydroxide gel for specific immunotherapy) in the treatment of IgE-mediated rhinitis, conjunctivitis and bronchial asthma to inhaled allergens. EXPERT OPINION: Cluster and shortened conventional schedules may offer a safe method of SCIT for the treatment of respiratory allergy and reduce the inconvenience associated with conventional schedules by reaching the maintenance dose in less time and with fewer visits; thereby this method could reduce discontinuation rates and increase compliance.

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.