Patients’ perception in assessing allergen immunotherapy

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Prevalence and incidence of reactions to insect stings in children: a reappraisal.

AIM: The prevalence of systemic reactions (SR) to Hymenoptera stings in children was estimated in values lower than 1% in early studies but much higher in recent surveys. We evaluated the current prevalence and the incidence of SR and large local reactions (LLR) to Hymenoptera stings in children in Italy. METHODS: The data on children were collected from the database of the population study on the city of Cotignola, analyzing the answers to the part of the questionnaire about Hymenoptera stings, that concerned if the subject was ever stung by apids or vespids, if there has been a SR or a LLR, and if subjects with reactions received a diagnostic evaluation and a medical treatment. RESULTS: Of the population of 1035 children, 173 (16.7%) were stung at least one time by Hymenoptera. Of them, 5 had had a SR and 9 had had a LLR. This defines a prevalence of SR of 0.5% and of LLR of 0.9%. Only one reaction was severe. Of the 14 subjects with SR or LLR, 5 (35.7%) underwent a diagnostic evaluation and one (7.1%) was treated with venom immunotherapy. The incidence of SR in the subsequent 2 years was 0.09% in the first year and 0.08% in the second year. CONCLUSIONS: These findings do not confirm the recent reports of an increased prevalence of Hymenoptera venom allergy in children. The incidence of SR to stings, thus far unreported for children, was very low both in the first and in the second year.

Evaluation of house dust mite allergy in real life: patients' characteristics and satisfaction with treatment.

BACKGROUND: HDMs are a ubiquitous allergen source, with a very well defined biology, but their role in clinical settings and in everyday clinical practice is not well characterized. Aim of this cross-sectional, questionnaire-based study was to assess the clinical characteristics of HDM-related respiratory allergy in a large population of Italian patients. METHODS: A structured questionnaire was sent to allergists randomly chosen among those of the Italian Federation of Immunology, Allergy and Clinical Immunology (IFIACI). They were asked to fill it with the clinical data of 10-12 consecutive patients referred for respiratory allergy, positive to HDM skin prick test. The questionnaire assessed type and severity of allergy, demographics, yearly distribution of symptoms, treatment, and satisfaction with the therapy. RESULTS: 45 allergists collected data from 499 patients. Within the evaluated population, 42% had rhinitis only, 45% asthma + rhinitis and 13% asthma alone. Rhinitis was moderate/severe in 51% of patients. Asthma was intermittent in 36% of patients, mild in 37% and moderate in 27%. Conjunctivitis was the most frequent comorbidity (36%), followed by rhinosinusitis (16%), adenoid hypertrophy (6%) and polyposis (5%). Out of the population, 56.2% of patients were not at all or partially not satisfied of their treatment for rhinitis, whereas the percentage of dissatisfied patients was about 53% for asthma therapy. 34% patients (n = 170) were monosensitized to HDM. It is confirmed that patients have more symptoms during the fall-winter periods. CONCLUSION: Patients with HDM allergy have frequently moderate-severe rhinitis, and about 50% of them are not satisfied with their treatment.

The evolution of allergen immunotherapy from empirical desensitization to immunological treatment.

In its century-long history, allergen immunotherapy (AIT), has shown continuous evolution in terms of the materials and the treatment schedules used, the adequate duration, and the mechanisms of action underlying its clinical efficacy. The passage from the empirical phase of AIT to the era of evidence-based medicine (EBM) was associated with achievement of the highest levels of evidence. This regarded both forms of AIT currently used, represented by subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). In particular, SLIT tablet preparations of pharmaceutical quality provided physicians and patients a treatment whose efficacy had been confirmed with the highest level of scientific evidence and improved the credibility of AIT for the entire medical field. However, further advances are needed for AIT in terms of optimal patient selection and the required dosage, as well as the quality and composition of the allergen extracts, factors favouring compliance, and the most appropriate duration capable of maintaining the clinical benefit over time.

Towards a global vision of molecular allergology: a map of exposure to airborne molecular allergens.

Allergy diagnostics have changed in the last 10-15 y, moving from the use of extracts for in vivo and in vitro diagnosis to the Component Resolved Diagnosis, based on purified or recombinant allergens. As expected, aerobiology developed similarly, and measurement of allergens in both outdoor and indoor air is now feasible. With the aim of promoting a global view of molecular allergy, we have drawn a map of exposure to molecular aeroallergens in Italy on the bases of geo-climatic regions, maps of pollen distribution, and published data on the molecular profile of sensitization in Italian patients. Given the latitudinal extension of Italy, the profile of exposure to some allergens, such as those of the "Birch Group" and weeds, varies greatly from North to South, while the distribution of exposure to grass allergens is more homogeneous. This map can contribute to a global molecular vision of allergy, helping clinicians to view exposure to pollen in a new way. The exposure profile of the area where patients live can also indicate the correct choice of molecular diagnostics and, therefore, of the appropriate allergen immunotherapy.

Factors influencing the prescription of allergen immunotherapy: the allergen immunotherapy decision analysis (AIDA) study.

The evidence of efficacy of allergen immunotherapy (AIT) for respiratory allergy has been demonstrated by a number of meta-analyses. However, the daily practice of AIT is quite different from controlled trials, facing challenges in terms of selection of patients, practical performance, and, of particular importance, use of allergen extracts of inadequate quality. We here performed a survey, named the Allergen Immunotherapy Decision Analysis (AIDA), to evaluate which criteria are used by specialists to choose a product for sublingual immunotherapy (SLIT) in patients with respiratory allergy. A questionnaire composed of 14 items to be ranked by each participant according to the importance attributed when choosing SLIT products was submitted to 444 Italian specialists. The responses of the 169 (38.1%) physicians, who answered all questions, were analysed. Most of the respondents were allergists (79%), followed by pulmonologists (10.8%), both allergists and pulmonologists (4.8%), and otorhinolaryngologists (3%); 59.8% of the respondents were males and 40.2% were females. The age distribution showed that 89.9% of the respondents were aged between 35 and 64 years. All respondents usually prescribed AIT products in their clinical practice: 31.4% used only SLIT, whereas 69.2% used both subcutaneous and sublingual administration. The rankings, expressed as means, attributed by physicians for each of the 14 items were as follows: level of evidence-based medicine (EBM ) validation of efficacy (3.44), level of EBM validation of safety (4.30), standardization of the product (5.37), efficacy based on personal experience (5.82), defined content(s) of the major allergen(s) in micrograms (5.96), scientific evidence for each single allergen (6.17), safety based on personal experience (6.32), ease of administration protocol (8.08), cost and terms of payment (e.g. instalments) (9.17), dose personalization (9.24), patient preference (9.25), ease of product storage (9.93), reimbursement (10.12), and availability of a helpline or on-line assistance from the manufacturer (11.89). These attitudes need to be taken into consideration by regulatory agencies as well as by producers.

Evaluation of stability of allergen extracts for sublingual immunotherapy during transport under unfavourable temperature conditions with an innovative thermal insulating packaging.

Many pharmaceutical and biotechnological products are temperature-sensitive and should normally be kept at a controlled temperature, particularly during transport, in order to prevent the loss of their stability and activity. Therefore, stability studies should be performed for temperature-sensitive products, considering product characteristics, typical environmental conditions, and anticipating environmental extremes that may occur during product transport in a specific country. Staloral products for sublingual immunotherapy are temperature sensitive and are labelled for maintenance under refrigerated conditions (2-8°C). Given the peculiar climatic context of Italy and the great temperature fluctuations that may occur during transport, this study was aimed at evaluating the impact of a new engineered thermal insulating packaging for Staloral. In particular, the purpose was to assess whether the new packaging could create a container condition able to preserve the stability and immunological activity of the product during the transport phase throughout Italy. The results showed that the range of temperatures that can affect the product, in the area surrounding the product packaging, may reach a peak of 63°C during transport under the most unfavourable climatic conditions, i.e. in a non-refrigerated van during the summer season, from the site of production in France to the patient's house in Catania, the city with the highest temperatures in Italy. However, the highest temperature reached inside the vaccine did not exceed 45°C over a period of about 2 h. The ELISA inhibition test on samples subjected to the extreme temperature conditions previously defined (45°C) showed an immunological activity higher than 75% of that initially measured and was comparable to those obtained with samples stored at controlled temperature (5°C). This means that, even in the worst case scenario, the structure of the allergen extracts is not influenced and the vaccine potency is preserved.

A survey on features of allergic rhinitis in children.

OBJECTIVE: A number of epidemiologic studies evaluated the prevalence of allergic rhinitis (AR), but few data are available on its different clinical presentations. We addressed this survey to assess the features of AR in children and adolescents. METHODS: Thirty-five centers in Italy included 2623 pediatric patients with rhinitis, of whom 2319 suffered from AR, while 304 had other kinds of rhinitis. For each patient a standardized questionnaire was filled in, including ARIA classification, the duration of symptoms, the allergen identified as clinically relevant, the co-morbidities, the kind of treatment, the response to treatment, the satisfaction with the treatment, and the feasibility of allergen immunotherapy (AIT). RESULTS: Of the 2319 patients, 597 (25.7%) had mild intermittent, 701 (30.2%) mild persistent, 174 (7.5%) moderate-severe intermittent, and 773 (33.3%) moderate-severe persistent AR. The allergens most relevant were grass pollen and dust mites. The most frequently used drugs were oral antihistamines (83.1%) and topical corticosteroids (63.5%). The response to treatment was judged as excellent in 13.5%, good in 45.1%, fair in 30.8%, poor in 10%, and very bad in 0.6% of cases. The satisfaction with treatment was judged as very satisfactory in 15.2%, satisfactory in 61.8%, unsatisfactory in 22.4%, and very unsatisfactory in 0.5% of cases. AIT was considered indicated in 53.1% of patients with mild intermittent, 79.2% of moderate-severe intermittent, 72.6% of mild persistent, and 82.7% of moderate-severe persistent AR. CONCLUSIONS: The limitation of this study is that the population was not unselected and this prevents epidemiological significance. These results offer confirmation of the adequacy of ARIA guidelines in classifying patients with AR and of the association of severe phenotype with lack of success of drug treatment.

Allergen immunotherapy may exert an extra-anti-allergic activity in children.

Allergic patients frequently suffer from infections. Allergen immunotherapy (AIT) usually improves respiratory symptoms, mainly in allergic rhinitis (AR). This study was aimed at evaluating the possible impact of AIT on extra-allergic outcomes in a cohort of Italian children with respiratory allergy patients. The study was performed on 77 children (43 males, mean age 10.5 years) with AR. The kind and the number of prescribed allergen extracts, type of diagnosis, severity of symptoms, and use of drugs were evaluated at baseline and after 2 year AIT. Globally 40 patients were treated with AIT, the remaining 37 children served as control. AIT-treated children had lower symptoms, drug use, and less severe extra-allergic surrogate markers of infection in comparison with children untreated with AIT. In conclusion, this study provides the first evidence that 2-year SLIT is able of exerting an adjunctive anti-allergic activity in AR children.