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Introduction : Venom immunotherapy (VIT) is an effective treatment for Hymenoptera venom allergy. The occurrence of severe reactions (SRs) to VIT, although infrequent, hampers the achievement of tolerance to insect stings. Risk factors for such reactions include allergy to honeybee venom, concomitant mast cell disorders, and the build-up phase of VIT. A role for omalizumab has come forward in recent years. Areas covered : This article reviews the available literature on the efficacy of omalizumab in preventing SRs and allowing the attainment of VIT maintenance doses. Pre- and co-treatments with omalizumab were evaluated, with positive overall results. Adding omalizumab to VIT in patients with SRs generally results in tolerance to VIT, thus restoring its precious preventive value. Expert opinion : VIT is effective for patients with Hymenoptera venom allergy and is recommended to prevent further (possibly fatal) reactions to stings. Omalizumab has shown efficacy in protecting patients from VIT-related SRs, particularly in those at high risk of SRs because of mast cell disorders and/or honeybee venom allergy. Notwithstanding, the accepted dose and time course of omalizumab for achieving tolerability and ensuring safety during VIT are not yet defined. In the future, other biologicals may play a role in preventing SRs during VIT.

The term compliance simply indicates how much doses of the prescribed medication are taken, whereas the term adherence implies also an agreement between patient and physician about the therapeutic plan, and it is therefore preferred. Adherence is a main problem in all long-term treatments. Thus, it represents a problem also in the case of rhinitis, expecially concerning specific immunotherapy that must be assumed continuously for several years. Many factors can affect the adherence, depending on patient, on treatment itself and on the healthcare context, and all those factors usually interact. The adherence measured in controlled trials is usually good, but this does not reflect what happens in real life, where adherence should be preferably measured. There are few data on the adherence in real life for pharmacological treatments of allergic rhinitis (e.g. nasal steroids or antihistamines), whereas more data are available for specific immunotherapy. In this latter case, in real life, adherence seems to be far from optimal, for both sublingual and subcutaneous immunotherapy, although the recent studies agree on the fact that some interventions (i.e. patients' education, strict follow-up, regular contacts) could effectively improve the adherence. In this article, the literature concerning the adherence to pharmacological treatments and immunotherapy in allergic rhinitis was searched and reviewed., (© 2012 Blackwell Publishing Ltd.)

Background: Subcutaneous immunotherapy is effective for the treatment of respiratory allergy, and it is largely used in Italy, but no systematic safety assessment has been carried out so far., Objective: To assess prospectively the safety of injection immunotherapy in a multicentre, real-life survey., Methods: Eleven Italian allergy departments recorded the clinical characteristics of systemic reactions (SRs) due to immunotherapy. Vaccines were prescribed according to guidelines; only standardized depot extracts were used. SRs were graded according to the EAACI recommendations, and were classified as immediate or delayed., Results: One thousand seven hundred and thirty-eight patients (847 males, age range 5-71) received immunotherapy from eight different manufacturers, for a total of 2038 courses (300 patients received two extracts). A total of 60 785 injections were given over a mean immunotherapy duration of 3 years. Overall, 95 reactions were observed in 57 patients (3.28%), corresponding to 4.7% of the courses and 1.56/1000 injections. Twenty-five patients experienced more than one adverse event. There were 34 grade 2, 60 grade 3 and one grade 4 reactions and no fatality. SRs occurred more frequently in patients with asthma than in patients with rhinitis alone (4.1% vs. 1.1%), and were equally distributed between the build-up and the maintenance phase. Ragweed and grass extracts caused significantly more side effects than other allergens., Conclusion: In this large prospective study, the rate of SRs was low, thus confirming that injection immunotherapy has an acceptable risk/benefit ratio when prescribed and carried out according to recommendations.

Background: Few data are available on the pharmacoeconomic aspects of immunotherapy., Objective: To evaluate, from the health care system and societal perspectives, the costs and consequences of sublingual immunotherapy (SLIT) added to pharmacotherapy compared with drugs alone for respiratory allergy., Methods: This study compared costs, clinical outcomes, and cost-effectiveness ratios of 2 strategies in the management of allergic rhinitis and asthma, namely, SLIT associated with pharmacotherapy and pharmacotherapy alone (no SLIT). A decision tree was developed and populated with epidemiologic and resource utilization data concerning approximately 2,200 patients. Direct costs included visits, tests, pharmacotherapy, immunotherapy, and hospitalizations. Indirect costs and out-of-pocket drugs were also included. Outcome was calculated as the number of improved patients and asthma cases avoided at 6 years. Sensitivity analysis was performed by varying costs and epidemiologic data., Results: SLIT improved the symptoms of 399 of 1,000 patients and prevented asthma in 229 of 1,000 patients compared with drugs alone. For SLIT added to pharmacotherapy and pharmacotherapy alone, the direct cost per patient at more than 6 years was Euro2,400 and Euro3,026, whereas the indirect cost was Euro1,913 and Euro3,400., Conclusion: From both perspectives and for both effectiveness end points, SLIT is less expensive and more effective than pharmacotherapy alone.

Background: Traditional subcutaneous immunotherapy has been proved effective in birch pollenosis. It has, however, some drawbacks as systemic reactions, which are rare but important. Local nasal immunotherapy (LNIT) represents a potential safer route of allergen administration., Objective: To study the clinical efficacy and safety of local nasal immunotherapy by means of an extract in powder form as treatment of birch allergic rhinitis., Methods: Thirty birch allergic patients have been selected on the basis of a positive history, skin test, radioallergosorbent test assay (RAST) and specific nasal challenge. Two 15 patient groups were randomly assigned to the active treatment or to the placebo one. Treatment lasted 22 weeks (14 for the build-up phase and eight for maintenance period) and symptoms were recorded during the treatment and the birch pollen season., Results: The clinical efficacy of LNIT is suggested by a significant reduction of medication score only in the treated group during the pollen season, although the symptom score was significantly lower in the treated group for 1 week only. Moreover, a significant increase of specific nasal threshold dose was observed after treatment only in the active treated group. Mild adverse reaction to LNIT, limited to the upper respiratory tract, were reported during the treatment in the active group, but they did not interfere with LNIT schedule. No asthmatic or systemic reaction were observed., Conclusions: This study indicates that LNIT with allergen in powder form has proven clinically effective in the treatment of birch allergic rhinitis. Further studies are needed to establish whether this treatment can be considered a real alternative to the traditional subcutaneous immunotherapy in birch allergic rhinitis.

Laura Tenero,1 Rachele Vaia,2 Giuliana Ferrante,1 Matteo Maule,3 Laura Venditto,1 Giorgio Piacentini,1 Gianenrico Senna,2,3 Marco Caminati3 1Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, Pediatric Clinic, University of Verona, Verona, Italy; 2Allergy Unit and Asthma Center, Verona University Hospital, Verona, Italy; 3Department of Medicine, University of Verona, Verona, ItalyCorrespondence: Marco Caminati, Department of Medicine, University of Verona, Piazzala L.A. Scuro, 10, Verona, 37134, Italy, Email marco.caminati@univr.itAbstract: Allergic rhinitis (AR) is a common upper airways inflammatory condition especially in paediatric population; its burden potentially impacts on quality of life, quality of sleep and daily performance, which can be difficult to perceive but not less relevant in the middle-long term. The present review aims to provide an updated overview on AR epidemiology, diagnosis and with a special focus on its connections with bronchial asthma. In fact, when considering asthmatic pediatric population, AR is probably the most important risk factor for asthma onset and the most impactful extra-bronchial determinant of asthma control. Under this perspective, allergen immunotherapy (AIT) should always be considered in the light of a precision medicine approach. In fact, AIT does represent a unique opportunity to specifically interfere with AR immunological background, improve both AR and bronchial asthma control and prevent allergic disease evolution. Verifying the patient’s eligibility to that option should be considered as a priority for every physician managing children suffering from AR, especially when associated with bronchial asthma.Keywords: asthma, asthma control, rhinitis, immunotherapy, personalized medicine

Introduction: Allergic rhinitis (AR) affects 20-30% of women in reproductive age and may worsen during pregnancy. About 10% of the elderly suffer from AR, and it could be under-diagnosed in these patients. Many drugs are currently available, however AR treatment during pregnancy and old age represents a challenging issue. Areas covered: A review of the literature on the topic has been performed. Expert commentary: In pregnancy, drug avoidance should be carefully balanced with the need for AR optimal control. Topical drugs are suggested as a first approach. The safety and tolerability profile of second-generation antihistamines is well supported. If allergen immunotherapy (AIT) is ongoing and well tolerated, there is no reason for stopping it. AIT initiation in pregnancy is not recommended. For elderly patients, no specific concerns have been highlighted regarding topical treatments, except from nasal decongestionants. Second generation antihistamines are generally well tolerated. Old age should not preclude AIT. [ABSTRACT FROM AUTHOR]

Participant dropouts can reduce the power of allergen immunotherapy clinical trials. Evaluation of the dropout rate and reasons for dropout are important not only in the planning of clinical studies but are also relevant for adherence to immunotherapy in daily clinical practice. A systematic review was carried out in order to establish the overall dropout rate among published double-blind, placebo-controlled randomized clinical trials of sublingual immunotherapy for respiratory allergic diseases. Dropouts were analysed in regards to allergen, formulation, treatment schedule, participant age, study size, number of centres and type of allergic disease. Relative dropout rates in placebo and active groups as well as reasons for dropout were also assessed. A total of 81 studies, comprising 9998 patients, were included. Dropout rates in sublingual immunotherapy controlled studies do not appear to be a major problem with a composite dropout percentage of 14% (95% CI:11.9-16). Furthermore, they are not different for active compared to placebo-treated participants. This lends support to the positive clinical outcomes seen in meta-analyses of these trials. [ABSTRACT FROM AUTHOR]

The modalities of administration of sublingual immunotherapy (SLIT), including dosing, build-up phase, duration of the treatment, and frequency of the maintenance dose are largely variable. In the case of pollen (SLIT), the complexity increases, since preseasonal, coseasonal and pre-coseasonal regimens can be used. The administration regimens are of relevance from a practical point of view, but can also have economic implications. We review herein the available literature (randomized double blind controlled studies) on pollen SLIT, in order to derive experimentally-supported suggestions about the regimens of administration that should be preferred. [ABSTRACT FROM AUTHOR]

Background: The clinical safety of sublingual immunotherapy (SLIT) has been repeatedly confirmed; nevertheless, the possible onset of local oral symptoms is still a concern, and nothing is known about the pathogenesis of this effect. We aimed to determine whether the administration of SLIT in allergic children can evoke an IgE-mediated reaction, by measuring the levels of sublingual tryptase and ECP. Methods: Thirty children (7–12 years old) with allergic rhinitis/asthma due to grass pollen were prescribed SLIT. In these children, an allergen-specific nasal challenge was performed, and nasal tryptase and ECP were measured before and after. Sublingual ECP and tryptase were also assessed before the SLIT, after 1 month, and after 6 months of treatment. Ten matched allergic children and 10 healthy ones served as controls for the baseline levels of sublingual ECP and tryptase. Results: The levels of nasal tryptase and ECP significantly increased after nasal challenge (P<0.001), whereas no change during the SLIT course (at the beginning, after 1 month, and after 6 months) could be detected in sublingual tryptase either before or after SLIT administration. The sublingual ECP significantly decreased after 6 months of SLIT. The baseline levels of nasal tryptase and ECP were significantly higher in allergic subjects than in healthy controls, as was the level of sublingual ECP. Conclusions: In the presence of an IgE-mediated reaction (ASNC), a significant increase of tryptase and ECP can be seen. When SLIT is administered, such a phenomenon does not occur; therefore, SLIT does not elicit any IgE reaction in the mouth. It is noteworthy that allergic subjects display higher levels of nasal ECP and tryptase than healthy subjects, even when symptom-free, and these observations may indicate the presence of subclinical inflammation. [ABSTRACT FROM AUTHOR]

Preseasonal local nasal immunotherapy (LNIT) by means of an extract in macronized powder form has been studied in allergic rhinitis to parietaria. Twenty-four Parietaria-sensitive patients have been studied for 18 weeks in a double-blind controlled trial. Subjects were selected on the basis of a positive skin test, RAST and intranasal challenge to Parietaria antigen. Three eight-patient groups were randomly planned: the first group was given native Parietaria product, the second modified Parietaria product, and the third placebo. During the pollen season no difference was observed in mean weekly symptom score between the three groups, while the mean weekly medication score was significantly lower in the treated groups than the control group. Only the treated groups showed a significant increase in specific nasal threshold to Parietaria after treatment. Adverse reactions to LNIT, limited to the upper respiratory tract, occurred rarely and did not interfere with the dose schedule. This study indicates that LNIT in powder form may be a suitable alternative to the traditional subcutaneous immunotherapy in terms of clinical efficacy and safety. [ABSTRACT FROM AUTHOR]

Local nasal immunotherapy represents an alternative route of allergen administration. It was proposed to overcome the risk of systemic reactions rarely reported during the traditional subcutaneous immunotherapy. Some studies carried out in the past generally showed good efficacy but poor tolerability. The aqueous extracts mostly used in these studies carry some drawbacks such as the volume effect, self-digestion and the difficulty of administering reproducible dosages. The recent availability of allergen extracts in powder form has led to better stability and standardization. The studies carried out with these freeze-dried allergens showed clinical efficacy and good tolerability in perennial (mite, cat) and seasonal (grass, birch, Parietaria) allergic rhinitis. According to these findings this new local nasal immunotherapy with extract in powder form represents a suitable alternative to the traditional immunotherapy in the treatment of allergic rhinitis. [ABSTRACT FROM AUTHOR]

The article presents an experiment which examines the effectiveness of American Polistes dominulus (PD), a common genus of social wasps, venom for the treatment of the Italian patient allergic to European Polistes. The experiment applied the practice of immunotherapy course with PD venom. According to the immunological results, the therapy was significant in the Mediterranean areas but ineffective to the Italian patient sensitive to European PD.

Abstract Allergy today is a public health concern of pandemic proportions, affecting more than 150 million people in Europe alone. In view of epidemiological trends, the European Academy of Allergy and Clinical Immunology (EAACI) predicts that within the next few decades, more than half of the European population may at some point in their lives experience some type of allergy. Not only do allergic patients suffer from a debilitating disease, with the potential for major impact on their quality of life, career progression, personal development and lifestyle choices, but they also constitute a significant burden on health economics and macroeconomics due to the days of lost productivity and underperformance. Given that allergy triggers, including urbanization, industrialization, pollution and climate change, are not expected to change in the foreseeable future, it is imperative that steps are taken to develop, strengthen and optimize preventive and treatment strategies. Allergen specific immunotherapy is the only currently available medical intervention that has the potential to affect the natural course of the disease. Years of basic science research, clinical trials, and systematic reviews and meta-analyses have convincingly shown that allergen specific immunotherapy can achieve substantial results for patients, improving the allergic individuals’ quality of life, reducing the long-term costs and burden of allergies, and changing the course of the disease. Allergen specific immunotherapy not only effectively alleviates allergy symptoms, but it has a long-term effect after conclusion of the treatment and can prevent the progression of allergic diseases. Unfortunately, allergen specific immunotherapy has not yet received adequate attention from European institutions, including research funding bodies, even though this could be a most rewarding field in terms of return on investments, translational value and European integration and, a field in which Europe is recognized as a worldwide leader. Evaluation and surveillance of the full cost of allergic diseases is still lacking and further progress is being stifled by the variety of health systems across Europe. This means that the general population remains unaware of the potential use of allergen specific immunotherapy and its potential benefits. We call upon Europe’s policy-makers to coordinate actions and improve individual and public health in allergy by: Promoting awareness of the effectiveness of allergen specific immunotherapy Updating national healthcare policies to support allergen specific immunotherapy Prioritising funding for allergen specific immunotherapy research Monitoring the macroeconomic and health economic parameters of allergy Reinforcing allergy teaching in medical disciplines and specialties The effective implementation of the above policies has the potential for a major positive impact on European health and well-being in the next decade.

Focuses on improving quality of life (QoL) as an optimal goal of allergen immunotherapy. Description of QoL; Definition of health-related quality of life (HRQL); Evaluation of HRQL in respiratory allergy.