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Importance: The lack of inclusion of diverse population samples in food allergy immunotherapy clinical trials not only leads to decreased applicability to the general population in terms of results and treatments but can also be seen as a broader social injustice contributing to inequity within the health care system., Objectives: To investigate the racial and ethnic distribution of participants included in food allergy immunotherapy clinical trials, and determine whether the racial and ethnic representation in trials accurately reflects the patients who experience food allergy., Evidence Review: Data were collected from articles found on PubMed and ClinicalTrials.gov using key terms of food hypersensitivity, food allergy, and immunotherapy, while also incorporating specific criteria such as clinical trials conducted within the last 5 years with children aged from birth to 18 years old. Articles were selected based on their relevance to the research question. Main outcomes were totals and percentages of trial participants by race and ethnicity, stratified by pediatric trials, site of study, and National Institutes of Health funding., Findings: Thirty-five articles were initially identified, of which 34 were classified as human clinical trials. Of these trials, 26 met criteria of an original randomized clinical trial and included racial and ethnic demographics for analysis in the study. Among trials included, the majority of the 3689 participants identified as White (2640 participants [72.0%]), followed by Black or African American (293 participants [8.0%]), Asian (239 participants [6.0%]), multiple races or other (210 participants [6.0%]), Hispanic or Latino (96 participants [3.0%]), American Indian (3 participants [<1.0%]), and Native American or Pacific Islander (3 participants [<1.0%]). We observed differences in racial and ethnic inclusion by study site (US vs external to US) and funding support (National Institutes of Health vs industry or other non-National Institutes of Health sources)., Conclusions and Relevance: In this systematic review of racial and ethnic diversity in food allergy immunotherapy trials, there was a lack of diversity relative to the overall food allergy burden among Black and Hispanic patients, indicating important gaps in the conduct of pediatric clinical trials, especially for treatments that are meant for use in broad populations where significant race- and ethnicity-related disparities exist. Working to correct this disparity will not only increase the usefulness of future clinical trial data but can further assist in alleviating public health inequities.

In this review, we outline and reflect on the important differences between allergen-specific immunotherapy for inhalant allergies (i.e., aeroallergens) and venom-specific immunotherapy (VIT), with a special focus on Venomil ® Bee and Wasp. Venomil ® is provided as a freeze-dried extract and a diluent to prepare a solution for injection for the treatment of patients with IgE-mediated allergies to bee and/or wasp venom and for evaluating the degree of sensitivity in a skin test. While the materials that make up the product have not changed, the suppliers of raw materials have changed over the years. Here, we consolidate relevant historical safety and efficacy studies that used products from shared manufacture supply profiles, i.e., products from Bayer or Hollister-Stier. We also consider the characterization and standardization of venom marker allergens, providing insights into manufacturing controls that have produced stable and consistent quality profiles over many years. Quality differences between products and their impacts on treatment outcomes have been a current topic of discussion and further research. Finally, we review the considerations surrounding the choice of depot adjuvant most suitable to augmenting VIT.

Background: Allergen-specific immunotherapy is a potentially disease-modifying therapy that is effective for the treatment of patients with allergic diseases. Although the pain caused by the administration of subcutaneous immunotherapy with allergens (SCITA) is considered to be minimal, no studies assessing that pain for the treatment of only pediatric patients have been reported. Objectives : This research aimed to evaluate the pain associated with SCITA for pediatric patients followed at our Immunoallergology Department., Methods: During four consecutive weeks, the nurse who administered the injection completed a questionnaire recording the child's assessment of the pain associated with SCITA; these questionnaires were randomized before any analyses were done. Two different pain evaluation scales were used, with the choice of scale being determined based on the child's age: the self-reporting faces scale (score: 0-10; 5 to 8 years old) and the numeric scale (score: 0-10; >8 years old). Demographic and clinical data, as well as any adverse reactions, were documented., Results: We included 46 pediatric patients (mean age: 12.3 ± 2.6 years; 69.5% male), most of whom were suffering from rhinitis/rhinoconjunctivitis and undergoing subcutaneous immunotherapy with mites. Seven local adverse reactions were recorded, and all were mild. Ten patients did not mention any pain associated with SCITA. Of the 36 patients who mentioned some pain, 33 mentioned mild pain (scores between 1 and 3); only three mentioned moderate pain (scores between 4 and 6). For both scales, the median score obtained was 1. The maximum pain reported had a score of 6. No significant differences were observed between different groups of patients., Conclusions: In this study, SCITA was shown to be a mildly painful procedure that is associated with only a few local reactions. Therefore, SCITA should be considered as a safe option for the treatment of most pediatric patients suffering from allergies.

Introduction: Although allergic diseases have been known since antiquity, both their understanding and systematics came later. The World Allergy Organization (WAO) defines the phenomenon of atopy as a predisposition of a person or family to the uncontrolled synthesis and release of IgE antibodies. Allergic rhinitis (AR) is one of the most important clinical diseases of rhinitis (NN, rhinitis). AR significantly reduces the quality of life, tends to increase, and its consequences may be life-threatening diseases., Objective: The aim of the study is to determine the quality of life of patients who underwent specific allergen immunotherapy in allergic rhinitis., Material and Methods: The study was conducted at the Center for Specialist Allergology in Lublin between October 2018 - February 2019. The study covered a group of 157 patients. The diagnostic method used was a questionnaire. The first research tool was own questionnaire consisting of 31 questions. The second tool was the standardized questionnaire, the Polish version of the SF-36 Quality of Life Questionnaire., Results: Studies have shown statistically significant changes in the symptoms of before and after immunotherapy, which means improving the quality of life and reducing the severity of symptoms and problems of respondents after therapy. The respondents were not in the best of health (50%). Over 50% of respondents said that the immunotherapy process significantly reduced personal / family expenses for treatment associated with allergic rhinitis., Conclusions: The conducted process of specific allergen immunotherapy improved the quality of life of respondents by increasing awareness of the quality of life through the prism of health change in relation to the general indicator in the area of mental problems by reducing their nuisance value more than in the area of somatic symptoms.

Hymenoptera venom allergy (HVA) is one of the most frequent causes of anaphylaxis following a bee, vespid or ant sting. Real-life data regarding the management of HVA in children are lacking. To address this unmet need, we carried out a survey defining the current management of HVA in children among pediatric allergists in Italy. Educational investments on the improvement of the management of pediatric patients with HVA are urgently needed, and our analysis represents a relevant instrument in targeting a roadmap with this aim. The time for pediatric allergists to take action has come, and a task force from the Rare Allergic Diseases Commission of the Italian Society of Pediatric Allergy and Immunology is working on the topic to improve pediatricians' knowledge and optimize the care of these patients., (Copyright © 2020 SEICAP. Published by Elsevier España, S.L.U. All rights reserved.)

Importance: Commercial epicutaneous peanut immunotherapy (EPIT) and peanut oral immunotherapy (POIT) may offer significant quality-of-life improvements for patients with peanut allergy, but the cost-effectiveness of commercial peanut immunotherapies is uncharacterized., Objective: To evaluate critical inputs associated with the cost-effectiveness of EPIT and POIT from a societal perspective., Design, Setting, and Participants: Economic evaluation in which microsimulations with Markov modeling were performed evaluating virtual children aged 4 years over an 80-year time horizon. The base-case costs included a caregiver-reported willingness to pay of $3839 annually for safe and effective food allergy treatment. Estimates of predictive biomarkers or oral challenges were incorporated after the first year of therapy with additional analyses of immunotherapy risk reduction of anaphylaxis and probability of sustained unresponsiveness (SU) to peanut after 4 years., Exposures: Children received EPIT, POIT, or no immunotherapy treatment (n = 10 000 per treatment strategy)., Main Outcomes and Measures: Rates of therapy-associated adverse reactions and quality-of-life improvements associated with changes in eliciting or tolerated peanut doses were modeled along with quality-adjusted life-years (QALYs), anaphylaxis, therapy-associated anaphylaxis, and fatalities., Results: In the base-case analysis without SU to peanut, the EPIT strategy cost less than POIT (mean [SD] cost, $154 662 [$46 716] vs $163 524 [$56 800]) and had fewer total episodes of anaphylaxis (mean [SD], 1.33 [1.55] vs 3.83 [5.02] episodes) and fewer episodes of therapy-associated anaphylaxis (mean [SD], 0.62 [1.30] vs 3.10 [4.94] episodes) but had lower QALY accumulation (mean [SD], 26.932 [2.241] vs 26.945 [2.320] QALYs). The incremental cost-effectiveness ratio was $216 061 for EPIT and $255 431 for POIT. Models were sensitive to therapy cost, SU rates, health state utility, and risk reduction of anaphylaxis. With health state utility sensitivity analyses, the ceiling value-based cost (willingness-to-pay threshold $100 000/QALY) was between $1568 and $6568 for EPIT and between $1235 and $5235 for POIT. If high rates of SU to peanut can be achieved in longer-term models, EPIT and POIT could produce savings in terms of both cost and QALY., Conclusions and Relevance: In this simulated analysis, findings showed that EPIT and POIT may be cost-effective under some assumptions. Further research is needed to understand the degree of health state utility improvement associated with each therapy, degree of protection against anaphylaxis, and rates of SU.

Background: Delayed drug hypersensitivity to first-line anti-tuberculosis medication is a major challenge in tuberculosis treatment., Objective: This study was performed to investigate the efficacy/tolerability of desensitization therapy in treatment of first-line anti-tuberculosis medication hypersensitivity and the usefulness of immunologic evaluation therein., Methods: This study was conducted as a prospective, observational cohort study. Subjects who experienced hypersensitivity reactions, including maculopapular exanthema (MPE) and drug reaction with eosinophilia and systemic symptoms (DRESS), to first-line anti-tuberculosis medications (isoniazid [INH], ethambutol [EMB], rifampin [RFP], and pyrazinamide [PZA]) were enrolled. Patch, intradermal, lymphocyte transformation, and oral provocation tests were performed to determine culprit drugs, which were desensitized with rapid and graded challenge protocols. Breakthrough reactions (BTRs) during or after desensitization were assessed., Results: In total, 31 desensitization treatments (INH, 8; EMB, 8; RFP, 11; PZA, 4) to 12 patients (8 with MPE and 4 with DRESS) were performed. The overall success rate of desensitization was 80.7%. All the study subjects except one completed the full course of anti-tuberculosis treatment. The overall BTR free rate was 64.5%. Sixteen (80%) treatments for MPE and four (36.4%) for DRESS were BTR free (P = 0.023). Drugs that were positive on any two of three immunologic studies showed significantly high BTR rates (P = 0.014), although this was not correlated with desensitization failure rate., Conclusion: Rapid desensitization therapy to multiple anti-tuberculosis medications for delayed drug hypersensitivity was safe and successful. Combination of multiple immunologic evaluations may predict BTR although it needs validation in larger studies., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Clinical trials on oral immunotherapy (OIT) have been increasing for nearly a decade; however, several national guidelines do not recommend OIT as a standardized procedure. The aim of this study was to obtain insights into the current use and practice of OIT in Japan., Methods: A first questionnaire was mailed to 524 training and teaching facilities of the Japan Pediatric Society. The first survey requested information on the implementation of OIT, whereas the second survey aimed to gather more detailed information on OIT, such as its safety., Results: In total, 360 facilities (69%) responded to the survey; among them, 102 (28%) provided OIT to 7973 patients [1544 received OIT while hospitalized (inpatient OIT), whereas 6429 received OIT without hospitalization (outpatient OIT)]. Approval for OIT was obtained from an ethics committee or institutional review board in 89% and 31% of facilities for inpatient and outpatient OIT, respectively. In inpatient OIT, immediate allergic reactions requiring treatment occurred in 68% of patients while hospitalized, and in another 56%, following discharge. In contrast, 11% of patients developed immediate allergic reactions in outpatient OIT. Adrenaline injections at home were required in 2%. Sixteen patients developed adverse reactions other than immediate allergic reactions, among which eosinophilic gastroenteritis was most common., Conclusions: OIT is widely provided not only as clinical research but also as general practice in Japan. However, because there is a high risk of developing anaphylaxis at home, OIT should be conducted carefully as in a clinical research setting taking safety into consideration., (Copyright © 2018 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.)

Background: Allergen-specific immunotherapy (AIT) is safe and effective for the treatment of allergic rhinitis and allergic asthma. However, patient non-compliance is a major barrier to achieving optimal outcomes Objective: To determine the level of compliance among patients using AIT and to identify factors associated with non-compliance Methods: A retrospective analysis using questionnaires was conducted to study compliance among 236 patients with allergic rhinitis with or without asthma who began AIT in 2009 or 2010 Results: The compliance rates at 3 y were 58.7% among patients on subcutaneous immunotherapy (SCIT) and 11.6% among those on sublingual immunotherapy (SLIT). The mean durations of treatment with SCIT and SLIT were 31 (+/-18.3) and 15.9 (+/-14.7) months, respectively. The most common causes of non-compliance among patients on SCIT were the frequency of injections (82.2%), the duration of treatment (70.9%), and commuting to the Allergy Center (67.7%). Reasons for non-compliance among patients on SLIT were related to inconvenience (43.4%), improvement without treatment (30.2%) and perception of poor efficacy (25.0%) Conclusion: Compliance with AIT is low, but at 3 years, it was higher among patients on SCIT than among patients on SLIT. Reasons for non-compliance include difficulty adjusting to treatment protocols and a perception that the efficacy is low. Patient education regarding the treatment course and the slow effect, as well as the need for close follow up to effectively prevent and treat adverse reactions, are important factors for improving compliance and treatment outcomes.

Background: Little is known about characteristics of patients receiving allergen-specific immunotherapy. Identifying obstacles to appropriate treatment according to guidelines may facilitate the development of strategies aiming at improved treatment of patients with allergic respiratory diseases. The objective of this study was to investigate differences in disease severity, demographic and socioeconomic status between allergic rhinitis patients receiving allergen-specific immunotherapy and allergic rhinitis patients not receiving allergen-specific immunotherapy., Methods: A total of 366 patients were studied of whom 210 were going to receive subcutaneously administrated immunotherapy (SIT) against grass pollen and/or house dust mite allergy. The severity of rhino-conjunctivitis (hay fever) and/or asthma was classified according to international guidelines. The questionnaires included an EQ-5D visual analogue scale instrument and some socio-economic questions., Results: Severity of disease, young age, high level of education as well as greater perceived impairment of health-related quality of life due to allergic symptoms were significantly associated with use of SIT. Somewhat unexpectedly, household income was not associated with use of SIT., Conclusion: Use of SIT was associated with both disease severity measures and educational level, but not income level. These results suggest social inequality as reflected by lower use of SIT among patients with lower educational level may represent an obstacle to treatment with SIT.

Background: Allergies are an increasingly relevant public health problem. Specific immunotherapy (sIT) is presently the only causal treatment option. This study aimed to assess the frequency and determinants of sIT use and factors associated with treatment outcome., Methods: A cross-sectional analysis based on data from the German National Health Interview and Examination Survey 1998., Results: 2727 (39.2%) of study participants reported physician-diagnosed allergic disease. Among these, 16.5% (n = 296) stated to have undergone sIT. In this subset 43.4% (n = 129) reported improvement of symptoms, 21.9% (n = 65) had not changed, and 34.6% (n = 102) had discontinued treatment. The majority of patients treated with sIT showed multiple allergic symptoms and sensitisations. Factors significantly correlated with sIT treatment in multivariable analyses included rhinitis, asthma, several sensitisations, higher social status and residence in larger cities. Rhinitis and neurodermatitis were positively, and food allergy was negatively associated with the completion of sIT. No factors predicting improvement due to sIT could retrospectively be identified., Conclusion: Treatment with sIT under 'real life' conditions does not exactly follow current clinical guideline recommendations. In addition, patients may be selected for IT by socio-demographic factors. Whether this contributes to considerable discontinuation rates and limited effectiveness as observed here, needs further investigation.

Asthma and rhinitis are often co-morbid conditions. As rhinitis often precedes asthma it is possible that effective treatment of allergic rhinitis may reduce asthma progression. The aim of our study is to investigate history of allergic rhinitis as a risk factor for asthma and the potential effect of allergen immunotherapy in attenuating the incidence of asthma. Hospital-referred non-asthmatic adults, aged 18-40 years between 1990 and 1991, were retrospectively followed up until January and April 2000. At the end of follow up, available subjects were clinically examined for asthma diagnosis and history of allergen specific immunotherapy, second-hand smoking and the presence of pets in the household. A total of 436 non-asthmatic adults (332 subjects with allergic rhinitis and 104 with no allergic rhinitis nor history of atopy) were available for final analyses. The highest OR (odds ratio) associated with a diagnosis of asthma at the end of follow-up was for the diagnosis of allergic rhinitis at baseline (OR, 7.8; 95%CI, 3.1-20.0 in the model containing the covariates of rhinitis diagnosis, sex, second-hand smoke exposure, presence of pets at home, family history of allergic disorders, sensitization to Parietaria judaica; grass pollen; house dust mites; Olea europea: orchard; perennial rye; and cat allergens). Female sex, sensitization to Parietaria judaica and the presence of pets in the home were also significantly predictive of new onset asthma in the same model. Treatment with allergen immunotherapy was significantly and inversely related to the development of new onset asthma (OR, 0.53; 95%CI, 0.32-0.86). In the present study we found that allergic rhinitis is an important independent risk factor for asthma. Moreover, treatment with allergen immunotherapy lowers the risk of the development of new asthma cases in adults with allergic rhinitis.

Background: The prevalence of respiratory allergy to fungi spores (FS) is not precisely known but is estimated at 20-30% of atopic patients. There are no aerobiological records, necessary for respiratory allergy diagnosis and treatment, in Thessaloniki and generally in Greece., Aim: Creation of a database on FS circulation and investigation of skin sensitivity (SS) of asthmatics by using skin prick tests (SPT)., Material and Methods: Daily records and identification of 15 airborne FS species were conducted, using a Burkard trap during 1987-2001. SS to 5 most common FS extracts was investigated, by using SPT in a total of 1311 asthmatics with atopy, submitted to the Out-Patient Clinic of Asthma (Pulmonary Dept, Aristotle Univ, Thessaloniki) in 1990-2001., Results: The FS recorded in the 15-year period were as follows: Cladosporium spp. (72.2%), Alternaria spp. (9.8%), Ustilago spp. (8.1%), Ascospores (2.7%), Agrocybe spp. (1.5%), Helminthosporium spp. (1.4%), Leptosphaeria spp (1.2%), Agrogybe spp. (1.1%), whereas the species Botrytis, Stemphylium, Pleospora, Nigrospora, Epicoccum. Fusarium, Torula and Phoma presented concentrations <1%. The highest numbers of airborne FS were recorded during summer. Positive skin reaction to FS was observed in 421 (32%) patients of the 1311 asthmatics. Positive skin reaction to Altemaria species was observed in 177 patients (13.5%), in 98 (7.4%) to Cladosporium, 65 (5%) to Aspergillus, 45 (3.4%) to Fusarium and 36 (2.7%) to Rhizopus. FS sensitivity is much more frequent in younger men., Conclusions: For the first time in Thessaloniki-Greece, 15 allergenic FS species circulation has been recorded for the last 15 years. SS was more frequently detected for the species of Alternaria, Cladosporium and Aspergillus.

Background: A recent study carried out in North of Milan, an area that was recently colonized both by birch and ragweed pollen, showed that subjects developing allergies to these "new" allergens were much older than those becoming allergic to "traditional" airborne allergens, which suggests that predisposition to develop respiratory allergies is probably allergen-specific, persists throughout life, and does not occur until the patient encounters the appropriate allergen for a sufficiently long period., Objective: The present study aimed to test this hypothesis by following-up a large cohort of patients monosensitized to airborne allergens., Methods: The prevalence and characteristics of new sensitizations to airborne allergens after >2 years of follow-up were retrospectively assessed in 726 patients monosensitized to grass, pellitory, mite, birch, ragweed, Alternaria, mugwort, or plantain living North of Milan., Results: The overall prevalence of new sensitizations was 35% (256/726), with marked differences between the subgroups ranging from 11% in Alternaria-allergic subjects to 46% in grass-allergic subjects. Patients allergic to grass, birch, or pellitory pollen showed a significantly higher propensity to become sensitized to a second airborne allergen than subjects allergic to ragweed, Alternaria, and mite. Overall, the "new" allergens (birch and ragweed) caused 228/256 (89%) new sensitizations detected in the whole study group. Ragweed pollen induced 90% (38/42) of new sensitizations in birch pollen allergic patients, and birch pollen induced 80% (8/10) of new sensitizations in ragweed allergic patients. No difference in age at the first visit or in duration of the follow-up between patients developing and not developing new respiratory allergies was observed., Conclusion: This study shows that: 1) predisposition to develop respiratory allergies is allergen-specific and persists throughout life; 2) proneness to become allergic to certain airborne allergens might be associated with primary sensitization to specific airborne allergens; 3) in monosensitized adults, sensitization to another airborne allergen that has been always present in that particular geographical area is unlikely.

Data from a large population-based case-control study conducted in the San Francisco Bay Area between 1994 and 2001 were analyzed to examine the association between pancreatic cancer and history of allergic conditions. Pancreatic cancer cases (n = 532) had to be 21-85 years of age and were identified using rapid case ascertainment. Random digit dialing and Health Care Financing Administration lists (age, > or = 65 years) were used to obtain 1,701 controls who were frequency-matched to cases by sex and age within 5 years. In-person interviews were conducted and detailed allergy history data were obtained for all participants. Prior history of any allergy was associated with a reduced risk estimate for pancreatic cancer (odds ratio (OR) = 0.77, 95% confidence interval (CI): 0.63, 0.95). Inverse associations were observed for common allergens, including house dust (OR = 0.72, 95% CI: 0.54, 0.94), cats (OR = 0.59, 95% CI: 0.41, 0.85), plants (OR = 0.77, 95% CI: 0.62, 0.96), and mold (OR = 0.49, 95% CI: 0.32, 0.75), and for all allergic symptoms, although some confidence intervals included unity. Trends were observed for decreased risks associated with increasing number of allergies (p = 0.0006) and severity of allergic symptoms (p = 0.003). These results provide support for the plausibility that immune function in relation to allergies may play a role in the etiology of pancreatic cancer.