The Cost-Effectiveness of Omalizumab for Treatment of Food Allergy.

BACKGROUND: Omalizumab is an anti-IgE therapy newly approved by the Food and Drug Administration for allergen agnostic treatment of single or multiple food allergies in patients aged 1 year or older. OBJECTIVE: Evaluate the cost-effectiveness of omalizumab as a food allergy treatment. METHODS: We evaluated health and economic outcomes in Markov cohorts of simulated food allergic infants randomized to receive omalizumab using a 15-year horizon. Monte Carlo simulation was used (n = 40,000 subjects) to evaluate cost-effectiveness from a societal perspective, incorporating both a family-level and individual-level analysis. We included family-level analysis to incorporate a broad perspective for health utility change, given treatment effects likely benefit all parties at home (eg, caregivers, siblings), not just the patient, representing the sum of changes in all such persons. Supplemental analyses explored lower omalizumab cost and home initiation. We performed deterministic and probabilistic sensitivity analyses. RESULTS: In the family-level cohort analysis, omalizumab exceeded cost-effectiveness thresholds ($185,183/quality-adjusted life-years [QALY]). In a comparison of the omalizumab strategy (OMA) with the non-omalizumab strategy, the cost of OMA exceeded the non-omalizumab strategy ($315,020 vs $136,609) with greater incremental effectiveness (12.668 vs 11.699 QALY). In the individual-level analysis, the cost-effectiveness of OMA was $573,698/QALY. In base-case assessments, OMA was cost-effective (willingness to pay, $100,000/QALY) at a health state utility (HSU) improvement of 0.265. The value-based cost of OMA ranged from $14,166 to $23,791 when it was considered at the individual and family-unit levels. Requiring OMA administration in the clinic was not cost-effective (incremental cost-effectiveness ratio, $260,239). CONCLUSIONS: In the base case and at current pricing, omalizumab is not cost-effective, but it could be at a lower retail price or when use creates large health utility shifts in the family and patient.

In Vitro Toxicity Assessment of Cortinarius sanguineus Anthraquinone Aglycone Extract.

Biocolourants could be a sustainable option for dyes that require fossil-based chemicals in their synthesis. We studied the in vitro toxicity of anthraquinone aglycone extract obtained from Cortinarius sanguineus fungus and compared it to the toxicity of its two main components, emodin and previously studied dermocybin. Cell viability, cytotoxicity, and oxidative stress responses in HepG2 liver and THP-1 immune cell lines were studied along with skin sensitisation. In addition, genotoxicity was studied with comet assay in HepG2 cells. Cellular viability was determined by MTT, propidium iodide, and lactate dehydrogenase assays, which showed that the highest doses of both the aglycone extract and emodin affected the viability. However, the effect did not occur in all of the used assays. Notably, after both exposures, a dose-dependent increase in oxidative stress factors was observed in both cell lines as measured by MitoSOX and dihydroethidium assays. C. sanguineus extract was not genotoxic in the comet assay. Importantly, both emodin and the extract activated the skin sensitisation pathway in the KeratinoSens assay, suggesting that they can induce allergy in humans. As emodin has shown cytotoxic and skin-sensitising effects, it is possible that the adverse effects caused by the extract are also mediated by it since it is the main component present in the fungus.

Food allergies around the world.

The increase in the prevalence of food allergy has been considered as the second wave in the allergy epidemic following the first wave of increase in asthma and allergic rhinitis. It is well known that the prevalence of allergic conditions would follow economic development and urbanization in many countries or regions. In developed countries, one in three children suffered from at least one allergic disorder and these conditions include food allergy, eczema, allergic rhinitis and asthma. Food allergy is very often the first allergic manifestation affecting infants and young children. The exact etiologies are not known. The clinical manifestations ranged from a simple rash or an itch around the mouth, to the more severe manifestations of angioedema and potentially fatal anaphylaxis. Among all cases of childhood anaphylaxis, food is the most common cause. The common allergens resulting in food allergies in developed countries include egg, milk, fish, wheat, peanuts and tree nuts. However, there are marked variations in the patterns of food allergens in developing countries. In line with the epidemiology of asthma, food allergy is also much less common in rural areas. Clear understanding of reasons explaining the disparity of food allergies between urban and rural population would pave the way to the development of effective primary prevention for food allergy.

Utility of beta-lactam allergy assessment in patients receiving vancomycin for surgical prophylaxis.

Background: Beta-lactam antibiotics are first-line agents for most patients receiving antimicrobial prophylaxis in surgical procedures. Despite evidence showing low cross-reactivity between penicillins and cephalosporins, patients with beta-lactam allergies commonly receive vancomycin as an alternative to avoid allergic reaction. Methods: Adult patients receiving vancomycin for surgical prophylaxis with a reported beta-lactam allergy at our institution between August 2017 to July 2018 were retrospectively evaluated for potential eligibility for penicillin allergy testing and/or receipt of standard prophylaxis. Results: Among 830 patients who received vancomycin for surgical prophylaxis, 196 reported beta-lactam allergy and were included in the analysis. Approximately 40 % of surgeries were orthopedic. Of patients receiving vancomycin as first-line therapy, 189 (96.4 %) were potentially eligible for beta-lactam prophylaxis. Conclusions: Patients with beta-lactam allergies often qualify for receipt of a first-line antibiotic. An opportunity exists for improved allergy assessment as an antimicrobial stewardship intervention in surgical prophylaxis.

Development of a low allergenic product for patients with milk allergy and assessment of its specific IgE reactivity.

BACKGROUND: Milk oral immunotherapy is the riskiest and most unpredictable form of oral immunotherapy. We aimed to produce a low allergenic product than conventional once baked-cake/muffin, to develop indirect in-house ELISA to check the tolerance status with milk products and evaluate IgE reactivity of patients' sera via western blotting (WB) and indirect in-house ELISA. METHOD: A low allergenic product named biscotti-twice baked-cake was developed, and the total protein concentration was determined. The protein content was studied by SDS-PAGE and proteomics. Milk-specific IgE (sIgE) binding assays were performed by WB and indirect in-house ELISA by using patients' sera. RESULTS: Casein band intensity was observed to be lower in the biscotti-twice baked-cake than in the once baked-cake (p = .014). Proteomics analysis and αS1-casein measurement showed that the lowest intensity of casein was found in biscotti. The low binding capacity of milk sIgE to biscotti compared with once baked-cake was shown by WB (p = .0012) and by indirect in-house ELISA (p = .0001). In the ROC analysis, the area under the curve (AUC) of the in-house ELISA IgE was comparable with Uni-CAP milk and casein sIgE. The AUC of the in-house ELISA IgE for cake (0.96) and biscotti (1) was slightly better than Uni-CAP milk sIgE (0.94; 0.97) and casein sIgE (0.96; 0.97), respectively. CONCLUSION: The low allergenicity of the newly developed low allergenic product "biscotti-twice baked-cake" has been demonstrated by in vitro experiments. Biscotti could be a safe treatment option than once baked-cake/muffin in patients who are reactive to once baked-milk products.

Hair Product Allergy: A Review of Epidemiology and Management.

Allergy to hair products is an increasingly common issue among people given the exposure to these products on a daily basis. Allergic reactions could be in the form of delayed-type contact dermatitis or the form of immediate-type hypersensitivity reactions. Hair products contain many ingredients and chemicals that patients may have allergies to, but common allergens are hair dyes, fragrances, persulfate salts, ammonium thioglycolate, coconut fatty acid derivatives, and acrylates. Allergy to hair dye is the most common followed by other allergens such as fragrances and persulfate salts. We discussed testing for hair dye allergy along with suggestions for alternative hair dyes that patients may use. Allergy to topical scalp medications is also seen in patients using those products. Allergy to topical minoxidil is seen more often due to the increased use of minoxidil sprays and foams among patients to increase hair growth. We will discuss in this review the diagnosis and alternatives for patients with minoxidil allergy. Hairdressers are at higher risk of allergy to hair products compared to the general population due to prolonged exposure to allergens and specific measures should be implemented to minimize the hazards of exposure.

[STATE-OF-THE-ART OF GLOBAL START-UP INVESTMENT FOR ALLERGY AND IMMUNOLOGY 2022].

BACKGROUND: In 2022, the "New Capitalism Grand Design and Implementation Plan" was adopted in Japan, emphasizing the promotion and environmental development of startups. Given this context, an investigation into the startup and investment landscape in the allergy sector, both domestically and internationally, becomes imperative. METHODS: We analyzed 156 allergy-related startups from Japan, the US, and Europe from 2010 to 2021. Data on corporate information and investment trends were extracted from databases and VC websites. RESULTS: The total investment reached approximately 7.2 billion USD, with a ratio of 20:6:1 for the US, Europe, and Japan, respectively. The US showed a decline post its peak from 2016-2018, while Europe and Japan experienced growth. Notably, the US primarily invested in biopharmaceuticals for atopic dermatitis and food allergies, Europe in asthma-related apps, and Japan in healthcare apps and cross-border startups. DISCUSSION AND CONCLUSION: While Japan's investment environment in the allergy sector remains in its nascent stages and has room for development, the US and Europe are evidently ahead. Considering the rise of startups and funding limitations in Japan, external funding from regions like the US becomes a potential avenue. These findings are anticipated to contribute to the strategic activation of startups in allergy research and development.

ß-Lactam allergy delabeling is safe and saves costs in Primary Care.

OBJECTIVE: To determine whether the ß-lactam allergy delabeling was safe and cost-saving in Primary Care (PC) patients. DESIGN: We have conducted a retrospective chart review of PC patients with ß-lactam allergy label evaluated in our Allergy Unit between 2017 and 2022. SITE: Allergy Department. Hospital Virgen del Rocio (Sevilla). PARTICIPANTS: A total of 391 patients labeled for ß-lactam allergy in PC were studied. MAIN MEASUREMENTS: (a) Outcome evaluation of a ß-lactam allergy delabeling procedure. (b) A ratio between the total e-prescribed antibiotic cost and the number of treatment days (the experimental daily antibiotic cost or EDAC) before and after delabeling was analyzed in delabeled and truly allergic patients. RESULTS: The results of skin testing were positive in 9.2% of the reported cases (36 of 391 patients). The reactions to oral provocation challenge (OPC) occurred in 2.14% of the patients who underwent negative skin testing to offending ß-lactam (in 15 of 699 OPC). A total of 307 patients (78.5%) were delabeled; 70 (17.9%) had a ß-lactam selective response and 14 (3.59%) reacted to both penicillin and cephalosporin. The EDAC before and after the procedure in delabeled patients was significantly lower (0.88 € vs 0.62 €, p<10-3), than that observed in truly allergic group (0.87 € vs. 0.76 €, p=not significant). CONCLUSION: To delabel ß-lactam allergy in Primary Care patients is safe in most patients, cost-saving in antibioticotherapy, and allows identify the main clinical ß-lactam allergy phenotypes that benefit from this procedure.

Working with companies that manufacture breastmilk substitutes: An EAACI position paper.

Breastmilk is the optimal source of nutrition for infants and should ideally be provided exclusively for the first 6 months of life, and alongside complementary food until 2 years of life. However, there are circumstances where a breastmilk substitute (BMS) may be required. This includes maternal and/or child conditions or personal preference. Whilst these circumstances should never be used as an opportunity to promote BMS, healthcare professionals (HCPs) need to have the knowledge of suitable alternatives and should always be guided by scientific and health motives when recommending a BMS. The Task Force 'Milk Formula Industry Sponsorship' from the European Academy of Allergy and Clinical Immunology (EAACI), provides with this publication recommendations for EAACI interactions with the BMS manufacturers and how this will be supervised.

Parvalbumin Gene: A Valuable Marker for Pike Authentication and Allergen Risk Assessment.

Fish from the pike (Esox) genus are valued in gastronomy for their superior meat quality. However, they can cause allergic reactions in sensitive consumers. This work aimed to fill the gap in the detection of pike allergens using molecular-biological techniques. New, fast, and accurate loop-mediated isothermal amplification (LAMP) and real-time PCR (qPCR) assays were designed to detect pike DNA using the parvalbumin gene as a marker. LAMP was assessed by electrophoresis, SYBR green optical detection, and real-time fluorescence detection. The latter was the most sensitive, detecting as little as 0.78 ng of pike DNA; the qPCR detection limit was 0.1 ng. The LAMP analysis took 20-70 min, which is significantly faster than qPCR. The study provides reliable detection and quantification of the parvalbumin gene in both fresh and processed samples and further highlights the versatility of the use of the parvalbumin gene for the authentication of food products and consumer protection via refined allergen risk assessment that is independent of the type of tissue or food processing method used.

Assessment of Knowledge, Attitude, and Practice of Pharmacovigilance and Materiovigilance among Oral Health Practitioners in India.

Aim: This electronic survey was carried out to assess the knowledge, attitude, and practices among the oral health practitioners. Methods: A questionnaire survey was conducted among undergraduates, graduated practitioners, and specialist practitioners. A Google Form that included a specified instruction format, informed consent with a clear description of the purpose of the study, and questions in different categories were sent through Whatsapp and email. Descriptive statistics were used to analyze responses. The association of knowledge and attitude with respect to oral health professionals was analyzed with the Chi-square test. Results: The questionnaire was completed by 570 participants. Thirty percent of participants encountered ADR related to the drugs available in the market and 33.2% of participants encountered adverse reaction related to materials used in practice. ADR should be reported as soon as it is detected, according to this study about 12.1% of participants reported the ADRs, and this reporting is primarily for patient safety. Almost 66.8% of participants perceived that dental products can cause ADR owing to a lack of information about ADR and reporting procedures, or due to fear of legal concerns. Only about 9.5% of the participants had previously attended an ADR workshop. Conclusion: Oral health practitioners have a general understanding of ADR; however, there is substantial evidence of underreporting and a lack of reporting system information. Organizing an orientation program and raising awareness about ADR reporting could help improve spontaneous reporting and better patient care.

Food allergy issues among consumers: a comprehensive review.

Food Allergy (FA) is a growing global public health concern. In the United States alone, 8% of children and 11% of adults have a convincing FA (symptoms consistent with an IgE-mediated reaction to a specific allergen). Given the significant prevalence of this condition, the objective of this mini-review is to illustrate the many dimensions of life that are impacted among those with FA. Summarizing findings from a breadth of current literature, we present how FA affects social, psychological, and economic-related quality of life. With this informative review, we endeavor to bring increased awareness to these issues and help cultivate a better future for individuals with FA.

Global assessment of the knowledge and confidence in managing allergic disorders among primary care pediatricians across Europe: An EAACI task force report.

BACKGROUND: Pediatricians are often the first point of contact for children in Primary Care (PC), but still perceive gaps in their allergy knowledge. We investigated self-perceived knowledge gaps and educational needs in pediatricians across healthcare systems in Europe so that future educational initiatives may better support the delivery of allergy services in PC. METHOD: A multinational survey was circulated to pediatricians who care for children and adolescents with allergy problems in PC by the EAACI Allergy Educational Needs in Primary Care Pediatricians Task Force from February to March 2023. A 5-point Likert scale was used to assess the level of agreement with questionnaire statements. Thirty surveys per country were the cut-off for inclusion and statistical analysis. RESULTS: In this study, 1991 respondents were obtained from 56 countries across Europe and 210 responses were from countries with a cut-off below 30 participants per country. Primary care pediatricians (PCPs) comprised 74.4% of the respondents. The majority (65.3%) were contracted to state or district health services. 61.7% had awareness of guidelines for onward allergy referral in their countries but only 22.3% were aware of the EAACI competencies document for allied health professionals for allergy. Total sample respondents versus PCPs showed 52% and 47% of them have access to allergy investigations in their PC facility (mainly specific IgE and skin prick tests); 67.6% and 58.9% have access to immunotherapy, respectively. The main barrier to referral to a specialist was a consideration that the patient's condition could be diagnosed and treated in this PC facility, (57.8% and 63.6% respectively). The main reasons for referral were the need for hospital assessment, and partial response to first-line treatment (55.4% and 59.2%, 47% and 50.7%, respectively). Learning and assessment methods preference was fairly equally divided between Traditional methods (45.7% and 50.1% respectively) and e-learning 45.5% and 44.9%, respectively. Generalist physicians (GPs) have the poorest access to allergy investigations (32.7%, p = .000). The majority of the total sample (91.9%) assess patients with allergic pathology. 868 (43.6%) and 1117 (46.1%), received allergy training as undergraduates and postgraduates respectively [these proportions in PCPs were higher (45% and 59%), respectively]. PCPs with a special interest in allergology experienced greater exposure to allergy teaching as postgraduates. GPs received the largest amount of allergy teaching as undergraduates. Identifying allergic disease based on clinical presentation, respondents felt most confident in the management of eczema/atopic dermatitis (87.4%) and rhinitis/asthma (86.2%), and least confident in allergen immunotherapy (36.9%) and latex allergy (30.8%). CONCLUSION: This study exploring the confidence of PCPs to diagnose, manage, and refer patients with allergies, demonstrated knowledge gaps and educational needs for allergy clinical practice. It detects areas in need of urgent improvement especially in latex and allergen immunotherapy. It is important to ensure the dissemination of allergy guidelines and supporting EAACI documents since the majority of PCPs lack awareness of them. This survey has enabled us to identify what the educational priorities of PCPs are and how they would like to have them met.

A comparison of healthcare utilization and outcomes following skin vs. serum-specific IgE allergy testing.

OBJECTIVE: To compare the cost, healthcare utilization, and outcomes between skin and serum-specific IgE (sIgE) allergy testing. METHODS: This retrospective cohort study used IBM® MarketScan claims data, from which commercially insured individuals who initiated allergy testing between January 1 and December 31, 2018 with at least 12 months of enrollment data before and after index testing date were included. Cost of allergy testing per patient was estimated by testing pattern: skin only, sIgE only, or both. Multivariable linear regression was used to compare healthcare utilization and outcomes, including office visits, allergy and asthma-related prescriptions, and emergency department (ED) and urgent care (UC) visits between skin and sIgE testing at 1-year post testing (α = 0.05). RESULTS: The cohort included 168,862 patients, with a mean (SD) age of 30.8 (19.5) years; 100,666 (59.7%) were female. Over half of patients (56.4%, n = 95,179) had skin only testing, followed by 57,291 patients with sIgE only testing and 16,212 patients with both testing. The average cost of allergy testing per person in the first year was $430 (95% CI $426-433) in patients with skin only testing, $187 (95% CI $183-190) in patients with sIgE only testing, and $532 (95% CI $522-542) in patients with both testing. At 1-year follow-up post testing, there were slight increases in allergy and asthma-related prescriptions, and notable decreases in ED visits by 17.0-17.4% and in UC visits by 10.9-12.6% for all groups (all p < 0.01). Patients with sIgE-only testing had 3.2 fewer allergist/immunologist visits than patients with skin-only testing at 1-year follow-up (p < 0.001). Their healthcare utilization and outcomes were otherwise comparable. CONCLUSIONS: Allergy testing, regardless of the testing method used, is associated with decreases in ED and UC visits at 1-year follow-up. sIgE allergy testing is associated with lower testing cost and fewer allergist/immunologist visits, compared to skin testing.

Delabeling of allergy to beta-lactam antibiotics in hospitalized patients: a prospective study evaluating cost savings.

BACKGROUND: Patients with a penicillin allergy label are at risk of an associated increase in adverse antibiotic events and hospitalization costs. AIM: We aimed to study the economic savings derived from the correct diagnosis and delabeling inpatients with suspected beta-lactam allergy, considering the acquisition cost of antimicrobials prescribed during a patient's hospital stay. METHOD: We prospectively evaluated patients admitted to the University Hospital of Salamanca who had been labeled as allergic to beta-lactams and performed a delabeling study. Subsequently, cost differences between antibiotics administered before and after the allergy study and those derived from those patients who received alternative antibiotics during admission and those who switched to beta-lactams after the allergy study were calculated. RESULTS: One hundred seventy-seven inpatients labeled as allergic to beta-lactams underwent a delabeling study; 34 (19.2%) were confirmed to have allergy to beta-lactams. Of the total number of patients, 136 (76.8%) received antibiotics during their hospitalization, involving a mean (SD) cost of €203.07 (318.42) and a median (IQR) cost of €88.97 (48.86-233.56). After delabeling in 85 (62.5%) patients, the antibiotic treatment was changed to beta-lactams. In this group of patients, the mean cost (SD) decreased from €188.91 (351.09) before the change to 91.31 (136.07) afterward, and the median cost (IQR) decreased from €72.92 (45.82-211.99) to €19.24 (11.66-168). The reduction was significant compared to the median cost of patients whose treatment was not changed to beta-lactams (p<0.001). CONCLUSION: Delabeling hospitalized patients represents a cost-saving measure for treating patients labeled as allergic to beta-lactams.

Sociodemographic inequities in food allergy: Insights on food allergy from birth cohorts.

A large and growing corpus of epidemiologic studies suggests that the population-level burden of pediatric FA is not equitably distributed across major sociodemographic groups, including race, ethnicity, household income, parental educational attainment, and sex. As is the case for more extensively studied allergic disease states such as asthma and atopic dermatitis epidemiologic data suggest that FA may be more prevalent among certain populations experiencing lower socioeconomic status (SES), particularly those with specific racial and ethnic minority backgrounds living in highly urbanized regions. Emerging data also indicate that these patients may also experience more severe FA-related physical health, psychosocial, and economic outcomes relating to chronic disease management. However, many studies that have identified sociodemographic inequities in FA burden are limited by cross-sectional designs that are subject to numerous biases. Compared with cross-sectional study designs or cohorts established later in life, birth cohorts offer advantages relative to other study designs when investigators seek to understand causal relationships between exposures occurring during the prenatal or postnatal period and the atopic disease status of individuals later in life. Numerous birth cohorts have been established across recent decades, which include evaluation of food allergy-related outcomes, and a subset of these also have measured sociodemographic variables that, together, have the potential to shed light on the existence and possible etiology of sociodemographic inequities in food allergy. This manuscript reports the findings of a comprehensive survey of the current state of this birth cohort literature and draws insights into what is currently known, and what further information can potentially be gleaned from thoughtful examination and further follow-up of ongoing birth cohorts across the globe.

Understanding Health Equity in Patient-Reported Outcomes.

Patient-reported outcomes (PROs) are measures of patients' health that are conveyed directly by individual patients. These measures serve as instruments to evaluate the impact of interventions on any aspect of patients' health, from specific symptoms to broader quality of life indicators. However, their effectiveness relies on capturing relevant factors accurately. Whereas they are commonly used in clinical trials, PROs extend their influence across health care settings, informing clinicians, health care payers, regulators, and administrators to guide quality improvement and reimbursement decisions. Neglecting health equity considerations in PRO development and implementation widens health disparities, leading to biased interpretations, medical mismanagement, and poor health outcomes among marginalized groups. To foster equitable health care, efforts must focus on considering the values of underrepresented populations in PRO design, addressing barriers to completion, enhancing representation in research, providing cultural competency training for clinicians, and allocating research funding to support health equity research. By addressing these issues, advances can be made toward fostering inclusive, equitable health care for all individuals.