Introduction : There are no reports regarding oral immunotherapy (OIT) with omalizumab (OMB) for hen’s egg allergy. This report describes the safety and efficacy of OIT with OMB for hen’s egg allergy. Case : A 7-year-old boy with allergies to hen’s egg and wheat, as well as exacerbated and persistent severe bronchial asthma, underwent rush OIT for anaphylaxis due to exposure to hen’s egg. His asthma had been alleviated at 9 months after initiating the rush OIT, and we began treatment with OMB. Results : The exposure threshold was 17.5 g of whole egg at the start of the OIT, and it reached 60 g via the maintenance dose at 5 months. The frequency of the patient’s symptoms was 11.6% between OIT initiation and 9 months. Between 9 months and 24 months (after starting OMB), we observed that the frequency of the patient’s symptoms decreased to 2.2-5.8%. After completing treatment, we confirmed that he could eat one whole hen’s egg. We also encouraged him to start wheat intake using a similar method, which cumulated in the patient being able to eat 700 g of udon noodles. Conclusion : OIT with OMB effectively reduced the frequency of the patient’s food allergy symptoms. These outcomes indicate that administering OIT with OMB is a potentially effective method for reducing the symptoms of hen’s egg allergy. However, tolerance acquisition should be confirmed after withdrawal of the OMB treatment.

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Background : The number of children with food allergies has been increasing in recent years and childcare facilities need to manage them. The objective of this study was to determine how children with food allergies are being managed at preschools and daycare centers in Yokohama. Methods : An anonymous questionnaire covering topics such as identification of children with food allergies, meals, and use of epinephrine auto-infectors (EpiPen^®) was sent to all preschools and daycare centers in Yokohama. Results : The percentage of children with food allergies at both preschools and daycare centers was higher than that seen in similar previous studies. Fewer preschools than daycare centers were able to provide allergen-free or alternative meals and more preschools identified children with food allergies by means other than a physician’s diagnosis. Similar trends were seen for unlicensed daycare centers. Though more children at preschools had an EpiPen^® prescription, fewer preschools than daycare centers were able to administer injections. Moreover, preschool staff tended to be less knowledgeable about food allergies compared with daycare center staff. Conclusions : Greater effort should be made to spread information on food allergies and expand the scope of food allergy management at childcare facilities, particularly at preschools and unlicensed daycare centers.

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In Japan, it is conventional and common that the severity of asthma exacerbation in children is estimated based on the criterion for asthma exacerbation applied by the Japanese Pediatric Guidelines for the Treatment and Management of Asthma (JPGL). We applied the Modified Pulmonary Index score (MPIS) to assess the exacerbation of children’s acute asthma, and compared these results with those based on the JPGL 2012 criterion. Total of 94 patients participated and 129 cases were investigated in this study. Sixty-four cases were evaluated as mild exacerbation, 55 as moderate exacerbation and 10 as severe exacerbation. Each MPIS was 4.5±2.1 points (0-9) for mild exacerbation, 8.1±2.1 points (4-13) for moderate exacerbation, 13.2±1.9 points (11-16) for severe exacerbation. The difference between the three groups showed statistical significance. The findings suggest that the levels of MPIS appropriately reflect the conventional criterion of JPGL 2012. MPIS is more objective than conventional method, and has been found to have high consistency level of evaluation for asthma exacerbation among estimators. Therefore, we believe that MPIS is likely to be a more appropriate method to evaluate asthma exacerbation in children.

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We report the case of a 15-year-old boy who developed anaphylactic symptoms including facial reddening and swelling and dyspnoea during running after taking ramen noodles. We suspected food dependent exercise-induced anaphylaxis (FDEIA) and performed challenge tests as he had no history of acute allergic reaction to wheat. Symptoms were not elicited with any of the three combination challenge tests ; wheat noodles and exercise, premedication of aspirin and wheat noodles, and premedication of aspirin, wheat noodles and exercise. However, plasma histamine concentration increased after each of the three tests ; 200%, 190% and 248% of each of pre-test values were obtained, respectively. A diagnosis of FDEIA was thus made. He was prescribed an epinephrine auto-injector, instructed not to exercise during two hours after wheat intake, and told to avoid taking wheat products and exercise after he takes aspirin. Incorporation of increase in the plasma histamine concentration in diagnosis of FDEIA is very clinically important to circumvent a possible false negative in the absence of symptoms with the challenge tests.

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Immediate cow’s milk (CM) allergy is known to seldom develop in neonates. We report here the first neonatal case of CM allergy developing urticarial rash immediately after ingesting the first CM formula on the day of birth. The case was a boy of full term normal delivery. He was fed 10 ml of CM formula for the first time at 6 hours after birth and developed urticarial rash in the trunk 40 minutes later. CM-specific IgE antibodies were not detected at this time point. At 7 days old, an oral food challenge test with CM formula was performed. He developed again urticarial rash 3 hours and 50 minutes after having 20 ml of CM formula. He also showed a positive result at an oral food challenge test at 4 months old, in which similar rash developed 30 minutes after ingesting 200 ml of CM formula. CM-specific IgE antibodies were detected at that time. Considering the symptoms and the clinical course, it is suggested that the IgE-mediated immediate-type hypersensitivity contributes to the development of symptoms in this case, although much remains to be elucidated.

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Pediatric asthma preceded by eczema is associated with genetic mutation in skin-barrier related molecule, filaggrin, suggesting that disruption of skin barrier is related with the development of asthma. Skin barrier function, constituted of filaggrin and extracellular lipids in the stratum corneum and tight junction in the stratum granulosum, can be disrupted not only by genetic abnormality, but also by many mechanical, chemical, and biological factors. Allergen sensitization through the impaired skin induces the expression of specific molecules such as thymic stromal lymphopoietin and interleukin-23. These molecules exacerbate type 2-immune responses essential for the development of asthma and other allergic diseases. In contrast, epicutaneous allergen immunotherapy, in which low dose antigen is applied on the normal skin, induces regulatory T cells, and possibly suppresses the progression of allergic march. Further studies to clarify the mechanisms and immunological responses of epicutaneous allergen sensitization would lead to novel therapeutics for the prevention of early-onset allergic asthma.

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[in Japanese]

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The aim of clinical research is to obtain and to generalize knowledge that elucidates mechanisms, causes and/or pathology of a disease or improves treatments and/or prophylaxis of a disease, in order to develop medical science. Researchers should conduct valuable and ethical study along with to protect human rights and welfare of people who participate in clinical research. Based upon the ethical guidance such as Nuremberg Code, Declaration of Helsinki, or Belmont Report that were primarily a response past abuses of research participants, seven main principles have been described as guiding the conduct of ethical research : 1) Social and clinical value, 2) Scientific validity, 3) Fair subject selection, 4) Favorable risk-benefit ratio, 5) Independent review, 6) Informed consent, 7) Respect for potential and enrolled subjects. The newly revised ethical guideline in our country named “Ethical Guidelines for Medical and Health Research Involving Human Subjects” proposes basic principles and rules of clinical research according to these seven principles. How to comply these ethical guidelines in clinical research has been considered in this review.

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