Long-term (68 weeks) administration of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: efficacy and safety data from a phase III study.

Background: A phase III clinical trial in Japanese children aged 6-12 years with atopic dermatitis (AD) and inadequately controlled moderate-to-severe pruritus found that 16 weeks of nemolizumab treatment (30 mg every 4 weeks [Q4W]) was clinically effective and tolerable, with early improvement in pruritus and associated skin signs and a positive impact on patient quality of life (QoL).

Objective: To report the findings from the long-term extension period of the study, and evaluate the efficacy and safety profiles of nemolizumab when administered concomitantly with topical agents over 68 weeks.

Methods: The study included a 16-week, randomized, placebo-controlled, double-blind, parallel-group period during which patients received nemolizumab 30 mg or placebo Q4W; those who completed this period could enter a 52-week, long-term treatment period during which all patients received nemolizumab Q4W.

Olfactory dysfunction in Japanese children with moderate-to-severe allergic rhinitis.

Objective: Detailed quantitative studies on olfaction remain inadequate in patients with paediatric allergic rhinitis (AR). This study examined olfactory dysfunction in children with AR.

Methods: From July 2016 to November 2018, children aged 6-9 years were recruited and grouped as AR (n = 30) or without AR (control group, n = 10).

Executive summary: Japanese guidelines for atopic dermatitis (ADGL) 2021.

This is an abridged edition of English version of the Clinical Practice Guidelines for the Management of Atopic Dermatitis 2021. Atopic dermatitis (AD) is a disease characterized by relapsing eczema with pruritus as a primary lesion. In Japan, from the perspective of evidence-based medicine, the current strategies for the treatment of AD consist of three primary measures: (i) use of topical corticosteroids, tacrolimus ointment, and delgocitinib ointment as the main treatment of the inflammation; (ii) topical application of emollients to treat the cutaneous barrier dysfunction; and (iii) avoidance of apparent exacerbating factors, psychological counseling, and advice about daily life.

English Version of Clinical Practice Guidelines for the Management of Atopic Dermatitis 2021.

This is the English version of the Clinical Practice Guidelines for the Management of Atopic Dermatitis 2021. Atopic dermatitis (AD) is a disease characterized by relapsing eczema with pruritus as a primary lesion. In Japan, from the perspective of evidence-based medicine, the current strategies for the treatment of AD consist of three primary measures: (i) use of topical corticosteroids, tacrolimus ointment, and delgocitinib ointment as the main treatment of the inflammation; (ii) topical application of emollients to treat the cutaneous barrier dysfunction; and (iii) avoidance of apparent exacerbating factors, psychological counseling, and advice about daily life.

Reproducibility of food challenge to cow's milk: Systematic review with individual participant data meta-analysis.

Background: Cow's milk (CM) is an increasingly common cause of severe allergic reactions, but there is uncertainty with respect to severity of reactions at low-level CM exposure, as well as the reproducibility of reaction thresholds.

Objective: We undertook an individual participant data (IPD) meta-analysis of studies reporting double-blind, placebo-controlled food challenges in CM to determine the rate of anaphylaxis to low-level exposures and the reproducibility of reaction thresholds.

Methods: We performed a systematic review and IPD meta-analysis of studies reporting relevant data.

The Japanese respiratory society guidelines for the management of cough and sputum (digest edition).

Cough and sputum are common complaints at outpatient visits. In this digest version, we provide a general overview of these two symptoms and discuss the management of acute (up to three weeks) and prolonged/chronic cough (longer than three weeks). Flowcharts are provided, along with a step-by-step explanation of their diagnosis and management.

Successful sublingual immunotherapy for severe egg allergy in children: a case report.

Background: Egg allergy is one of the most common food allergies in children. To date, oral immunotherapy (OIT) has been considered as a promising treatment option for egg allergy. However, safety issues remain concerning severe adverse events requiring epinephrine injection.

Effect of oral immunotherapy in children with milk allergy: The ORIMA study.

Background: This study was aimed at evaluating the efficacy and safety of oral immunotherapy (OIT) in children with severe cow's milk allergy.

Methods: The subjects comprised 28 children (aged 3-12 years) with allergic symptoms that were induced by ≤ 10 mL of cow's milk in an oral food challenge test (OFC). The subjects were randomly allocated to the treatment group (n = 14) and control group (n = 14); the former received rush immunotherapy for 2 weeks, followed by a gradual increase of cow's milk volume to 100 mL for 1 year, and the latter completely eliminated cow's milk for 1 year.

[A PHASE III STUDY TO EVALUATE SAFETY AND EFFICACY OF FLUTICASONE/FORMOTEROL COMBINATION (FLUTIFORM AEROSOL) IN LONG-TERM ADMINISTRATION (24 WEEKS) IN JAPANESE PEDIATRIC PATIENTS WITH BRONCHIAL ASTHMA].

Background: The combination drug of inhaled corticosteroid (ICS)/long-acting β2 agonist is being used as a long-term control medication for pediatric asthma patients for those who are poorly controlled by ICS alone. Long-term efficacy and safety of Fluticasone propionate/formoterol fumarate hydrate (FP/FM) was evaluated in pediatric patients with bronchial asthma.

Methods: Two inhales of FP/FM (50/5μg) at one time, twice daily were administered for 24 weeks to Japanese asthma patients aged 5 to ＜16 years who had asthma symptoms during the observation period while using the same dosage of ICS during a certain period of time.

Accidental ingestion of food allergens: A nationwide survey of Japanese nursery schools.

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Low-dose l-isoproterenol versus salbutamol in hospitalized pediatric patients with severe acute exacerbation of asthma: A double-blind, randomized controlled trial.

Background: Although the guidelines in most countries do not recommend continuous inhalation of l-isoproterenol to treat pediatric patients with acute severe exacerbation of asthma, lower dose of l-isoproterenol has been widely used in Japan. To determine whether the efficacy of low-dose l-isoproterenol was superior to that of salbutamol, we conducted a double-blind, randomized controlled trial.

Methods: Hospitalized patients aged 1-17 years were eligible if they had severe asthma exacerbation defined by the modified pulmonary index score (MPIS).

[MINISTRY OF HEALTH "2015 PENULTIMATE YEAR CHILDREN AND SURVEY AND RESEARCH PROJECT PROMOTING THE PARENTING SUPPORT" ACTUAL CONDITIONS REPORT ON THE RESULTS OF THE INVESTIGATION ON ALLERGY CONTROL IN DAY-CARE CENTERS ADMISSIONS CHILDREN OF ALLERGIC DISEASES SITUATION AND DAY-CARE CENTERS].

Background: There are no reports on the prevalence and social acceptance of food allergies (FAs) and FAinduced symptoms in nursery schools in Japan.

Purpose: The purpose of this study is to clarify the current status of FA among children in nurseries.

Methods: Investigations were conducted in childcare facilities nationwide through survey request forms found on the Web page or sent via post.

Long-term safety of subcutaneous immunotherapy with TO-204 in Japanese patients with house dust mite-induced allergic rhinitis and allergic bronchial asthma: Multicenter, open label clinical trial.

Background: To evaluate the long-term safety of subcutaneous immunotherapy with TO-204, a standardized house dust mite (HDM) allergen extracts, we conducted a multicenter, open label clinical trial.

Methods: Japanese patients aged 5-65 years were eligible for the study, if they had HDM-induced allergic rhinitis (AR), allergic bronchial asthma (BA), or both. TO-204 was administered in a dose titration scheme, and the maintenance dose was determined according to the predefined criteria.

Up-regulation of serum periostin and squamous cell carcinoma antigen levels in infants with acute bronchitis due to respiratory syncytial virus.

Background: Periostin and squamous cell carcinoma antigen (SCCA) are involved in the pathogenesis of asthma. Acute bronchitis due to respiratory syncytial virus (RSV) infection during infancy exhibits an asthma-like pathogenesis, suggesting that it may be associated with the subsequent development of asthma. However, the mechanism by which RSV infection leads to development of asthma has not yet been fully elucidated.

Early control treatment with montelukast in preschool children with asthma: A randomized controlled trial.

Background: While Japanese guideline recommends initial control treatment for preschool children with asthma symptoms more than once a month, Western guidelines do not. To determine whether control treatment with montelukast was more effective than as-needed β-agonists in this population, we conducted a randomized controlled trial.

Methods: Eligible patients were children aged 1-5 years who had asthma symptoms more than once a month but less than once a week.

[Treatment and managements of pediatric asthma].

In Japan, pediatric asthma is managed based on the Japanese Pediatric Guideline for the Treatment and Management of Asthma 2012 (JPGL 2012). JPGL 2012 also recommends treat- ment and management aimed at complete control through avoiding exacerbation factors and appropriate use of anti-inflammatory drugs. In this review, we describe an overview of the newer treatment options available for treatment and management of pediatric asthma and some topics.

Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma.

Background: Omalizumab is effective and well-tolerated in children with moderate to severe allergic asthma. However, the effects of long-term treatment with omalizumab in this population haven't been well investigated. The objective of this study is to evaluate the long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with uncontrolled severe asthma.

Optimal step-down approach for pediatric asthma controlled by salmeterol/fluticasone: A randomized, controlled trial (OSCAR study).

Background: Several guidelines, including the Japanese Pediatric Guideline for the Treatment and Management of Asthma (JPGL), recommend salmeterol/fluticasone combination therapy (SFC) as step 3 to 4 treatment for moderate to severe asthma. However, the optimal step-down approach to SFC remains unclear. In the current study, we examined step-down approaches in asthmatic children whose symptoms had been stabilized by SFC 100/200 μg/day.

Periostin as a biomarker for the diagnosis of pediatric asthma.

Background: There are some biomarkers for asthma diagnosis but they are often difficult in clinical use, particularly in pediatric cases. Periostin is an extracellular matrix protein, upregulated in response to IL-4 or IL-13. Serum periostin is expected to be used as a non-invasive biomarker for asthma diagnosis and management.