Dermatitis In Japan Research Articles

Cost-effectiveness analysis of abrocitinib compared with standard of care in adult moderate-to-severe atopic dermatitis in Japan.

Atopic dermatitis (AD) is a chronic inflammatory skin disease with a significant clinical, economic, and human burden. The JAK1 Atopic Dermatitis Efficacy and Safety (JADE) program's Phase 3 trials demonstrated that as a treatment for moderate-to-severe AD in adults with previous exposure to immunotherapy, abrocitinib showed superior efficacy and safety compared with standard of care (SoC), consisting of topical corticosteroids. This study assessed the cost-effectiveness of abrocitinib with SoC versus SoC alone for this patient population in Japan from a societal perspective. A hybrid decision tree and Markov model were used to capture the initial treatment and long-term maintenance phases. Clinical inputs at 16 weeks were obtained through a Bayesian network meta-analysis of four pivotal trials from the JADE program. Clinical inputs at 52 weeks were derived from the JADE EXTEND trial. Response-specific utility inputs were obtained from published literature. Resource use, costs, and productivity inputs were gathered from Japanese claims analysis, literature, public documents, and expert opinion. Costs and quality-adjusted life years (QALYs) were discounted at 2.0% per year and incremental cost-effectiveness ratios (ICERs) were calculated. Sensitivity and scenario analyses were performed to validate the base case results and explore a payer perspective. Over a lifetime horizon and with the base-case societal perspective, abrocitinib produced a mean gain of 0.75 QALYs, incremental costs of JPY (¥) 2 270 386 (USD [$] 17 265.6), and a resulting ICER of ¥3 034 514 ($23 076.5) per QALY compared with SoC. From a payer perspective, the incremental costs increased to ¥4 476 777 ($34 044.4), with an ICER of ¥5 983 495 ($45 502.6) per QALY. The results were most sensitive to treatment-specific, response-based utility weights, drug costs, and productivity-related inputs. From a Japanese societal perspective, abrocitinib demonstrated superior QALYs and with a willingness-to-pay threshold of ¥5 000 000 ($38 023.4) per QALY, can be considered cost-effective compared with SoC as a treatment for moderate-to-severe AD in adult patients with previous immunosuppressant exposure.

Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: Analysis of the 3-Year Phase 3 Rising Up Study.

Upadacitinib is an oral Janus kinase inhibitor approved in multiple countries for moderate-to-severe atopic dermatitis (AD). Here we present long-term data for up to 3years of continuous upadacitinib treatment in Japanese patients with AD. Rising Up was a phase 3, randomized, multicenter study in Japan investigating the safety and efficacy of upadacitinib in patients with moderate-to-severe AD. Patients aged 12-75years (weight ≥ 40kg if < 18years) were randomized 1:1:1 to receive upadacitinib 15mg, upadacitinib 30mg, or placebo through week16 (all in combination with topical corticosteroids). At week16, patients who received placebo were rerandomized 1:1 to upadacitinib 15mg or 30mg; topical corticosteroids were optional per investigator discretion from weeks16-160. Safety was assessed by monitoring adverse events (AEs). Efficacy assessments included patients who achieved ≥ 75%/≥ 90% improvement from baseline in Eczema Area and Severity Index (EASI 75/90), clear/almost clear on the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD 0/1), or a ≥ 4-point improvement from baseline in Worst Pruritus Numerical Rating Scale (WP-NRS). Of 272 patients enrolled, 230 completed the study. Through week160, the long-term incidence rate of overall AEs was numerically higher with upadacitinib 30mg than 15mg; rates of serious AEs, AEs considered possibly related to study drug, AEs leading to discontinuation, and AEs of special interest were generally low and similar between dose groups. EASI 75, EASI 90, vIGA-AD 0/1, and WP-NRS response rates were generally greater with upadacitinib 30mg than 15mg and maintained through week160 with either dose. For up to 3years of continuous treatment, upadacitinib was well tolerated in Japanese patients, with a similar safety profile to that of short-term studies and durable long-term response rates for skin clearance and itch improvement. ClinicalTrials.gov identifier, NCT03661138.

Evaluating the usefulness of the Atopic Dermatitis Control Tool for assessing disease control in individuals with atopic dermatitis in Japan.

An online questionnaire assessed atopic dermatitis (AD)-related patient-reported outcome measures [including the Atopic Dermatitis Control Tool (ADCT)] in 5546 patients with AD. Spearman’s rank correlation coefficients showed that total ADCT scores had strong correlations with established AD assessment tools (including the DLQI, POEM and WI-NRS). ADCT subitem scores also had moderate correlations with the other AD assessment tools, except for Q4 (sleep) with the Global Questions assessment tool. This demonstrates that ADCT scores can effectively characterize multidimensional AD disease burden.

The disease burden of pediatric patients with atopic dermatitis in Japan.

Atopic dermatitis (AD) is a chronic skin condition that is associated with significant patient burden and decreased health-related quality of life (HRQoL). We report results of the real-world Epidemiology of Children with Atopic Dermatitis Reporting on their Experience study in Japanese pediatric patients, focusing on the impact of AD severity on disease burden. Children and adolescents aged 6 months to 17 years (or their caregivers/parents) completed an online survey between September 26, 2018, and March 5, 2019. Patients with diagnosed AD (i.e., met International Study of Asthma and Allergies in Childhood criteria and had a self-reported AD diagnosis) were evaluated for disease severity using the Patient-Oriented Eczema Measure (POEM). Impact of AD severity on AD symptoms (itching, pain, and sleep disturbance), disease flares, atopic comorbidities, healthcare resource utilization, school days missed, and HRQoL were assessed. Of 5702 Japanese pediatric patients, 547 had diagnosed AD and were included in this analysis. Based on POEM scores, AD severity was clear/mild in 346 patients (63.3%), moderate in 177 (32.5%), and severe in 24 (4.4%). Across all age groups (i.e., less than 6, 6-11, and 12-17 years), increased AD severity was associated with increased AD symptom severity, number of flares, atopic comorbidities, healthcare resource utilization, and school absences, as well as worsened HRQoL. This population-based study of Japanese children and adolescents showed that greater AD severity had a high impact on disease burden.

Impact of the Family and Household Environment on Pediatric Atopic Dermatitis in Japan.

Pediatric atopic dermatitis (AD) can negatively impact the family quality of life (QoL). We report data from the real-world Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE) study in Japanese pediatric patients, focusing on disease impact on family QoL. Children and adolescents aged 6 months to <18 years completed an online survey between September 2018-December 2019. The impact of disease severity on family QoL and its effect on parents' time were assessed using the dermatitis family impact (DFI) questionnaire. The impact of a family history of allergic conditions, current residency, second-hand smoke exposure, and household pets on AD prevalence and severity was also assessed. Family QoL decreased as AD severity increased, particularly in families with children aged <6 years; but had the greatest impact on sleep and tiredness in families with children aged <12 years. Parents spent at least 4.6 h/week caring for children <6 years, including those with mild symptoms. Most children (>80%) had a family history of allergic conditions; AD prevalence was increased in those exposed to second-hand smoke or household pets. This study demonstrated that pediatric AD in Japanese individuals has negative impacts on family QoL and that family and household environments can influence pediatric AD prevalence.

Safety and effectiveness of dupilumab in the real‐world treatment of atopic dermatitis in Japan: 1‐year interim analysis from a post‐marketing surveillance

AbstractObjectivesAtopic dermatitis (AD) is a common chronic inflammatory skin disorder in Japan. Dupilumab, a fully human monoclonal antibody, targets a shared subunit of the interleukin (IL)‐4 and IL‐13 receptors. Post‐marketing surveillance of the safety and effectiveness of dupilumab in adult AD patients was conducted in Japan, where the drug is also allowed for use in older adolescents (i.e., ≥15 years), and interim results are reported here.MethodsThis observational, multicenter study enrolled Japanese patients with AD who initiated dupilumab between July 2018–June 2020 (UMIN‐CTR Trials Registry: UMIN000032807). Baseline demographics, clinical history, medication data and dupilumab safety and effectiveness data were collected.ResultsBy the data cut‐off date of March 26, 2021, information from 600 patients has been collected. All the available safety and 1‐year effectiveness data are presented. The mean (standard deviation) age was 42.0 (15.9) years, the majority (69.1%) were male, and asthma was present in 12.2%. Adverse drug reactions (ADRs) were observed in 98 patients (16.4%), including conjunctivitis (n = 40; 6.7%), conjunctivitis allergic (n = 30; 5.0%), blepharitis (n = 5; 0.8%), headache and eye pruritus (n = 4; 0.7% each) and eosinophilia (n = 3; 0.5%). Six patients experienced asthma, all of whom had a history of, or concurrent, asthma. Disease severity improved remarkably at 4 months in most patients, which was maintained up to 1 year.ConclusionDupilumab appears to be a safe and effective treatment for patients aged ≥15 years with moderate‐to‐severe AD in routine clinical practice in Japan. Dupilumab was well tolerated, with no new safety signals and no new‐onset asthma.

Impact of Patient and Physician Disconnect on Satisfaction with Treatment for Atopic Dermatitis in Japan.

Atopic dermatitis (AD) is an inflammatory disease causing severe skin itching. Data on patient-physician disconnect on treatment satisfaction in patients with AD in Japan are limited. We investigated patient-physician disconnect on treatment satisfaction in AD and if it influences treatment patterns, clinical characteristics, and patient-reported outcomes (PROs). Data were drawn from the Adelphi AD Disease Specific Programme (DSP), a real-world, point-in-time survey of physicians and patients with AD conducted in Japan from April to July 2019. Patients and physicians were grouped according to level of treatment satisfaction ("extremely satisfied" to "extremely dissatisfied"); with any level of dissatisfaction recorded as "less than satisfied." Data were collected on treatment patterns, clinical characteristics, and PROs including the Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), EQ-5D-3L questionnaire, and Work Productivity and Activity Impairment (WPAI) questionnaire. Data were provided by 184 patients with AD and 56 physicians; 72.8% of patient-physician pairs reported a fair (kappa coefficient: 0.40) level of agreement on treatment satisfaction, 51.6% of patient-physician pairs were both satisfied, and 21.2% were both less than satisfied. Satisfied physicians prescribed a mean 1.2 fewer treatments than dissatisfied physicians (p < 0.05). Cases where both physician and patient were less than satisfied or where patients were less satisfied than their physicians reported the worst PROs, DLQI (both less than satisfied: mean 10.7 versus patient less satisfied than physician: 10.6 versus overall: 7.9), POEM (19.5 versus 17.3 versus 17.0), EQ-5D-3L (0.82 versus 0.81 versus 0.87) (all, p < 0.05). Work impairment was highest when both patient and physician were less than satisfied (p < 0.05). Physicians cited treatment efficacy and patients cited efficacy and usability as main reasons for dissatisfaction. Overall, 12.0% of patients were less satisfied with their AD treatment than the physician, demonstrating some of the worst PROs, suggesting unmet need that could be improved by better patient-physician communication.

Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study.

Upadacitinib, an oral, selective Janus kinase inhibitor, is approved in Japan for the treatment of moderate-to-severe atopic dermatitis (AD), a chronic inflammatory skin disease characterized by eczematous morphology and intense itch. Rising Up is an ongoing phase 3, randomized, multicenter study evaluating the long-term safety and efficacy of upadacitinib in Japan. Patients with moderate-to-severe AD were randomized 1:1:1 to topical corticosteroids plus upadacitinib 15mg (UPA15), upadacitinib 30mg (UPA30), or placebo at baseline; at week16, placebo patients were rerandomized 1:1 to UPA15 or UPA30 (plus topical corticosteroids per investigator discretion). This 2-year interim analysis evaluated safety and efficacy through 112weeks (data cutoff date: 11 August 2021). Adverse events (AEs), AEs of special interest (AESIs), and laboratory data were assessed. Efficacy assessments included ≥ 75% and ≥ 90% improvement from baseline in Eczema Area and Severity Index (EASI 75/90), achievement of clear or almost clear on the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD 0/1), and ≥ 4-point improvement in the Worst Pruritus Numerical Rating Scale (WP-NRS). A total of 272 patients were enrolled and 242 were ongoing at data cutoff (UPA15, n = 120; UPA30, n = 122). After 112weeks of treatment, serious AEs, AEs leading to discontinuation, and most AESIs were generally infrequent, and rates were similar between the two upadacitinib groups. One event each of rectal cancer and cerebellar hemorrhage was reported in the UPA15 group; no thrombosis events were observed. The most common AEs included acne, nasopharyngitis, and herpes zoster. EASI 75, EASI 90, vIGA-AD 0/1, and WP-NRS response rates were maintained through week112. UPA15 and UPA30 were well tolerated through 112weeks of treatment with similar safety profiles to short-term studies and demonstrated durable long-term efficacy for the treatment of moderate-to-severe AD in adults and adolescents. ClinicalTrials.gov identifier, NCT03661138.

Impact of itch and skin pain on quality of life in adult patients with atopic dermatitis in Japan: results from a real-world, point-in-time, survey of physicians and patients

Objective Itch is a common symptom of atopic dermatitis (AD), however, there is limited evidence of the frequency and association of skin pain alongside itch. This study assessed the incremental dual burden and impact of itch and skin pain on satisfaction, quality of life and work productivity in patients with AD in Japan. Methods Data were drawn from the 2020 Adelphi AD Disease Specific Programme, a point-in-time survey of dermatologists (n = 56) and their patients with history of moderate/severe AD (n = 265). Patients were grouped accordingly: no itch/skin pain (No I/SP, reference group, n = 89), itch/no skin pain (I-only, n = 71), and itch and skin pain (I + SP, n = 26). Descriptive analyses were performed alongside a range of regression models, dependent on outcome variables. Results I + SP patients had a 4.97-point worse POEM score (p = .005) and 14.5% more overall work impairment (p = .034) versus the reference group. I-only and I + SP patients were 8.92 and 23.5 times more likely, respectively, to experience sleep disruption on a day-to-day basis (both p < .001). I + SP patients were 4.6 times more likely to be bothered by their symptoms (p = .034), had a mean EASI score 6.7 points higher (p = .008) and had 1.39 more areas affected (p = .001). I + SP patients were 7.26 times more likely to express dissatisfaction with lack of improvement in their condition and 8 times more likely to be dissatisfied with convenience of treatment (both p < .05). Conclusion This dissatisfaction, alongside variations in reported symptomatic burdens, suggests that physicians could consider alternative and/or novel therapeutic approaches for the management of both itch and skin pain.

Desire for Alternative Treatment Options in Patients with Atopic Dermatitis in Japan: Results of a Web-Based Cross-Sectional Study (AD-JOIN Study).

IntroductionTreatment satisfaction in patients with atopic dermatitis (AD) has been investigated in several studies, but the desire for alternative treatment options is unclear and has not been previously evaluated. We conducted a cross-sectional, web-based survey aimed at evaluating the desire for alternative treatment options in adults with AD from a patient registry in Japan.MethodsMain eligibility criteria were adults aged ≥ 18 years with AD who were receiving treatment with topical corticosteroids (TCS) and not systemic therapy. Questionnaires included the Patient Oriented Eczema Measure (POEM) and pruritus Numeral Rating Scale. The proportion of patients with a desire for an alternative treatment option was assessed, overall (Overall Desire) and by specific type of alternative treatment option (Specific Desire), including change in medication, hospital transfer, and complementary and alternative medicine (CAM) use. Patient background factors associated with desire were evaluated using multivariate logistic regression.ResultsOf the 1500 patients included in the analysis, 91.5% (n = 1372) had an Overall Desire, with the most common Specific Desire being a change in medication (n = 1213, 80.9%), followed by CAM (n = 593, 39.5%) and hospital transfer (n = 429, 28.6%). Dissatisfaction with current treatment was significantly (p < 0.05) associated with Overall Desire and Specific Desire (p < 0.001 each). Severe disease according to POEM was significantly associated with Overall Desire and a change in medication (p < 0.001 each).ConclusionsA high proportion of Japanese patients with AD being treated with TCS had a desire for alternative treatment options. The desire was greatly affected by patients’ satisfaction with their current treatment and perception of disease severity. These findings highlight the importance of assessing patients’ satisfaction or perception of disease severity, and facilitating early discussions between patient and doctor on their available treatment options, including new treatment options.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-022-00738-6.

The home environment and current dermatitis in Japanese junior high school children in Kansai area

There is little information on indoor risk factors for dermatitis in Japan. We studied associations between dermatitis in Japanese junior high school students in Hyogo prefecture and the home environment. A standardised questionnaire was sent to students in four schools (12–15 years old), 1048 (99%) participated. Data on the home environment was collected by the questionnaire. Associations were analysed by multilevel logistic regression in mutually adjusted models, calculating odds ratio (OR) with 95% confidence intervals. A total of 15.2% reported current dermatitis, 8.8% cat allergy, 6.1% dog allergy, 6.0% mould allergy, 25.7% pollen allergy and 32.3% any allergy (a history of atopy). Female gender (OR 1.65), a history of atopy (OR 2.14), new building materials (indoor paint or floor materials) (OR 1.59), dampness or indoor mould (OR 1.51) and windowpane condensation in winter (OR 1.45) were associated with current dermatitis. The association between window pane condensation and dermatitis was stronger in students without a history of atopy (interaction p=0.02). In conclusion, dampness, indoor mould and window pane condensation in wintertime can be household risk factors for dermatitis in adolescents. Chemical emissions from new building materials, especially paint and floor materials, can be another risk factor.

A phase 3 randomized, multicenter, double-blind study to evaluate the safety of upadacitinib in combination with topical corticosteroids in adolescent and adult patients with moderate-to-severe atopic dermatitis in Japan (Rising Up): An interim 24-week analysis

BackgroundSystemic atopic dermatitis treatments that have acceptable safety are needed.ObjectiveTo evaluate the safety of the oral Janus kinase inhibitor upadacitinib in combination with topical corticosteroids (TCSs) for the treatment of atopic dermatitis.MethodsIn this phase 3, double-blind study (Rising Up), Japanese patients (12-75 years) with moderate-to-severe atopic dermatitis were randomized in a 1:1:1 ratio to receive 15 mg of upadacitinib + TCS, 30 mg of upadacitinib + TCS, or a placebo + TCS (rerandomized in a 1:1 ratio to receive either 15 or 30 mg of upadacitinib + TCS at week 16). Adverse events and laboratory data were assessed for safety.ResultsIn 272 treated patients, the serious adverse event rates were similar for 15- and 30-mg upadacitinib + TCS at week 24 (15 mg, 56%; 30 mg, 64%) but greater than those for placebo + TCS (42%). Acne (all mild or moderate; none leading to discontinuation) occurred more frequently with upadacitinib + TCS (15 mg, 13.2%; 30 mg, 19.8%) than with placebo + TCS (5.6%). Furthermore, herpes zoster infection (4.4% vs 0%), anemia (1.1% vs 0%), neutropenia (4.4% vs 1.1%), and creatine phosphokinase elevations (2.2% vs 1.1%) occurred more frequently with 30-mg upadacitinib + TCS than with 15-mg upadacitinib + TCS; none of these events were reported with placebo + TCS. No thromboembolic events, malignancies, gastrointestinal perforations, active tuberculosis, or deaths occurred.LimitationsThe limitations included a small sample size and short observation period as well as nongeneralizability of the results beyond Japanese populations.ConclusionsThe results were generally consistent with those of previous reports; no new safety risks were detected.

Juzentaihoto Exerts Anti-Allergic Effects by Inhibiting Effector T-Cell Activation and Inducing and/or Activating Regulatory T Cells in a Murine Model of Contact Hypersensitivity

Background: Juzentaihoto (JTT) is a Kampo prescription that has been used clinically for treating skin diseases such as atopic dermatitis in Japan. We have previously studied the anti-allergic effects of JTT on 2,4,6-trinitrochlorobenzene (TNCB)-induced contact hypersensitivity (CHS) in mice and demonstrated that it significantly suppresses ear swelling in a dose-dependent manner. However, the mechanism underlying the anti-allergic actions of JTT is obscure. Methods: We investigated the mechanism underlying the anti-allergic effects of JTT using a TNCB-induced murine CHS model and adoptive cell transfer experiments. Results: We showed that the anti-allergic effects of JTT are due to inhibition of effector T-cell activation and induction and/or activation of regulatory T cells. Furthermore, ex vivo experiments confirmed the effect of JTT on the activation of effector T cells and regulatory T cells, as interferon-γ production decreased, whereas interleukin (IL)-10 production increased, in the cultured lymphocytes obtained from 5% TNCB-sensitized mice treated with anti-CD3ε and anti-CD28 monoclonal antibodies. Flow cytometry showed that the CD4⁺CD25⁺Foxp3⁺, CD4⁺CD25⁺Foxp3⁻, and CD8⁺CD122⁺ cell population increased after oral administration of JTT. Finally, the anti-allergic effect of JTT by inducing and/or activating regulatory T cells (Tregs) was confirmed to be mediated by IL-10 through in vivo neutralization experiments with anti-IL-10 monoclonal antibodies. Conclusion: We suggested that JTT exerts anti-allergic effects by regulating the activation of effector T cells and Tregs involved in murine CHS model.

Real‐world treatment patterns of patients with atopic dermatitis in Japan: Analysis of the JMDC Claims Database

AbstractObjectivesThis study was conducted to assess changes in the real‐world treatment of atopic dermatitis (AD) in Japan.MethodsPatients from the JMDC Claims Database with ≥1 confirmed diagnosis of AD, an identifiable medical care start date for AD, and ≥2 AD–related treatments on separate dates between January 1, 2005, and May 31, 2019, were included; data were analyzed on a yearly basis.ResultsIn total, 411,102 patients were included. The average age of patients increased from 12.0 to 18.8 years between 2005 and 2017. In any given year, the prevalence of AD was highest in patients aged &lt;2 years and lowest in patients aged ≥50 years. Dermatology (65.1%‐69.5% from 2005 to 2017) and clinics (92.3%‐93.4%) were the main department and medical facility, respectively, providing daily medical care for AD. The proportion of patients who were given the thymus and activation‐regulated chemokine test increased from 2008 to 2017 (0.03%‐3.5%). From 2005 to 2017, the proportion of patients who received moisturizer (68.8%‐79.1%), topical calcineurin inhibitors (8.2%‐17.8%), very strong topical corticosteroids (26.0%‐40.6%), strongest topical corticosteroids (3.5%‐7.8%), cyclosporine (0.01%‐0.3%), or phototherapy (0.06%‐1.8%) increased, and the proportion of patients who received topical non‐steroidal anti‐inflammatory drugs (12.0%‐3.1%) decreased. Annual costs for medication associated with AD per person/visit increased between 2005 and 2017; however, the ratio of medication to total cost did not.ConclusionsThe results of this analysis show that Japanese patients used increasingly potent treatments for AD, and overall AD‐related medication costs increased between 2005 and 2017.

Global publication productivity in dermatology: a bibliometric description of the past and estimation of the future.

In the past two centuries, generations of dermatologists around the world have created an enormous number of publications. To our knowledge, no bibliometric analysis of these publications has been performed so far, nor have registered trials been analysed to anticipate future publication trends. To determine the global distribution of national publication productivity, most published topics, institutions and funding sources contributing most to publications and to anticipate future trends based on registered clinical trials. Following pre-assessment on PubMed, Embase, Web of Science and Scopus, the number of publications for 'dermatology' was determined for each of 195 countries, normalized per 1 Mio inhabitants and bibliometrically analysed. Dermatology-related trials registered at clinicaltrials.gov were specified by the top-10 diagnoses for the top-10 countries. The search yielded 1071518 publications between 1832 and 2019 with the top-5 diagnoses being melanoma, basal cell carcinoma, psoriasis, pruritus/itch and atopic dermatitis. The top-3 countries with highest absolute numbers of publications were the USA (30.6%), Germany (8.1%) and the UK (8.1%), whereas Switzerland, Denmark and Sweden had the highest publication rates when normalized by inhabitants. The most productive affiliation was the Harvard Medical School, the leading funding source the National Institutes of Health. Currently, maximum number of trials are registered in the USA (8111), France (1543) and Canada (1368). The highest percentage of all dermatology-related trials in a specific country were as follows: Melanoma in the Netherlands (24.8%), psoriasis in Germany (21.7%) and atopic dermatitis in Japan (15.9%). The top-10 countries including the USA, Canada, a few European and Asian countries contributed more than 3/4 of all publications. The USA hold the dominant leader position both in past publication productivity and currently registered trials. While most Western countries continue to focus their research on the top-10 topics, China and India appear to prioritize their scope towards other topics.

Cost‐effectiveness analysis of delgocitinib in adult patients with atopic dermatitis in Japan

AbstractObjectivesThis study evaluated the cost‐effectiveness of delgocitinib relative to moisturization therapy in adult patients with moderate to severe atopic dermatitis.MethodsThe analysis was performed by using the simulation model with the patient‐level data from a phase 3 study and its longterm extension study (QBA4‐1 Study). The analysis was conducted from the Japanese public healthcare payer's perspective and included only direct medical costs. Health outcomes were evaluated by quality‐adjusted life years. The time horizon of the analysis was one year and no discount rate was applied. In this analysis model, health states were divided into four according to the Investigator's Global Assessment score. The cost‐effectiveness was determined by the incremental cost‐effectiveness ratio using the willingness‐to‐pay threshold of 5 million JPY/quality‐adjusted life years. A probabilistic sensitivity analysis was conducted to evaluate the uncertainty of each parameter used for the analysis.ResultsTotal cost and quality‐adjusted life years gained were 358,810 JPY and 0.867 quality‐adjusted life years for delgocitinib, and 85,890 JPY and 0.798 quality‐adjusted life years for moisturization therapy, respectively. The incremental cost‐effectiveness ratio of delgocitinib relative to moisturization therapy was estimated to be 3.92 million JPY/quality‐adjusted life years. The probability of incremental cost‐effectiveness ratio of delgocitinib vs moisturization therapy being below 5 million JPY/quality adjusted life years was 79.1%.ConclusionsDelgocitinib was rated as a cost‐effective treatment relative to moisturization therapy in adults with moderate to severe atopic dermatitis. Data comparing the drug for reducing inflammation is required.

Evaluating the burden of pruritus due to atopic dermatitis in Japan by patient-reported outcomes

Aims Although pruritus is a hallmark feature of atopic dermatitis, no study has investigated the associated impact of pruritus, due to atopic dermatitis in Japan. The study aimed to evaluate the real-life burden of atopic dermatitis by pruritus severity in adult Japanese patients. The primary objective was to assess the correlation between pruritus severity and work productivity and activity impairment. A secondary objective was to characterize the impact of pruritus on quality of life and to evaluate the burden of symptoms severity and frequency. Materials and methods A cross-sectional internet-based survey was conducted. Eligible patients were currently employed and working adults with atopic dermatitis for at least 6 months. Stratification on pruritus severity assessed by the Worst Pruritus Numerical Rating Scale at the screening was performed to ensure that different severity groups are represented. Correlations were assessed using Spearman’s rank-order correlation coefficient. Multivariate regression analyses were performed to assess the impact of pruritus severity on work productivity and quality of life. Results The study analyzed 370 patients. Pruritus severity significantly correlated with work impairment (Rho = 0.622, P value (H0: Rho > 0.5) <.001). A greater pruritus severity was associated with greater work productivity and activity impairment and a greater impact on quality of life, sleep, emotional state, and everyday activities. Patients with a greater pruritus severity carried a higher economic burden of treatment and were more often not satisfied with the received therapy. Limitations All data were self-reported by patients via an online survey, which is associated with the risk of misclassification for diagnosis, recall bias, and limited participation of patients. Conclusions The study provides evidence that pruritus is associated with the overall disease burden and impacts many important life aspects of patients with atopic dermatitis in Japan.

Current treatments for atopic dermatitis in Japan.

The goal of a treatment regimen for atopic dermatitis is to reach and maintain a state where the patient exhibits mild symptoms or an absence of symptoms, and the patient should not experience disturbance during daily activities. The basis of a treatment regimen for atopic dermatitis is topical therapy, and currently there exist topical corticosteroids, tacrolimus and delgocitinib. Using these, proactive therapy is performed as maintenance therapy after remission induction therapy. However, in cases of moderate to severe atopic dermatitis, topical drugs alone cannot induce remission and systemic therapies such as cyclosporin, ultraviolet therapy, and dupilumab should be used in combination. In particular, dupilumab has many advantages such as high efficacy, relatively few adverse reactions, and ease of use in elderly patients with severe atopic dermatitis. In this review, we present a treatment algorithm for atopic dermatitis that emphasizes the importance of maintaining remission after induction of remission, and summarizes the characteristics of current medication therapy for atopic dermatitis in Japan.

Maternal psychological distress during and after pregnancy and atopic dermatitis in children

Abstract Background Previous studies reported the association between maternal psychological distress (PD) during or after pregnancy and atopic dermatitis in children. However, studies examining the association from both pre- and post-natal aspects are limited. Methods We analysed data from 6,366 mother-child pairs who participated in the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study in Japan. Mothers were categorised into four groups of PD (K6 scores ≥5) during early pregnancy and one year after delivery; no PD in both periods, prenatal PD only, postnatal PD only, and PD in both periods. Mothers reported on their children's atopic dermatitis at age two using the International Study of Asthma and Allergies in Childhood (ISAAC). Multivariate logistic regression analysis was conducted to examine the association between maternal PD and atopic dermatitis in children adjusting for maternal age at delivery, maternal education, maternal smoking during early pregnancy, maternal history of atopic diseases, paternal history of atopic diseases, preterm birth, parity, and child's sex. Results The study population included 51.9% without PD in both periods, 14.6% with prenatal PD only, 14.0% with postnatal PD only, and 19.4% with PD in both periods. The prevalence of atopic dermatitis in children at age two was 18.8%. Mothers with postnatal PD only and mothers with PD in both periods had higher risks of children's atopic dermatitis compared with mothers without PD in both periods; the adjusted odds ratios (95% confidence intervals) were 1.37 (1.14-1.65) and 1.38 (1.17-1.63), respectively. The corresponding odds ratio (95% confidence interval) of mothers with prenatal PD only was 1.08 (0.89-1.31). Conclusions Postnatal PD was associated with an increased risk of atopic dermatitis in children. This finding suggests the importance for monitoring mental health among postpartum women. Key messages Postnatal PD has significant effects on atopic dermatitis in children. This study is a first study to examine the association between maternal PD and children’s atopic dermatitis in Japan. Improvements of postnatal care including social support might be effective in preventing atopic dermatitis in children.

Washing with water alone versus soap in maintaining remission of eczema.

There is no consensus on the use of soap in skin care for atopic dermatitis in Japan. Thus, this study aimed to evaluate the efficacy of soap to maintain eczema remission in atopic dermatitis patients during the fall-winter period in Japan. This assessor-blinded, pragmatic randomized, non-inferiority study enrolled atopic dermatitis patients whose eczema was controlled by regular steroid ointment application less thanor equal to2days / week (tacrolimus ointment was permitted). For 8±3weeks, participants washed their upper and lower limbs on one side with soap (soap side) and on the other side with water alone (water side). The primary outcome was an Eczema Area and Severity Index score at week 8±3. Twenty-nine participants were analyzed. The Eczema Area and Severity Index scores at week 8±3 of the water and soap sides were 0.0 (0.0-0.4) and 0.0 (0.0-0.4), respectively (P=0.18). The difference between both sides was -0.02 (-0.11-0.08), and the limits of the 95% confidence interval did not reach the prespecified non-inferiority margin. The average Patient-Oriented Eczema Measure score was 1.27±1.7 and 1.32±1.8 for the water and soap sides, respectively (P=0.92). The total number of additional steroid ointment applications was four (0-20) times and six (0-23) times, respectively (P=0.98). Participants were categorized according to self-assessments of the usefulness of soap, with 2, 24, and 3 participants in the water-effective, invariant, and soap-effective groups, respectively. For children with controlled atopic dermatitis, washing with water alone was not inferior to washing with soap for maintaining remission of eczema during the fall-winter period in Japan.