Scoring Atopic Dermatitis Score Research Articles

Long-term, observational, real-world study of dupilumab for the treatment of moderate-to-severe atopic dermatitis: a 52-week single-center retrospective analysis in China.

For dupilumab, real-world long-term follow-up data remain scarce, and studies on optimized treatment modes as well as drug survival rate and its predictors are lacking. To explore the effectiveness of different treatment modes of dupilumab and to understand the drug survival rates of dupilumab in China and its predictive factors. This retrospective study included patients with moderate-to-severe AD who received dupilumab treatment. Their clinical data were collected and analyzed. Compared with baseline, the SCORing Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI), numerical rating scale (NRS), and Atopic Dermatitis Control Tool (ADCT) scores significantly decreased at 12, 24, and 52 weeks (p < 0.0001),and the continuous medication group had more significant improvements in SCORAD, EASI, NRS, and ADCT scores at 52 weeks than the noncontinuous medication group (p < 0.05). The 6-month and 1-year drug survival rates of dupilumab were 59.7% and 51.9%, respectively. The most common reason for treatment discontinuation was the satisfactory control of AD. Patients with adult-onset AD (adjusted odds ratio [OR]: 0.15, 95% confidence interval [CI]: 0.03-0.73) ,not complicated by other systemic diseases (adjusted OR: 0.17, 95% CI: 0.04-0.84) and eosinophilia at baseline (adjusted OR: 3.71, 95% CI: 1.12-12.26) had a higher probability of drug discontinuation. In real-world practice in China, dupilumab has exhibited good long-term effectiveness and safety for the treatment of moderate-to-severe AD, and continuous administration can benefit patients in the long term.

Real-World Clinical, Psychosocial, and Economic Burden of Atopic Dermatitis: Results From the ESSENTIAL AD Multicountry Study.

Limited real-world evidence exists about the burden of atopic dermatitis (AD) in patients receiving systemic or non-systemic therapies in clinical practices. ESSENTIAL AD was an observational study that aimed to fill this information gap. ESSENTIAL AD enrolled (September 2021-June 2022) adult patients with physician-confirmed AD that was routinely managed with systemic and non-systemic treatment in a real-world setting from 15 countries in Eastern Europe, the Middle East, and Africa. Primary outcome variables were Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and Dermatology Life Quality Index (DLQI) assessed during one office visit. A total of 799 enrolled patients fulfilled selection criteria and were included in the study. Patients mean (standard deviation [SD]) age was 36.3 (14.4) years, 457 (57.2%) were female, and the majority of patients were white (647 [81.0%]). Mean (SD) time since AD diagnosis was 17.6 (15.2) years (median 16.5; interquartile range [IQR] 3.3-26.8). The mean (SD) EASI, SCORAD, and DLQI total scores were 11.3 (11.3 [median 8.1; IQR 3.6-15.8]), 37.8 (17.9 [median 35.5; IQR 24.2-49.0]), and 10.6 (7.2 [median 10.0; IQR 5.0-15.0]), respectively. Patients receiving systemic treatment had significantly higher disease burden (mean [SD] EASI 13.3 [13.0]; median [IQR] 9.6 [3.9-17.9]) versus non-systemic treatment (mean [SD] 9.3 [8.7]; median [IQR] 6.8 [3.0-13.2]; P < 0.0001). Results were similar for SCORAD (39.9 [19.6] vs 35.6 [15.7]; median [IQR] 38.6 [24.7-53.1] vs 32.6 [23.9-44.6]; P = 0.0017), and DLQI total scores (11.4 [7.4] vs 9.9 [6.9]; median [IQR] 11.0 [5.0-16.0] vs 9.0 [5.0-14.0]; P = 0.0033, respectively). Patients with AD continue to have substantial disease burden despite treatment with systemic therapy, suggesting that a need for effective disease management remains, including effective therapies that improve psychological outcomes and reduce economic burden of AD, in Eastern Europe, the Middle East, and Africa.

Clinical efficacy and safety of autologous serum intramuscular injection in patients with mild-to-moderate atopic dermatitis: a prospective, open-label, uncontrolled study

Background: Autologous blood therapy (ABT) has been used to treat atopic dermatitis (AD) for over a century, even though evidence supporting its efficacy is lacking. We aimed to investigate the effectiveness and safety of autologous serum intramuscular injection (ASIM), which is a modified form of ABT, in treating mild-to-moderate AD. Methods: This study was a 12-week, open-label, prospective, uncontrolled trial. Following a 4-week run-in period, 22 out of 25 screened patients received ASIM once a week for 4 weeks in conjunction with standard treatment. The primary outcome measure was the Eczema Area and Severity Index (EASI), while the secondary outcomes included the Scoring Atopic Dermatitis (SCORAD) score, Dermatologic Life Quality Index (DLQI), and patient ratings of pruritus, sleep difficulty, disease status, and treatment effectiveness. Safety parameters were also assessed. Results: EASI scores showed a non-statistically significant trend toward improvement during ASIM intervention. Patients with at least a 50% improvement in the EASI score at 4 weeks were older and had lower peripheral eosinophil counts (p&lt;0.05). Secondary endpoints, including the SCORAD score, pruritus, sleep difficulty, and DLQI, demonstrated statistically significant improvements at week 4 compared to baseline (p&lt;0.05). No significant adverse reactions were observed. Conclusions: This pioneering study suggests that repeated ASIM may improve the clinical symptoms of mild-to-moderate AD, particularly in terms of pruritus and overall quality of life. However, further research with a larger sample size is required to establish the clinical significance of these findings.

538 - Physician-assessed effectiveness and patient-reported outcomes in adult and adolescent patients with atopic dermatitis in the Asian subpopulation treated with dupilumab: real-world insights 1 year into the GLOBOSTAD multinational prospective observational study

Abstract Introduction In multiple randomized controlled clinical trials, dupilumab demonstrated robust efficacy in patients with moderate-to-severe atopic dermatitis (AD). Long-term effectiveness of dupilumab in real-world AD treatment is one of the main objectives of the ongoing GLOBOSTAD study. Comprehensive data on Asian patients with moderate-to-severe AD treated with dupilumab are limited. Objectives To report patient-reported outcomes and physician-assessed AD clinical measures to evaluate disease characteristics, severity, and treatment effectiveness 1 year after initiating dupilumab treatment in Asian patients. The baseline disease severity and patient demographics have been reported previously1. Methods This 5-year, multinational, multicentre, prospective, observational study (GLOBOSTAD; NCT03992417) included Asian patients ≥12 years-old with moderate-to-severe AD who initiated dupilumab treatment based on country-specific prescribing criteria. Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD), Patient-Oriented Eczema Measure (POEM), Peak Pruritus Numerical Rating Scale (PP-NRS) and Dermatology Life Quality Index (DLQI) were assessed at baseline, 3 months (± 1 month), 6 months (± 2 months), and 12 months (± 2 months). Data are reported as observed in patients self-reported as Asian for enrolment/safety (N = 204; data cutoff: March 2023) and follow-up (N = 194) populations. Results During the study, EASI (&amp;gt;21 = severe; ≤7 = mild/no disease) score improved from 28.0 (12.1), mean (SD) at baseline to 7.4 (8.5) at 3 months, 5.7 (6.9) at 6 months, and was sustained until the end of observation period, 12 months, at 4.7 (7.1). Similarly, SCORAD (&amp;gt;50 = severe; &amp;lt;25 = mild/no disease) score improved from 61.5 (16.9) at baseline to 25.4 (16.6) at 3 months, 22.5(14.8) at 6 months, and further improved to 18.6 (13.3) at 12 months. During the study, patients also reported early improvements in POEM, mean (SD) from 19.1 (7.3) at baseline to 8.0 (5.8) at 3 months, 7.6 (5.5) at 6 months, and to 7.2 (5.0) at end of observation period (12 months); PP-NRS decreased from 5.7 (2.3) to 2.1 (2.2) to 1.7 (1.8), and to 1.4 (1.7) at 3 months, 6 months, and 12 months respectively; and DLQI improved from 13.2 (7.4) to 4.9 (4.6) to 4.0 (3.8), and to 4.1 (4.0) at 3 months, 6 months and 12 months respectively. Dupilumab-related adverse events were reported in 44 (21.5%) patients while 4 (2.0%) reported dupilumab-related severe adverse events. Conclusion In Asian patients, the initiation of dupilumab treatment led to early improvements in all AD outcome measures, sustained throughout the 1-year observational period. Safety and treatment effectiveness were consistent with overall population.

Prediction of Food Sensitization in Children with Atopic Dermatitis Based on Disease Severity and Epidermal Layer Impairment

Plain Language SummaryThe study has revealed notable associations between food sensitizations (FSs) and the disease severity as well as epidermal barrier impairment in children with atopic dermatitis (AD). Specifically, the findings indicate that children with AD who were sensitized to higher numbers of food allergens (FAs) had higher SCORAD scores and greater epidermal barrier impairment. In addition, SCORAD score and stratum corneum hydration (SCH) levels at lesional skin could be predictive factors for FS in children with AD. The findings of this study suggest that clinicians should consider screening for food sensitization in children with moderate-severe AD and/or low SCH levels at lesional skins.

Dupilumab and subcutaneous immunotherapy for the treatment of refractory moderate to severe atopic dermatitis: A preliminary report

Subcutaneous immunotherapy (SCIT) and dupilumab are important treatments for patients with moderate to severe atopic dermatitis (AD). However, in clinical practice, poor response to allergen immunotherapy (AIT) or dupilumab has been observed in some patients. It is unknown whether combining dupilumab and SCIT can improve treatment responses in patients with moderate to severe AD that is resistant to dupilumab or SCIT monotherapy. This single-centre, retrospective, observational, real-world study evaluated the efficacy and safety of dupilumab and SCIT for refractory moderate to severe AD. The data of ten patients with moderate to severe atopic dermatitis who were treated with dupilumab and SCIT were retrospectively analysed. The scoring atopic dermatitis (SCORAD) score, numerical rating scale (NRS), and atopic dermatitis control test (ADCT) scores and eosinophil and total IgE levels before and after add-on therapy were compared and analysed. The SCORAD, NRS, and ADCT scores decreased significantly at four and 12 weeks after the initiation of add-on therapy and plateaued during maintenance treatment. The eosinophil and total IgE levels were not significantly different before and after add-on therapy. No serious adverse reactions were reported in any patient during add-on therapy. This study indicates that the combination of dupilumab and SCIT safely improves the treatment response of patients with moderate to severe AD who are resistant to dupilumab or SCIT monotherapy.

Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study.

Atopic dermatitis (AD) is a chronic disease that occurs mainly in children. Topical corticosteroids are the main treatment for mild to moderate AD, although they can induce side effects. The efficacy and tolerability of xyloglucan and pea protein (XG-PP) was compared with hydrocortisone in pediatric patients with AD as a steroid-sparing solution. A prospective, multicenter, comparative study enrolled 42 patients (age 0.5-12years) with mild-to-moderate AD, assigned 1:1 to XG-PP or hydrocortisone ointment. Treatments were applied twice daily for 14 consecutive days and assessed at baseline, day8, and day15. Efficacy endpoints were AD Severity Index (ADSI) score, Scoring Atopic Dermatitis (SCORAD) index, and Patient-Oriented Eczema Measure (POEM). Tolerability was assessed by the occurrence of adverse events (AEs). Both treatments significantly improved ADSI mean score from baseline to day15; in the XG-PP arm, ADSI score decreased from 10.55 to 4.15 (p = 0.00001), and in the hydrocortisone arm, from 10.65 to 4.30 (p = 0.0001). In the XG-PP arm, the mean SCORAD score decreased from 65.86 to 30.26 (p = 0.00001) and in the hydrocortisone arm from 68.84 to 31.19 (p = 0.0001) at day15. An overall decrease from moderate to mild AD for both arms (p = 0.0001) was observed with POEM. For all the three indexes evaluated, no statistical significant differences between the study arms evolution from baseline to day8 or to day15 were found. No AEs were reported. XG-PP provided a comparable efficacy to hydrocortisone ointment in managing AD, thus representing a safe and effective steroid-sparing alternative in pediatric patients with AD. Retrospectively registered on 24 November 2021 in the ISRCTN registry: 11118799.

438 Potentially greater efficacy with CBP-201 for adults with severe vs. moderate atopic dermatitis at baseline: subgroup analyses from the WW001 phase 2 randomized trial

Abstract CBP-201 is a next-generation monoclonal antibody targeting the IL-4Rα subunit. Rapid efficacy with CBP-201 was demonstrated in global phase 2 (WW001) and China-only pivotal trials (CN002) in patients with moderate-to-severe atopic dermatitis (AD). Previous studies of AD therapy demonstrated similar efficacy between moderate and severe disease, with a trend toward greater improvement in moderate patients. It is unknown whether there are differences in clinical response to CBP-201 with moderate vs.severe AD. We report post hoc efficacy analyses at Week 16 with CBP-201 300 mg from WW001 in baseline severity subgroups, based on validated Investigator Global Assessment (vIGA™) scores of 3 (moderate) and 4 (severe). In WW001 (NCT04444752), adults with moderate-to-severe AD were enrolled in a RDBPC 16-week trial of subcutaneous CBP-201 or placebo. For post hoc analysis, data for 300 mg every 2- and 4-week dose regimens were pooled. Investigators assessed AD severity using Eczema Area and Severity Index (EASI), SCORing AD (SCORAD), percent Body Surface Area (BSA) of AD involvement and vIGA. Patient-reported outcomes were assessed with the Dermatology Life Quality Index (DLQI) and Patient Oriented Eczema Measure (POEM). Least squares mean (LSM) score changes were analysed using ANCOVA modeling (including treatment, baseline score and baseline vIGA), with missing data interpolated by last observation carried forward. Responder endpoints were analysed using Clopper–Pearson methodology and, for missing values, nonresponder imputation. P-values are for CBP-201 vs. placebo, per baseline severity subgroup, at Week 16. At baseline, 113 patients had moderate AD (n = 74 CBP-201, n = 39 placebo) and 56 patients had severe AD (n = 39 CBP-201, n = 17 placebo). Baseline EASI scores were lower in the moderate subgroup [mean (SD): CBP-201, 21.5 (7.0); placebo, 22.2 (6.3)] vs. the severe subgroup [CBP-201, 33.6 (11.9); placebo, 31.9 (10.8)]. In both the moderate and severe AD subgroups, significant improvements with CBP-201 vs. placebo were observed. Except for the proportion of patients achieving vIGA 0/1, numerically greater CBP-201 responses were observed in patients with severe vs. moderate AD at Week 16; placebo responses were comparable per subgroup. In the severe and moderate subgroups, LSM SCORAD scores decreased by −42.8% (severe) and −29.8% (moderate), and LSM percent BSA decreased by −29.8% and −17.3%, respectively. Clinically meaningful 2-point improvement in vIGA was reported for 48.7% and 27.0% of patients with severe and moderate AD, respectively. The proportions of patients achieving vIGA 0/1, with 2-point improvement, were 20.5% and 27.0% with severe and moderate AD, respectively. Numerically greater proportions of patients with severe vs. moderate AD experienced EASI responses with CBP-201: EASI-50, 66.7% vs. 54.1%; EASI-75, 53.8% vs. 39.2%; EASI-90, 28.2% vs. 23.0%. Patients with severe vs. moderate AD reported greater improvements in patient reported outcomes with CBP-201: DLQI, −8.7 vs. −7.0; POEM, −12.5 vs. −8.7. Clinically meaningful improvements were observed in patients with AD with either moderate or severe AD after 16 weeks of treatment with CBP-201 300 mg at either 2- or 4-week dosing. There were no differences noted between moderate and severe patients in the placebo treatment group. In most severity readouts, greater proportions of patients with AD with severe disease on study entry experienced clinically meaningful improvements with CBP-201. In future CBP-201 trials, a more severe AD population needs to be examined to determine if this same observation is also noted. Collectively, the WW001 findings support further investigation of CBP-201, at both the 2- and 4-week dosing schedules enrolling larger numbers of moderate and severe patients with AD and with prespecified analyses by baseline AD severity.

Epidermal differentiation complex genetic variation in atopic dermatitis and peanut allergy

Deleterious variation in the epidermal differentiation complex (EDC) on chromosome 1 is a well-known genetic determinant of atopic dermatitis (AD) and has been associated with risk of peanut allergy (PA) in population-based studies. Our aim was to determine the effect of genetic variation in the EDC on AD trajectory and risk of PA in early life. Genome sequencing was used to measure genetic variation in the EDC in the Learning Early about Peanut Allergy (LEAP) study participants. Association tests were done to identify gene- and variant-level predicted deleterious variation associated with AD severity by using the Scoring Atopic Dermatitis (SCORAD) tool (n= 559) at baseline and each follow-up visit, as well as PA and food allergy in peanut avoiders (n= 275). Predicted deleterious variants included missense variants that were frameshift insertions, frameshift deletions, stop-gain mutations, or stop-loss mutations. Associations between variant load, SCORAD score, and PA were tested by using linear and generalized linear regression models. The genes FLG, FLG2, HRNR, and TCHH1 harbored the most predicted deleterious variation (30, 6, 3, and 1 variant, respectively). FLG variants were associated with SCORAD score at all time points; 4 variants (R1798X, R501X, S126X, and S761fs) drove the association with SCORAD score at each time point, and higher variant load was associated with greater AD severity over time. There was an association between these variants and PA, which remained significant independent of baseline AD severity (odds ratio= 2.63 [95% CI= 1.11-6.01] [P= .02]). Variation in FLG predicted to be deleterious is associated with AD severity at baseline and longitudinally and has an association with PA independent of baseline severity.

The effects of auricular acupuncture at lung, shenmen, endocrine, adrenal points on adult eczema: a randomized trial

Adult eczema (AE) has been reported to have a poor quality of life (qoL). Auricular acupuncture (AA) is a method that has been studied a lot recently. Our study is to determine the effects of combining AA and modern medication in the relief of symptoms and the improvement in qoL in AE. A single-blind randomized study on 65 AE at the University Medical Center Ho Chi Minh City Branch 3; was randomized into an auricular acupuncture (AA) group and a Sham acupuncture (SA) group. All AA group patients will receive AA at Lung, Shenmen, Endocrine, and Adrenal points. The score of scoring atopic dermatitis (SCORAD) and the score of dermatology life quality index (DLQI) were compared in two groups before and after treatments. There were 33 patients in the AA group and 32 patients in the SA group. After 2 weeks, in the SA group, the SCORAD score of 46.4 ± 1.3 decreased to 28.2 ± 1.2, compared with the AA group’s SCORAD score of 47.5 ± 1.5 decreased to 24 ± 1.3; the DLQI score of 14.7 decreased to 7.6, compared with the intervention group DLQI score of 15, reduced to 5.7. The difference in improving the SCORAD score and the DLQI score between the two groups was statistically significant. No patient had any adverse events during the study. Combining auricular acupuncture Lung, Shenmen, Endocrine, Adrenal points, and modern medication treatment may relieve effectively symptoms and improve the QoL in AE.

Efficacy of Dupilumab in Children 6 Months to 11 Years Old With Atopic Dermatitis: A Retrospective Real-World Study in China.

Background: Atopic dermatitis (AD) is a common skin disease that affects patients' quality of life, especially in the pediatric population. Dupilumab has shown good efficacy and safety in the treatment of AD in adolescents and adults, but the real data on younger children using dupilumab are scarce. Objectives: We investigated the doses, efficacy, and safety of dupilumab in children with moderate-to-severe AD aged ≥6 months to 11 years. Methods: This single-center retrospective cohort analysis included dupilumab-treated patients with severe AD under 12 years of age. Primary endpoints included the proportion of Validated Investigator Global Assessment (vIGA) 0/1 achieved and the percentage change from baseline in eczema area and severity index (EASI) and SCORing Atopic Dermatitis (SCORAD) at week 24 (W24). Secondary endpoints were mean change in pruritus numerical rating score (P-NRS) and body surface area (BSA) after W24 of treatment, description of adverse events, and Children's Dermatology Life Quality Index (CDLQI) improvement from baseline in endpoints. Results: Fifty-seven patients were included (mean age 7.2 ± 3.0 years). The primary endpoint (vIGA = 0/1) was achieved by 51 of 57 (89.5%) patients at W24. Significant improvements in EASI, SCORAD, P-NRS, and CDLQI scores were observed from baseline to W24 with dupilumab treatment and remained until W40. In different age groups, the endpoint vIGA achieved 0/1: 95.2% (20/21) of younger children and 88.9% (32/36) of older children. No serious adverse drug reactions were reported. Conclusions: This study aimed to describe the safety and efficacy of dupilumab in pediatric patients and examined differences of efficacy with various doses. The outcomes are comparable with those of existing clinical trials. Phase III Clinical Trial: NCT03346434.

A Study of Sleep Quality and Quality of Life in Children with Atopic Dermatitis between 6 and 12 Years of Age

Abstract Introduction: Atopic dermatitis (AD) is a common, chronic, relapsing dermatitis, affecting mainly children. It is associated with intense pruritus which can disrupt the sleep and quality of life (QOL), thereby impairing the neurocognitive development. An understanding of the link between severity of AD and sleep quality in children may help in better treatment of this condition. Materials and Methods: A hospital-based cross-sectional study was conducted to correlate severity of AD with sleep quality and QOL. Sixty-six children with AD were enrolled for the study. In addition to basic demographic details, all patients were analyzed for disease severity using SCORing AD (SCORAD) score. The QOL and sleep quality were evaluated using Children’s Dermatology Life Quality Index (CDLQI) questionnaire and Children’s Sleep Habits Questionnaire (CSHQ), respectively. Results: The mean age of the study group was 8.94 ± 1.94 years and mean body mass index was 19.97 ± 2.69 kg/m2. The median SCORAD score was 32 ± 50. Mean CSHQ score was 43.17 ± 7.15, and it showed a positive correlation with SCORAD score (R 2 = 0.655; P = 0.000). Similarly, median score of CDLQI was 14 ± 18, which also showed a positive correlation with SCORAD score (R 2 = 0.822; P = 0.000). All the domains of CDLQI questionnaire were affected by the disease. In the CSHQ questionnaire, all parameters were affected except parasomnias and sleep-disordered breathing. Conclusion: The study demonstrated a significant association between severity of AD with sleep quality and QOL. It highlights the need for interventions to diminish sleep problems and to improve QOL in children with AD.

Sensitivity to treatment and score bands of the Infants and Toddlers Dermatology Quality of Life questionnaire

The Infants and Toddlers Dermatology Quality of Life (InToDermQoL) questionnaire is the first dermatology-specific proxy health related QoL instrument for children from birth to 4years. Score meaning bands and the sensitivity to successful therapeutic intervention are important to interpret the clinical meaning of an instrument. The aim of the present study was to check the sensitivity to successful therapeutic intervention and establish score bands of the InToDermQoL questionnaire. Parents or grandparents of 424 children with skin diseases from Spain, Malta, Croatia, Romania, Greece, and Ukraine filled in national language versions of the InToDermQoL questionnaire. Disease severity of children with atopic dermatitis was assessed by SCORAD (Scoring atopic dermatitis). Cohen's d was used to assess the responsiveness of the instrument. The mean total InToDermQoL scores significantly decreased after treatment. Severity grading of the SCORAD scores gave stratification of the InToDermQoL severity grades based on 95% confidence intervals. Scores below a calculated minimal important difference of 2 corresponded to no effect on patient's health related QoL. Score banding may be slightly different across patient population and study context. All 3 age-specific versions of the InToDermQoL questionnaire showed sensitivity to treatment. Score bands for the InToDermQoL questionnaire have been established.

Serum thymus and activation-regulated chemokine (TARC) levels correlate with atopic dermatitis disease severity in patients < 6 months.

Background: Atopic dermatitis (AD) may develop by 6 months of age, and its severity assessment is essential for appropriate treatments. Scoring Atopic Dermatitis (SCORAD) is suggested to evaluate the severity of AD but is cumbersome for routine clinical use. The serum thymus and activation-regulated chemokine (TARC) is used as a marker of AD severity. However, the normal range of the TARC levels varies by age, and its usefulness for the evaluation of AD severity has not been established in patients ages < 6 months. Here, we evaluated the correlation between serum TARC levels and SCORAD scores in early infancy and sought the optimal cutoff level to indicate AD severity. Methods: The subjects were 35 patients with AD (16 girls and 19 boys; 3-5 months of age) who visited our clinic between April 2015 and March 2017. All the patients were physically examined by a board-certified allergist. The AD severity was determined by using the SCORAD, together with serum levels of TARC, total immunoglobulin E (IgE), lactate dehydrogenase, and peripheral eosinophil counts. Receiver operating characteristic curve analysis was performed to determine the cutoff levels of serum TARC to indicate AD severity. Results: Significant correlations were observed between SCORAD scores and the serum TARC levels, peripheral eosinophil counts, and serum IgE levels (r = 0.640, r = 0.723, r = 0.533, respectively). The optimal cutoff levels of serum TARC to indicate mild and severe AD were <3523 pg/mL (area under the curve [AUC] = 0.856) and >6192 pg/mL (AUC = 0.833), respectively. Conclusion: Although this study had limitations, we suggest that serum TARC is useful as a marker of AD severity in patients <6 months of age.

Omalizumab for severe atopic dermatitis in 4- to 19-year-olds: the ADAPT RCT

BackgroundEvidence for systemic treatments for severe childhood eczema is limited. Systemic immunosuppressants are unlicensed for use in children and are associated with unwanted side effects.ObjectiveTo examine the role of anti-immunoglobulin E (IgE) [omalizumab (Xolair®, Novartis Pharmaceuticals UK Ltd, Frimley, UK)] in children and young people with severe eczema.DesignA double-blind, placebo-controlled, parallel-arm randomised (1 : 1) trial.SettingA single specialist centre – Guy’s and St Thomas’ NHS Foundation Trust, London.ParticipantsAtopic children and young people (aged 4–19 years) with severe eczema.InterventionsTreatment with omalizumab or placebo for 24 weeks.Main outcome measuresThe primary outcome was eczema severity, measured using the objective SCORing Atopic Dermatitis (SCORAD) at 24 weeks. Secondary outcomes included validated measures of eczema severity, quality of life (QoL) and potent topical steroid use.ResultsSixty-two participants, with a median baseline total IgE level of 8373 kU/l, received treatment with omalizumab (n = 30) or placebo (n = 32). The unadjusted mean objective SCORAD score at week 24 was 43.1 [standard deviation (SD) 12.5] for participants in the omalizumab arm and 49.2 (SD 11.3) for participants in the placebo arm. After adjustment for baseline objective SCORAD score, age and IgE level, the mean difference between arms at 24 weeks was –6.9 [95% confidence interval (CI) –12.2 to –1.5;p = 0.013], in favour of omalizumab. The mean objective SCORAD scores improved by –12.4 and –5.1 in the omalizumab and placebo arms, respectively, by 24 weeks. Secondary outcome measure estimates were also in favour of omalizumab for eczema severity at 24 weeks: the adjusted mean treatment arm difference was –8.3 (95% CI –15.1 to –1.1;p = 0.024) for total combined objective and subjective SCORAD and –6.7 (95% CI –13.2 to –0.1;p = 0.046) for the Eczema Area and Severity Index, with less effect on the Patient-Oriented Eczema Measure (POEM; –1.1, 95% CI –4.6 to 2.4;p = 0.527). Treatment estimate precision was limited by the sample size. The QoL measures favoured omalizumab, with an improvement (reduction) in both (Children’s) Dermatology Life Quality Index [(C)DLQI] score (mean –3.5, 95% CI –6.4 to –0.5;p = 0.022) and Paediatric Allergic Disease Quality of Life Questionnaire score (mean –0.5, 95% CI –0.9 to 0.0;p = 0.050). The mean (C)DLQI score improved by 50%, from 17.0 (SD 5.6) at baseline to 8.5 (SD 5.9) at week 24, for patients treated with omalizumab. Improvements were seen despite lower potent topical steroid use in the omalizumab arm, with 48% more days of use than (109 days in the placebo arm vs. 161 days in the omalizumab arm) and twice the body surface area coverage of (15.5% in the placebo arm vs. 31.3% in the omalizumab arm) the placebo arm. There were fewer treatment failures and new systemic immunosuppression initiations in the omalizumab arm. There was no difference in the numbers of cases of infective eczema and eczema exacerbation. There was one suspected severe adverse reaction in the omalizumab arm. In each arm, six participants reported a total of seven severe adverse events that were unrelated to treatment. Non-serious respiratory and dermatological adverse event rates were higher in the placebo arm (incidence rate ratio 0.69, 95% CI 0.49 to 0.96).ConclusionsOmalizumab, in a highly atopic paediatric population with severe eczema, reduced eczema severity and improved QoL despite a reduction in potent steroid use and highly elevated total IgE levels. Omalizumab, with its favourable side effect profile, warrants further study as a treatment option for this difficult-to-manage population. Further studies are needed to clarify the role of omalizumab. Treatment benefit became more apparent towards 24 weeks and persisted after treatment stopped. The optimal duration of treatment needs to be determined.Trial registrationThis trial is registered as ISRCTN15090567, EudraCT 2010-020841-29 and ClinicalTrials.gov NCT02300701.FundingThis project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health and Care Research (NIHR) partnership. This will be published in full inEfficacy and Mechanism Evaluation; Vol. 9, No. 5. See the NIHR Journals Library website for further project information. A grant from the Guy’s and St Thomas’ Charity supported the Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT). Omalizumab and the placebo were supplied by Novartis Pharmaceuticals UK Ltd.

Sublingual immunotherapy with Dermatophagoides farinae drops for pediatric atopic dermatitis.

We evaluated the clinical effect and safety of sublingual immunotherapy (SLIT) with Dermatophagoides farinae drops for pediatric atopic dermatitis (AD). We enrolled children aged 4-13 years with AD and grouped them into the SLIT and control groups using the random number table method. We subdivided each group based on treatment duration (1-, 2-, and 3-year subgroups). The SLIT group received Dermatophagoides farinae drops, and both groups received conventional treatment (topical glucocorticoids, skin moisturizers, oral antihistamines, and allergen avoidance). Effective rate and effect were compared between groups after 1, 2, and 3 years of treatment. We assessed 309 SLIT cases (male, 192; age, 4-13 years) and 131 controls (male, 79; age 4-13 years). The effective rate and curative effect after 2 and 3 years of treatment were significantly different between the groups (P < 0.05). The effect and effective rates between corresponding SLIT and control group treatment duration subgroups were significantly different (P < 0.05). SLIT group duration subgroups showed significant differences in the effect and effective rates (P < 0.05). Posttreatment Scoring Atopic Dermatitis (SCORAD) scores in the SLIT group duration subgroups were significantly lower than those of the corresponding control subgroups (P < 0.05). Upon follow-up at 1 year post treatment completion, the SLIT group's SCORAD score was significantly lower than its baseline score and the control group's follow-up score (P < 0.05). SLIT with Dermatophagoides farinae drops for pediatric AD is safe and effective; effectiveness is maintained after treatment cessation, and prolonged treatment improves efficacy.

Efficacy of House Dust Mite Sublingual Immunotherapy in Patients with Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Sensitization to house dust mites (HDMs) is frequent in patients with atopic dermatitis. To investigate the efficacy of sublingual immunotherapy (SLIT) with Dermatophagoides pteronyssinus extract in patients with atopic dermatitis sensitized to HDM. In this randomized, double-blind, placebo-controlled trial, we enrolled 91 patients 3 years or older, with SCORing Atopic Dermatitis (SCORAD) score greater than or equal to 15 and positive skin test result and/or IgE to D pteronyssinus. Patients were stratified according to age (<12 and ≥12 years) to receive HDM SLIT or placebo for 18 months. Primary outcome was a greater than or equal to 15-point decrease in SCORAD score. Secondary outcomes were decreases in SCORAD and objective SCORAD, Eczema Area and Severity Index, visual analog scale for symptoms, and pruritus scale scores; Investigator's Global Assessment 0/1; and decrease greater than or equal to 4 points in Dermatology Life Quality Index. Background therapy was maintained. A total of 66 patients completed the study (35 HDM SLIT, 31 placebo). After 18 months, 74.2% and 58% of patients in the HDM SLIT group and the placebo group, respectively, showed greater than or equal to 15-point decrease in SCORAD score (relative risk, 1.28; 95% CI, 0.89-1.83). Significant SCORAD score decreases from baseline of 55.6% and 34.5% in HDM SLIT and placebo groups (mean difference, 20.4; 95% CI, 3.89-37.3), significant objective SCORAD score decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (mean difference, 21.3; 95% CI, 0.66-41.81), and more patients with Investigator's Global Assessment 0/1 in the HDM SLIT group as compared with the placebo group (14 of 35 vs 5 of 31; relative risk, 2.63; 95% CI, 1.09-6.39) were observed at 18 months. Our results suggest that HDM SLIT may be effective in HDM-sensitized patients as an add-on treatment for atopic dermatitis.

Anti-Interleukin Biologics for the treatment of the Atopic March Diseases

The atopic march refers to the natural history of allergic disorders as they develop from infancy to childhood. Classically, the atopic march begins with atopic dermatitis (AD), followed by food allergy, advancing to asthma, allergic rhinitis (AR), and finally to the fifth member eosinophilic esophagitis. The pathogenesis of the atopic march is complex, and involves genetic, immunological, and environmental factors. T helper type 2 (Th2) lymphocytes, and epithelial cells play a key role in the pathogenesis of the diseases in the atopic march. Th2 cells secrete cytokines, such as interleukin-5 (IL-5), IL-4, and IL-13, whereas, epithelial cell injury release alarmin cytokines, including IL-25, IL-33, and thymic stromal lymphopoietin (TSLP). Th2 cells and alarmin cytokines play an important role in the development of eczematous skin lesions, airway inflammation and remodeling, and oesophageal mucosal inflammation. Treatment of eosinophilic asthma and associated comorbid disorders is challenging, and requires a precision targeted approach with biologics. Dupilumab is a fully humanized IgG4 monoclonal antibody to the IL-4Rα, which mediates signaling to both IL-4 and IL-13, and blocks their immunopathological effects. Dupilumab is the only biologic that has been approved for the treatment of eosinophilic asthma, AD, and eosinophilic esophagitis. In patients with eosinophilic asthma treatment with dupilumab has been shown to improve asthma control, reduce exacerbations, and improve lung function. In patients with atopic dermatitis dupilumab has been demonstrated to improve the Eczema Area Severity Index (EASI) score, Investigator’s Global Assessment (IGA) response, SCORing Atopic Dermatitis (SCORAD) score, and the Peak Pruritus Numerical Rating (PNR) scale. Lebrikizumab and Tralokinumab (anti-IL-13) failed to show the expected results for the treatment of asthma, astoundingly, in several clinical trials they have been shown to significantly improvement EASI score, IGA response, SCORAD score, PNR scale, sleep architecture, and Dermatology Life Quality Index (DLQI). They have been granted First Tract Designation, and European Commission regulatory approval, respectively. Tezepelumab (anti-TSLP) is approved for the treatment of eosinophilic asthma, and has been shown to significantly reduce exacerbations, and improve asthma control, lung function, and HLQoL. However, tezepelumab did not meet the endpoints in phase II for the treatment of AD. Keywords: Atopic March; Atopic Dermatitis; Eosinophilic Asthma; Interleukin; Dupilumab; Tralokinumab

Impact of Althaea Officinalis extract in patients with atopic eczema: a double-blind randomized controlled trial

BackgroundAlthaea Officinalis introduced as an emerging anti-inflammatory agent with immunomodulatory effects that may suppress the symptoms of atopic eczema. In this study, we aimed to investigate the impact of liposomal formulation of Althaea Officinalis flower extract compared with steroids for atopic eczema treatment.MethodsIn this randomized, double-blind controlled trial phase II, forty patients with moderate to severe allergic atopic eczema confirmed by skin prick test were enrolled in the study from October 2018 to January 2019. Steroids on the lesions of the left side of the body and topical Althaea Officinalis extract (intervention) or eucerin as a topical placebo on the lesions of the right side of the body were tested. SCORAD (SCORing Atopic Dermatitis) was assessed at the baseline, and two, and four weeks after completing the trial. Data were analyzed by SPSS version 22.ResultsIn the active treatment group, after two weeks, the SCORAD was significantly lower in the left side (recovery with steroid treatment) (p < 0.001), and after 4 weeks the SCORAD was lower on both sides, and there were no significant differences between two sides (similarity between Althaea Officinalis and steroid effects). In the control group, the SCORAD score was significantly lower on the left side (steroid) after two and four weeks (p < 0.001). There was no side effect and reaction to drugs.ConclusionsConsidering the potential side effects of steroids, and the similar efficacy of Althaea Officinalis flower extract, using this component may be accompanied by higher benefits in patients with atopic eczema.Trial registrationIRCT2016102323235N5.

Correlation of low vitamin D status with atopic dermatitis severity in children

Introduction: Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disorder. Vitamin D has some roles in immunologic mechanisms. Vitamin D may influence the severity of AD. Previous studies of vitamin D correlation in children with atopic dermatitis have revealed conflicting results. This study determines the correlation between low vitamin D status with the severity of atopic dermatitis in children. Methods: This is a cross-sectional analytical study with a cross-sectional approach that involved DA subjects aged ≤17 years with low vitamin D status. The recording of basics data and examination of subjects included assessing the scoring atopic dermatitis (SCORAD) score and measuring 25-hydroxyvitamin D (25(OH)D) level for all subjects. Statistical analyses were performed using Pearson's correlation coefficients, with P&lt;0.05 was considered statistically significant. Result: A total of 30 subjects with AD with the most extensive distribution was in the age group of 11–17 years (53.33%), sex proportions were equal both male (50%) and female (50%), all subjects have an atopic family history (100%). The mean vitamin D level was 18,02 ± 4,56 ng/ ml (deficiency), and the mean SCORAD score was 20,03 ± 5,80 (mild). There was a significantly strong negative correlation between low serum vitamin D level and severity of AD in children (r = -0.666, p = 0.001). Conclusion: Lower vitamin D status is inversely associated with the severity of AD in children.Â