Multidisciplinary educational programme for caregivers of children with atopic dermatitis- in South East Norway \u2013 an observational study

Disease characteristics, comorbidities, treatment patterns and quality of life impact in children <12 years old with atopic dermatitis: Interim results from the PEDISTAD Real-World Registry

Objectives: Atopic dermatitis (AD) is a chronic inflammatory skin disease that is more frequent among children. Childhood is a critical time for physical and psychosocial development and AD develops more commonly in children in the first five years of life. The objective of the study was to determine the impact of AD on the quality of life (QoL) of Indian children and their families and correlate it with AD severity and the perception of severity as estimated by the family. Material and Methods: In the present study, 30 children clinically diagnosed with AD and 30 age- and sex-matched healthy controls presenting to our hospital were evaluated. Data on QOL were obtained through a questionnaire; Infants Dermatitis Quality of Life Index (IDQOL), Children’s Dermatology Life Quality Index (CDLQI), and Dermatology Life Quality Index (DQLI) were used for patients,and the Dermatitis Family Impact (DFI) questionnaire for the family of the patients. The severity of the disease was determined using the Scoring for AD (SCORAD) index. Results: In our study, there were 16 male patients and 14 female patients. History of atopy was significantly higher in children with AD (p &lt;0.001); 13 patients had mild, 17 had moderate, and none of the patients had severe disease. The severity of the disease was found to correlate negatively with the age of the child. IDQOL positively correlated with the age of children with AD (r = 0.865, P &lt; 0.001). CDLQI negatively correlated with the age of children with AD (r = −0.616, P = 0.033). Impairment in IDQOL and CDLQI showed a significant positive correlation with DFI (r = 0.846, P &lt; 0.001; r = 0.910, P &lt; 0.001). Conclusion: AD is associated with lowered QOL of the patient,which increases with the severity of the disease. Itch and sleep disturbance were the most severely affected symptoms of AD. The disease significantly impacted the QOL of the family. The main issue with parents caring for AD children is continuous expenditure on treatment, emotional distress, and physical exhaustion. Therefore, efforts are needed to help parents by medical care personnel so that the outcomes in both the child and the significantly burdened parent caregiver can be improved.

Atopic dermatitis (AD) can be traumatizing to family life. Little is known about the relationship between quality of life in AD and disease severity. To document family quality of life and relate this to severity of AD in children, for a 6-month period from a given point in time. These data are part of a longitudinal study conducted in two parts of the UK to investigate risk factors for AD severity and its impact on quality of life. and methods Thetargetedpopulation comprised children with AD aged 5-10 years in a primary-care setting. The general practitioners identified potential subjects and the UK diagnostic criteria for AD were used to verify the diagnosis. Both the children and their parents were interviewed. Eczema severity was assessed using a modified form of the SCORAD (SCORe Atopic Dermatitis) Index (SCORAD-D) from which parents' score of itching and sleep loss were excluded. The quality of family life was quantified by the Dermatitis Family Impact (DFI) questionnaire. These two parameters were evaluated on two occasions 6 months apart. Multiple regression analysis was used to investigate the relationship between the quality of family life and the severity of the AD in the children, at a specific point in time and over the following 6-month period. Of the 116 children attending the first visit, mean age 8 years, 106 attended the second visit (91%) and were included in the analysis. Quality of family life was shown to be significantly affected in 48 (45%) cases at the first visit and 38 (36%) cases at the second visit. The initial means of the DFI and SCORAD-D were 2.4 and 8.2, respectively. Six months later the mean final DFI and SCORAD-D were 1.9 and 7.7, respectively. Using multiple regression on the first and second visits, each unit increase in SCORAD-D was associated with 0.21 [95% confidence interval (CI) 0.06-0.37 P = 0.008] and 0.37 (95% CI 0.15-0.59, P = 0.001) units increase in quality of family life, respectively. This relationship remained significant even after adjustment for potential confounders (black skin, social class, sex, child's age, family size and location) each unit increase in SCORAD-D led to a 0.25 unit (95% CI 0.11-0.4, P = 0.001) and 0.23 unit (95% CI 0.05-0.42, P = 0.014) increase in DFI on the first and second visits, respectively. Changes in the DFI scores were significantly related to changes in the SCORAD-D scores (regression coefficient; 0.17 (95% CI 0.06-0.29, P = 0.002). We show that quality of family life is related to the severity of AD in children. This confirms the importance of parental assessment of the impact of the disease in the management of AD, because the disease affects the entire family. Also, these results show the response of DFI to change predictably with disease severity. This may imply that the DFI questionnaire could be used as an extra measure of outcome in everyday clinical practice as well as in research studies.

Atopic Dermatitis in Latin America: A Roadmap to Address Data Collection, Knowledge Gaps, and Challenges.

BackgroundEducational intervention (EI) could improve understanding of atopic dermatitis (AD) and adherence to treatment, decreasing severity, and improving quality of life (QoL).ObjectiveThis study aims to evaluate the influence of an EI on the severity of the disease and on the QoL in children with AD.MethodsA controlled clinical trial was performed, including children up to 14 years of age with AD. Patients were allocated into control group (CG), which received usual guidelines on AD during the outpatient visit, and a study group (SG) that, in addition to the usual guidelines, participated in the EI. The severity of AD was assessed by Scoring Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI). QoL was assessed by the Children's Dermatology Life Quality Index and the Dermatitis Family Impact Questionnaire.ResultsTwenty-seven participants were included in the CG and 21 in the SG. There was a decrease in the median value for the QoL of children in the SG after the intervention (p = 0.04), as well as in the caregiver's (p = 0.04). In the CG, the median QoL of children and caregivers remained unaltered, for caregivers the median value for the QoL was equal throughout first and second evaluation (p = 0.32). In the SG, EASI values decreased after the intervention (p = 0.04), as well as SCORAD (p = 0.04). The CG did not show any decrease in the values of EASI (p = 0.88) scores nor of SCORAD scores (p = 0.82).ConclusionThe EI rendered a decrease in severity of the disease and improvement in the QoL of patients and their caregivers.

Atopic dermatitis (AD) accounts for 10-20% of referrals to secondary care dermatology, often requiring multiple visits and occupying much valuable time and resources. We audited the usefulness (ease of use, reliability and sensitivity to change) of two simple and easy to use quality of life (QoL) measures, the Infants' Dermatitis Quality of Life Index (IDQOL) and Dermatitis Family Impact (DFI), for assessing the impact on QoL of AD in infants and their families in a routine clinical setting. We also examined the impact of an initial consultation with a dermatology team on AD severity and QoL impairment from the parent's perspective. The parents of 203 infants (mean age 19.8 months) with AD attending paediatric dermatology clinics completed the DFI and IDQOL. The parents of 50 of these infants completed both questionnaires before first and second consultations. In the 203 children the mean of both the IDQOL and DFI scores was 8.47 (median 8 and 7 and SD 5.8 and 6.5, respectively). The IDQOL and DFI correlated well (r(s) = 0.776, P < 0.0001). The parent's assessment of the global severity of AD correlated well with the IDQOL score (r(s) = 0.636, P < 0.0001) but less well with the DFI (r(s) = 0.394, P < 0.001). The highest-scoring IDQOL items were itching and scratching, problems at bathtime and time taken to fall asleep. The highest-scoring DFI items were tiredness/exhaustion, sleep loss and emotional distress. In both measures these domains also correlated most strongly with eczema severity. After dermatology consultation the median global severity score, rated by 50 parents, fell from 2 (SD 0.83) to 1 (SD 0.8; 95% confidence interval, CI 0.5-1), the median IDQOL score fell from 8 (SD 5.92) to 5.5 (SD 5.92; 95% CI 2-5.5) and the median DFI score fell from 9 (SD 6.45) to 3 (SD 6.56; 95% CI 2-5.5). In 50 infants the median IDQOL scores for those infants with global AD severity scores of 1, 2 and 3 were 5 (SD 5.65), 8 (SD 4.27) and 14 (SD 5.67), respectively and improved by 10%, 38% and 64%, respectively while the median DFI scores improved by 54%, 56% and 79%, respectively. The most improved IDQOL items were the time taken to get to sleep and difficulty at mealtimes and the most improved DFI domains were tiredness/exhaustion and emotional distress in the parents. We have provided further important information on the effects of AD on infants and their families using the IDQOL and DFI QoL measures. We demonstrate the usefulness of these measures in routine clinical management of AD and show the beneficial effect for both infants and parents of the initial consultation by a dermatology team in a secondary care setting.

Atopic dermatitis (AD) is a common, chronic, recurrent inflammatory skin disease. Poorly controlled AD can lead to reduced quality of life (QoL) and psychosocial impairment. Dupilumab is the first approved monoclonal antibody targeting type 2 inflammation, for adolescent and adult patients with moderate-to-severe AD. We performed a retrospective analysis of the efficacy and safety of dupilumab in a cohort of Asian children and adolescents with moderate-to-severe AD. Clinical response was documented with investigator global assessment (IGA) and eczema area and severity index (EASI) scores. Improvement in QoL was assessed using child dermatology life quality index (CDLQI) or Teenager's quality of life (T-QoL), and caregivers' QoL was assessed using dermatitis family impact (DFI) questionnaire. Twelve patients were recruited, aged between 6 to 18 years of age (mean 13.3 years), with mean duration of AD of 9.8 years. At baseline, the mean IGA score was four and the mean EASI was 48.2. The mean T-QoL and DFI scores at baseline were 18.7 and 19.6, respectively. After 12 to 16 weeks of treatment, the mean IGA score decreased to 2.2. The mean EASI decreased to 19.3 with mean reduction of 28.9. The mean T-QoL decreased to 7.5 with mean reduction of 11.2, and the mean DFI decreased to 8.6 with mean reduction of 11. Adverse events included mild conjunctivitis in two patients and paradoxical head and neck erythema in one patient. Our study supports dupilumab as an effective and safe treatment option for Asian children and adolescents with moderate-to-severe AD.

BackgroundAtopic dermatitis (AD) is a common, chronic, recurrent inflammatory skin disease. Poorly controlled AD can lead to reduced quality of life (QoL) and psychosocial impairment. Dupilumab is the first approved...

Lebrikizumab (LEB), a high-affinity anti-interleukin-13 monoclonal antibody, showed efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD). Ciclosporin A (CsA) is indicated for severe AD, but its efficacy may not be optimal and its safety limits longer-term use. The objective of this study was to assess the quality of life (QoL) and wellbeing of patients with moderate-to-severe AD receiving LEB. Eligible patients were inadequately controlled with or ineligible for CsA and were followed up to week 76 (German extension of the ADvantage study, NCT05149313). ADvantage is a 52-week study with a 16-week placebo (PBO)-controlled induction period plus a 36-week open-label maintenance period with LEB dosed every 2 weeks. Eligible patients were adults and adolescents (≥ 12 to &amp;lt; 18 years) with Eczema Area and Severity Index ≥ 16, Investigator’s Global Assessment ≥ 3, and ≥ 10% body surface area of AD involvement, and not adequately controlled with or not eligible for CsA. Patients received concomitant low-to-mid-potency topical corticosteroids (TCS) through week 16; from W16 onwards TCS use was at investigator discretion. Patients who completed the 52-week maintenance period were eligible to join the extension-period, to continue LEB every 4 weeks for a minimum of 24 additional weeks (German extension). QoL was assessed as the percentage of change from baseline in the Dermatology Life Quality Index (DLQI) score. From week 0 to week 16, Ancova models were applied, and from week 16 to week 76, analyses were performed as observed. Wellbeing was assessed through the five-item WHO Well-being Index (WHO-5). WHO-5 has a range of 0–100, with 100 representing maximal wellbeing. The mean WHO-5 score in the German general population was 64.7, with a score of 52.2 in women with breast cancer and 51.4 in patients with diabetes with distress. Analyses were performed as observed. In total, 43 patients were included. At week 16 the change in DLQI from baseline was −78.0% (n = 31) for LEB every 2 weeks + TCS, and −59.2% (n = 12) for PBO every 2 weeks + TCS. At week 52 (LEB every 2 weeks ± TCS) the change in DLQI from baseline was −77.1% (n = 38), and at week 76 (LEB every 4 weeks ± TCS) it was −78.9% (n = 29). At baseline, the mean WHO-5 score was 40.1 (n = 28) in patients in the LEB arm and 35 (n = 12) in patients on PBO. At week 16 these scores had increased to 61.7 (n = 28) in patients treated with LEB every 2 weeks + TCS and 51.7 (n = 12) in those treated with PBO every 2 weeks + TCS. From week 16, the WHO-5 scores remained stable: at week 52 it was 60.9 (n = 28) in patients with LEB every 2 weeks ± TCS, and at week 76 it was 61.7 (n = 30) in patients treated with LEB every 4 weeks ± TCS. In the German extension population with moderate-to-severe AD inadequately controlled with or ineligible for CsA, LEB showed improvements in QoL and wellbeing up to week 76. Almirall, S.A. has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Lilly has exclusive rights for the development and commercialization of lebrikizumab in the USA and the rest of the world outside of Europe. Medical writing was funded by Almirall S.A.

Purpose : The aim of this study was to longitudinally examine the correlation between the change of atopic dermatitis (AD) severity and the change of quality of life (QOL). Methods : We assessed AD severity and QOL of patients and their families, by a prospective followed up for at least 12 months. AD severity was assessed, using the scoring of atopic dermatitis (SCORAD) index. A questionnaire based on dermatitis family impact (DFI), infants' dermatologic quality of life (IDQoL) and children's dermatology life quality index (CDLQI) were used to determine QOL Results : Seventy-nine AD patients were assessed for total and objective SCORAD and DFI. Among them, 45 patients that were less than 36 months old completed IDQoL and 13 patients that were equal to or more than 36 months old completed CDLQI. Objective SCORAD (oSCORAD) were correlated with DFI (r=0.235), IDQoL (r=0.602) and CDLQI (r=0.589) (P <0.05). At the 2nd interview, median oSCORAD (from 17.4 to 7.8), DFI (from 23.0 to 18.0) and IDQoL (from 9.0 to 6.0) were significantly decreased (P <0.01). The changes of oSCORAD were linearly related with the change of IDQoL (P <0.01), but neither with DFI (P =0.356) nor with CDLQI (P =0.267). Of the 64 patients with decreased oSCORAD, food allergy was accompanied more frequently in those with an increased DFI than those with a decreased DFI (60.7% vs. 27.8%, P <0.01). Conclusion : In this longitudinal study, the improvement of AD severity is correlated with the improvement of the patient's QOL, under the age of 3. To improve the family's QOL, we need to find out accompanying factors, such as food allergy, and to support the family accordingly. (Pediatr Allergy Respir Dis(Korea) 2012;22:86-99)

Bacterial infections and atopic dermatitis.

Background. Atopic dermatitis (AD) is known to adversely affect patients’ quality of life (QOL). However, less is known about the extent to which caregivers are affected, particularly in developing countries. Objectives. To investigate factors affecting QOL in caregivers of children with AD in the South African (SA) setting and to document the associated effect of disease severity. Methods. This was a prospective study of 142 AD patients and their caregivers attending Grey’s Hospital in KwaZulu-Natal, SA, between May and September 2016. Disease severity was assessed according to the Objective Scoring of Atopic Dermatitis (Objective SCORAD) index. The Dermatitis Family Impact (DFI) questionnaire was used to assess QOL. Results. The study population included 119 (84%) black, 20 (14%) Indian and 3 (2%) coloured patients. Among the group, 44% of cases ( n =62) were classified as mild, 53% ( n =76) as moderate and 3% ( n =4) as severe. The DFI score was significantly associated with the Objective SCORAD index ( p <0.0001). QOL factors significantly affected were emotional distress of the caregiver ( p <0.0001), tiredness of the caregiver ( p <0.0001) and family leisure activities ( p <0.0001). Involvement in treatment ( p =0.016), food preparation and feeding ( p =0.003), the family’s sleep ( p =0.001) and the caregiver’s relationships ( p =0.025) were moderately affected. Conclusion. The QOL of caregivers of children with AD in this setting was adversely affected and declined with increasing disease severity. An evaluation of the psychosocial health of caregivers and appropriate referral where necessary are important for holistic management of both the patient and the caregiver and to improve disease outcome.

BackgroundAtopic dermatitis (AD), a chronic systemic disease, can cause intense skin itching and negatively impact sleep, mood, and quality of life (QoL) for patients and families.MethodsPEDISTAD is an ongoing, 10-year, observational registry describing disease characteristics, atopic comorbidities, and treatment patterns in pediatric patients (aged <12 years at enrollment) with moderate-to-severe AD. This 3-year interim analysis evaluates clinician-reported and caregiver-reported/patient-reported outcomes (Eczema Area and Severity Index [EASI], percent body surface area affected, worst itching/scratching, Children’s Dermatology Life Quality Index, and Dermatitis Family Impact) in children treated with dupilumab, methotrexate, and/or cyclosporine. Outcomes were assessed as change from therapy start to last observation (either data cutoff date or treatment discontinuation).ResultsMean (±SE) EASI scores at the time of the last 3-year interim observation were consistent with mild disease in the dupilumab cohort and moderate disease in the methotrexate and cyclosporine cohorts. Improvements in pruritus were numerically greater in the dupilumab cohort relative to the methotrexate and cyclosporine cohorts, while improvements in QoL were similar in the dupilumab and methotrexate cohorts, with no significant change in the cyclosporine cohort. Rates of AD exacerbation were numerically lower with dupilumab treatment relative to methotrexate treatment which were numerically lower than cyclosporine treatment. Dupilumab discontinuation rates were numerically lower relative to methotrexate which were numerically lower than cyclosporine.ConclusionsThis PEDISTAD 3-year interim analysis of dupilumab, methotrexate, and cyclosporine treatment in children with AD demonstrates numerically greater improvements in AD signs, symptoms and QoL with dupilumab treatment relative to methotrexate and cyclosporine [Video abstract and graphical abstract available].Clinical Trial RegistrationNCT03687359.Graphical abstractVideo abstractSupplementary file1 (MP4 58163 KB)Supplementary InformationThe online version contains supplementary material available at 10.1007/s40257-025-00962-8.

BackgroundThe efficacy and safety of tralokinumab, a fully human monoclonal antibody that specifically neutralizes interleukin-13, plus topical corticosteroids (TCS) as needed were evaluated over 32 weeks in the phase III ECZTRA 3 trial. Significantly more tralokinumab- versus placebo-treated patients achieved the primary endpoints of Investigator’s Global Assessment (IGA) score of 0/1 and 75% improvement in Eczema Area and Severity Index (EASI-75) and all confirmatory endpoints at Week 16.ObjectiveThis post hoc analysis investigated the impact of tralokinumab plus TCS on atopic dermatitis (AD) severity, symptoms, and health-related quality of life (QoL) over the entire 32-week treatment period of ECZTRA 3, including all patients initiated on tralokinumab irrespective of the response achieved at Week 16.MethodsPatients were randomized 2:1 to receive subcutaneous tralokinumab 300 mg or placebo every 2 weeks (q2w) with TCS as needed for an initial 16 weeks. At Week 16, patients who achieved the clinical response criteria (IGA 0/1 and/or EASI-75) with tralokinumab were re-randomized 1:1 to tralokinumab q2w or every 4 weeks (q4w), with TCS as needed, for another 16 weeks. Patients not achieving the clinical response criteria with tralokinumab received tralokinumab q2w plus TCS from Week 16. All patients randomized to tralokinumab in the initial treatment period were pooled for this analysis, irrespective of response at Week 16 or dosing regimen beyond Week 16.ResultsContinued tralokinumab (q2w, N = 164; q4w, N = 69) plus TCS treatment provided progressive improvements from Week 16 onwards in AD signs, with 70.2% (177/252) of patients achieving EASI-75 and 50.4% (127/252) achieving EASI-90 at Week 32. Improvements in patient-reported outcomes were observed within the first few weeks of tralokinumab q2w plus TCS treatment and were sustained throughout the 32-week period. At Week 32, patients initiated on tralokinumab q2w plus TCS achieved a relative improvement versus baseline of 70.8% (standard error (SE), 2.4) in eczema-related sleep interference numeric rating scale (NRS) and 66.8% (SE, 3.1) in Dermatology Life Quality Index (DLQI). Mean TCS use during Weeks 16–32 ranged from 9.2 to 13.6 g (SE, 1.2–2.0) q2w. Most patients (89.9% (222/247)) initiated on tralokinumab q2w plus TCS achieved a meaningful improvement in at least one of the three disease domains, including AD signs (EASI-50), symptoms (pruritus NRS improvement ≥ 3), and QoL (DLQI improvement ≥ 4) at Week 16. Of patients initiated on tralokinumab q2w plus TCS, 53.4% (132/247) achieved a clinically meaningful improvement in all three domains at Week 16 (vs. placebo, 28.5% (35/123); p < 0.001).ConclusionsContinued tralokinumab treatment plus TCS as needed provides progressive and sustained improvements in AD signs, symptoms, and health-related QoL over 32 weeks.Clinical trial registrationNCT03363854; study start date: 22 February 2018; primary completion date: 8 March 2019; study completion date: 26 September 2019.InfographicVideo abstract: What is the impact of tralokinumab plus topical corticosteroids in adults with moderate-to-severe atopic dermatitis over 32 weeks? (MP4 216,988 KB)Supplementary InformationThe online version contains supplementary material available at 10.1007/s40257-022-00702-2.

Introduction/Background Dupilumab and lebrikizumab are both monoclonal antibodies that have demonstrated efficacy and safety in clinical trials of patients with moderate-to-severe atopic dermatitis (AD). Dupilumab targets both interleukin (IL)-4 and IL-13, and is fully human, whereas lebrikizumab selectively targets IL-13 and is humanized. However, no direct head-to-head clinical trials have been performed to compare efficacy of dupilumab vs lebrikizumab in combination with topical corticosteroids (TCS). Bucher indirect treatment comparisons (ITCs), in which treatment effects are anchored to a common comparator (e.g. placebo), provide a robust and widely accepted method of evaluating the relative efficacy of drugs in the absence of direct comparisons. Objective To report the results of a placebo-adjusted Bucher ITC of 16-week therapy for moderate-to-severe AD, comparing the efficacy of dupilumab every 2 weeks (q2w) (LIBERTY AD CHRONOS) vs lebrikizumab q2w (ADhere), in combination with TCS. Methods Placebo-adjusted Bucher ITC was conducted using published phase 3 trial data from LIBERTY AD CHRONOS (NCT02260986) and ADhere (NCT04250337). For both studies, data from the 16-week period were used, employing non-responder imputation, with the following doses: 300mg dupilumab + TCS q2w, or placebo + TCS, and 250mg lebrikizumab q2w + TCS, or placebo + TCS. No adjustments were made for baseline characteristics. Outcomes included proportion of patients achieving ≥75% improvement from baseline in Eczema Area and Severity Index (EASI-75), Investigator’s Global Assessment score 0/1 (IGA-0/1; clear/almost clear), 4-point improvement from baseline in peak pruritus Numerical Rating Scale score (PP-NRS ≥4), and ≥4-point improvement from baseline in Dermatology Life Quality Index (DLQI ≥4). Odds ratio (OR) with 95% confidence interval (CI) are reported. Results Examination of baseline disease characteristics indicated that the patient populations enrolled in ADhere presented with lower disease severity compared with LIBERTY AD CHRONOS, based on IGA; however, PP-NRS, EASI, and DLQI scores were similar between both trials. This placebo-adjusted Bucher ITC favored dupilumab vs lebrikizumab with TCS combination treatment for all outcomes evaluated. Patients treated with dupilumab + TCS had a significantly higher likelihood of achieving EASI-75 (OR=2.39, 95%CI 1.10–5.19) and PP-NRS ≥4 (OR=2.63, 95%CI 1.17–5.95) at Week 16 vs those treated with lebrikizumab + TCS. OR for the endpoints IGA 0/1 and DLQI ≥4 favored dupilumab, but did not reach statistical significance: IGA 0/1 (OR=1.90, 95%CI 0.81–4.42), DLQI ≥4 (OR=2.35, 95%CI 0.94–5.87). Conclusion A placebo-anchored Bucher ITC approach showed that the likelihood of achieving improvements in signs, symptoms, and quality of life is higher for patients treated with dupilumab + TCS vs lebrikizumab + TCS.