Patient-Oriented Eczema Measure Research Articles

Comparison of Patient-Oriented Eczema Measure and Patient-Oriented Scoring Atopic Dermatitis vs Eczema Area and Severity Index and other measures of atopic dermatitis: A validation study

BackgroundLittle is known about the measurement properties of Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD) in adults with atopic dermatitis (AD). Even less is known about how PO-SCORAD performs compared with the Patient-Oriented Eczema Measure (POEM). ObjectiveTo examine the measurement properties of PO-SCORAD and compare them with those of POEM. MethodsA prospective dermatology practice–based study of 291 patients with AD (age range, 18-72 years). ResultsPO-SCORAD and POEM were moderately correlated with each other (Spearman ρ = 0.56) and had weak-moderate correlations with the Numeric Rating Scale (NRS) worst itch and average itch, Dermatology Life Quality Index (DLQI), ItchyQOL, Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI), Patient Health Questionnaire-9 (PHQ-9), and Eczema Area and Severity Index (EASI) (P < .001). POEM had significantly stronger correlations with DLQI, ItchyQOL, and EASI than did PO-SCORAD. PO-SCORAD and POEM had fair discriminant validity. Changes from baseline in PO-SCORAD and POEM were moderately correlated with each other; were weakly to strongly correlated with NRS worst itch and average itch, DLQI, ItchyQOL, PROMIS SD, PROMIS SRI, PHQ-9, and EASI; and had good test-retest reliability. There was no differential item functioning of items or floor or ceiling effects for PO-SCORAD or POEM. The thresholds for meaningful change for PO-SCORAD and POEM were −15.5 and −5.0, respectively. Median completion times for PO-SCORAD and POEM were 3 minutes and 1 minute, respectively. ConclusionPO-SCORAD and POEM had good construct and cross-cultural validity, reliability, and responsiveness in adults with AD and were feasible for use in clinical trials and practice. However, POEM had better measurement properties than PO-SCORAD.

Clinical Response and Quality of Life in Patients with Severe Atopic Dermatitis Treated with Dupilumab: A Single-Center Real-Life Experience.

Dupilumab is an anti-interleukin-4 receptor monoclonal antibody that was recently approved for the treatment of atopic dermatitis (AD). In this single-center retrospective study, clinical baseline data of 117 severe AD patients treated with dupilumab were collected. At baseline and at weeks 4 and 16, disease severity was assessed through the Eczema Area and Severity Index (EASI) and quality of life through the Dermatology Life Quality Index (DLQI) questionnaire, Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), Peak Pruritus Numerical Rating Scale (NRS-itch), and VAS-sleep. Response to dupilumab was defined as an improvement of ≥75% in EASI from baseline (EASI75). At multivariate analysis, AD onset before 18 years [OR, 2.9; 95% CI, 1.2–7.2; p = 0.0207] and absence of hypereosinophilia [OR, 2.24; 95% CI, 1.03–4.86; p = 0.0412] were identified as significant predictive parameters for response to dupilumab in terms of EASI75 at week 4 but not at week 16. Significant reductions in EASI, DLQI, POEM, HADS, NRS-itch, and VAS-sleep were found between week 4 versus baseline (p < 0.0001 for all) and week 16 versus baseline (p < 0.0001 for all). Early AD onset and absence of hypereosinophilia may be suggested as predictive markers of early response to dupilumab. We confirmed the efficacy and safety of this agent along with the improvement of life quality in severe AD patients.

Validation of Patient-Reported Outcomes Information System Sleep Disturbance and Sleep-Related Impairment in adults with atopic dermatitis.

Sleep disturbances are common in adults with atopic dermatitis (AD). Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI) are validated questionnaires to assess sleep in adults. Little is known about their measurement properties in adults with AD. To assess the measurement properties of the PROMIS SD and SRI eight-item short forms in AD. We performed a prospective dermatology-practice-based study using questionnaires and evaluation by a dermatologist (n = 420). PROMIS SD and SRI showed moderate correlations to each other (ρ = 0·67), and weak correlations with Patient-Oriented Eczema Measure (ρ = 0·43 and 0·39, respectively); average (ρ = 0·31/0·30) and worst numerical rating scale for itch (ρ = 0·32/0·30); Eczema Area and Severity Index (ρ = 0·41/0·31); and Scoring Atopic Dermatitis (SCORAD) (ρ = 0·44/0·30) (Spearman correlations, P < 0·001). PROMIS SD and SRI increased significantly and stepwise with more frequent sleep disturbance, severe itch and self-reported global AD severity (ancova,P < 0·001). PROMIS SD and SRI showed good internal consistency (Cronbach alpha 0·84 and 0·91). Changes from baseline in PROMIS SD and SRI were weakly to moderately correlated with each other and with changes of multiple patient-reported and clinician-reported AD outcomes. There were no floor or ceiling effects for PROMIS SD or SRI. The median completion time for PROMIS SD and SRI was 2 min. PROMIS SD and SRI showed good construct validity, internal consistency, responsiveness and feasibility to assess sleep in adult patients with AD. What is already known about this topic? The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI) scales were found to be valid in adults with chronic disease. However, the validity and feasibility of PROMIS SD and SRI in atopic dermatitis remain unknown. What does this study add? This study demonstrated that PROMIS SD and SRI had good content, concurrent, convergent and discriminant validity; feasibility; and responsiveness, with no floor or ceiling effects observed. What are the clinical implications of this work? The PROMIS SD and SRI eight-item bank short forms appear to have sufficient validity and feasibility to be used as assessments for burden of sleep in adults with atopic dermatitis in clinical practice.

The use of complementary and alternative medicine in children with atopic eczema at a tertiary care centre in Malaysia

ObjectiveGlobally, the use of complementary and alternative medicines (CAMs) for children with atopic eczema (AE) is gaining popularity. At present, information on the pattern of CAM use in Malaysia among children with AE is limited. This study aimed to investigate the pattern of CAM use in children with AE and factors associated with its use. MethodsThis was a cross-sectional survey conducted at a tertiary care centre in Kuala Lumpur, Malaysia among parents of children with AE aged ≤ 12 years using validated questionnaires including Beliefs about Medicines Questionnaire (BMQ-General) and Patient-Oriented Eczema Measure (POEM) scale. ResultsIn total, 173 parents were recruited. The prevalence of CAM use over the last 12-month period was 46.8 %. The most commonly used CAM was Ruqyah (Islamic prayer), followed by Malay herbs, virgin coconut oil, nutritional therapy and homeopathy. AE severity from parental perspective was the major predictor of CAM use based on multiple logistic regression analysis. Parents of children with ‘clear or almost clear’ (adjusted OR 0.06; 95 % CI 0.01-0.54; p = 0.012) and ‘mild’ (adjusted OR 0.15; 95 % CI 0.03-0.85; p = 0.032) eczema were less likely to use CAM than those with ‘very severe eczema’. Conclusion: CAM use was prevalent among children with AE. Its use was significantly associated with AE severity from a parental perspective. Healthcare providers may need to enquire parents about CAM use for their child during routine clinic appointment.

Insights From Caregivers on the Impact of Pediatric Atopic Dermatitis on Families: "I'm Tired, Overwhelmed, and Feel Like I'm Failing as a Mother".

The impact of pediatric atopic dermatitis (AD) on families is largely hidden from view, and AD is commonly misunderstood as a minor skin condition. Few studies have examined the full burden of AD from the family perspective. The aim of the study was to assess the burden of AD on children and families using a caregiver-centered survey. A 72-item anonymous online survey was posted on social media sites targeted to or composed of parents of children with AD. It explored the following 9 domains of impact: sleep, social isolation, time requirements, life decisions, family relationship dynamics, energy/fatigue, mental health impacts, and unmet treatment needs. Atopic dermatitis severity was reported by respondents using the Patient-Oriented Eczema Measure. Statistical analyses were conducted using R 3.6.0. Two hundred thirty-five individuals completed the survey during the 1-month period that it was promoted via social media. Caregivers reported frequent sleep disturbance, exhaustion, worry, and social isolation related to their child's AD. Results highlight the need for psychosocial support and respite care for caregivers of children with AD.

Development and initial testing of a new instrument to measure the experience of eczema control in adults and children: Recap of atopic eczema (RECAP).

SummaryBackgroundEczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals and researchers) but no validated instruments for the domain have been identified.ObjectivesTo develop a measurement instrument to capture a patient's perspective of eczema control that is suitable for use in eczema clinical trials.MethodsBest practice for the development of a patient‐reported outcome was followed. A mixed‐methods approach was used to develop and refine a conceptual framework, generate, refine and select items and to test the distribution and construct validity of the final scale. The mixed‐methods approach involved expert panel meetings (including patient representatives, healthcare professionals and methodologists), and data collection using a focus group, cognitive interviews and an online survey with people with eczema and caregivers. Multivariable linear regression was used in the item selection process.ResultsFourteen expert panel members co‐produced the instrument, with input from people with eczema and caregivers via a focus group (n = 6), cognitive interviews (n = 13) and an online survey (n = 330). The resulting instrument, Recap of atopic eczema (RECAP), is a seven‐item questionnaire that captures eczema control via self or caregiver report. The development process aimed to ensure good content validity and feasibility. Initial testing suggested no floor or ceiling effects and good construct validity. Hypothesized correlation with the Patient‐Oriented Eczema Measure was confirmed [r(258) = 0·83, P < 0·001].Conclusions RECAP has the potential to improve reporting of eczema control in research and clinical practice. Further exploration of measurement properties is required. Linked Comment: Pattinson and Bundy. Br J Dermatol 2020; 183:418–419. What's already known about this topic? Eczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals and researchers).Qualitative studies suggest eczema control is a multifaceted and individual experience and no instrument has been identified that captures eczema control in this way. What does this study add? We have developed Recap of atopic eczema (RECAP), a seven‐item questionnaire to capture the experience of eczema control in all ages and eczema severities; there are two versions: a self‐reported version for adults and older children with eczema, and a caregiver‐reported version for younger children with eczema.Designed with input from people with eczema, caregivers and healthcare professionals to ensure good content validity.Initial testing of score distributions and construct validity suggests good measurement properties. What are the clinical implications of the work? The RECAP instrument is appropriate and feasible for measuring eczema control in clinical trials and may also be useful in routine practice.

Baseline characteristics, disease severity and treatment history of patients with atopic dermatitis included in the German AD Registry TREATgermany.

The Atopic Dermatitis (AD) TREATgermany registry was initiated by the German Society for Dermatology (DDG) in 2011 to evaluate the 'real-life' situation of health care for patients with AD. Interim data analysis on baseline characteristics as well as current and prescribed systemic treatments of the TREATgermany registry patients. Patients (≥18years) with moderate-to-severe AD [objective (o)SCORAD>20], or with current or previous anti-inflammatory systemic treatment for AD within 24months, were included and are followed up over at least 24months. To assess clinical signs, the eczema area severity index (EASI, 0-72), the oSCORAD (0-83) and the Investigator Global Assessment (IGA; 6-point scale) were used. The disease severity was globally scored by the patients [Patient Global Assessment (PGA); six-step Likert scale]. Disease symptoms were assessed by the patient-oriented eczema measure (POEM, 0-28) and numeric rating scales (NRS, 0-10). Health-related quality of life was measured using the dermatological life quality index (DLQI, 0-30). A total of 612 patients were recruited across 32 sites between 06/2016 and 01/2019 (mean age: 42.6±14.2years; mean oSCORAD: 40.8±16.3). The mean POEM score was 16.3±7.5. Pruritus was rated highest among subjective symptoms (NRS: 5.4±2.7). The mean DLQI value was 11.3±7.5. The frequency of arterial hypertension was lower (20.8%) compared with the general population, whilst this was higher for depression (10%). More than 60% of the patients had received systemic glucocorticosteroids, and 36.8% had received cyclosporine A prior to inclusion. Dupilumab was the leading substance documented as either 'current' (12.1%) or 'prescribed' (31.4%) at baseline. These 'real-life' data clearly demonstrate the substantial disease burden. Most of TREATgermany patients were already treated with or prescribed dupilumab at baseline. Moreover, current findings indicate the urgent need for further alternative agents in order to achieve a perceptible improvement of quality of life of patients with moderate-to-severe AD.

The Patient-Oriented Eczema Measure: estimating the minimal important change in an outpatient clinic cohort.

Patient-Oriented Eczema Measure (POEM) measures patient-reported symptoms in atopic dermatitis (AD). It is the recommended core outcome instrument to capture the symptoms domain in AD clinical trials. Understanding the minimal important change (MIC) in the POEM score is therefore important in both trial and clinical care settings. Previous studies have mainly evaluated MIC estimates among children in trial settings. The MIC estimate for POEM in a clinical setting is often lacking. We aim to estimate the MIC of the POEM using both distribution-based and anchor-based methods in a clinical cohort of adult eczema patients. Both distribution-based and anchor-based methods were used to calculate the MIC of the POEM in a clinical cohort of Asian adult patients attending the eczema clinic at a tertiary dermatology centre in Singapore. Scoring AD (SCORAD) was used as the disease severity anchor for the anchor-based methods. The smallest detectable change (SDC) for POEM was also calculated as the threshold for any measurement error. There were a total of 85 adult AD patients in the cohort that contributed a total of 114 paired measurements of both POEM and SCORAD. The SDC in our study was 1.68. The MIC estimates were 3.64 and 1.46 based on 0.5 standard deviation (SD) and 0.2 SD distribution-based methods. Anchor-based methods such as the receiver operating curve and predictive modelling methods yielded MIC values of 0.50 and 1.05, respectively. Minimal important change for POEM varied according to the methods and approaches used. Only a change of two points or more in POEM could be considered beyond any measurement errors and clinically important. This finding is consistent even in a clinical setting of Asian adults with eczema.

Patient-Oriented Eczema Measure score: A Useful Tool for Web-Based Surveys in Patients with Atopic Dermatitis

The Patient-Oriented Eczema Measure (POEM, 0–28 points) is a self-assessed, repeatable measurement tool for measuring atopic dermatitis (AD) severity. However, whether POEM score is influenced by allergic comorbidities and whether POEM’s severity banding is applicable in web-based surveys for AD remain unclear. A web-based questionnaire survey was conducted in 329 patients with AD. POEM, self-reported severity of AD, and comorbidity of allergic diseases including asthma, pollen rhinitis, allergic conjunctivitis, and food allergy were assessed. POEM scores were not affected by a history of comorbid allergic diseases. The severity banding for POEM scores on the web-based survey was as follows: clear/almost clear=0, mild=1–8, moderate=9–21, and severe/very severe=22–28, which was comparable to previous banding. These results suggest that POEM is useful for determining AD severity, even in web-based surveys. Patients with POEM scores above 9 points may be grouped into moderate, severe, and very severe AD.

Validation of four single-item patient-reported assessments of sleep in adult atopic dermatitis patients

BackgroundThe optimal approaches for monitoring sleep disturbances in adults with atopic dermatitis (AD) is not established. Multiple patient-reported outcome measures for AD and itch have sleep-related items. These items have not been validated previously. ObjectiveAssess the measurement properties of sleep-related items from the Patient-Oriented Eczema Measure (POEM), SCORing AD (SCORAD), 5-dimensions of itch (5D), and ItchyQOL in adults with AD. MethodsWe performed a prospective dermatology practice-based study using questionnaires and evaluation by a dermatologist (n = 115). ResultsThere was modest overlap and weak-moderate concordance of responses to the different assessments. Regarding concurrent validity, POEM-sleep, SCORAD-sleep, 5D-sleep, and ItchyQOL-sleep showed moderate correlations with each other. Regarding convergent validity, all items showed moderate correlation with total POEM, but weak correlations with Eczema Area and Severity Index (EASI), objective and total SCORAD, moderate to strong correlations with mean ItchyQOL and Dermatology Life Quality Index (DLQI), but poor or no significant correlation with Numeric Rating Scale (NRS) for worst or average itch. Regarding discriminant validity, all items showed significant and stepwise increases with increasing self-reported and physician-reported AD severity (Kruskal-Wallis, P < .01 for all). Floor effects were observed for POEM-sleep (n = 53, 46.1%), SCORAD-sleep (n = 28, 24.4%), 5D-sleep (n = 41, 35.7%), and ItchyQOL-sleep (n = 33, 28.7%); no ceiling effects were observed. Change in sleep-related item scores showed moderate strong correlations with change in POEM, 5Ditch, mean ItchyQOL, DLQI, objective and total SCORAD, and EASI, but inconsistent correlations with change of itch severity. ConclusionSleep-related items from POEM, SCORAD, 5D and ItchyQOL showed good validity and responsiveness to monitor sleep disturbances in adult AD patients.

Measurement properties of the Patient-Reported Outcomes Measurement Information System Itch Questionnaire item banks in adults with atopic dermatitis

ThePatient-Reported Outcomes Measurement Information System (PROMIS) Itch Questionnaire (PIQ) was recently developed. To validate PIQ short forms in adults with AD. Self-administered questionnaires and skin examinations were performed in 239 adults with atopic dermatitis (AD) in a dermatology practice setting. PIQ items had good content validity. PIQ item bank T-scoresstrongly correlated with each other, moderately correlated with numeric and verbal rating scales for worst or average itch and with itch frequency, moderately to strongly correlated with patient-oriented eczema measure, and weakly to moderately correlated with the Eczema Area and Severity Index and Objective-Scoring AD (Spearman correlations, P<.0001). There were significant and stepwise increases of T-scores for all item banks with increasing patient-reported global severity (Wilcoxon rank sum test, P<.0001). However, there was limited ability to discriminate between the lowest or highest 2 levels of AD or itch severity. Item banks showed good internal consistency (Cronbach α, 0.91-0.95). No differential item functioning was identified by age, sex, race/ethnicity, or educational level. There were floor effects for total scores, particularly in almost clear/mild AD or itch. Single-center study. PIQ item bank short forms showed good content and construct validity and are feasible for potential use in clinical trials and practice.

Acupuncture for patients with atopic dermatitis: A systematic review protocol.

Background:The systematic review protocol is aim to evaluate the efficacy and safety of acupuncture in the treatment of atopic dermatitis (AD).Methods:We will search the database on the Cochrane Library, PubMed, Medline, Excerpta Medica Database, Chinese Biomedical Literature Database, PsychINFO, China National Knowledge Infrastructure, Wanfang data, Chinese Scientific Journal Database, including studies and published systematic review in the reference list and grey. And will use Cochrane Collaboration's tools to evaluate the risk of bias of the included randomized controlled trials. The Review Manager 5.3 will be used to synthesize collected data.Results:This study will assess the safety and effectiveness based on current evidence of acupuncture for AD, especially scoring atopic dermatitis, eczema area, and severity index, patient-oriented eczema measure, and quality of life.Conclusion:This study will provide high-quality recently evidence for evaluating the efficacy of acupuncture for patients with AD.PROSPERO registration number: CRD42019135919.

Atopic eczema score of emotional consequences — a questionnaire to assess emotional consequences of atopic eczema

Atopic eczema (AE, atopic dermatitis), one of the most common chronic skin diseases worldwide, can dramatically influence the lives of affected patients as well as the lives of their families. Despite the availability of several questionnaires for assessing the impairment of quality of life, so far the emotional consequences of AE have received limited attention. The purpose therefore was to develop an instrument to assess the emotional consequences of AE in affected adults. The Atopic Eczema Score of Emotional Consequences (AESEC) was developed based on a review of available instruments and by consulting individuals with AE about the emotional consequences of AE through social media. Validation was performed in a test-sample, followed by a large cross-sectional study in patients with AE across nine European countries. AESEC results were compared with the Patient Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI) and the Hospital Anxiety and Depression Scale (HADS). A 28-item questionnaire on emotional consequences of having AE was developed. Applied to 1189 participants, AESEC showed high reliability and correlated well with DLQI, HADS and POEM. More than half (57%) of the respondents were emotionally burdened. Large to very large emotional consequences were reported by 43.8% of those with currently moderate AE, 62.2% with severe AE and 66.7% with very severe AE-symptoms. AESEC is a questionnaire for assessing the emotional consequences of living with AE. It may prove useful in evaluating the burden of disease, beyond skin symptoms and time-specific quality of life.

PSY52 PATIENT-REPORTED OUTCOME MEASURES IN ATOPIC DERMATITIS AND CHRONIC HAND ECZEMA IN ADULTS

Patient-reported outcome measures (PROMs) provide an important complement to physician-assessed clinical outcome measures in dermatologic diseases such as atopic dermatitis (AD) and chronic hand eczema (CHE). AD and CHE are chronic and relapsing inflammatory skin conditions that often co-occur. While both diseases result in various signs and symptoms that are burdensome and can negatively affect patients’ lives, there may be distinct differences in the signs, symptoms, burden, and health-related quality of life (HRQOL) impact of these diseases. The objective of this study was to identify and evaluate PROMs used in studies of AD and CHE. The aim was to explore the assessment of key symptoms and impacts, and identify any gaps in the measures in use. A structured review of the PubMed database was conducted to identify PROMs used or developed for use in AD or CHE. The Dermatology Life Quality Index (DLQI), the Pruritus/Itch Numeric Rating Scale (NRS), the Patient-Oriented Eczema Measure (POEM), and the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) were identified and reviewed in detail. With these measures, the AD and CHE symptoms and impacts most commonly evaluated in the literature include dermatology-related HRQOL in the domains of symptoms and feelings, daily activities, leisure, work and school, personal relationships, and adverse effects; pruritus; sleep disturbance; AD-specific symptoms (dryness, itching, flaking, cracking, bleeding, and weeping/oozing); and CHE-specific symptoms (pain, itch, fissuring, redness, bleeding, and dryness). A review of regulatory labels of drugs approved for AD by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) found that, among the four measures reviewed, the Pruritus NRS was included in the FDA and EMA labels for dupilumab, the DLQI was included in the EMA labels for dupilumab and tacrolimus, and the POEM was included in the EMA label for dupilumab. Key symptoms of AD (e.g. itching, flaking, cracking) and CHE (e.g. pain, itching, fissuring) are increasingly being assessed with PROMs; however, primary endpoints in clinical trials are often based on clinician-reported outcome measures. As therapeutic strategies in dermatology are targeted at specific dermatologic symptoms and diseases affecting specific sites (e.g. CHE), future research should explore patients’ experiences with these symptoms and sites and the changes with treatment that are most meaningful to them.

Best emollients for eczema (BEE) – comparing four types of emollients in children with eczema: protocol for randomised trial and nested qualitative study

IntroductionAtopic dermatitis/eczema affects around 20% of children and is characterised by inflamed, dry, itchy skin. Guidelines recommend ‘leave-on’ emollients that are applied directly to the skin to add or trap...

Dupilumab is very effective in a large cohort of difficult-to-treat adult atopic dermatitis patients: First clinical and biomarker results from the BioDay registry.

Dupilumab has recently been approved for the treatment of moderate to severe atopic dermatitis (AD) in adults. Daily practice data on dupilumab treatment are scarce. To study the effect of 16-week treatment with dupilumab on clinical response and serum biomarkers in adult patients with moderate-severe AD in daily practice. Data were extracted from the BioDay registry, a prospective multicenter registry. Sixteen-week clinical effectiveness of dupilumab was expressed as number of patients achieving EASI-50 (Eczema Area and Severity Index) or EASI-75, as well as patient-reported outcomes measures (Patient-Oriented Eczema Measure, Dermatology Life Quality Index, Numeric Rating Scale pruritus). Twenty-one biomarkers were measured in patients treated with dupilumab without concomitant use of oral immunosuppressive drugs at five different time points (baseline, 4, 8, 12, and 16weeks). In total, 138 patients treated with dupilumab in daily practice were included. This cohort consisted of patients with very difficult-to-treat AD, including 84 (61%) patients who failed treatment on ≥2 immunosuppressive drugs. At week 16, the mean percent change in EASI score was 73%. The EASI-50 and EASI-75 were achieved by 114 (86%) and 82 (62%) patients after 16weeks of treatment. The most reported side effect was conjunctivitis, occurring in 47 (34%) patients. During dupilumab treatment, disease severity-related serum biomarkers (TARC, PARC, periostin, and IL-22), eotaxin-1, and eotaxin-3 significantly decreased. Treatment with dupilumab significantly improved disease severity and decreased severity-related serum biomarkers in patients with very difficult-to-treat AD in a daily practice setting.

Higher self-reported severity of atopic dermatitis in adults is associated with poorer self-reported health-related quality of life in France, Germany, the U.K. and the U.S.A.

SummaryBackgroundBetter understanding of the relationship between atopic dermatitis (AD) severity and health‐related quality of life (HRQoL) could help improve knowledge of a more effective treatment for people with AD.ObjectivesTo assess the relationship between AD severity and HRQoL and perception of AD symptoms in adults with moderate‐to‐severe AD in Europe and the U.S.A.MethodsParticipants for this cross‐sectional, internet‐based survey were recruited from the larger population‐based National Health and Wellness Survey. AD severity was measured by Patient‐Oriented SCORing of AD. HRQoL was measured by the five‐level EuroQol‐5D, Dermatology Life Quality Index (DLQI) and Patient‐Oriented Eczema Measure (POEM).ResultsAltogether, 1232 respondents were included: 1098 (89·1%) with moderate‐to‐severe AD [221 (20·1%) from France, 209 (19·0%) from Germany, 118 (10·7%) from the U.K. and 550 (50·1%) from the U.S.A.]. An additional 134 (10·9%) respondents with mild AD were included. Sociodemographic and clinical AD characteristics were similar between countries. In adults with moderate‐to‐severe AD, higher AD severity correlated with poorer HRQoL (Spearman's r = –0·38 and 0·61 for EQ‐5D and DLQI, respectively; both P < 0·001). AD severity was positively correlated with POEM (Spearman's r = 0·51; P < 0·001). People with moderate‐to‐severe vs. those with mild AD had poorer health outcomes (EQ‐5D, DLQI and POEM, P < 0·001 for all). These results were similar and consistent for the European and the U.S. populations separately.ConclusionsHigher AD severity is associated with poorer HRQoL across Europe and the U.S.A. This is a burden for patients and may provide encouragement for more effective management of AD. What's already known about this topic? Atopic dermatitis (AD) is associated with a detrimental effect on health‐related quality of life (HRQoL), including sleep disturbance, anxiety and depression.Limited data describing the relationship between different levels of AD severity and self‐reported HRQoL have been published. What does this study add? There is a positive association between increasing AD severity (Patient‐Oriented SCORing of AD) and decreasing HRQoL (EQ‐5D and Dermatology Life Quality Index) and the perception of AD symptoms (Patient‐Oriented Eczema Measure) from the patient's perspective.AD severity according to geographic locations was explored (France, Germany, the U.K., and the U.S.A.), showing that the decreasing HRQoL associated with increasing AD severity was quite consistent between the geographic locations. What are the clinical implications of this work? The results of this study showed that higher AD severity is associated with poorer HRQoL from the subject’s perspective in both Europe and the US. This fact confirms that there is a burden for these patients and may provide encouragement for a more effective management of AD, especially among those with greater AD severity.

Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children's Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis.

IntroductionThe Patient-Oriented Eczema Measure (POEM) assesses patient-reported frequency of atopic dermatitis (AD) symptoms, while the Children’s Dermatology Life Quality Index (CDLQI) measures the impact of skin disease on health-related quality of life (HRQoL) in children. There is currently no threshold for clinically meaningful within-person change in POEM or CDLQI scores in adolescents. Here we empirically derive within-person thresholds of meaningful within-person change in POEM and CDLQI scores in adolescents with moderate-to-severe AD.MethodsData were used from a phase 3, randomized, double-blind, placebo-controlled trial of dupilumab in adolescents (aged ≥ 12 to < 18 years) with moderate-to-severe AD. Anchor-based methods were employed using the mean change in POEM and CDLQI scores from baseline to week 16 linked with a 1-point improvement in Patient Global Assessment of Disease (PGAD), a score of “a little better” on the Patient Global Assessment of Treatment effect (PGAT), a 50–74% improvement from baseline in the Eczema Area and Severity Index (EASI-50–74), and a 1-point improvement in Investigator’s Global Assessment (IGA) score.ResultsA mean change of − 7.8 and − 5.6 in the POEM score was associated with PGAD and PGAT anchors, respectively. EASI-50–74 was associated with a mean change in POEM score of − 8.2, while the IGA anchor was associated with a mean change of − 7.9 in POEM score. The mean changes in CDLQI score associated with PGAD and PGAT anchors were − 6.4 and − 6.6, respectively, while CDLQI mean scores changed by − 8.3 and − 8.0 for the EASI and IGA anchors, respectively.ConclusionIn adolescents (aged ≥ 12 to < 18 years) with moderate-to-severe AD, a within-person change of 6–8 points in POEM and CDLQI scores, independently, can be considered a reasonable responder threshold for clinically meaningful change in each of the two scales, respectively.Trial RegistrationClinicalTrials.gov Identifier: NCT03054428.FundingSanofi and Regeneron Pharmaceuticals, Inc.Electronic supplementary materialThe online version of this article (10.1007/s13555-019-00333-2) contains supplementary material, which is available to authorized users.

Validation of five patient-reported outcomes for atopic dermatitis severity in adults.

Structured patient-reported outcomes of atopic dermatitis (AD) severity are not standardized in clinical practice. To determine the construct validity, internal consistency, cross-cultural validity and floor or ceiling effects of multiple AD severity assessments. This is a cross-sectional, population-based study of 2893 adults, including 602 adults who met a modified set of U.K. diagnostic criteria for AD. AD severity was assessed using self-reported global AD severity, Patient-Oriented Eczema Measure (POEM), Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD) and its objective and subjective components, and numerical rating scale (NRS)-itch. Quality of life was assessed using Short-Form (SF)-12 mental and physical health scores, Short-Form Six Dimensions (SF-6D) health utility scores and Dermatology Life Quality Index (DLQI). Mental health was assessed with the Hospital Anxiety and Depression Scale (HADS). PO-SCORAD, PO-SCORAD objective and subjective subscores, NRS-itch and POEM all had moderate-to-strong correlations with each other and DLQI, fair-to-moderate correlations with HADS-anxiety and HADS-depression, and inverse correlations with SF-12 mental component score and SF-6D (Pearson correlations, P < 0·001). All scores showed good criterion validity as judged by anova and receiver operator characteristics. PO-SCORAD, PO-SCORAD objective subscore and POEM had similarly good internal consistency (Cronbach's alpha = 0·84, 0·82 and 0·86); the PO-SCORAD subjective subscore was less internally consistent (alpha = 0·57). All scores showed potentially poor cross-cultural validity as demonstrated by uniform and nonuniform differential item functioning by age, sex and/or race/ethnicity for multiple items. There were floor effects for POEM, but not for the other assessments. PO-SCORAD, PO-SCORAD objective and subjective subscores, NRS-itch and POEM appear to be valid for assessing AD severity in clinical practice. What's already known about this topic? Few studies have demonstrated the validity of the atopic dermatitis severity assessments Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD), PO-SCORAD subscores, numerical rating scale (NRS)-itch and Patient-Oriented Eczema Measure (POEM). What does this study add? This study demonstrates that PO-SCORAD, PO-SCORAD subscores, NRS-itch and POEM all had good construct validity in the assessment of atopic dermatitis severity in adults. Only POEM demonstrated floor effects. What are the clinical implications of this work? PO-SCORAD, PO-SCORAD subscores, NRS-itch and POEM all appear to have sufficient validity to be used as assessments of atopic dermatitis severity in clinical practice.

A real-world study evaluating adeQUacy of Existing Systemic Treatments for patients with moderate-to-severe Atopic Dermatitis (QUEST-AD): Baseline treatment patterns and unmet needs assessment

BackgroundSystemic therapies are commonly used for patients with uncontrolled moderate-to-severe atopic dermatitis (AD) and impaired quality of life (QoL). However, real-world treatment patterns and unmet needs of adults with moderate-to-severe AD receiving systemic therapies are poorly quantified. ObjectiveTo evaluate unmet needs in patients with moderate-to-severe AD treated with systemic therapies. MethodsAdults with AD diagnosis in past 5 years and a prescription for systemic treatment or phototherapy in past 6 months were identified from the Optum Research Database. Patients completed a survey about symptoms, treatment, and QoL. Chi-squared and t tests analyzed bivariable comparisons of demographics and outcomes. Spearman's rank-order correlation analyses examined the relationship between frequency of flares and outcomes. ResultsEight hundred and one participants were included (mean age, 45.2 years; 71.8% female). In the 12 months before baseline survey, 38.3% reported no remission from AD. In the month before baseline survey, 63.6% used topical corticosteroids, and 81.3% of patients experienced 1 or more flares. Patients experiencing flares reported worse Patient-Orientated Eczema Measure (POEM), Peak Pruritus Numeric Rating Scale (NRS), and Dermatology Life Quality Index scores (DLQI), lower treatment satisfaction, and greater work productivity loss than patients without flares (all P < .001). Patients with severe atopic dermatitis reported worse POEM, Peak Pruritus NRS, and DLQI, lower treatment satisfaction, and greater work productivity loss than patients with moderate AD (all P < .001). ConclusionDespite receiving systemic therapies, adults with moderate-to-severe AD reported disease symptoms, recurrent flares, and impaired QoL, suggesting unmet therapeutic needs.