To characterize treatment satisfaction and impact of dupilumab on HRQoL from the perspective of Black/African American patients, a population in which clinical study data are limited CONCLUSIONS• In Black/African American adults with moderate-to-severe AD treated with dupilumab, rapid and sustained patient satisfaction was observed • Similarly, signi cant improvement in HRQoL was reported after dupilumab treatment, with clinically meaningful improvement in HRQoL during the study period • Interpretation of the results of this subgroup analysis should account for the small sample size and attrition over the study period

BackgroundDespite high disease burden, systemic treatment options for patients with atopic hand and/or foot dermatitis (H/F AD) are limited.ObjectivesTo evaluate efficacy and safety of dupilumab in H/F AD using specific instruments for assessing disease severity on hands and feet.MethodsIn this multicenter phase 3 trial, adults and adolescents with moderate-to-severe H/F AD were randomized to dupilumab monotherapy (regimen approved for generalized AD), or matched placebo. The primary endpoint was proportion of patients achieving Hand and Foot Investigator's Global Assessment score 0 or 1 at week 16. Secondary prespecified endpoints assessed the severity and extent of signs, symptom intensity (itch, pain), quality of life, and sleep.ResultsA total of 133 patients (adults = 106, adolescents = 27) were randomized to dupilumab (n = 67) or placebo (n = 66). At week 16, significantly more patients receiving dupilumab (n = 27) than placebo (n = 11) achieved Hand and Foot Investigator's Global Assessment score 0 or 1 (40.3% vs 16.7%; P = .003). All other prespecified endpoints were met. Safety was consistent with the known AD dupilumab profile.LimitationsShort-term, 16-week treatment period.ConclusionDupilumab monotherapy resulted in significant improvements across different domains of H/F AD with acceptable safety, supporting dupilumab as a systemic treatment approach for this often difficult to treat condition.

Background Few large-scale international studies have broadly characterized the burden of atopic dermatitis (AD) across age groups among children and adolescents. Objectives To better characterize the AD burden in paediatric patients by disease severity. Methods This cross-sectional, web-based survey of paediatric patients (6 months to < 18 years old) was conducted in 18 countries representing North America, Latin America, Europe, Middle East/Eurasia and East Asia. Patients with diagnosed AD were identified based on the International Study of Asthma and Allergies in Childhood criteria and self-/parent-report of ever being told by a physician that they or their child had eczema. AD severity was assessed using the Patient-Oriented Eczema Measure and Patient Global Assessment. Outcomes included measures of itch, skin pain, sleep, health-related quality of life (HRQoL), missed school days and atopic comorbidities. Results The survey included 1489 children aged 6 months to < 6 years; 2898 children aged 6 to < 12 years; and 3078 adolescents aged 12 to < 18 years diagnosed with AD. Although the burden of mild AD was substantial, paediatric patients with moderate or severe AD had more itch, skin pain, sleep problems and impaired HRQoL, and missed more school days relative to those with mild AD; greater burden was observed among those with severe relative to moderate AD. At least one atopic comorbidity was present in 92.5% of all respondents. Conclusions These results highlight the burden of AD in paediatric patients, especially those with moderate-to-severe disease, and suggest the need for assessments that include the impact of AD on function and daily life.

To evaluate the real-world impact of dupilumab on concomitant AD therapy use from the perspective of Black/African American patients, a population in which clinical study data are limited CONCLUSIONS• In Black/African American adults with moderate-to-severe AD treated with dupilumab, concomitant AD medication use was significantly reduced in a real-world clinical practice setting • Interpretation of the results of this subgroup analysis should account for the small sample size and attrition over the study period

OBJECTIVE• To evaluate the real-world effectiveness of dupilumab on disease control and AD-related symptoms from the perspective of Black/African American patients, a population in which clinical study data are limited CONCLUSIONS• In Black/African American adults with moderate-to-severe AD, treated with dupilumab, significant and rapid improvements in disease control, sleep problems, and skin symptoms were observed • Improvements in disease control and PRO were sustained over the 1-year study period • Interpretation of the results of this subgroup analysis should account for the small sample size and attrition over the study period

Background: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, life-threatening disease caused by chronic dysregulation of the complement system. PNH has a high symptom burden with significant impacts on the life of a patient. The PNH Symptom Questionnaire (PNH-SQ) is a PNH-specific patient-reported outcome (PRO) questionnaire designed to assess daily symptom severity in patients with PNH. The objective of this current study was to evaluate PNH-SQ psychometric properties among patients with PNH from three phase 2 clinical trials with pozelimab monotherapy or in combination with cemdisiran. Methods: PRO data from three phase 2 PNH clinical trials, study 1852 (NCT03946748; pozelimab monotherapy; n=24), study 2092 (NCT04811716; combination therapy; n=24), and study 20105 (NCT04888507; combination therapy; n=6), were used for analysis. The PNH-SQ is a patient-reported daily diary that assesses 10 core symptoms of PNH using a five-point severity scale (none; very mild; mild; moderate; severe; very severe) for fatigue, shortness of breath, muscle weakness, headaches, abdominal pain, pain in back or legs, and chest discomfort, and a five-point difficulty scale (none, not at all, a little bit, somewhat, quite, very) for difficulty sleeping, difficulty thinking clearly, and difficulty swallowing. Prespecified psychometric analyses were performed after study database lock using blinded data. Analyses included quality of completion (ie ePRO prevented item-level missingness) and item responses over time. Reliability and validity of daily assessments with classical test theory (internal consistency and test-retest reliability, construct validity by observing correlations between pairs of PNH-SQ items and of the PNH-SQ daily score with other PRO scores from the EORTC QLQ-C30, FACIT-Fatigue and EQ-5D) and Rasch measurement theory (RMT) analyses were conducted. Test-retest reliability (within stable patients 4 weeks apart) and construct validity of various exploratory methods for aggregating daily scores over time were assessed. Results: Completion rates of PNH-SQ items were higher in studies 20105 and 2092 (at Day 1: 54.2% in 1852 vs 83.3% in 20105 and 91.7% in 2092). Fatigue was consistently the most experienced symptom at baseline of the three studies, while difficulty swallowing was not experienced by any patient. A high proportion of ‘none’ responses were observed across all assessments. Cronbach's alpha calculated using all daily assessments was 0.75, indicating modest reliability. The correlation between each pair of items at Day 1 ranged between 0.11 and 0.93, with the lowest correlations being observed between pain items and sleep/cognitive items, and between abdominal pain and fatigue/dyspnea. At Day 1, PNH-SQ daily score trended higher according to the Patient Global Impression of Severity (PGIS)-symptoms categories and showed moderate correlations in expected direction with fatigue and pain, as assessed by FACIT-Fatigue and EORTC QLQ-C30, and lower correlations with dyspnea and overall health status (EQ-5D visual analog scale). RMT analyses of the daily PNH-SQ data highlighted that for response options “Very mild” for severity/“Not at all” for difficulty did not provide any useful information. RMT also uncovered a meaningful hierarchy of symptoms ranging from fatigue to difficulty swallowing. A fixed 7-day average led to the best test-retest reliability (intraclass correlation coefficient, 0.76). Conclusions: Our analyses documented the PNH-SQ as an instrument to capture symptoms of PNH. The most frequent symptoms reported in our sample using the PNH-SQ, fatigue, dyspnea, and headaches, were aligned with observational study data. The sample of observations from the three trials was strongly skewed towards absence of symptoms, probably reflecting the low symptomatic severity of patients included in the study. Despite this restriction, early supportive data for the scoring of the PNH-SQ from a sample of patients with PNH were obtained, generating useful insights into the function of the response scales, opportunities for the creation of daily assessments of symptom severity, and for the creation of a measure reflecting severity over a longer period, for which a fixed 7-day average appeared as a potential good scoring approach. Generating further evidence, especially in a sample of more symptomatic patients, is recommended to substantiate these results.

Atopic dermatitis (AD) can require long-term therapy. Few real-world studies have evaluated long-term effectiveness from the patients’ perspective. The aim of this study was to evaluate patient-reported outcomes (PROs) during long-term dupilumab treatment. Adults with moderate-to-severe AD who initiated dupilumab through the US manufacturer patient support program and participated in RELIEVE-AD (a prospective patient survey study with a 12-month follow-up) were recontacted 30–36 months post-initiation regardless of current dupilumab use. The online questionnaire consisted of PROs, including the Atopic Dermatitis Control Tool (ADCT), use of concomitant AD therapies, satisfaction with current therapy, global change in itch relative to before dupilumab initiation, non-itch skin symptoms (skin pain/soreness, hot/burning feeling, and sensitivity to touch), flares, Dermatology Life Quality Index, sleep problems, and the AD-specific Work Productivity and Activity Impairment Questionnaire. Of 698 patients who initiated dupilumab (baseline) and were recontacted, 425 completed the 30–36-month survey. Significant reductions from baseline were reported in concomitant AD therapy use (P < 0.05); 54.4

Introduction: Dupilumab is a fully human anti-IL-4Rα monoclonal antibody approved in the US for patients aged ≥6 years with moderate-to-severe AD inadequately controlled by topical therapies. This analysis evaluated the long-term use of concomitant therapy among adult patients treated with dupilumab from RELIEVE-AD, a prospective, longitudinal patient survey conducted in the US. Methods: Adults with moderate-to-severe AD who were prescribed dupilumab but had not yet initiated treatment were recruited to the RELIEVE-AD study from the dupilumab patient support program. Based on a 4-week recall, surveys assessed concomitant AD therapy use, including oral/ injectable steroids, immunosuppressants, and topical medications (steroids, calcineurin inhibitors, crisaborole), at baseline, throughout 1 year after treatment initiation, and at 30-36 months. Results: Of 698 patients completing the baseline survey, 425 (61.0%) responded at Month 30-36. A significant reduction in concomitant AD medication use from baseline was reported across all medication categories assessed: topical use significantly decreased from 81.2% (baseline) to 57.7% (Month 1) and 44.5% (Month 30-36) (both P < .001). Oral steroid use decreased from 30.1% (baseline) to 6.2% (Month 1) and 4.0% (Month 30-36) (both P < .001). Steroid injection treatment decreased from 8.7% (baseline) to 1.7% (Month 1) and 0.9% (Month 30-36) (both P < .001). The proportion of patients reporting no concomitant treatment use significantly increased from 12.8% (baseline) to 39.6% (Month 1) and 54.4% (Month 30-36) (both P < .001). Conclusions: Dupilumab treatment led to a rapid reduction in concomitant medication use that was sustained through 30–36-month follow-up among adults with moderate-to-severe AD.

Clinical trial populations may not reflect clinical practice: knowledge generated in other settings can inform clinical decision-making.To evaluate self-reported disease control and quality of life after initiating dupilumab treatment in patients with atopic dermatitis (AD) in the the clinical setting.This cohort study using an online survey administered prior to (baseline) and at 1, 2, 3, 6, 9, and 12 months after dupilumab initiation included adults with moderate-to-severe AD who initiated treatment with dupilumab through the US patient support program and agreed to participate in the study. Data were collected between January 2018 and January 2020 and the analysis was completed in May 2020.Clinically driven treatment with dupilumab.Disease control measured by the Atopic Dermatitis Control Tool (ADCT); concomitant AD therapies; satisfaction with therapy; skin symptoms (skin pain/soreness, hot/burning feeling, sensitivity to touch) assessed using numerical rating scales; flares; health-related quality of life assessed using the Dermatology Life Quality Index; sleep problems assessed using the ADCT item and a stand-alone question; and the AD-specific Work Productivity and Activity Impairment Questionnaire.Of 699 patients who initiated dupilumab (431 [61.7%] female, 515 [73.7%] White), 632 and 483 completed the survey at months 1 and 12, respectively. As-observed results showed that most patients achieved adequate disease control (ADCT total score) at month 1 with further improvement at month 12 (385 of 632 patients [60.9%] and 374 of 483 [77.4%] for the 2 time points, respectively, vs 41 of 699 [5.3%] at baseline; both P < .001). Use of other AD therapies was reduced at each follow-up vs baseline, including topical and systemic corticosteroids, which were reduced at month 12 to 40.4% (195 of 483 patients) and 6.2% (30 of 483 patients), respectively, from 68.1% (476 of 699) and 34.9% (244 of 699), respectively, at baseline (both P < .001 vs baseline). Patient satisfaction with AD treatment was higher than baseline (120 of 699 [17.7%]) at each follow-up to 85.1% (411 of 483) at month 12 (P < .001). At each follow-up, patients reported reductions in flares, itch, skin symptoms, and improved sleep, health-related quality of life, and daily activities vs baseline. Results were consistent based on observed data and imputed data using pattern mixture models for missing data.Consistent with patient-reported outcomes in clinical trials, this cohort study found that dupilumab treatment was associated with rapid and sustained disease control for up to 12 months as demonstrated by statistically significant improvements relative to baseline on all patient-reported outcomes including treatment satisfaction.

IMPORTANCE:Clinical trial populations may not reflect clinical practice: knowledge generated in other settings can inform clinical decision-making. OBJECTIVE:To evaluate self-reported disease control and quality of life after initiating dupilumab treatment in patients with atopic dermatitis (AD) in the the clinical setting. DESIGN, SETTING, AND PARTICIPANTS:This cohort study using an online survey administered prior to (baseline) and at 1, 2, 3, 6, 9, and 12 months after dupilumab initiation included adults with moderate-to-severe AD who initiated treatment with dupilumab through the US patient support program and agreed to participate in the study. Data were collected between January 2018 and January 2020 and the analysis was completed in May 2020. INTERVENTIONS:Clinically driven treatment with dupilumab. MAIN OUTCOMES AND MEASURES:Disease control measured by the Atopic Dermatitis Control Tool (ADCT); concomitant AD therapies; satisfaction with therapy; skin symptoms (skin pain/soreness, hot/burning feeling, sensitivity to touch) assessed using numerical rating scales; flares; health-related quality of life assessed using the Dermatology Life Quality Index; sleep problems assessed using the ADCT item and a stand-alone question; and the AD-specific Work Productivity and Activity Impairment Questionnaire. RESULTS:Of 699 patients who initiated dupilumab (431 [61.7%] female, 515 [73.7%] White), 632 and 483 completed the survey at months 1 and 12, respectively. As-observed results showed that most patients achieved adequate disease control (ADCT total score) at month 1 with further improvement at month 12 (385 of 632 patients [60.9%] and 374 of 483 [77.4%] for the 2 time points, respectively, vs 41 of 699 [5.3%] at baseline; both P < .001). Use of other AD therapies was reduced at each follow-up vs baseline, including topical and systemic corticosteroids, which were reduced at month 12 to 40.4% (195 of 483 patients) and 6.2% (30 of 483 patients), respectively, from 68.1% (476 of 699) and 34.9% (244 of 699), respectively, at baseline (both P < .001 vs baseline). Patient satisfaction with AD treatment was higher than baseline (120 of 699 [17.7%]) at each follow-up to 85.1% (411 of 483) at month 12 (P < .001). At each follow-up, patients reported reductions in flares, itch, skin symptoms, and improved sleep, health-related quality of life, and daily activities vs baseline. Results were consistent based on observed data and imputed data using pattern mixture models for missing data. CONCLUSIONS AND RELEVANCE:Consistent with patient-reported outcomes in clinical trials, this cohort study found that dupilumab treatment was associated with rapid and sustained disease control for up to 12 months as demonstrated by statistically significant improvements relative to baseline on all patient-reported outcomes including treatment satisfaction.

Itch associated with atopic dermatitis (AD) has a profoundly negative effect on patients of all ages. Therefore, itch is a main target for AD therapeutic approaches, and treatments are perceived as beneficial when they achieve an itch reduction. In the absence of a validated scale for children aged 6–11 years that is suitable for assessing itch intensity in clinical trial settings, the Worst Itch Scale was developed. Qualitative interviews, comprising concept elicitation and cognitive debriefing, were conducted to develop and evaluate the content validity of the Worst Itch Scale. Psychometric assessments used data from the LIBERTY AD PEDS phase 3 trial of dupilumab in patients aged 6–11 years with severe AD. These included test–retest reliability, construct validity, known-groups validity and responsiveness. Thresholds for clinically meaningful change were defined using anchor- and distribution-based methods. The Worst Itch Scale consisted of two items asking about ‘worst itching’ experienced ‘last night’ and ‘today’. Worst Itch Scale scores showed large, positive correlations with existing patient-reported outcome (PRO) measures of itch, and weaker correlations with clinician-reported outcome (ClinRO) measures assessing objective signs of AD. Improvements in Worst Itch Scale scores were highly correlated with improvements in other itch PROs and moderately correlated with improvements in ClinROs. The responder definition based on the primary anchor, a 1-point improvement in the Patient Global Impression of Disease, was 2.84. Supportive anchors produced response estimates ranging from 2.43 to 4.80 points. The Worst Itch Scale is a fit-for-purpose (e.g. well-defined, reliable, responsive and valid) scale for evaluating worst itch intensity in children aged 6–11 years with severe AD. The within-patient threshold for defining a clinically meaningful response was a ≥ 3–4-point change in the Worst Itch Scale score. NCT03345914.

For adolescent patients (aged ≥ 12 to < 18 years) with uncontrolled moderate-to-severe atopic dermatitis (AD), 16 weeks of treatment with dupilumab resulted in substantial clinical benefit compared with placebo, with an acceptable safety profile. However, long-term data on the approved dose regimens of dupilumab in adolescents with AD are lacking. This open-label extension study (LIBERTY AD PED-OLE, NCT02612454) reports the long-term safety, efficacy, and pharmacokinetics of dupilumab in adolescents with moderate-to-severe AD who had participated in dupilumab parent trials. Patients enrolled under the original study protocol received subcutaneous dupilumab according to a weight-based regimen (2 or 4 mg/kg every week). Following protocol amendment, patients were switched to subcutaneous dupilumab 300 mg every 4 weeks (q4w) irrespective of weight, and newly enrolled patients were started on dupilumab 300 mg q4w. Patients with an inadequate clinical response (Investigator’s Global Assessment [IGA] score of 0/1 was not reached) to the q4w regimen could be uptitrated to the approved dupilumab dose regimens of 200 or 300 mg every 2 weeks (body weight < 60 or ≥ 60 kg, respectively). Patients whose IGA score of 0/1 was maintained continuously for a 12-week period after week 40 were discontinued from dupilumab, monitored for relapse, and re-initiated on dupilumab if required. Data for 294 patients (mean age 14.7 years) were analyzed, 102 (34.7%) of whom had completed the 52-week visit at the database lock. The dupilumab long-term safety profile was comparable to that seen in adults and consistent with the known safety profile. Most treatment-emergent adverse events were mild/moderate. By week 52, 42.7% of patients had an IGA score of 0/1 (clear/almost clear), and 93.1%, 81.2%, and 56.4%, respectively, had at least a 50%, 75%, or 90% improvement in Eczema Area and Severity Index (EASI). Most (70.9%) patients required uptitration to the approved dupilumab dose regimen. The proportions of uptitrated patients with an IGA score of 0/1 or 75% improvement in EASI increased over time, reaching 35.7% and 51.9%, respectively, 48 weeks after the first uptitration visit. By week 52, 29.4% of patients had clear/almost clear skin sustained for 12 weeks and had stopped medication; 56.7% relapsed and were subsequently re-initiated on treatment, with a mean time to re-initiation of 17.5 (± standard deviation 17.3) weeks. Consistent with results seen with short-term treatment, long-term treatment with dupilumab showed an acceptable safety profile while providing incremental clinical benefit with continued treatment over time. The high proportion of patients who needed uptitration because of inadequate response to q4w dosing supports the q2w dose regimen as optimal for this age group. Finally, the majority of patients who stopped medication after having clear/almost clear skin sustained over 12 weeks experienced disease recurrence, suggesting the need for continued dupilumab dosing to maintain efficacy. ClinicalTrials.gov Identifiers: NCT02612454, NCT02407756, NCT03054428, and NCT03050151. Atopic dermatitis, or eczema, is a common chronic skin disease that can cause intense and persistent itching and rashes. Atopic dermatitis remains a problem for many adolescent patients, even if they use a number of different treatments. Dupilumab is a newer treatment for atopic dermatitis. In short-term clinical studies, dupilumab improved the disease with acceptable safety. In this study, adolescents with moderate-to-severe atopic dermatitis who had completed one of the short-term studies continued dupilumab treatment for 1 year. The patients started treatment with dupilumab once every 4 weeks. But if their atopic dermatitis did not improve sufficiently, they were given dupilumab every 2 weeks. Through a year of treatment, there were no unexpected side effects. The side effects that did occur were mild or moderate in severity and in most cases did not lead to interruption of treatment. Almost half of the patients achieved skin that was clear or almost clear of atopic dermatitis during the study. But their atopic dermatitis often returned if they stopped being treated, and about half of them needed to start treatment again. Most patients needed to be treated every 2 weeks. The positive effects of dupilumab generally increased the longer patients were treated.

Objective To evaluate the impact of atopic dermatitis on families of pediatric patients. Study design This cross-sectional, web-based survey of children/adolescents (6 months to <18 years old) with atopic dermatitis and their parents and caregivers was conducted in 18 countries encompassing North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Children and adolescents with atopic dermatitis and their parents and caregivers were identified by the International Study of Asthma and Allergies in Childhood criteria and ever being told by a physician that they had "eczema". Atopic dermatitis severity was assessed using the Patient-Oriented Eczema Measure and the Patient Global Assessment. Atopic dermatitis impact on families' lives was evaluated using the Dermatitis Family Impact questionnaire and stand-alone questions on hours of atopic dermatitis-related care (past week) and missed work days (past 4 weeks) owing to their child's atopic dermatitis. Results A total of 7465 pairs of pediatric participants with atopic dermatitis and their parents or caregivers were surveyed. Across age groups, the Dermatitis Family Impact questionnaire total score for all regions ranged from 7.1 to 8.6, 13.2 to 14.9, and 17.0 to 17.2 for Patient-Oriented Eczema Measure mild, moderate, and severe atopic dermatitis, respectively. Subscale scores showed that greater atopic dermatitis severity had a greater impact on all family life domains, including sleep and tiredness. No specific patterns or trends were observed across age groups. Time spent on childcare and missed work days increased with atopic dermatitis severity. Conclusions Across pediatric age groups and geographic regions, greater atopic dermatitis severity was associated with a greater negative impact on physical, emotional, social, and economic components of family life.

While the efficacy of dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) has been demonstrated in several clinical trials, patients in such trials may not necessarily reflect the real-world clinical practice setting. This study evaluated the real-world effectiveness of dupilumab in adults with moderate-to-severe AD based on physician global assessment, percent body surface area affected, and patient-reported itch. From Modernizing Medicine’s Electronic Medical Assistant dermatology-specific electronic medical records, adults (≥ 18 years) were identified with a diagnosis of AD and ≥ 1 dupilumab prescription (index event) between 1 April 2017 and 31 January 2019. Three cohorts were identified based on 3-month pre-index (1) Investigator Global Assessment (IGA) score ≥ 3, (2) an itch severity numerical rating scale (NRS) score ≥ 3, and (3) body surface area (BSA) affected ≥ 10%. Changes from pre-index on the outcome within each cohort were evaluated at 4 months post-index. Patients were also stratified for evaluation of outcomes by baseline demographic (sex, age) and prior AD treatments (topical therapy only or no treatment, any systemic therapy). More than 70% of the 435 AD patients with baseline IGA score ≥ 3 improved to an IGA score of ≤ 2 at month 4 post-dupilumab initiation, including 42.8% who achieved IGA 0/1 (clear/minimal). Among 112 patients with a pre-index itch severity NRS ≥ 3, scores were reduced from mean (SD) 7.0 (2.4) pre-index to 2.8 (2.8) at month 4 (p < 0.0001); 70.5% of patients had a reduction ≥ 3 points. In the BSA cohort (n = 387), affected BSA was significantly reduced from a pre-index mean (SD) of 39.3% (26.1%) to 16.3% (21.2%) at month 4 (p < 0.0001). Significant improvements in IGA, itch NRS, and BSA were observed regardless of demographic (age and sex) or clinical characteristics such as treatment history (all p < 0.0001 compared with pre-index). Consistent with outcomes observed in clinical trials, patients treated with dupilumab in real-world clinical settings achieved clinically meaningful improvements in severity and extent of AD and severity of itch comparable to those reported in clinical trials at a similar time point.

Introduction: This analysis of RELIEVE-AD, a prospective, longitudinal survey in US adults with moderate-to-severe AD, evaluates the long-term impact of dupilumab therapy on patient-reported AD flares, skin symptoms, itch, and sleep.

Introduction: AD is a chronic, systemic inflammatory disease, associated with decreased HRQoL and work productivity. Dupilumab is approved in the US for patients aged ≥6 years with moderate-to-severe AD inadequately controlled by topical therapies. We evaluated the long-term impact of dupilumab on HRQoL and work productivity outcomes among US adult AD patients from the RELIEVE-AD study, a prospective, longitudinal patient survey.

Atopic dermatitis (AD) can have a profound negative impact on the quality of life (QoL) of patients. We analyzed the long-term changes in AD symptoms, QoL, and patient assessment of treatment effect in adults with moderate-to-severe AD treated for 2 years with dupilumab. LIBERTY AD OLE (NCT01949311) is a multicenter, open-label extension (OLE) study in adults with moderate-to-severe AD who previously participated in dupilumab clinical trials (parent studies). Patients received dupilumab 300 mg weekly. Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), EQ-5D-3L, and the Patient Global Assessment of Treatment Effect (PGATE) were assessed at weeks 48 and 100. A total of 2677 patients were included in the OLE, and 1028 completed week 100. By weeks 48 and 100, 94.1% and 95.6% of patients achieved a ≥ 4-point change in POEM from the parent study baseline (PSBL), respectively, and 93.3% and 93.4% of patients had achieved a ≥ 4-point change in DLQI from PSBL, respectively. At week 100, 35.1% of patients had a POEM score ≤ 2 (AD clear/almost clear) compared with 0.1% at PSBL, and 49.9% had a DLQI score of 0 or 1 (no effect at all on patient’s life) compared with 1.5% at PSBL. At week 100, 74.5–97.3% of patients reported no effect of AD on the individual EQ-5D-3L domains, and 93.8% rated the effect of dupilumab treatment as “excellent,” “very good,” or “good” according to PGATE. In adults with moderate-to-severe AD, dupilumab treatment over 2 years resulted in sustained improvements in patient-reported symptoms and QoL and a favorable patient perception of treatment effect. ClinicalTrials.gov Identifier: NCT01949311. Atopic dermatitis is a common skin disease that causes scaly, itchy skin. It can have a profoundly negative effect on a patient’s quality of life (QoL). In short-term clinical trials, dupilumab treatment resulted in significant improvements in signs and symptoms of atopic dermatitis, and in the QoL reported by patients, together with acceptable safety. In this study, adults with moderate-to-severe atopic dermatitis who had completed one of the short-term clinical trials continued dupilumab treatment, including those who had taken placebo. This study allowed researchers to continue to evaluate how dupilumab worked in the long term, including its impact on patient-reported outcomes, which measure the success of treatment from the patient’s own perspective. The results were evaluated at approximately 1 and 2 years of this open-label extension study and were compared with the period just before the patient was first treated with dupilumab so that the effect of dupilumab could be seen. At approximately 1 and 2 years, most patients had achieved clinically meaningful improvements in two measures: Patient Oriented Eczema Measure, a tool used by patients to self-report the severity of their symptoms, and Dermatology Life Quality Index, which allows patients to report the effect of the disease on their QoL. Additionally, in this open-label extension study, most patients described their experience of being treated with dupilumab as “excellent,” “very good,” or “good” using the Patient Global Assessment of Treatment Effect questionnaire. Dupilumab treatment resulted in sustained improvements in atopic dermatitis and was regarded favorably by patients.

Recent information on the prevalence of atopic comorbidities among children with AD is lacking. This worldwide survey describes the burden of atopic comorbidities across AD severity strata. This cross-sectional, web-based survey of children aged 0.5–<18years was conducted in 18 countries (5 regions), with quotas for age, sex, region (urban/rural split), and weighting adjustment applied for representative population for each country. Parents (children ≥12yrs) were asked whether the child had ever suffered from hay fever/asthma or been diagnosed with atopic comorbidities. Results were stratified by parent/patient global assessment (PtGA) of AD severity and POEM in the past week. Among 7465 included children, 92.5% reported ≥1 atopic comorbidity (84.7% in Europe [n=2700]; 87.6% in Asia [n=743]; 88.5% in North America [n=980]; 95.9% in Latin America [n=1959]; 98.1% in Eurasia/Middle-East [n=1083]). Atopic comorbidities tended to increase slightly with increasing age (90.0% with ≥1 comorbidity for 0.5–5yrs; 92.0% for 6–11yrs; 94.1% for 12–<18yrs). Overall, 4478, 2722, and 376 (weighted-base) reported clear/mild, moderate, and severe AD (by PtGA), respectively, in the past week; 90.9%, 94.5%, and 97.5%, respectively, reported ≥1 atopic comorbidity, mostly hay fever (64.4%, 73.5%, 83.3%), asthma (51.0%, 65.5%, 77.9%), seasonal allergies (41.7%, 51.4%, 53.5%), and allergic rhinitis (41.3%, 50.2%, 52.2%). Similar results were observed when stratified by POEM; 13.7% (overall) had chronic rhinosinusitis with nasal polyps and 3.5% had eosinophilic esophagitis. Worldwide, children with AD have a high burden of self-reported atopic comorbidities. The burden was high even among those with clear/mild AD, increasing further with AD severity