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Summary: Background: Chronic pruritus is a clinically heterogeneous symptom that manifests itself with varying duration, intensity, or quality. To date, there is no validated German‐language instrument that systematically assesses the relevant parameters. With the support of the Pruritus Research Working Group (Arbeitsgemeinschaft Pruritusforschung, AGP), a questionnaire for the assessment of chronic pruritus (AGP questionnaire) was developed in 2008. The subsequently revised instrument, now called the German Pruritus Questionnaire, records pruritus‐specific parameters such as localization, course, intensity and quality, anamnestic data on the general state of health, sociodemographic data, quality of life, and coping methods. It is to be validated in the study presented here. Patients and methods: The questionnaire was used in 366 patients with chronic pruritus of different etiologies from Germany (University Hospitals Heidelberg, Münster, Mainz, Erlangen, Giessen, private practice Bad Bentheim, TU Munich, Wiesbaden Kidney Center), Austria (Graz University Hospital) and Switzerland (Aarau Cantonal Hospital). Results: The reliability for repeated completion (retest reliability) with regard to localization, first occurrence, and concomitant diseases showed high values for Cohen's kappa (> 0.8). The data on the retest reliability of the pruritus characteristics showed lower values (< 0.7). With regard to the measurability of practically relevant changes (change sensitivity), medium to strong effect sizes were found (0.09–0.19). A statistically significant differentiation of the pruritus etiologies based on the recorded parameters was not possible. Conclusions: The German Pruritus Questionnaire allows a comprehensive and structured recording of patient‐ and clinician‐reported, relevant dimensions of chronic pruritus of different etiologies. Further adaptation and development are planned. [ABSTRACT FROM AUTHOR]

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The article discusses the results of two phase III clinical trials, ADvocate1 and ADvocate2, which examined the efficacy and safety of lebrikizumab monotherapy in patients with moderate-to-severe atopic dermatitis (AD). The trials found that lebrikizumab significantly improved patient-reported itch and reduced sleep loss due to itch. The improvements in itch and sleep loss were observed as early as the first few days of treatment and were consistent with previous studies on lebrikizumab. The study was funded by Dermira, a subsidiary of Eli Lilly and Company, and medical writing assistance was provided by ProScribe–Envision Pharma Group. [Extracted from the article]

Background Itch is the most burdensome symptom of atopic dermatitis (AD) that severely affects sleep and overall and quality of life.1,2 Rapid control of itch could be instrumental in minimizing disease symptoms and the associated burden for patients.3,4 Nemolizumab, an interleukin-31 (IL-31) alpha antagonist, inhibits the IL-31 pathway of itch and inflammation in AD.5 Objectives To evaluate speed of onset of itch relief and sleep improvements with nemolizumab in moderate-to-severe AD. Methods ARCADIA-1 and ARCADIA-2 were two identical, randomized, double-blinded, placebo-controlled studies. Patients (≥12 years) with moderate-to-severe AD and inadequate response to topical corticosteroids (TCS) were randomized (2:1) to receive nemolizumab 30mg every 4 weeks (60mg baseline loading dose) or matching placebo, both with background TCS of low/medium potency with/without topical calcineurin inhibitors (TCI). Results Significant improvements in itch (least squares [LS] mean±standard error [SE] change from baseline [CFB] in Peak Pruritus Numeric Rating Scale [PP-NRS]) were noted in nemolizumab-treated vs placebo-treated patients by Day 1 in ARCADIA-1 (-0.9±0.08 vs -0.4±0.10) and ARCADIA-2 (-1.1±0.09 vs -0.4±0.12), reaching -2.4±0.08 vs -1.2±0.11 and -2.3 ±0.09 vs -0.9±0.12 respectively at Day 14 (p <0.001 for all). Significantly greater proportions of nemolizumab-treated vs placebo-treated patients achieved ≥4-point improvement in PP-NRS by Day 2 in ARCADIA-1 (9.4% vs 3.4%, p<0.01) and Day 1 in ARCADIA-2 (8.2% vs 1.9%, p<0.001) and through Day 14 (ARCADIA-1: 22.7% vs 10.6%, p<0.0001; ARCADIA-2: 23.4% vs 6.8%, p <0.0001). Conclusions Treatment with nemolizumab plus TCS/TCI resulted in rapid, statistically and clinically significant improvements in itch in moderate-to-severe AD. [ABSTRACT FROM AUTHOR]

Background Atopic dermatitis (AD) is a common, chronic, and flaring itchy inflammatory skin disease requiring long-term treatment. Nemolizumab significantly improved skin lesions, itch, and sleep through Week (W) 16 in two global phase 3 studies (ARCADIA-1 [NCT03985943] and ARCADIA-2 [NCT03989349]) in adolescents and adults with moderate-to-severe AD.1 Introduction/Background To evaluate the efficacy and the safety of maintenance treatment with nemolizumab with background topical therapy for up to 32 weeks in patients (≥12 years) with moderate-to-severe atopic dermatitis Methods This analysis pooled 32-week maintenance data from two double-blind, placebo controlled, phase 3 studies (N =507) in moderate-to-severe AD. Clinical responders (IGA 0/1 [clear/almost-clear] or EASI-75 [75% improvement in EASI score]) to nemolizumab at W16 were re-randomized (1:1:1) to receive nemolizumab 30mg every 4 weeks (Q4W), nemolizumab 30mg Q8W, or placebo (nemolizumab withdrawal) Q4W subcutaneously for further 32 weeks in combination with topical corticosteroids of low/medium potency and/or topical calcineurin inhibitors. Safety was assessed throughout the study. Results At W48, the proportion of patients who maintained IGA success (defined as IGA score of 0 [clear] or 1 [almost clear] and a ≥2-point improvement from baseline) was 61.5% (nemolizumab-Q4W), 60.4% (nemolizumab-Q8W), and 49.7% (placebo); EASI-75 was maintained in 76.3% (nemolizumab-Q4W), 75.7% (nemolizumab-Q8W), and 63.9% (placebo); and itch response (≥4 points improvement in weekly average PPNRS) was achieved in 76.2% (nemolizumab-Q4W), 59.7% (nemolizumab-Q8W), and 41.0% (placebo). Similarly, response in sleep and quality of life was well maintained at W48. The safety profile was consistent across treatment arms; most treatment-emergent adverse events were non-serious and mild/moderate in intensity. Conclusions Among patients with clinical responses in skin lesions at W16, the majority maintained skin and itch responses at W48 with nemolizumab Q4W/Q8W. Nemolizumab was well-tolerated up to W48, and no safety signals were identified. [ABSTRACT FROM AUTHOR]

Background Treatment with nemolizumab plus topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) achieved improvements in itch and sleep (measured using Peak Pruritus Numerical Rating Scale and Sleep Disturbance Numerical Rating Scale) at Week (W) 16 and maintained them up to W48 in patients with moderate-to-severe AD.1,2 Objectives To evaluate the efficacy of nemolizumab in maintaining itch and sleep responses (using SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale [VAS] Pruritus and SCORAD VAS Sleep) over 48 weeks in patients with moderate-to-severe AD. Methods We analyzed 32-week maintenance data pooled from two double-blinded, placebo-controlled, phase 3 studies (ARCADIA-1 and ARCADIA-2). Clinical responders (those achieving IGA 0/1 or EASI-75 at W16) were re-randomized (1:1:1) to receive nemolizumab 30mg every 4 weeks (nemolizumab-Q4W), nemolizumab 30mg every 8 weeks (nemolizumab-Q8W), or placebo Q4W (nemolizumab-withdrawal arm) subcutaneously, all with TCS and/or TCI up to W48. Results At W48, response rates for ≥4-point improvement in SCORAD VAS Pruritus were maintained in nemolizumab-Q4W (72.8%, p <0.0001) and nemolizumab-Q8W (66.9%, p ≤0.001) vs placebo (49.1%) groups. Similarly, response rates for ≥4-point improvement in SCORAD VAS Sleep were maintained in nemolizumab-Q4W (61.5%, p <0.001) and nemolizumab-Q8W (56.2%, p <0.05) vs placebo (43.2%) groups at W48. Response rates for SCORAD VAS Pruritus-75 (≥75% improvement in VAS Pruritus from initial baseline) were also maintained in nemolizumab-Q4W (63.3%, p <0.0001) and nemolizumab-Q8W (58.6%, p <0.0001) vs placebo (37.3%) groups at W48. Similar maintenance of response rates for SCORAD VAS Sleep-75 (≥75% improvement in VAS Sleep from initial baseline) was noted in nemolizumab-Q4W (60.4%, p <0.01) and nemolizumab-Q8W (56.8%, p <0.05) vs placebo (43.8%) groups at W48. Conclusions Treatment with nemolizumab plus TCS/TCI maintained rate of improvements in itch and sleep through W48 in patients who achieved clinical response at W16. The Q8W regimen was similar to Q4W in maintenance of the rate of itch and sleep response. [ABSTRACT FROM AUTHOR]

Summary: Background: Body dysmorphic disorder (BDD) is a common psychiatric disorder associated with high costs for healthcare systems as patients may repeatedly ask for different, often not effective, interventions. BDD symptoms are more prevalent in patients with dermatological conditions than in the general population, but there are no large sample studies comparing the prevalence of BDD symptoms between patients with dermatological conditions and healthy skin controls. Objectives: To compare the prevalence of BDD symptoms between patients with different dermatological conditions and healthy skin controls and to describe sociodemographic, physical and psychological factors associated with BDD symptoms to identify patients who may have a particularly high chance of having this condition. Methods: This observational, cross‐sectional, comparative multicentre study included 8295 participants: 5487 consecutive patients with different skin diseases (56% female) recruited among dermatological outpatients at 22 clinics in 17 European countries, and 2808 healthy skin controls (66% female). BDD symptoms were assessed by the Dysmorphic Concern Questionnaire. Sociodemographic data and information on psychological factors and physical conditions were collected. Each patient was given a dermatological diagnosis according to ICD‐10 by a dermatologist. The study was registered with number DRKS00012745. Results: The average participation rate of invited dermatological patients was 82.4% across all centres. BDD symptoms were five times more prevalent in patients with dermatological conditions than in healthy skin controls (10.5% vs. 2.1%). Patients with hyperhidrosis, alopecia and vitiligo had a more than 11‐fold increased chance (adjusted Odds Ratio (OR) > 11) of having BDD symptoms compared with healthy skin controls, and patients with atopic dermatitis, psoriasis, acne, hidradenitis suppurativa, prurigo and bullous diseases had a more than sixfold increased chance (adjusted OR > 6) of having BDD symptoms. Using a logistic regression model, BDD symptoms were significantly related to lower age, female sex, higher psychological stress and feelings of stigmatization. Conclusions: Clinical BDD symptoms are significantly associated with common dermatological diseases. As such symptoms are associated with higher levels of psychological distress and multiple unhelpful consultations, general practitioners and dermatologists should consider BDD and refer patients when identified to an appropriate service for BDD screening and management. What is already known about this topic?Body dysmorphic disorder (BDD) is a common psychiatric disorder with a prevalence of about 2% in the general population.Skin diseases pose a high psychological burden on patients. People with these problems often experience increased self‐consciousness, skin‐related shame and stigmatization.Single‐centre studies including small samples of patients with skin conditions showed that these patients show symptoms of a similar nature to BDD more often than the general population. What does this study add?In this large multicentre study, BDD symptoms were fivefold more prevalent in dermatological patients than in healthy skin controls, and were related to young age, female sex, psychological stress and stigmatization experience.Certain patient groups (e.g. hyperhidrosis) had a greater than 11‐fold increased chance of BDD symptoms compared with controls.Doctors should consider appearance‐related concern and BDD more often and refer patients when needed to an appropriate service for assessment and treatment. Body dysmorphic disorder (BDD) is a psychiatric condition affecting about 2.5 % of the general population. Patients with this condition are preoccupied with negative thoughts about their own appearance which highly impair their daily functioning. Skin diseases can pose a high psychological burden on patients partly due to visible skin lesions. BDD has been shown to affect dermatological patients quite often, but there are no large studies that include both patients with different dermatological conditions and healthy skin controls. This study included 8295 participants: 5487 patients with different skin diseases (56% female) recruited among dermatological out‐patients at 22 clinics in 17 European countries and 2808 people with healthy skin (66% female). Symptoms of BDD were measured using a self‐report questionnaire. In addition, each patient was given a dermatological diagnosis by a dermatologist. It was shown that BDD symptoms were five times more prevalent in patients with dermatological conditions than in people with healthy skin (10.5% vs. 2.1%). Certain dermatological patients (e.g. with excessive sweating, circular hairloss and white spot disease) had a more than eleven‐fold increased chance of BDD symptoms compared to people with healthy skin. It was also shown that BDD symptoms more often occurred in younger and in female persons, and those experiencing higher psychological stress and feeling stigmatized. As BDD symptoms are so common in dermatological patients, general practitioners and dermatologists should consider both BDD and appearance related distress and refer patients when identified to an appropriate service for further assessment and management. Linked Comment: P. Magin and K. Fisher. Br J Dermatol 2022; 187:5. Plain language summary available online [ABSTRACT FROM AUTHOR]