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Effect of Cetaphil RestoraDerm skin care regimen on sleep quality in pediatric patients with atopic dermatitis: A pilot study
2903
3690
Effect of Cetaphil RestoraDerm skin care regimen on sleep quality in pediatric patients with atopic dermatitis: A pilot study W. David Brown, PhD, UT Southwestern Medical School, Dallas, TX, United States; Peter Lio, MD, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Hanh Pham, MS, Galderma Laboratories, LP, Fort Worth, TX, United States; Staci Brandt, PA, MBA, Galderma Spirig AG, Egerkingen, Switzerland; Patricia Meuse, PhD, Galderma Laboratories, LP, Fort Worth, TX, United States; Matthew Meckfessel, PhD, Galderma Laboratories, LP, Fort Worth, TX, United States
IL-4 and IL-13 inhibition in atopic dermatitis, a review Matthew Matsunaga, MS, University of Minnesota Medical School, Minneapolis, MN, United States; Paul Yamauchi, MD, PhD, David Geffen School of Medicine at UCLA, Dermatology Institute and Skin Care Center, Santa Monica, CA, United States
Pediatric atopic dermatitis (AD) is a chronic skin condition characterized by xerosis, pruritic outbreaks and eczematous lesions, which can lead to sleep disturbances that affect quality of life and family dynamics. A pilot study was conducted to evaluate the effect of a skincare regimen, specifically formulated for AD (Cetaphil RestoraDerm Body Wash [CRW] and Moisturizer [CRM]), on quality of sleep and signs/symptoms of AD. Pediatric subjects with AD and their caregivers wore an actigraphy device for 3 weeks to assess sleep patterns. Baseline sleep patterns in the absence of CRW and CRM were measured for the first week. On day 8, the skin care regimen was initiated for 14 days consisting of body wash used as needed, and twicedaily use of the moisturizer. Evaluation of skin dryness, pruritus, and assessment of quality of life using the ‘‘Dermatitis Family Impact’’ (DFI) questionnaire were made on days 1, 8, and 23. Actigraphy data indicated a trend toward improved sleep quality in pediatric subjects. Interestingly, caregiver data did not follow the same trend, and tended to slightly decrease in sleep quality. Pediatric skin dryness and pruritus was improved at day 23, relative to baseline. Although sleep patterns did not show any strong trends, DFI responses indicated improved quality of life at the end of the study. The results of this pilot study suggest that a skincare regimen of CRW and CRM may improve sleep quality in pediatric AD subjects and improve family-related dynamics, however further studies are necessary to validate this trend.
Atopic dermatitis (AD) is a chronic, prevalent, multifactorial condition that affects infants, children, and adults. Beyond topical therapy, a variety of systemic agents such as steroids, methotrexate, cyclosporine, azathioprine, mycophenolic acid, and other agents are utilized to treat moderate to severe AD. However, these agents are associated with potential serious adverse events and organ toxicity. There is an unmet need for a safer, long-term systemic agent to adequately control moderate to severe AD. The role of the Th2 cytokines, IL-4 and IL-13 in AD has led to the development of biologic agents to treat AD. The aim of this poster is to review the role of IL-4 and IL-13 in the pathogenesis of AD and to discuss some of the clinical trial data that target and inhibit IL-4 and IL-13 to positively alter the course and outcome of AD. Commercial support: None identified.
Supported by Galderma Laboratories, LP.
2875 High-resolution actigraphy and advanced signal processing objectively quantifies nocturnal scratching events in patients with atopic dermatitis Timothy Almazan, MD, Science 37, Inc, Los Angeles, CA, United States; Noah Craft, MD, PhD, Science 37, Inc, Los Angeles, CA, United States; Juan Torres, UCLA School of Medicine, Los Angeles, CA, United States; Katy Preciado, MPH, Science 37, Inc, Los Angeles, CA, United States; Marie Crisel Erfe, MD, LA Biomedical Research Institute, Torrance, CA, United States; Samantha Eells, MPH, PhD, Science 37, Inc, Los Angeles, CA, United States; Barry Peterson, PhD, Philips Respironics, Bend, OR, United States; Arnaud Moreau, MS, Philips Respironics, Bend, OR, United States; Peter Anderer, PhD, Philips Respironics, Bend, OR, United States; Andreas Cerny, MS, Philips Respironics, Bend, OR, United States Background: Atopic dermatitis is a chronic inflammatory skin condition affecting both children and adults and is associated with pruritus. A method for objectively quantifying nocturnal scratching events could aid in the development of therapies for atopic dermatitis and other pruritic disorders. Objective: To assess the accuracy of an objective, noninvasive method to quantify nocturnal scratching events in patients with atopic dermatitis using high-resolution actigraphy. Methods: Nine adults who fulfilled Hanifin/Rajka diagnostic criteria for atopic dermatitis, and three healthy adults were enrolled in the study. High-resolution actigraphy devices were placed on both wrists and worn for one night at home and during one night in a sleep lab that included video recording. Time, duration, and intensity of scratching events were recorded by a trained medical observer watching the video. The subjects also completed scratching questionnaires in the morning. The actigraphy devices captured three-dimensional acceleration data 100 times per second. A combined neural networks and features analysis algorithm was used to distinguish scratching episodes from all other movements using data acquired by the device. Algorithm-detected scratching data was then compared to scratching data obtained visually from video recordings. Results: Total nighttime scratching events detected by the wrist-worn actigraphy device data had a correlation of 0.96 (P \.001) when compared to total nighttime scratching events determined by scoring the videos. Among the subjective assessments, the visual analog scale provided the closest correlation with the video scoring but it was not very strong (r ¼ 0.77, P \.01). The number of scratching events during the home night also correlated well with the number measured during the sleep lab night (r ¼ 0.90, P \.001). Conclusion: In this initial study, nocturnal scratching determined by high-resolution and advanced signal processing strongly correlated with scratching episodes identified visually. Additional data is needed to confirm the validity of this approach. The ease of actigraphy use in a home setting makes it a potentially useful tool in the management of atopic dermatitis, and in clinical trials to evaluate new therapies for atopic dermatitis. Supported by Philips Respironics.
MAY 2016
2818 Impact of atopic dermatitis on patient self-reported quality of life, productivity loss, and activity impairment: An analysis using the National Health and Wellness Survey Laurent Eckert, Sanofi Aventis Recherche Developpement, Chilly-Mazarin, France; Shaloo Gupta, Kantar Health, Princeton, NJ, United States; Caroline Amand, Sanofi Aventis Recherche Developpement, Chilly-Mazarin, France; Abhijit Gadkari, Regeneron Pharmaceuticals Inc, Tarrytown, NY, United States; Sunny Mahajan, Sanofi, Bridgewater, NJ, United States Atopic dermatitis (AD) is an immune-mediated inflammatory skin disease associated with chronic, severe itch and poor quality of life (QoL). This study characterized the self-reported impact of AD on QoL, work productivity, and daily activities in an adult US population. Data were obtained from the 2013 US National Health and Wellness Survey (NHWS), a large general population survey. Adults ($18 years) who selfreported a diagnosis of AD and experienced symptoms in the past 12 months were propensity-score matched (1:2) to non-AD controls based on age, gender, ethnicity, education, income, insurance status, alcohol consumption, exercise behavior, and Charlson Comorbidity Index (CCI). QoL (past 4 weeks) and work productivity/daily activities (past 7 days) were evaluated using the 36-Item Short Form Health Survey (SF-36v2), and the Work Productivity and Activity Impairment (WPAI) questionnaire, respectively. The SF-36v2 was used to derive SF-6D health utility scores. Mood and sleep disorders were compared as they are not included in CCI. Outcomes were also stratified by self-reported AD severity (mild, moderate/severe). Chi-square and ttests compared differences between AD and non-AD patients, and between AD severity strata. A total of 349 AD patients were matched to 698 controls; overall, mean age was 46.1 yrs, 68.3% female, and 66.8% white. Relative to controls, AD patients reported reduced QoL on the SF-36v2 Physical Component (PCS; 47.6 vs 49.5; P ¼ .004) and Mental Component (44.5 vs 48.0; P \ .001) summary scores; SF-6D health utility scores were significantly lower in AD patients (0.67 vs 0.72; P \ .001). Employed AD patients (n ¼ 195) reported significantly greater overall percent impairment at work than employed controls (n ¼ 408; 21.1% vs 16.1%; P ¼.027) and all AD patients reported greater impairment in daily activities (33.6% vs 25.2%; P \.001). Relative to controls, significantly higher proportions of AD patients self-reported a diagnosis of depression (31.2% vs 17.3%), anxiety (29.8% vs 16.1%), and sleep disorders (33.2% vs 19.2%); all P \.001. Within the AD cohort, patients who reported moderate/severe disease reported significantly worse PCS and utility scores and greater activity impairment relative to mild AD; all P \.05. In summary, AD patients reported worse QoL and greater impairment in work and daily activities compared with matched non-AD patients; these burdens were generally greater in patients with moderate/severe AD relative to mild disease. Editorial support for the preparation of this abstract was provided by E. Jay Bienen, PhD, funded by Sanofi and Regeneron Pharmaceuticals Inc.; submission support was provided by Excerpta Medica funded by Sanofi and Regeneron Pharmaceuticals Inc.
J AM ACAD DERMATOL
AB87
3690
Effect of Cetaphil RestoraDerm skin care regimen on sleep quality in pediatric patients with atopic dermatitis: A pilot study W. David Brown, PhD, UT Southwestern Medical School, Dallas, TX, United States; Peter Lio, MD, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Hanh Pham, MS, Galderma Laboratories, LP, Fort Worth, TX, United States; Staci Brandt, PA, MBA, Galderma Spirig AG, Egerkingen, Switzerland; Patricia Meuse, PhD, Galderma Laboratories, LP, Fort Worth, TX, United States; Matthew Meckfessel, PhD, Galderma Laboratories, LP, Fort Worth, TX, United States
IL-4 and IL-13 inhibition in atopic dermatitis, a review Matthew Matsunaga, MS, University of Minnesota Medical School, Minneapolis, MN, United States; Paul Yamauchi, MD, PhD, David Geffen School of Medicine at UCLA, Dermatology Institute and Skin Care Center, Santa Monica, CA, United States
Pediatric atopic dermatitis (AD) is a chronic skin condition characterized by xerosis, pruritic outbreaks and eczematous lesions, which can lead to sleep disturbances that affect quality of life and family dynamics. A pilot study was conducted to evaluate the effect of a skincare regimen, specifically formulated for AD (Cetaphil RestoraDerm Body Wash [CRW] and Moisturizer [CRM]), on quality of sleep and signs/symptoms of AD. Pediatric subjects with AD and their caregivers wore an actigraphy device for 3 weeks to assess sleep patterns. Baseline sleep patterns in the absence of CRW and CRM were measured for the first week. On day 8, the skin care regimen was initiated for 14 days consisting of body wash used as needed, and twicedaily use of the moisturizer. Evaluation of skin dryness, pruritus, and assessment of quality of life using the ‘‘Dermatitis Family Impact’’ (DFI) questionnaire were made on days 1, 8, and 23. Actigraphy data indicated a trend toward improved sleep quality in pediatric subjects. Interestingly, caregiver data did not follow the same trend, and tended to slightly decrease in sleep quality. Pediatric skin dryness and pruritus was improved at day 23, relative to baseline. Although sleep patterns did not show any strong trends, DFI responses indicated improved quality of life at the end of the study. The results of this pilot study suggest that a skincare regimen of CRW and CRM may improve sleep quality in pediatric AD subjects and improve family-related dynamics, however further studies are necessary to validate this trend.
Atopic dermatitis (AD) is a chronic, prevalent, multifactorial condition that affects infants, children, and adults. Beyond topical therapy, a variety of systemic agents such as steroids, methotrexate, cyclosporine, azathioprine, mycophenolic acid, and other agents are utilized to treat moderate to severe AD. However, these agents are associated with potential serious adverse events and organ toxicity. There is an unmet need for a safer, long-term systemic agent to adequately control moderate to severe AD. The role of the Th2 cytokines, IL-4 and IL-13 in AD has led to the development of biologic agents to treat AD. The aim of this poster is to review the role of IL-4 and IL-13 in the pathogenesis of AD and to discuss some of the clinical trial data that target and inhibit IL-4 and IL-13 to positively alter the course and outcome of AD. Commercial support: None identified.
Supported by Galderma Laboratories, LP.
2875 High-resolution actigraphy and advanced signal processing objectively quantifies nocturnal scratching events in patients with atopic dermatitis Timothy Almazan, MD, Science 37, Inc, Los Angeles, CA, United States; Noah Craft, MD, PhD, Science 37, Inc, Los Angeles, CA, United States; Juan Torres, UCLA School of Medicine, Los Angeles, CA, United States; Katy Preciado, MPH, Science 37, Inc, Los Angeles, CA, United States; Marie Crisel Erfe, MD, LA Biomedical Research Institute, Torrance, CA, United States; Samantha Eells, MPH, PhD, Science 37, Inc, Los Angeles, CA, United States; Barry Peterson, PhD, Philips Respironics, Bend, OR, United States; Arnaud Moreau, MS, Philips Respironics, Bend, OR, United States; Peter Anderer, PhD, Philips Respironics, Bend, OR, United States; Andreas Cerny, MS, Philips Respironics, Bend, OR, United States Background: Atopic dermatitis is a chronic inflammatory skin condition affecting both children and adults and is associated with pruritus. A method for objectively quantifying nocturnal scratching events could aid in the development of therapies for atopic dermatitis and other pruritic disorders. Objective: To assess the accuracy of an objective, noninvasive method to quantify nocturnal scratching events in patients with atopic dermatitis using high-resolution actigraphy. Methods: Nine adults who fulfilled Hanifin/Rajka diagnostic criteria for atopic dermatitis, and three healthy adults were enrolled in the study. High-resolution actigraphy devices were placed on both wrists and worn for one night at home and during one night in a sleep lab that included video recording. Time, duration, and intensity of scratching events were recorded by a trained medical observer watching the video. The subjects also completed scratching questionnaires in the morning. The actigraphy devices captured three-dimensional acceleration data 100 times per second. A combined neural networks and features analysis algorithm was used to distinguish scratching episodes from all other movements using data acquired by the device. Algorithm-detected scratching data was then compared to scratching data obtained visually from video recordings. Results: Total nighttime scratching events detected by the wrist-worn actigraphy device data had a correlation of 0.96 (P \.001) when compared to total nighttime scratching events determined by scoring the videos. Among the subjective assessments, the visual analog scale provided the closest correlation with the video scoring but it was not very strong (r ¼ 0.77, P \.01). The number of scratching events during the home night also correlated well with the number measured during the sleep lab night (r ¼ 0.90, P \.001). Conclusion: In this initial study, nocturnal scratching determined by high-resolution and advanced signal processing strongly correlated with scratching episodes identified visually. Additional data is needed to confirm the validity of this approach. The ease of actigraphy use in a home setting makes it a potentially useful tool in the management of atopic dermatitis, and in clinical trials to evaluate new therapies for atopic dermatitis. Supported by Philips Respironics.
MAY 2016
2818 Impact of atopic dermatitis on patient self-reported quality of life, productivity loss, and activity impairment: An analysis using the National Health and Wellness Survey Laurent Eckert, Sanofi Aventis Recherche Developpement, Chilly-Mazarin, France; Shaloo Gupta, Kantar Health, Princeton, NJ, United States; Caroline Amand, Sanofi Aventis Recherche Developpement, Chilly-Mazarin, France; Abhijit Gadkari, Regeneron Pharmaceuticals Inc, Tarrytown, NY, United States; Sunny Mahajan, Sanofi, Bridgewater, NJ, United States Atopic dermatitis (AD) is an immune-mediated inflammatory skin disease associated with chronic, severe itch and poor quality of life (QoL). This study characterized the self-reported impact of AD on QoL, work productivity, and daily activities in an adult US population. Data were obtained from the 2013 US National Health and Wellness Survey (NHWS), a large general population survey. Adults ($18 years) who selfreported a diagnosis of AD and experienced symptoms in the past 12 months were propensity-score matched (1:2) to non-AD controls based on age, gender, ethnicity, education, income, insurance status, alcohol consumption, exercise behavior, and Charlson Comorbidity Index (CCI). QoL (past 4 weeks) and work productivity/daily activities (past 7 days) were evaluated using the 36-Item Short Form Health Survey (SF-36v2), and the Work Productivity and Activity Impairment (WPAI) questionnaire, respectively. The SF-36v2 was used to derive SF-6D health utility scores. Mood and sleep disorders were compared as they are not included in CCI. Outcomes were also stratified by self-reported AD severity (mild, moderate/severe). Chi-square and ttests compared differences between AD and non-AD patients, and between AD severity strata. A total of 349 AD patients were matched to 698 controls; overall, mean age was 46.1 yrs, 68.3% female, and 66.8% white. Relative to controls, AD patients reported reduced QoL on the SF-36v2 Physical Component (PCS; 47.6 vs 49.5; P ¼ .004) and Mental Component (44.5 vs 48.0; P \ .001) summary scores; SF-6D health utility scores were significantly lower in AD patients (0.67 vs 0.72; P \ .001). Employed AD patients (n ¼ 195) reported significantly greater overall percent impairment at work than employed controls (n ¼ 408; 21.1% vs 16.1%; P ¼.027) and all AD patients reported greater impairment in daily activities (33.6% vs 25.2%; P \.001). Relative to controls, significantly higher proportions of AD patients self-reported a diagnosis of depression (31.2% vs 17.3%), anxiety (29.8% vs 16.1%), and sleep disorders (33.2% vs 19.2%); all P \.001. Within the AD cohort, patients who reported moderate/severe disease reported significantly worse PCS and utility scores and greater activity impairment relative to mild AD; all P \.05. In summary, AD patients reported worse QoL and greater impairment in work and daily activities compared with matched non-AD patients; these burdens were generally greater in patients with moderate/severe AD relative to mild disease. Editorial support for the preparation of this abstract was provided by E. Jay Bienen, PhD, funded by Sanofi and Regeneron Pharmaceuticals Inc.; submission support was provided by Excerpta Medica funded by Sanofi and Regeneron Pharmaceuticals Inc.
J AM ACAD DERMATOL
AB87