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Current trends in the use of disease severity and quality of life measures for atopic dermatitis: A systematic review
3831 Creation and evaluation of a topical steroid therapy educational video for atopic dermatitis Gordon Bae, Harvard Medical School, Boston, MA, United States; Vinod Nambudiri, MD, MBA, Brigham and Women’s Hospital, Boston, MA, United States; Lilit Garibyan, MD, PhD, Massachusetts General Hospital, Boston, MA, United States; Susan Huang, MD, Beth Israel Deaconess Medical Center, Boston, MA, United States Introduction: Educational interventions in atopic dermatitis (AD) such as live sessions and videos may lead to improvements in disease severity, quality of life, and treatment adherence. Topical steroid application causes anxiety for patients and providers due to nonadherence and fear of side effects. We constructed and evaluated the efficacy of a video on proper topical steroid use for AD. Methods: A high-definition video on topical steroid use for AD was created with the National Eczema Association’s (NEA) Scientific Advisory Board. Content included application method, side effects, formulations, and steroid mechanisms. The video was placed on NEA websites and advertised to eczema patients and their caretakers. Viewers completed pre- and postvideo surveys on basic eczema knowledge, topical steroids, video content, and demographics. Pre- and postvideo knowledge and satisfaction were assessed using two-sample Z tests. Results: 412 viewers completed the survey; 71% were female and 76% had eczema. 73% were between ages 25-54 and most had post graduate education. 32% had ‘‘no knowledge’’ of topical steroid therapy, 58% were ‘‘somewhat knowledgeable’’ and 8% were ‘‘very knowledgeable’’ at baseline. Topical steroid therapy knowledge significantly improved after the video for questions of ‘‘steroids should be applied to rashy and normal appearing skin’’ and ‘‘applied/topical steroids have fewer side effects than steroids taken by mouth’’ (P \ .05 for both). Nonsignificant improvement was noted regarding ‘‘steroids reduce itch and redness in eczema,’’ ‘‘steroid should be used indefinitely for eczema,’’ and ‘‘steroids are only available in cream and ointment form.’’ Subgroup analyses based on having eczema, having seen a healthcare professional, caring for someone with eczema, gender, age, knowledge of eczema, and education did not show a significant trends. Pre-video, 18% were ‘‘not comfortable,’’ 57% were ‘‘somewhat comfortable,’’ and 24% were ‘‘very comfortable.’’ Postvideo, the proportions changed to 5%, 40%, and 54% respectively. 93% would recommend the video to others; 80% wished for another video.
scores (51.7% vs 40.6%, P ¼.005; 48.5 vs 29.7%, P\.001). Patients achieved success in ISGA earlier when treated with crisaborole than V (P \.001). Treatment-related adverse events (AE) were mostly mild and included application site pain (pooled data, crisaborole vs V: 4.4% vs 1.2%) and upper respiratory tract infections (3.0% vs 3.0%). Discontinuation rates due to AEs were 1.2% for both crisaborole and V. Conclusion: Crisaborole topical ointment 2% demonstrated favorable efficacy and safety in patients as young as 2 years old with mild to moderate AD in 2 large Phase 3 studies. Crisaborole may represent a safe and efficacious treatment for AD in children and adults. Anacor Pharmaceuticals has provided editorial and printing support.
Discussion: Our study shows the positive impact of online video education on patient comfort and knowledge of topical steroid use for AD. The video created a significant difference in patient comfort with topical steroids. Content learning may be related to the time spent on each topic. Similar videos targeting young adults for further AD educational initiatives are warranted. Commercial support: None identified.
2476 3519 Crisaborole topical ointment, 2%: A novel, nonsteroidal, topical antiinflammatory, phosphodiesterase 4 inhibitor: Results from two phase 3 studies treating children and adult patients with mild to moderate atopic dermatitis Amy Paller, MS, MD, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Wynnis Tom, MD, University of California, San Diego and Rady Children’s Hospital, San Diego, CA, United States; Mark M. Lebwohl, MD, Mount Sinai Health System, New York, NY, United States; Robin L. Blumenthal, PhD, Anacor Pharmaceuticals, Palo Alto, CA, United States; Mark Boguniewicz, MD, National Jewish Health, Denver, CO, United States; Lawrence S. Eichenfield, MD, University of California, San Diego, San Diego, CA, United States; Douglass W. Forsha, MD, South Valley Dermatology, West Jordan, UT, United States; Eric L. Simpson, MD, Oregon Health and Science University, Portland, OR, United States; Linda Stein Gold, MD, Henry Ford Hospital, Detroit, MI, United States; Andrea L. Zaenglein, MD, Pennsylvania State University and Milton S. Hershey Medical Center, Hershey, PA, United States; R. S. Call, Clinical Research Partners, Richmond, VA, United States; W. C. Rees, PI-Coor Clinical Research, Burke, VA, United States; L. T. Zane, Anacor Pharmaceuticals, Inc, Palo Alto, CA, United States; A. A. Hebert, University of Texas Health Science Center Houston, Houston, TX, United States Objective: To evaluate the efficacy and safety of crisaborole topical ointment 2% in children and adults with mild to moderate atopic dermatitis (AD) in 2 phase 3 clinical studies (NCT02118766; NCT02118792). Background: AD is an inflammatory skin disease affecting children and adults, and up to 90% of patients present with mild to moderate AD. Crisaborole topical ointment 2% (Anacor Pharmaceuticals, Palo Alto, CA), is an investigational nonsteroidal, topical, antiinflammatory inhibitor of phosphodiesterase 4. Method: Patients $2 years old with mild to moderate AD affecting $5% of body surface area (BSA) were enrolled in 2 multicenter, double-blind, vehicle (V)-controlled studies of identical design. Patients were randomized 2:1 to receive crisaborole or V twice daily for 28 days and evaluated on days 8, 15, 22, and 29. The primary endpoint defined success in the Investigator’s Static Global Assessment (ISGA) as ‘‘clear/0’’or ‘‘almost clear/1’’ with $2-grade improvement from baseline at day 29. Secondary endpoints measured the percentage of patients achieving ‘‘clear/0’’ or ‘‘almost clear/1’’ on ISGA and time to success in ISGA. Results: Studies 1 and 2 enrolled 503:256 and 513:250 patients crisaborole:V, respectively. There were no significant differences in key baseline characteristics across all groups/studies (pooled data: mean age ;12 years, mean BSA ;18%, ISGA ;60% ‘‘moderate/3’’ and 40% ‘‘mild/2’’). More patients achieved success in ISGA with crisaborole than V at day 29 (study 1: 32.8% vs 25.4%, P ¼.038; study 2: 31.4% vs 18.0%, P \.001), with a greater percentage of ‘‘clear/0’’ or ‘‘almost clear/1’’ ISGA
AB86
J AM ACAD DERMATOL
Current trends in the use of disease severity and quality of life measures for atopic dermatitis: A systematic review Mary K. Hill, University of Colorado School of Medicine, Aurora, CO, United States; Azin Kheirandish Pishkenari, University of Colorado School of Medicine, Aurora, CO, United States; April W. Armstrong, MD, MPH, University of Colorado Anschutz Medical Campus, Aurora, CO, United States; Cory A. Dunnick, MD, University of Colorado Anschutz Medical Campus, Aurora, CO, United States Background: Over the past two decades, there has been a proliferation of available instruments for quantifying atopic dermatitis (AD) outcomes. Rehal and Armstrong identified by systematic review a total of 14 quality of life (QoL) indices and 20 disease severity scales used in 382 randomized controlled trials (RCTs) on AD treatment between 1985 and July 2010. To our knowledge, no systematic review has assessed trends in the use of outcome measures by AD studies published since July 2010. Objective: The purpose of this study was to systematically review the use of QoL and disease severity outcomes instruments in RCTs on AD between July 2010 and July 2015. Methods: Studies were identified through Scopus and Ovid MEDLINE using variations of the terms ‘‘atopic dermatitis,’’ ‘‘randomized controlled trial,’’ ‘‘quality of life,’’ and ‘‘severity of illness index.’’ A total of 540 nonduplicate records were identified. Studies were excluded if they were published prior to July 2010 (n ¼ 53), not RCTs (n ¼ 195), not on AD (n ¼ 58), not on humans (n ¼ 39), not in English (n ¼ 16), and if they did not report QoL and/or disease severity outcome measures (n ¼ 43). Results: All of the 136 included studies assessed disease severity, while only 46 studies reported QoL outcomes. Sixty-seven included studies used more than one disease severity scale, and fifteen studies used more than one QoL measure. A total of 61 disease severity scales and 29 QoL measures were identified. The most frequently used disease severity scale was the Scoring Atopic Dermatitis tool (n ¼ 79; 58%), followed by the Visual Analogue Scale for pruritus (n ¼ 30; 22%) and the Investigator’s Global Assessment scale (n ¼ 30; 22%). The most common QoL instrument, the Dermatology Life Quality Index, was used in 20 RCTs (15%), whereas the next most common measure, the Infant’s Dermatology Quality of Life Index, was used in only eight RCTs (6%). Forty-four of the identified disease severity scales and 23 identified QoL instruments were used only once. Conclusion: The number of different QoL and disease severity scales used in AD studies has grown since 2010. This systematic review highlights the increasing heterogeneity of reported outcomes in AD research. Knowledge of such trends in utilized outcomes instruments offers insight into the field’s quality of research evidence. Commercial support: None identified.
MAY 2016
scores (51.7% vs 40.6%, P ¼.005; 48.5 vs 29.7%, P\.001). Patients achieved success in ISGA earlier when treated with crisaborole than V (P \.001). Treatment-related adverse events (AE) were mostly mild and included application site pain (pooled data, crisaborole vs V: 4.4% vs 1.2%) and upper respiratory tract infections (3.0% vs 3.0%). Discontinuation rates due to AEs were 1.2% for both crisaborole and V. Conclusion: Crisaborole topical ointment 2% demonstrated favorable efficacy and safety in patients as young as 2 years old with mild to moderate AD in 2 large Phase 3 studies. Crisaborole may represent a safe and efficacious treatment for AD in children and adults. Anacor Pharmaceuticals has provided editorial and printing support.
Discussion: Our study shows the positive impact of online video education on patient comfort and knowledge of topical steroid use for AD. The video created a significant difference in patient comfort with topical steroids. Content learning may be related to the time spent on each topic. Similar videos targeting young adults for further AD educational initiatives are warranted. Commercial support: None identified.
2476 3519 Crisaborole topical ointment, 2%: A novel, nonsteroidal, topical antiinflammatory, phosphodiesterase 4 inhibitor: Results from two phase 3 studies treating children and adult patients with mild to moderate atopic dermatitis Amy Paller, MS, MD, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Wynnis Tom, MD, University of California, San Diego and Rady Children’s Hospital, San Diego, CA, United States; Mark M. Lebwohl, MD, Mount Sinai Health System, New York, NY, United States; Robin L. Blumenthal, PhD, Anacor Pharmaceuticals, Palo Alto, CA, United States; Mark Boguniewicz, MD, National Jewish Health, Denver, CO, United States; Lawrence S. Eichenfield, MD, University of California, San Diego, San Diego, CA, United States; Douglass W. Forsha, MD, South Valley Dermatology, West Jordan, UT, United States; Eric L. Simpson, MD, Oregon Health and Science University, Portland, OR, United States; Linda Stein Gold, MD, Henry Ford Hospital, Detroit, MI, United States; Andrea L. Zaenglein, MD, Pennsylvania State University and Milton S. Hershey Medical Center, Hershey, PA, United States; R. S. Call, Clinical Research Partners, Richmond, VA, United States; W. C. Rees, PI-Coor Clinical Research, Burke, VA, United States; L. T. Zane, Anacor Pharmaceuticals, Inc, Palo Alto, CA, United States; A. A. Hebert, University of Texas Health Science Center Houston, Houston, TX, United States Objective: To evaluate the efficacy and safety of crisaborole topical ointment 2% in children and adults with mild to moderate atopic dermatitis (AD) in 2 phase 3 clinical studies (NCT02118766; NCT02118792). Background: AD is an inflammatory skin disease affecting children and adults, and up to 90% of patients present with mild to moderate AD. Crisaborole topical ointment 2% (Anacor Pharmaceuticals, Palo Alto, CA), is an investigational nonsteroidal, topical, antiinflammatory inhibitor of phosphodiesterase 4. Method: Patients $2 years old with mild to moderate AD affecting $5% of body surface area (BSA) were enrolled in 2 multicenter, double-blind, vehicle (V)-controlled studies of identical design. Patients were randomized 2:1 to receive crisaborole or V twice daily for 28 days and evaluated on days 8, 15, 22, and 29. The primary endpoint defined success in the Investigator’s Static Global Assessment (ISGA) as ‘‘clear/0’’or ‘‘almost clear/1’’ with $2-grade improvement from baseline at day 29. Secondary endpoints measured the percentage of patients achieving ‘‘clear/0’’ or ‘‘almost clear/1’’ on ISGA and time to success in ISGA. Results: Studies 1 and 2 enrolled 503:256 and 513:250 patients crisaborole:V, respectively. There were no significant differences in key baseline characteristics across all groups/studies (pooled data: mean age ;12 years, mean BSA ;18%, ISGA ;60% ‘‘moderate/3’’ and 40% ‘‘mild/2’’). More patients achieved success in ISGA with crisaborole than V at day 29 (study 1: 32.8% vs 25.4%, P ¼.038; study 2: 31.4% vs 18.0%, P \.001), with a greater percentage of ‘‘clear/0’’ or ‘‘almost clear/1’’ ISGA
AB86
J AM ACAD DERMATOL
Current trends in the use of disease severity and quality of life measures for atopic dermatitis: A systematic review Mary K. Hill, University of Colorado School of Medicine, Aurora, CO, United States; Azin Kheirandish Pishkenari, University of Colorado School of Medicine, Aurora, CO, United States; April W. Armstrong, MD, MPH, University of Colorado Anschutz Medical Campus, Aurora, CO, United States; Cory A. Dunnick, MD, University of Colorado Anschutz Medical Campus, Aurora, CO, United States Background: Over the past two decades, there has been a proliferation of available instruments for quantifying atopic dermatitis (AD) outcomes. Rehal and Armstrong identified by systematic review a total of 14 quality of life (QoL) indices and 20 disease severity scales used in 382 randomized controlled trials (RCTs) on AD treatment between 1985 and July 2010. To our knowledge, no systematic review has assessed trends in the use of outcome measures by AD studies published since July 2010. Objective: The purpose of this study was to systematically review the use of QoL and disease severity outcomes instruments in RCTs on AD between July 2010 and July 2015. Methods: Studies were identified through Scopus and Ovid MEDLINE using variations of the terms ‘‘atopic dermatitis,’’ ‘‘randomized controlled trial,’’ ‘‘quality of life,’’ and ‘‘severity of illness index.’’ A total of 540 nonduplicate records were identified. Studies were excluded if they were published prior to July 2010 (n ¼ 53), not RCTs (n ¼ 195), not on AD (n ¼ 58), not on humans (n ¼ 39), not in English (n ¼ 16), and if they did not report QoL and/or disease severity outcome measures (n ¼ 43). Results: All of the 136 included studies assessed disease severity, while only 46 studies reported QoL outcomes. Sixty-seven included studies used more than one disease severity scale, and fifteen studies used more than one QoL measure. A total of 61 disease severity scales and 29 QoL measures were identified. The most frequently used disease severity scale was the Scoring Atopic Dermatitis tool (n ¼ 79; 58%), followed by the Visual Analogue Scale for pruritus (n ¼ 30; 22%) and the Investigator’s Global Assessment scale (n ¼ 30; 22%). The most common QoL instrument, the Dermatology Life Quality Index, was used in 20 RCTs (15%), whereas the next most common measure, the Infant’s Dermatology Quality of Life Index, was used in only eight RCTs (6%). Forty-four of the identified disease severity scales and 23 identified QoL instruments were used only once. Conclusion: The number of different QoL and disease severity scales used in AD studies has grown since 2010. This systematic review highlights the increasing heterogeneity of reported outcomes in AD research. Knowledge of such trends in utilized outcomes instruments offers insight into the field’s quality of research evidence. Commercial support: None identified.
MAY 2016