An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology
Issue link: http://jcadonline.epubxp.com/i/677940
[ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y S21 S 2 1 target SK lesions on the face compared with a matching vehicle. Methods: This randomized, multi-center, double-blind, vehicle- c ontrolled study, enrolled subjects having one SK lesion on the face for treatment with A-101 40% Solution, A-101 32.5% Solution, or vehicle. Eligible subjects were at least 18 y ears of age and had one clinically typical stable SK on the face that was graded as 2 or 3 on the Physician Lesion Assessment (PLA) scale, a validated 4-point assessment scale. Study medication was applied to subjects at the baseline visit with a re-treatment 21 days later for lesions with a PLA score >0. The study included a no- treatment follow-up period of 84 days. Results: 116 of 119 subjects randomized completed the study. In the primary analysis, a pairwise comparison between vehicle and each active medication group based on mean change from baseline in PLA score at each visit, A-101 Solution achieved statistical significance in reducing SK lesions in a dose-related fashion beginning at Day 22 and at all other visits through the end of the study, Day 106 (p<0.001). In the secondary responder analysis, the percentage of subjects achieving clear (PLA = 0) was 59.5 percent in the A-101 40% Solution group, 46.2 percent in the A-101 32.5% Solution group, and 2.5 percent in the vehicle group (p<0.0001). Primarily mild, transient local skin reactions were observed and reported. No hypopigmentation was observed in any of the treatment groups at Day 106. No subjects in the study experienced serious AEs that were deemed related to study medication. Conclusion: A-101 Solution was clinically and statistically effective in treating SK lesions on the face with A-101 40% Solution being more effective than A-101 32.5% Solution. A-101 Solution had a favorable safety and tolerability profile at both concentrations when applied up to two times to SK lesions on the face. Financial disclosures/funding: Aclaris Therapeutics. URTICARIA Patient-reported Impact of Chronic Hives Relative to Psoriasis in the US Presenters: 1 Susan Gabriel; 2 J effrey Vietri; 1 M eryl Mendelson; 1 Haijun Tian; 3 Maria-Magdalena Balp; 4 Mark Lebwohl Affiliations: 1 Novartis Pharmaceuticals Corporation, East Hanover, NJ; 2 Kantar Health, Horsham, PA; 3 Novartis Pharma AG, Basel, Switzerland; 4 Mount Sinai Hospital, New York, NY Background: Chronic idiopathic urticaria (CIU) is associated with impaired health outcomes, but few studies place the burden in the context of dermatological conditions where disease impact is better understood. Objective: To assess the burden of CIU according to patient-reported outcomes using psoriasis (PsO) of varying severity as a benchmark. Methods: Data came from the 2010–2012 US National Health and Wellness Surveys (NHWS). A diagnosis of chronic urticaria (CU; ≥6 weeks) served as proxy for CIU (the most common type of CU) since CIU was not specifically assessed in NHWS. Respondents diagnosed with PsO were analyzed by self-reported body surface area (BSA), with <2–3% classified as mild (category varied by data year), ≤10% moderate, and >10% severe. Severity was not assessed for CU. Measures included health-related quality of life (SF-12v2/SF-36v2 mental and physical component summary scores [MCS and PCS, respectively], SF-6D health utility), psychological complaints, the Work Productivity and Activity Impairment questionnaire and healthcare visits. Results: A total of 747 respondents reported CU, and 5,107 reported PsO (n=3,468 mild, n=1,336 moderate, and n=303 severe). MCS scores among patients with CU (44.7), moderate and severe PsO (44.7 and 44.3) indicated lower mental health status than the US norm (50). PCS scores indicated physical health status was l ower still: 43.8 for CU, and 46.5, 44.1, and 40.3 for mild, moderate, and severe PsO, respectively. The mean SF-6D score of patients with CU (0.67) was similar to patients w ith moderate PsO (0.72, 0.67, and 0.65 for mild, moderate, and severe PsO, respectively). Depression was reported by 39 percent of patients with CU, and 26 percent, 32 percent, and 33 percent of patients with mild, moderate, and severe PsO, respectively. Anxiety was reported by 42 percent of patients with CU, and 29 percent, 36 percent, and 30 percent of patients with mild, moderate, and severe PsO; and sleep difficulties by 50 percent for CU, and 38 percent, 44 percent, and 47 percent for mild, moderate, and severe PsO. Patients lost substantial work productivity, with mean overall work impairment of 29 percent for CU, and 19 percent, 27 percent, and 31 percent for mild, moderate, and severe PsO, respectively. Mean activity impairment was also substantial, 39 percent for CU, 28 percent, and 37 percent, and 43 percent for mild, moderate, and severe PsO, respectively. These patients were also frequent users of healthcare, with a mean of 7.1 visits in the past six months for CU and 5.2, 5.6, and 6.6 visits for mild, moderate, and severe PsO, respectively. Conclusion: The average patient with CU in the survey had impairments to health-related quality of life, work, and non-work activities similar to the average patient with moderate PsO. High levels of depression, anxiety, and overall healthcare use among patients with CU suggest a need for better management of this disease. Financial disclosures/funding: This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, and Genentech, Inc., South San Francisco, CA.