Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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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 [ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] [ NCT01555125], and JUNCTURE [NCT01636687]), and two double- blind, randomized, placebo-controlled Phase 3 studies in patients with active PsA (FUTURE 1 [NCT01392326] and F UTURE 2 [NCT01752634]). In the FUTURE 1 study, patients received 10mg/kg secukinumab i.v. loading followed by s.c. maintenance dosing (75mg or 150mg). In all other studies, p atients received s.c. loading and maintenance with secukinumab (300, 150, or 75mg). All randomized patients were included in the pooled safety analysis. Data were pooled at the patient level, and safety analyses were performed for the entire treatment period (≥52 weeks for FUTURE 1; Week 52 for ERASURE, FIXTURE, SCULPTURE, FEATURE, and JUNCTURE; ≥24 weeks for FUTURE 2). Results: 3,928 patients received ≥1 dose of secukinumab (3,225 patient- years of exposure, respectively). Baseline demographics, disease/medical history, and concomitant medications were similar between the pooled secukinumab and placebo populations. Exposure- adjusted incidence rates for adverse events (AEs)/serious adverse events (SAEs) across the entire safety period (mean exposure: 299.8 days secukinumab; 105.7 days placebo) were, 240.5/7.9 and 329.6/9.9 per 100 patient-years with secukinumab and placebo, respectively; 115 (2.9%) patients discontinued secukinumab treatment due to AEs. There were four deaths in secukinumab-treated patients: one due to intracranial hemorrhage; one due to cardio- respiratory arrest; one due to alcohol intoxication; and one of unknown cause. There were two (0.05%) cases of suicidality with secukinumab: one attempted suicide and one case of suicidal ideation. Nasopharyngitis and upper respiratory tract infections were the most frequently reported AEs with secukinumab. The incidence of inflammatory bowel disease (IBD)/ Crohn's, infections, neutropenia, major adverse cardiac events (MACE), and malignancy with secukinumab was low. Conclusion: Secukinumab was well-tolerated in a large cohort of 3 ,928 patients across seven Phase 3 studies with PsA and PSO. The safety profile was consistent with previous reports. Financial disclosures/funding: T his research was funded by Novartis Pharma AG, Basel, Switzerland. ROSACEA L ong-term Use of Once-daily Brimonidine Gel 0.33% for Treating Facial Erythema of Rosacea, Improved Quality of Life, and Decreased Basal Levels of Erythema Presenters: 1 Jonathan Weiss, MD; 2 Angela Moore, MD; 3 Steven Kempers, MD; 4 George Murakawa, MD; 5 Amanda Tauscher, MD; 6 Leonard Swinyer, MD; 7 Matthew Leoni, MD; 8 Gregor Schaefer, MD Affiliations: 1 Gwinnett Clinical Research, Snellville, GA; 2 Arlington Center for Dermatology, Arlington, TX; 3 Minnesota Clinical Study Center, Fridley, MN; 4 Dermcenter PC, Troy, MI; 5 Compliant Clinical Research, Olathe, KS; 6 Dermatology Research Center, Salt Lake City, UT; 7 Galderma R&D, Princeton, NJ; 8 Galderma SAS, Paris, France Objectives: Investigate safety and efficacy of 12 months of once-daily topical brimonidine gel 0.33% for facial erythema of rosacea treatment. Compare pre- and post-treatment subject social life questionnaire responses. Observe treatment effect on pre-application erythema and telangiectasia. Materials and Methods: Once-daily application of topical brimonidine gel 0.33% was investigated in a 12-month, open-label, 27-center, US study of moderate-to-severe erythema of rosacea. There were no facial lesions of rosacea or concomitant medication restrictions. Pre-application erythema and telangiectasia severity were assessed at baseline, Week 1, and Months 1, 3, 9, and 12. Social life impact questionnaires were completed at baseline and every third month. Results: Two-hundred and seventy- nine subjects completed the study. Compared to baseline, one-grade pre- application erythema improvements w ere 69.6 percent (Patient's Self- Assessment) and 66.0 percent (Clinician's Erythema Assessment). At study end, 44.0 percent of subjects exhibited one-grade improvement in p re-application telangiectasia compared to baseline. Social life impact questionnaire responses indicated that treatment improved subject perception of social life impact of rosacea. C onclusion: Pre-application erythema severity was lower after 12 months of study treatment in subjects with moderate-to-severe erythema of rosacea. Telangiectasia scores also improved and fewer patients reported negative social life impact compared to baseline. SEBORRHEIC KERATOSIS A Randomized, Double-blind, Vehicle-controlled, Parallel Group Study of the Dose-response Profile of A-101 Solution in Subjects with Seborrheic Keratosis of the Face Presenters: Diane S. Berson, MD; Stuart D. Shanler, MD; Christopher V. Powala; Brian B. Beger Clinical Trial Investigators: Andrew Blauvelt, MD; Michael Jarrett, MD; Andrew Pollack, MD; David Wilson, MD. All received remuneration from Aclaris Therapeutics as investigators. Background: Seborrheic keratosis (SK) is one of the most common cutaneous lesions and affects over 83 million Americans. Treatment options, such as cryosurgery, electrosurgery, curettage, or surgical excision are employed; however, pain during treatment, long-term pigmentary changes (particularly hypopigmentation), and/or scarring at the treatment site are common. A-101 Solution, an investigational new drug, is a patented, proprietary, topical formulation of stabilized hydrogen peroxide with a surface tension reducing agent, which may offer a safe, noninvasive approach to removing SK lesions. The main objective of this study was to evaluate the dose- response relationship of two concentrations of the active ingredient when A-101 Solution is applied to S 2 0

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