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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[ 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 S9 c omparator groups, respectively, and this improvement continued to the end-of-study visit at 16 weeks with decreases of -2.70 and -1.83 in the Microcyn scar gel and comparator g roups. Pain and itch decreased (improved) in both groups with greater improvement with Microcyn scar gel; however, no notable differences were observed. The IGA of e fficacy was good/very good in six (30%) subjects at Day 56 and 11 (55%) subjects at Day 112 with Microcyn scar gel, which compares favorably with five (28%) subjects at both timepoints with the comparator. Subject global satisfaction was similar between treatment groups and at various timepoints. Adverse events were reported in 18 percent of subjects on Microcyn scar gel and 35 percent on the comparator. Most were mild to moderate and not related to treatment. Conclusion: This randomized, double blind study demonstrated that Microcyn scar gel performed better than the comparator gel for the management of hypertrophic or keloid scars. Both treatments were well tolerated. ACTINIC KERATOSIS Regression Analysis of Local Skin Responses to Predict Clearance of Actinic Keratoses on the Face in Patients Treated with Ingenol Mebutate Gel Presenters: 1 S Jim On; 2 Kim Mark Knudsen; 2 T Skov; 1 Mark Lebwohl Affiliations: 1 Department of Dermatology, Mount Sinai School of Medicine, New York, NY; 2 LEO Pharma A/S, Ballerup, Denmark Introduction: Ingenol mebutate gel is a topical field treatment for actinic keratosis (AK). The treatment elicits application site reactions in most patients. This analysis explores the relationship between the severity of the local skin reactions (LSRs) and efficacy, as expressed by percentage reduction from baseline of AKs. Materials and Methods: The analysis included 218 subjects from two of the pivotal Phase 3 trials with ingenol mebutate gel, 0.015%, who w ere treated for AK on the face. Subjects had 4 to 8 AKs within a 25cm 2 area and were treated with ingenol mebutate gel, 0.015%, once daily for three days. Severity of LSRs was a ssessed on Days 4, 8, 15, 29, and 57. Efficacy was assessed on Day 57. Erythema, flaking/scaling, crusting, swelling, pustulation/vesiculation, and erosion/ulceration (LSRs) were a ssessed on a 5-point scale from 0 to 4 yielding a maximum composite score of 24. The analysis models the AK count at Day 57 with the LSR score on Day 4 for each subject as independent variable. A negative binomial regression was applied for modeling subjects' eight-week AK count with the number of baseline lesions as offset variable and anatomic location and study site as explanatory factors. This extension of the Poisson regression model for over-dispersed count outcomes is used to account for a correlation in clearance between AK lesions within a subject. The expected percent reduction in AK count across 57 days can be derived from this model. The modeling results were used to calculate 90-percent prediction interval for the AK reduction as a function of the composite LSR score. Results: Composite LSR scores assessed on Day 4 were predictive of efficacy. For example, at a composite score of 10, the model predicts that the subject was 90-percent certain to experience at least 50-percent reduction in the lesion count. Higher LSRs predicted greater rates of response. At low scores, the LSR had no predictive value, i.e., it neither predicted treatment success nor treatment failure. Conclusion: Composite LSR scores were predictive of efficacy at high scores and had little predictive power at low scores. ATOPIC DERMATITIS Efficacy and Safety of Dupilumab for Moderate-to-Severe Atopic Dermatitis in Adults: A Pooled Analysis of Two Phase 2 Clinical Trials Presenters: 1 Kim Papp; 2 Eric Simpson; 3 Lisa Beck; 4 Diamant Thaci; 5 T homas Bieber; 6 A ndrew Blauvelt; 7 Howard Sofen; 8 Richard Wu; 8 Neil Graham; 9 Gianluca Pirozzi; 10 E Rand Sutherland; 8 Marius Ardeleanu Affiliations: 1 K. Papp Clinical R esearch and Probity Medical Research, Waterloo Ontario, Canada; 2 Oregon Health & Science University, Portland, OR; 3 Department of Dermatology, University of Rochester M edical Center, Rochester, NY; 4 Comprehensive Center for Inflammation Medicine, University Medical School Schleswig-Holstein, Campus Lübeck, Lübeck, Germany; 5 Department of Dermatology and Allergy, University of Bonn, Bonn, Germany; 6 Oregon Medical Research Center, Portland, OR; 7 Department of Medicine/Dermatology, UCLA School of Medicine, Los Angeles, CA; 8 Regeneron Pharmaceuticals, Tarrytown, NY; 9 Sanofi, Bridgewater, NJ; 1 0 Sanofi, Cambridge, MA Background: Atopic dermatitis (AD) is characterized by Th2 inflammation (interleukin [IL]-4 and IL-13). Dupilumab, a fully-human monoclonal antibody directed against IL-4Rα, blocks biological actions of IL- 4 and IL-13 Objectives: To evaluate efficacy of dupilumab 300mg weekly in adults with moderate-to-severe AD using pooled data from two Phase 2 trials (NCT01548404; NCT01859988). Methods: Adults with moderate-to- severe AD were enrolled in a 12 week (Study 1117) or 16-week dose-ranging study (Study 1021). Both studies were randomized, double-blind, and placebo- controlled, with once-weekly subcutaneous placebo or dupilumab. Efficacy outcomes included absolute and percent change in Eczema Area and Severity Index (EASI) and SCORing Atopic Dermatitis (SCORAD); patients who achieved EASI improvement ≥50 percent (EASI-50) and ≥75 percent (EASI-75); and patients who achieved Investigator's Global Assessment (IGA) score of 0 ("clear") or 1 ("almost clear"). This analysis reflects pooled efficacy and safety results after 12 weeks of treatment. Analysis of covariance (treatment and baseline as covariates) was used to compare changes and percent changes; chi-square test was S 9

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