Cemiplimab (REGN2810), a fully human anti-PD-1 monoclonal antibody, for patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Initial safety and efficacy from expansion cohorts of Phase I study

Cemiplimab (REGN2810), a fully human anti-PD-1 monoclonal antibody, for patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Initial safety and efficacy from expansion cohorts of Phase I study

Presenters: Papadopoulos KP1,Owonikoko TK2, Johnson ML3, Bra?a I4, Gil-Martin M5, Perez RP6, Moreno V7, Salama AK8, Calvo E9,Yee NS10, Safran H11, González-Martín A12, Aljumaily R13, Mahadevan D14, Mohan KK15, Li J16, Stankevich E15, Israel Lowy I15, Fury MG15, Homsi J17

Affiliations: 1South Texas Accelerated Research Therapeutics, San Antonio, TX; 2Emory Winship Cancer Institute, Atlanta, GA; 3Sarah Cannon Research Institute, Nashville, TN; 4Vall D’HebronInstitute of Oncology, Barcelona, Spain; 5InstitutCatalàd’Oncologia, Barcelona, Spain; 6Unversity of Kansas, Fairway, KS; 7START Madrid Fundacion Jimenez Diaz, Madrid, Spain; 8Duke University Medical Center, Durham, NC; 9START Madrid, Hospital Madrid Norte Sanchinarro, Madrid, Spain; 10Penn State Cancer Institute, Hershey, PA; 11Miriam Hospital, Providence, RI; 12Formerly of MD Anderson International España, Madrid, Spain; 13University of Oklahoma Health Sciences Center, Oklahoma City, OK; 14Formerly of University of Arizona Cancer Center, Tucson, AZ; 15Regeneron Pharmaceuticals Inc., Tarrytown, NY; 16Regeneron Pharmaceuticals Inc., Basking Ridge, NJ; 17Formerly of Banner MD Anderson Cancer, Gilbert, AZ.

Background/Objective: Cemiplimab (REGN2810) is a human immunoglobulin G4 monoclonal antibody directed against PD-1.1. Phase I results from the first 60 patients with advanced solid tumors showed no dose-limiting toxicities. The most common treatment-related adverse events (AEs) in these patients were fatigue (28%), arthralgia (12%), and nausea(12%); the overall response rate was 18 percent. Cemiplimab 3mg/kg every two weeks (Q2W) was selected for further study in Expansion Cohorts. As of April 27, 2017, 392 patients have been enrolled in the Phase I study. The coprimary objectives of the CSCC Expansion Cohorts of this Phase I open-label study were to characterize the safety and tolerability of intravenous cemiplimab 3mg/kg and to evaluate the efficacy of cemiplimab by measuring overall response rate (ORR).

Methods: CSCC Expansion Cohorts (NCT02383212): Cohort 7 enrolled 10 patients with mCSCC, and Cohort 8 enrolled 16 patients with unresectable locally and/or regionally advanced CSCC. All patients received cemiplimab 3mg/kg Q2W for up to 48 weeks (if no progression or intolerance), followed by post-treatment follow-up. There was an option for re-treatment for patients who experienced disease progression during post-treatment follow-up, but no CSCC patients required this re-treatment option at the time of this study. All patients underwent tumor imaging every eight weeks, and response assessments were per RECIST 1.1. Research biopsies were performed at baseline and at Day 29. Subjects included scored a 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status, had a measurable disease by RECIST 1.1, had adequate organ function (bone marrow, kidney, liver), were in the mCSCC(M1): Expansion Cohort 7 and/or the unresectablelocally and/or regionally advanced CSCC (M0): Expansion Cohort 8. Exclusion criteria included presence of an autoimmune disease within five years, active brain metastases, or other invasive malignancy within five years (no exclusion for tumors considered cured by localized treatment), immunosuppressive doses of steroids (>10mg prednisone daily or equivalent), systemic antitumor treatment within four weeks of initial dose of cemiplimab, history of solid organ transplant, and tumors of lip or eyelid not eligible for CSCC cohorts.

Results: Investigator-assessed preliminary ORR (complete response [CR] + partial response [PR] + one unconfirmed PR) by RECIST 1.1 was 46.2 percent (12/26 patients; 95% confidence interval [CI]: 26.6–66.6; intent-to-treat [ITT] population). Disease control rate (DCR = ORR + stable disease [SD]) was 69.2 percent (18/26 patients; 95% CI: 48.2–85.7). Cemiplimab also produced rapid, deep, and durable tumor reductions in target lesions in both cohorts. As of April 27, 2017 (data cut-off date), 26 patients (median age, 73 years) from the CSCC expansions cohorts have been treated with cemiplimab. A total of 17 of 21 evaluated tumors (81%) were positive (?1%) for tumor expression of PD-L1 by immunohistochemistry. There was no apparent association between PD-L1 immunohistochemistry results and objective responses. The most common treatment-emergent adverse event (AEs) were fatigue, occurring among six patients. Two patients discontinued study treatment after treatment-related AEs: an 86-year-old woman developed a Grade 3 rash after three doses (she continued post-treatment follow-up) and an 88-year old male withdrew consent following Grade 3 transaminase elevation and Grade 2 fatigue after six doses. There were two deaths within 30 days of last dose of study drug, both considered unrelated to study drug.

Conclusion: This is the first prospective study of a PD-1 inhibitor in patients with advanced CSCC. Cemiplimab was generally well tolerated in CSCC in this predominantly older population. Both locally advanced and mCSCC are highly responsive to cemiplimab (combined ORR 46.2%), and durability is emerging. Eighty-one percent of pre-treatment tumor samples were PD-L1 positive. A unifying characteristic of cutaneous malignancies appears to be responsiveness to immune checkpoint inhibition. A Phase II study is ongoing in patients with unresectablelocally advanced and mCSCC(NCT02760498).

Funding/Disclosures: This study was funded by Regeneron Pharmaceuticals Inc, and Sanofi. Dr. Papadopoulos has received institutional research funding from Regeneron and Sanofi. Taofeek Owonikoko holds a consulting/advisory role for Regeneron. Melissa Johnson receives research funding from Regeneron. Raymond Perez receives institutional research funding from Regeneron. Emiliano Calvo receives institutional research funding from Sanofi. Nelson Yee receives institutional research funding from Regeneron. Kosalai Mohan, Jingjin Li, Elizabeth Stankevich, Israel Lowy, Matthew Fury, are stockholders and employees of Regeneron Pharmaceuticals, Inc. Matthew Fury also receives research funding, institutional patents, royalties, and other intellectual property from Regeneron. Jade Homsi receives research funding from Regeneron.

A real-world study evaluating adequacy of existing systemic treatments for patients with moderate-to-severe atopic dermatitis (AD-QUEST): baseline treatment patterns and unmet needs assessment

A real-world study evaluating adequacy of existing systemic treatments for patients with moderate-to-severe atopic dermatitis (AD-QUEST): baseline treatment patterns and unmet needs assessment

Presenters: Wei W1, Ghorayeb W2, Andria ML3, Walker V4, Chao J3, Schnitzer J2, Kennedy M3, Chen Z3; Belland A4, White J4, Silverberg JI5

Affiliations: 1Formerly of Sanofi, Bridgewater, NJ; 2Sanofi, Bridgewater, NJ; 3Regeneron Pharmaceuticals, Inc., Tarrytown, NY; 4Optum, Eden Prairie, MN; 5Northwestern University Feinberg School of Medicine, Chicago, IL

Objective: To evaluate potential unmet needs in the treatment of moderate-to-severe atopic dermatitis (AD) from a patient perspective.

Methods: Adults with an AD diagnosis in the last five years and a prescription for systemic treatment in the last six months were identified using claims data from Optum Research Database. Patients with self-assessed moderate-to-severe AD were invited to participate in monthly surveys over 12 months about disease signs and symptoms, quality of life (QoL) and AD treatment. We report baseline survey data.

Results: Of 6,000 patients invited to participate, 1,485 responded and 801 were eligible for inclusion (mean age: 45 years; female: 72%; Caucasian: 84%; employed: 79%; AD severity [Rajka & Langeland criteria]: moderate 74%, severe 26%). In the 12 months before baseline, 38 percent and 36 percent reported no remission or less than three months remission from AD. In the month before baseline, most reported using topical corticosteroids (64%) or calcineurin inhibitors (8%), some reported using antihistamines (38%), and a few reported using systemic steroids (11%) or immunosuppressants (5%). In the same period over 81 percent reported AD flares (1: 23%; 2: 20%; ?3: 38%), of which, 65 percent and 22 percent had partial or no recovery. Patients experiencing a flare versus those with no flare at baseline reported significantly worse POEM (13.5 vs. 6.2), peak pruritus NRS (worst itch in previous 24 hours: 6.3 vs. 3.5) and DLQI scores (8.6 vs. 3.7), and greater work productivity loss in previous seven days (8.2 vs. 3.4) (all P<0.001).

Conclusion: This suggests that despite standard-of-care treatments, adults with moderate-to-severe AD report disease symptoms, recurrent flares, and impaired QoL, suggesting unmet therapeutic needs.

Funding/Disclosures: Wenhui Wei is a former employee and current stockholder of Sanofi and an employee of Regeneron Pharmaceuticals, Inc. Eric Ghorayeb and James Schnitzer are employees of and stockholders in Sanofi. Michael Andria, Jingdong Chao, Martha Kennedy and Zhen Chen are employees of and stockholders in Regeneron Pharmaceuticals, Inc. Valery Walker, Angela Belland, and John White are employees of Optum, a company that received research funding for the current study. Jonathan Silverberg is a member of an institution that received research funding for the current study. This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc.

An investigator blinded randomized study evaluating hypochlorous acid (HOCl) in the treatment of atopic dermatitis-associated pruritus

An investigator blinded randomized study evaluating hypochlorous acid (HOCl) in the treatment of atopic dermatitis-associated pruritus

Presenters: Berman B, Nestor M

Affiliation: Center for Clinical and Cosmetic Research and University of Miami Miller School of Medicine, Miami, FL

Background/Objective: Hypochlorous acid (HOCl) might potentially reduce pruritus in atopic dermatitis (AD) by its microbicidal qualities, particularly in reducing Staphylococcus aureus, and by its anti-inflammatory qualities that reduce the activities of histamine, leukotriene B4, and interleukin-2, all of which contribute to the pathophysiology of itch. Here, we present the results of a three-day study designed to evaluate the effect of HOCl on pruritus in patients with AD.

Methods: The study was conducted according to the protocol and in compliance with Good Clinical Practice (GCP) and other applicable regulatory requirements. This investigator-blinded, randomized Phase II, 72-hour study investigated the antipruritic effect of HOCl with patients diagnosed with AD. Subjects enrolled had AD as defined by the Hanifin criteria and had scored higher than 2 on an itch severity scale (0–4). Thirty subjects were enrolled, 20 randomized to the treatment group (HOCl), and 10 randomized to the untreated control group. Subjects used a HOCl containing solution BID or PRN for 72 hours and recorded applications in a diary. Subjects randomized to the untreated group received no treatment and were only instructed to come to follow-up visits for study-specific assessments.

The three primary measures used were Participant Global Assessment (PGA), Investigator Global Assessment (IGA), and Visual Analog Scale (VAS) itch score. Adverse events (AEs) and serious adverse events (SAEs) and incidence of local skin reactions leading to discontinuation were recorded as well. Measurements were taken at baseline, 24 hours, and 72 hours post-treatment. Photographs of representative areas of affected skin were taken.

Results: The mean VAS itch score between the two groups was similar at baseline. Mean change in PGA and IGA scores between baseline and 72 hours both significantly decreased in favor of the HOCl treatment group (PGA: p value=0.128; IGA: p=0.012). The mean itch VAS scores between the treated and untreated groups were significantly different between baseline and 72 hours post-application, with the percent mean change shown to be significantly lower (improved) in the HOCl treated group.

The analysis showed 73.7 percent of the subjects in the HOCl treated and 30.0 percent of the subjects in the untreated group experienced a reduction in itching between baseline and 72 hours after initial application. There were no treatment related discontinuations or SAEs.

Conclusion: This study demonstrated that application of HOCl-containing solution leads to a reduction in itching associated with AD at 24 hours with significantly better results when compared to the untreated cohort at 72 hours.

A Phase IIb dose-ranging efficacy and safety study of tralokinumab in adult patients with moderate-to-severe atopic dermatitis (AD)

A Phase IIb dose-ranging efficacy and safety study of tralokinumab in adult patients with moderate-to-severe atopic dermatitis (AD)

Presenters: Wollenberg A1, Howell MD2, Guttman-Yassky E3, Silverberg JI4, Birrell C5, Kell C5, Ranade K2, Dawson M5, van der Merwe R5

Affiliations: 1Ludwig Maximillian University, Munich, Germany; 2MedImmune, LLC, MD; 3Mount Sinai School of Medicine, NY; 4Northwestern University Feinberg School of Medicine, IL; 5MedImmune, Ltd., Cambridge, UK

Background/Objective: AD is a chronic inflammatory skin disease characterized by increased interleukin (IL)-13 levels. Tralokinumab, an anti-IL-13 monoclonal antibody, has shown efficacy and an acceptable safety profile in patients with severe, uncontrolled asthma driven by the T-helper 2 pathway. Serum dipeptidyl peptidase 4 (DPP-4) has been reported as a predictive marker for tralokinumab in patients with severe asthma. Here, we evaluated whether tralokinumab offers therapeutic benefit to adults with moderate-to-severe AD.

Methods: In this Phase IIb, randomized, placebo-controlled, double-blind study (NCT02347176), patients were randomized 1:1:1:1 to receive tralokinumab 45mg, 150mg, or 300mg, or placebo every two weeks with mid-strength topical corticosteroids (TCS) for 12 weeks. Coprimary endpoints were change from baseline in Eczema Area Severity Index (EASI) and percentage of patients with clear or almost clear Investigator’s Global Assessment (IGA 0/1) at Week 12. Further efficacy, patient-reported outcomes, serum biomarkers, and safety endpoints were assessed.

Results: Overall, 204 patients were randomized. Tralokinumab 300mg treatment significantly reduced EASI scores (adjusted mean [standard error] change from baseline: 15.7 [1.3]; p=0.011) vs. placebo (-10.8 [1.4]) and more patients had IGA 0/1 (26% vs. 12%). Significant improvements were observed in patients who received tralokinumab 300mg versus placebo for Scoring of Atopic Dermatitis (p=0.002), Dermatology Life Quality Index (p=0.006), Pruritus Numeric Rating Scale (p=0.002), EASI75 (p=0.003), and EASI50 (p=0.025). Tralokinumab 300mg significantly reduced the number of Staphylococcus aureus-colonized patients (p=0.015), the concentration of serum immunoglobulin E, periostin, and TARC/CCL17, dose-dependently versus placebo (p<0.001). Patients with increased IL-13 activity (n=102), identified by baseline serum DPP-4 concentrations above median, showed an increased response to tralokinumab 300mg; more patients achieved IGA 0/1 (35% vs. 8%) and EASI75 (52% vs. 13%) than patients receiving placebo. The most frequent adverse events in all groups were nasopharyngitis (17%), upper respiratory tract infection (9%), headache (6%) and AD (6%).

Conclusion: Tralokinumab with TCS was more efficacious than TCS alone and demonstrated clinically relevant efficacy and an acceptable safety profile in patients with moderate-to-severe AD. DPP-4 might become a predictive marker for patients with AD who respond to tralokinumab 300mg, allowing a personalized medicinal approach.

Funding: This study was funded by MedImmune.

Clinical efficacy and tolerability of a hydroquinone-free and retinol-free topical brightening serum on females with facial melasma

Clinical efficacy and tolerability of a hydroquinone-free and retinol-free topical brightening serum on females with facial melasma

Presenters: Makino ET, Tan P; Mehta RC

Affiliation: Research & Development SkinMedica, an Allergan Company, Irvine, CA

Background/Objective: Melasma, a progressive form of hyperpigmentation, occurs more often in healthy women than men. The actual etiology is indefinite; however, pregnancy, hormonal changes, ultraviolet (UV) light exposure, photosensitizing medications, and genetic predisposition have all been considered as contributing factors. This dysfunction of the pigmentary system results in symmetric brown or gray-brown patches on sun exposed areas of the face, particularly on the forehead, cheeks, upper lip, and chin. Often, the psychosocial impact of melasma leads to a negative effect on quality of life and emotional well-being. The purpose of this study was to assess the cosmetic efficacy and tolerability of a HQ-free and retinol-free serum (LYT2) in nonpregnant women with mild-to-severe melasma that was self-perceived as being induced by a previous pregnancy.

Methods: This was a 12-week, single-center, clinical usage study with visits at baseline and Weeks 4, 8 and 12. Thirty female subjects aged 30 to 50 years with Fitzpatrick Skin Types (FST) II to IV presenting with mild-to-severe overall hyperpigmentation on the face due to melasma, which was self-perceived to be induced by a previous pregnancy, completed the study. Seventy-three percent of the subjects were Caucasian, 20 percent were Asian, and seven percent were African American. All subjects received LYT2, cleanser, moisturizer, and sunscreen. Subjects applied LYT2 twice-daily after cleansing. All subjects used cleanser and moisturizer twice-daily and a physical sunscreen once in the morning (and as needed throughout the day). At all visits, the investigator assessed for overall hyperpigmentation (0–9 scale; 0=none, 1–3=mild, 4–6=moderate, 7–9=severe), global Improvement in Overall Hyperpigmentation (0–5 scale), and Melasma Area and Severity Index (MASI). Each subject’s face was divided into four areas that were evaluated separately (forehead [F], right malar region [MR], left malar region [ML], and chin [C]). For each area, the pigment intensity (PI), lesion size (A), and homogeneity (H) were assessed. MASI score for the whole face was calculated using the following equation: MASI=0.3 (PIF + HF) AF + 0.3 (PIMR + HMR) AMR + 0.3 (PIML+ HML) AML + 0.1 (PIC + HC) AC. The values 0.3, 0.3, 0.3, and 0.1 represent the respective percentages of total facial area. The maximum score for MASI is 48 and the minimum score is 0. Tolerability assessments for erythema, scaling, edema, burning, stinging, and itching were graded on a 4-point scale at all visits. At all follow-up visits, subjects completed a self-assessment questionnaire on self- perceived efficacy, product texture, and product attributes. At baseline and Week 12, subjects completed a Melasma Quality of Life (MelasQol) Questionnaire (Likert Scale: 1=not bothered at all to 7=bothered all the time).Standardized digital photographs were taken using the VISIA-CR Imaging System (Canfield Imaging Systems) at all visits. Image analysis on a target dark spot for skin brightness (L*) was conducted for each time point. Corneometer and tewameter measurements were conducted for all visits.

Results: The HQ-free and retinol-free serum demonstrated a statistically significant decrease in clinical grading scores at Weeks 4, 8, and 12 when compared with baseline for overall hyperpigmentation, global improvement in overall hyperpigmentation, and MASI (all p<0.001; Wilcoxon Signed-Rank Test). Statistically significant increase in mean scores for global improvement in overall hyperpigmentation at all visits (all p<0.001; Wilcoxon Signed-Rank Test). MelasQol Combined Score showed a statistically significant improvement at Week 12 compared to baseline, indicating an increased perception of quality of life (p<0.03; Wilcoxon signed-rank test). Corneometer and tewameter measurements continuously improved from baseline at all follow-up visits, indicating an improvement in skin hydration and skin barrier function, respectively. Image analysis for brightness (L*) showed statistically significant improvements from baseline at all follow up visits (all p?0.025; paired t-test). LYT2 was well tolerated with tolerability scores remaining similar to baseline scores, and highly rated by subjects for self-perceived efficacy and product attributes with a significant proportion of subjects agreeing to favorable responses by Week 12. Ninety-seven percent of subjects were satisfied with LYT2 by Week 12. Seventy-seven percent of subjects saw moderate or marked improvement by Week 12. Eighty-three percent of subjects agreed it performed better than past facial treatments.

Conclusion: Results from this study support the efficacy and tolerability of this HQ-free and retinol-free serum in improving the appearance of mild-to-severe facial melasma in subjects with self-perceived pregnancy-induced melasma.

Funding/Disclosures: This study was sponsored by Allergan. All authors met the ICMJE authorship criteria. All authors are employees of Allergan.

Understanding the African American facial aesthetic patient

Understanding the African American facial aesthetic patient

Presenters: Boyd C1, Alexis A2, Callender V3, Downie J4, Shumate GT5, Gallagher CJ5

Affiliations: 1BOYD, Birmingham, MI; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3Callender Dermatology and Cosmetic Center, Glenn Dale, MD; 4Image Dermatology, Montclair, NJ; 5Allergan plc, Irvine, CA

Background/Objective: Aesthetic injectors might perceive challenges when addressing the aesthetic needs of African American patients. Understanding the anatomical considerations, facial aging patterns, aesthetic concerns, and treatment preferences might increase the comfort level for the injector and improve outcomes for African American patients. Injectors should also consider any patient misconceptions (e.g., keloid scarring) associated with injection procedures. Accordingly, clinical case studies can provide practical examples of how to implement this knowledge during patient consultation, assessment, and treatment. Two studies were performed to gain insights into self-reported facial aging characteristics and treatment considerations among African American patients.

Methods: Eight-hundred and fifty-nine African American men (145) and women (714) completed an online evaluation in which they assessed their facial features against photonumeric scales depicting degrees of severity for 10 facial characteristics. Four-hundred and one African American women completed a separate online evaluation to identify areas of aesthetic concern, relative prioritization of treatment areas, and attitudes toward injectable treatments. Respondents for both evaluations were naïve to facial aesthetic treatments. A subsequent meeting of experts with significant experience in treating African American patients produced case studies to illustrate the translation of these data to the clinical setting.

Results: In the African American population, moderate-to-severe signs of facial aging were not generally reported until 50 to 79 years of age. At ages 70 to 79 years, over 70 percent were still without moderate-to-severe perioral lines, loss of lip fullness, or midface volume loss. The majority reported having uneven skin tone/color (57%) and dark circles under the eyes (48%). African American patients were most bothered by their tear trough and submental regions. Areas most likely to be prioritized for treatment included tear trough, submental region, and horizontal forehead lines. In contrast, African American patients were less likely to prioritize treatment of perioral lines, lips, temples, and cheeks. African American women reported the lowest consideration rate for injectables (64%), compared to Asian or Hispanic individuals. “Looking good for their age” was the top reason for considering aesthetic treatment, but the cost, perceived safety, and side effects were the largest barriers. Clinical case studies demonstrated practical treatment strategies utilizing commercially available facial aesthetic products.

Conclusion: Across the two research studies, self-reported facial aging characteristics correlated with bothersome areas; both tear trough treatment and submental fat reduction could be seen as entry points for facial aesthetic injectables for this population. An understanding of these objective research findings and practical case studies might increase the comfort level for an injector and improve outcomes for African American patients.

Efficacy, safety, and patient-reported outcomes following onabotulinumtoxinA treatment for moderate-to-severe forehead lines: a pooled analysis of two Phase III pivotal trials

Presenters: De Boulle K1, Fagien S2, Mao C3, Shumate GT3, Gallagher CJ3

Affiliations: 1Aalst Dermatology Clinic, Aalst, Belgium; 2Aesthetic Eyelid Plastic Surgery, Boca Raton, FL; 3Allergan plc, Irvine, CA

Background/Objective: Two pivotal, Phase III studies were conducted to evaluate the safety and efficacy of onabotulinumtoxinA (onabotA) versus placebo (PBO) for treatment of moderate-to-severe forehead lines (FHL).

Methods: In both studies, neurotoxin-naïve subjects were randomized to receive onabotA 40U (frontalis 20U, glabella 20U) or PBO. The second study included an additional treatment arm in which bilateral crow’s feet regions (CFL) were also treated for a total dose of 64U (FHL 20U, GL 20U, CFL 24U) or PBO. After Day 180, all eligible subjects could receive up to two additional open-label onabotA treatments, with assessments to Day 360. Dynamic and static FHL were assessed at all timepoints by both investigator and subject using the Facial Wrinkle Scale with photo numeric guide. Subject satisfaction with treatment was evaluated using the validated Facial Lines Satisfaction Questionnaire (FLSQ).

Results: This pooled analysis comprised 1,178 subjects in the intent-to-treat (ITT) population (onabotA 40U n=608, onabotA 64U n=313; PBO n=257). At maximum eyebrow elevation, Day 30 responder rates for those achieving more than a 2-grade composite FHL improvement based on investigator and subject FWS were 53.1 (40U) and 53.0 (64U) percent, respectively. Responder rates for those achieving more than a 1-grade FHL improvement were 97.9 (40U) and 99.0 (64U) percent, respectively. Percentage of subjects achieving a score of none/mild FHL were 92.3 (40U) and 94.9 (64U) percent, respectively. Of those subjects with at least mild static FHL at baseline, 85.4 (40U) and 84.8 (64U) percent achieved more than a 1-grade improvement at rest. Efficacy and patient satisfaction were comparable across treatment cycles. Based on the FLSQ, 85.6 (40U) and 87.9 (64U) percent of subjects reported being mostly satisfied or very satisfied with the effect treatment had on their forehead lines at Day 60. Across all treatment cycles over 12 months, 25.4 percent of subjects had treatment-related adverse events; of note were brow ptosis (2.6%) and lid ptosis (1.8%). Most frequently reported treatment-emergent adverse events included headache (11.8%), injection site bruising (7.4%), nasopharyngitis (8.3%), and upper respiratory tract infection (4.3%). No new safety signals were detected with repeated upper facial line treatments.

Conclusion: OnabotA significantly improved the appearance of FHL. Treatment of upper facial lines was well tolerated with efficacy and patient satisfaction maintained across repeat treatments.

Reduction of submental fat continues beyond 28 days after ATX-101 treatment: results from a post-hoc analysis

Reduction of submental fat continues beyond 28 days after ATX-101 treatment: results from a post-hoc analysis

Presenters: Dover JS1, Shridharani SM2, Bloom JD3, Somogyi C4, Gallagher CJ4

Affiliations: 1SkinCare Physicians, Chestnut Hill, MA; 2LUXURGERY, New York, NY; 3Main Line Center for Laser Surgery, Ardmore, PA; 4Allergan plc, Irvine, CA

Background/Objective: ATX-101 (deoxycholic acid injection) is approved in the United States, Australia, Canada, and Europe for reduction of submental fat (SMF). When injected into subcutaneous fat, ATX-101 results in adipocytolysis, which induces a localized inflammatory response to clear cellular debris and lipids liberated from the injection site. In ATX-101 clinical trials, subjects received 4 to 6 treatments spaced at intervals of 28 ± 5 days. A post-hoc analysis was conducted to characterize the response after a single ATX-101 treatment using data from a patient experience management study (NCT02007434).

Methods: Adults aged 18 to 65 years with a moderate or large amount of SMF (as assessed via the validated 5-point Clinician-Reported and Patient-Reported SMF Rating Scales) who were dissatisfied with the appearance of their face or chin were enrolled. Subjects were randomized to one treatment with either ATX-101 (area-adjusted dose: 2mg/cm2) or placebo. This post-hoc analysis evaluated efficacy among ATX-101-treated subjects (n=68); subjects with moderate SMF at baseline based on clinician assessment (n=49) received 6mL of ATX-101 while subjects with severe SMF (n=19) received 8mL. Outcomes, evaluated at Days 28 and 84 following ATX-101 treatment, included the percentage of subjects who achieved at least a 1-grade improvement in SMF from baseline based on clinician assessment (CR-1 response), percentage of subjects who achieved at least 1-grade improvement in SMF from baseline based on clinician and subject assessment (composite CR-1/PR-1 response), and mean change in SMF thickness from baseline (measured with calipers).

Results: Most ATX-101-treated subjects were female (62%) and Caucasian (79%). At baseline, 72 percent versus 28 percent of subjects had a moderate versus large amount of SMF, respectively. At Day 28, the CR-1 response rate was 14.1 percent. By Day 84, the CR-1 response rate increased to 47.0 percent. Similarly, the composite CR-1/PR-1 response rate was 7.8 percent at Day 28, and increased to 37.9 percent by Day 84. SMF thickness increased from baseline by 2.1mm at Day 28, which might be related to residual swelling and/or induration within the treatment area. However, SMF thickness decreased from baseline by 1.3mm at Day 84.

Conclusion: Results from this analysis demonstrate that reduction of SMF continues in 2 to 3 months following ATX-101 treatment. Overall, these data provide evidence of a progressive reduction in SMF beyond the 28-day retreatment interval used in the pivotal clinical trials and suggest that benefit might be gained by extending the interval between ATX-101 treatments beyond 28 days.

Funding: Funded by Allergan plc.

Subject satisfaction demonstrated for two on-label injection volumes of abobotulinumtoxinA (ABO) when used to treat moderate-to-severe glabellar lines

Subject satisfaction demonstrated for two on-label injection volumes of abobotulinumtoxinA (ABO) when used to treat moderate-to-severe glabellar lines

Presenters: Cohen J1, Kaufman J2, Peredo M3, Jonas B4, Nogueira A4, Mashburn J4

Affiliations: 1Director of AboutSkin Dermatology and DermSurgery, Greenwood Village and Lone Tree, CO, Associate Clinical Professor, Department of Dermatology, University of Colorado, CO, and Assistant Clinical Professor, Department of Dermatology, University of California Irvine; 2Skin Associates of South Florida, Skin Research Institute, Coral Gables, FL; 3Marina I. Peredo, MD, Smithtown, NY; 4Galderma Laboratories, L.P., Fort Worth, TX

Background/Objective: In the United States (US), glabellar lines (GLs) are most often treated with botulinumtoxin type A (BoNT-A), and satisfaction with treatment is typically measured using patient-reported outcomes. Dysport (abobotulinumtoxinA [ABO]) is approved in the United States for the treatment of GLs and can be injected at two different injection volumes­—0.05mL and 0.08mL. This was a multicenter, randomized, subject- and evaluator-blinded study to evaluate the safety, efficacy, and subject satisfaction of two on-label injection volumes, 0.05mL/injection (Group A) and 0.08mL/injection (Group B), for the treatment of GLs. This report focuses on the subject satisfaction health-related quality of life aspects of the study.

Methods: Subjects with moderate-to-severe GLs at maximum frown were treated with ABO. Subjects were randomized to receive either 0.05mL/injection (Group A) or 0.08mL/injection (Group B), per the approved US label (5 injection points in the glabella area totaling 50U [10U at each injection site] for 1 treatment session). Subjects were given one treatment, then followed for up to four months. Subject assessments were completed before and after treatment.

Results: At 30 days posttreatment, the majority of subjects reported they were satisfied with how attractive they looked (86.7% for Group A, 76.7% for Group B), compared to baseline pretreatment, 20.0 and 36.7 percent, respectively. Subjects also felt more confident after either treatment (90.0% and 80.0% at Day 30, Group A and B, respectively) compared to baseline, 33.3 and 33.3 percent, respectively. At Day 30, subjects also reported an increase in psychological well-being (mean change from baseline 29.5 [P<0.0001] for Group A and 25.0 [P<0.0001] for Group B), being less bothered by their GLs (mean change from baseline 52.2 [P<0.0001] for Group A and 45.7 [P<.0001] for Group B), and looking four years younger than their current age compared to baseline (mean change from baseline -4.4 [P<0.0001] for Group A and -4.3 [P<0.0001] for Group B). These results were mostly maintained through 120 days posttreatment. There were no significant differences between treatment groups.

Conclusion: Subjects treated with two on-label injection volumes of ABO for moderate-to-severe GLs reported high subject satisfaction and increased psychological well-being through Day 120.

Funding: Galderma Laboratories, L.P.

Differential facial aesthetic treatment considerations for skin of color populations: African American, Asian and Hispanic

Differential facial aesthetic treatment considerations for skin of color populations: African American, Asian and Hispanic

Presenters: Boyd C1, Chiu A2, Montes JR3, Narurkar V4; Shumate GT5, Gallagher CJ5

Affiliations: 1BOYD, Birmingham, MI; 2The Derm Institute, Hermosa Beach, CA; 3José Raúl Montes Eyes & Facial Rejuvenation, San Juan, PR; 4Bay Area Laser Institute, San Francisco, CA; 5Allergan plc, Irvine, CA

Background/Objective: By 2050, more than half of the total population in the United States will be of African American, Asian, or Hispanic descent. The unique anatomical needs, aesthetic goals, and cultural considerations for these growing patient populations should be evaluated to optimize treatment expectations and outcomes. A research study was performed to gain insights into the areas of aesthetic concern, relative prioritization of treatment areas, and any barriers to receiving injectables among these populations.

Methods: Four-hundred and one African American, 403 Asian, and 401 Hispanic women living in the United States, aged 30 to 65 years, completed an online evaluation in which questions focused on identifying bothersome facial areas, consideration levels for facial aesthetic treatments, and any barriers to receiving injectables. A maximum difference scaling method was used to identify which of the 15 facial areas would be prioritized for treatment. Respondents were naïve to facial aesthetic treatments but were aesthetically oriented and were considering physician administered aesthetic treatment within the next two years.

Results: The Hispanic population reported the highest consideration rate for injectables (85%), followed by Asian (75%) and African Americans (64%). African American and Hispanics were most bothered by their submental region, whereas Asian respondents were most bothered by the area underneath the eyes (infraorbital area). All skin of color populations prioritized first the periorbital region (infraorbital and crow’s feet areas) followed by the submental area and forehead lines. Relative to the other populations, African American respondents expressed the highest prioritization of the submental region. All respondents then prioritized treatment of glabellar lines, nasolabial folds, and oral commissures. Analysis by increasing Fitzpatrick Type (I–VI) showed an increasing prioritization of the periorbital region and decreasing prioritization of the chin and perioral lines. Most frequently cited barriers to considering injectable treatment included safety and side effects, concern about injecting a foreign substance into the body, and cost.

Conclusion: Understanding the unique aesthetic considerations of a diversifying patient population is imperative. Differences in injectable consideration rates and bothersome areas were apparent across the patient populations evaluated, but there was consensus regarding the facial areas most likely to be prioritized for treatment. An understanding of the differential aging patterns, cultural considerations, and aesthetic goals for each patient population may help optimize treatment expectations and outcomes.