H I G H L I G H T S

O F

A CME/CE CERTIFIED SUPPLEMENT TO

SKIN DISEASE EDUCATION FOUNDATION’S

40th Annual

Hawaii Dermatology Seminar ™

A CONTINUING MEDICAL EDUCATION CONFERENCE

Faculty Joseph F. Fowler, Jr, MD

Clinical Professor of Dermatology University of Louisville Louisville, Kentucky

Theodore Rosen, MD Professor of Dermatology Baylor College of Medicine Houston, Texas

Jeffrey M. Sobell, MD

Introduction Update on TNF Inhibitors in Dermatology Facial Dermatitis and Rosacea Tinea and Onychomycosis Acne: What’s New Fillers: What’s Here and What’s Ahead The Aging Face: Global Approach With Fillers and Neuromodulators Facial Rejuvenation: 40th Anniversary Review Post-Test and Evaluation Form Original Release Date: June 2016 • Expiration Date: June 30, 2017 Estimated Time to Complete Activity: Update to 2.33 hours Jointly provided by

Supported by educational grants from

AbbVie Inc.,Bayer Healthcare,Merz North America Inc., and Valeant Pharmaceuticals North America LLC

Assistant Professor of Dermatology Tufts University School of Medicine Director, Psoriasis Treatment Center SkinCare Physicians Chestnut Hill, Massachusetts

Nowell Solish, MD, FRCP(C) Assistant Professor University of Toronto Toronto, Ontario, Canada

Linda F. Stein Gold, MD Director of Dermatology Research Henry Ford Health System Detroit, Michigan

Christopher B. Zachary, MBBS, FRCP Professor and Chair Department of Dermatology University of California, Irvine Irvine, California

A CME/CE CERTIFIED SUPPLEMENT TO

H I G H L I G H T S

O F

SKIN DISEASE EDUCATION FOUNDATION’S

40th Annual

Hawaii Dermatology Seminar ™

Reprinted from Seminars in Cutaneous Medicine and Surgery The manuscript was originally published as a supplement to Seminars in Cutaneous Medicine and Surgery, Vol. 35, No. 4S, June 2016. It has been reviewed and approved by the faculty as well as the Editors of Seminars in Cutaneous Medicine and Surgery. This continuing medical education (CME/CE) supplement was developed from faculty presentations at the Skin Disease Education Foundation’s 40th Annual Hawaii Dermatology Seminar™, February 14-19, 2016. The Guest Editors/Faculty acknowledge the editorial assistance of Global Academy for Medical Education, LLC, and Josh Kilbridge, medical writer, in the development of this supplement. The manuscript was reviewed and approved by the Guest Editors as well as the Editors of Seminars in Cutaneous Medicine and Surgery for publication as a supplement to the journal. This activity was developed under the direction of the Faculty/Guest Editors, Global Academy for Medical Education, and Rutgers. The ideas and opinions expressed in this supplement are those of the Guest Editors and do not necessarily reflect the views of the supporters, Global Academy for Medical Education, Rutgers, or the Publisher. Copyright © 2016 by Global Academy for Medical Education, LLC; Rutgers, The State University of New Jersey; and its Licensors. All rights reserved. No part of this publication may be reproduced or transmitted in any form, by any means, without prior written permission of the Publisher. Global Academy for Medical Education, LLC, and Rutgers will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.

A CONTINUING MEDICAL EDUCATION CONFERENCE

Table of Contents Introduction..................................................................... 5 Joseph F. Fowler, Jr, MD Christopher B. Zachary, MBBS, FRCP

Update on TNF Inhibitors............................................. 6 in Dermatology Jeffrey M. Sobell, MD

Facial Dermatitis............................................................ 9 and Rosacea Joseph F. Fowler, Jr, MD

Tinea and Onychomycosis....................................... 12 Theodore Rosen, MD

Acne: What’s New........................................................ 16 Theodore Rosen, MD

Fillers: What’s Here....................................................... 19 and What’s Ahead Nowell Solish, MD, FRCP(C)

The Aging Face:........................................................... 22 Global Approach With Fillers and Neuromodulators Nowell Solish, MD, FRCP(C)

Facial Rejuvenation:................................................... 24 40th Anniversary Review Christopher B. Zachary, MBBS, FRCP

Post-Test and Evaluation Form................................. 27 2 

globalacademycme.com/dermatology • Highlights of Skin Disease Education Foundation’s 40th Annual Hawaii Dermatology Seminar

Highlights of Skin Disease Education Foundation’s 40th Annual Hawaii Dermatology Seminar Original Release Date: June 2016 Expiration Date: June 30, 2017 Estimated Time to Complete Activity: Up to 2.33 hours Participants should read the CE information below, review the activity in its entirety, and complete the online post-test and evaluation. Upon completing this activity as designed and achieving a passing score on the post-test, you will be directed to a Web page that will allow you to receive your certificate of credit via e-mail or you may print it out at that time. The online post-test and evaluation can be accessed at http://tinyurl.com/ HDS16Supp. Inquiries may be directed to Global Academy for Medical Education at [email protected] or (973) 290-8225.

• Implement updated strategies for managing acne, rosacea, and psoriasis • Discuss the use of biologic agents in the treatment of adult and pediatric psoriasis • Review the status of biosimilars for use in dermatology • Incorporate the recent advances in the treatment of acne vulgaris • Discuss the safety, efficacy, and dosing of antibiotics for acne vulgaris • Analyze emerging treatments for tinea and onychomycosis • Identify the considerations in the selection of appropriate filler agents for treating different areas of the face • Compare and contrast the efficacy and safety of agents, devices, and techniques currently available in aesthetic and procedural dermatology • Determine the appropriate nonsurgical techniques for facial rejuvenation • Describe the appropriate use of neuromodulators in the treatment of the aging face.

Disclosure Declarations

Accreditation Statements

Individuals in a position to control the content of this educational activity are required to disclose: 1) the existence of any relevant financial relationship with any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients with the exemption of non-profit or government organizations and non-health care related companies, within the past 12 months; and 2) the identification of a commercial product/device that is unlabeled for use or an investigational use of a product/device not yet approved.

Rutgers, The State University of New Jersey designates this enduring material for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Faculty

Physicians: This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Rutgers, The State University of New Jersey and Global Academy for Medical Education. Rutgers, The State University of New Jersey is accredited by the ACCME to provide continuing medical education for physicians. 

Nurses: Rutgers,The State University of New Jersey, Center for Continuing and Outreach Education (CCOE) is an approved provider of continuing nursing education by the New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. Provider Number P173-5/31/16. This activity is awarded 2.33 contact hours. (60 minute CH) Nurses should only claim those contact hours actually spent participating in the activity.

Target Audience

This supplement is intended for dermatologists, family practitioners, internists, nurse practitioners, nurses, physician assistants, and other clinicians who practice medical dermatology or aesthetic medicine.

Educational Needs

Research continues to expand our understanding of the pathophysiology and management of skin diseases and age-related skin damage. Based on this evidence, new pharmacologic agents and medical devices continue to be developed, researched, and approved for use in the United States. New evidence and therapies have been developed for acne vulgaris, rosacea, psoriasis, onychomycosis/tinea, and facial rejuvenation. Clinicians need to understand the safety and efficacy of these new therapies in specific patient types. Acne vulgaris affects 40 to 50 million people in the United States, with a prevalence as high as 85% in teenagers. A wide range of effective treatment strategies are now available to manage acne vulgaris, and new agents continue to be developed, offering an enhanced range of options. Psoriasis is an inflammatory skin disease for which a variety of agents, including several tumor necrosis factor (TNF) inhibitors, are approved for treatment. Recently, the use of TNF inhibitors for pediatric psoriasis has been investigated, and new biosimilar agents are in late stages of development for psoriasis. Clinicians may be reluctant to use TNF inhibitors in children with psoriasis and do not yet have clinical experience with biosimilar agents. Rosacea is a common chronic skin condition affecting the face, affecting approximately 14 million Americans. No cure exists for rosacea, but health care professionals have several options to treat the symptoms, including new agents to treat facial erythema and inflammation. The use of these agents requires an understanding of their safety and use in combination therapy. Onychomycosis and tinea pedis are common fungal infections affecting the nails and feet, respectively. Newly approved topical agents for onychomycosis and tinea have demonstrated high cure rates in clinical studies. Among the most common cosmetic procedures performed in the United States are the use of botulinum toxin A, soft tissue fillers, and laser treatments. In the last decade, a multitude of new products and devices have been developed for these indications, including new soft tissue fillers and novel laser technologies. The increased availability of options also increases the challenge of selecting the most appropriate agent or combination of agents for each patient.

Learning Objectives

By reading and studying this supplement, participants should be better able to: • Integrate into daily practice evidence-based recommendations on new and emerging therapies for common and uncommon dermatologic diseases

Joseph F. Fowler, Jr, MD, Consultant: Bayer Healthcare, Galderma Laboratories, L.P., GlaxoSmithKline, Johnson & Johnson, Medimetriks Pharmaceuticals, Inc., Ranbaxy Laboratories Ltd., SmartPractice Dermatology/Allergy, Valeant Pharmaceuticals North America LLC; Speakers Bureau: Galderma, SmartPractice, Valeant; Grant/ Research Support: AbbVie Inc., Allergan, Inc., Amgen Inc., Anacor Pharmaceuticals, Inc., Bayer, Celgene Corporation, Centocor, Inc., Chugai Pharma USA, Inc., Dow Chemical Company, Eli Lilly and Company, Galderma, Genentech, Inc., Innovaderm Research Inc., Janssen Biotech, Inc., Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Onset Dermatologics, LLC, Pfizer Inc., Precision Dermatology, Regeneron Pharmaceuticals, Inc., SmartPractice, Taisho Pharmaceutical Co., Ltd., Taro Pharmaceutical Industries Ltd., Valeant Theodore Rosen, MD, Scientific Advisory Board: Anacor Pharmaceuticals, Inc., Merz North America Inc., Valeant Jeffrey M. Sobell, MD, Grant/Research Support: Amgen, Celgene, Eli Lilly, Janssen, Merck, Novartis; Consultant: AbbVie, Amgen, Celgene, Eli Lilly, Janssen; Speakers Bureau: AbbVie, Amgen, Celgene, Janssen, Novartis Nowell Solish, MD, FRCP(C), Consultant/Grant/Research Support: Allergan, Galderma, Indeed Labs, Inc., Merz, Revance Therapeutics, Inc., Valeant Linda F. Stein Gold, MD, Consultant and Scientific Advisory Board: Anacor, Bayer, Eli Lilly, Foamix Pharmaceuticals Inc., Galderma, LEO Pharma Inc., Medimetrix Pharmaceuticals, Inc., Novartis, Pfizer, Taro Christopher B. Zachary, MBBS, FRCP, Consultant: Kythera Biopharmaceuticals, Inc., Sciton, Inc., Solta Medical; Scientific Advisory Board: Sciton and ZELTIQ Aesthetics, Inc. In order to help ensure content objectivity, independence, and fair balance, and to ensure that the content is aligned with the interest of the public, CCOE has resolved all potential and real conflicts of interest through content review by a non-conflicted, qualified reviewer.This activity was peer-reviewed for relevance, accuracy of content, and balance of presentation by: Jean C. Sines, RN, BSN, Staff Nurse, Department of Dermatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ. Ms. Sines has no relevant financial relationships to disclose. Field Testers: This activity was pilot-tested for time required by: Physicians: Brian Lee, MD, Sima Patel, DO, and Vijay Vanchinathan, MD. Nurses: Geraldine Bocchieri, RN, BSN, Kathleen Brown, LPN, and Stacy Johnson, RN.The field testers have no relevant financial relationships to disclose. Rutgers, The State University of New Jersey: Tristan Nelsen, MNM, CMP, and Elizabeth Ward, MSJ, have no relevant financial relationships to disclose. Global Academy for Medical Education Staff: Shirley V. Jones, MBA; Sylvia H. Reitman, MBA, DipEd; and Josh Kilbridge have no relevant financial relationships to disclose.

Off-Label/Investigational Use Disclosure

This activity discusses the off-label use of the following approved agents: adalimumab, cyclosporine ophthalmic emulsion, doxycycline, etanercept, fluconazole, isotretinoin, itraconazole, ketoconazole, methotrexate, minocycline (oral and foam), secukinumab, ustekinumab, and tumor necrosis factor inhibitors as a class.

Highlights of Skin Disease Education Foundation’s 40th Annual Hawaii Dermatology Seminar • globalacademycme.com/dermatology 

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Guest Editors Joseph F. Fowler, Jr, MD

Clinical Professor of Dermatology University of Louisville Louisville, Kentucky

Theodore Rosen, MD

Professor of Dermatology Baylor College of Medicine Houston, Texas

Jeffrey M. Sobell, MD

Assistant Professor of Dermatology Tufts University School of Medicine Director, Psoriasis Treatment Center SkinCare Physicians Chestnut Hill, Massachusetts

Nowell Solish, MD, FRCP(C) Assistant Professor University of Toronto Toronto, Ontario, Canada

Linda F. Stein Gold, MD

Director of Dermatology Research Henry Ford Health System Detroit, Michigan

Christopher B. Zachary, MBBS, FRCP Professor and Chair Department of Dermatology University of California, Irvine Irvine, California

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globalacademycme.com/dermatology • Highlights of Skin Disease Education Foundation’s 40th Annual Hawaii Dermatology Seminar

Introduction

D

ermatology is a diverse and expanding field, and new research continues to improve our understanding of the mechanisms of disease and opportunities for therapeutic intervention. This expanding knowledge base also creates a broad range of educational needs for practicing clinicians. Skin Disease Education Foundation’s 40th Hawaii Dermatology Seminar offers updates from experts that cover advances in both medical and aesthetic dermatology. The articles in this educational supplement summarize the highlights of clinical sessions presented during the CME/CE conference by leading experts in the field of dermatology. Tumor necrosis factor (TNF) inhibitors play a critical role in the treatment of psoriasis and continue to be evaluated for new indications. This supplement includes a discussion of TNF inhibitors for use in new indications—such as pediatric psoriasis and hidradenitis suppurativa—as well as the impending introduction of biosimilars in the United States. Although the pathophysiology of rosacea is not well understood, chronic inflammation and vascular changes are believed to be central to the disease process. And new evidence implicates a family of antimicrobial peptides called cathelicidins. New therapies targeting the inflammatory, erythematous, and/or antimicrobial components of the disease are now available or in development. This CME/CE supplement summarizes the latest evidence for these therapies and disease mechanisms. Our faculty discusses the evolving management of toenail onychomycosis and tinea pedis, including two new topical therapies recently approved by the US Food and Drug Administration. The faculty summarizes the evidence supporting these therapies, as well as data describing the benefits of early intervention and how to manage recurrence of these infections. Acne is an extremely common condition in dermatologic practice. Our faculty reviews recent studies addressing key considerations in the use of antibiotics, topical treatments approved and in development, and novel agents that target sebum production. The faculty also discusses several approaches to aesthetic medicine, including the use of fillers and other technologies to treat the aging face. This educational supplement reviews multiple new and emerging soft tissue augmentation products and techniques for facial rejuvenation. The wide range of dermatology treatments and new therapies for skin conditions challenge the busy clinician to remain abreast of the latest information. We hope that you can apply these updates from our seminar to your clinical practice.

Joseph F. Fowler, Jr, MD, Chair Clinical Professor of Dermatology University of Louisville Louisville, Kentucky

Publication of this CME/CE article was jointly provided by Rutgers, The State University of New Jersey, and Global Academy for Medical Education, LLC, with Skin Disease Education Foundation (SDEF) and is supported by educational grants from AbbVie Inc., Bayer Healthcare, Merz North America Inc., and Valeant Pharmaceuticals North America LLC.

Christopher B. Zachary, MBBS, FRCP, Chair Professor and Chair Department of Dermatology University of California, Irvine Irvine, California

Dr Fowler and Dr Zachary have received an honorarium for their participation in this activity. They acknowledge the editorial assistance of Josh Kilbridge, medical writer, and Global Academy for Medical Education in the development of this continuing medical education journal article. Joseph F. Fowler, Jr, MD, Consultant: Bayer, Galderma Laboratories, L.P., GlaxoSmithKline, Johnson & Johnson, Medimetriks Pharmaceuticals, Inc., Ranbaxy Laboratories Ltd., SmartPractice Dermatology/Allergy, Valeant; Speakers Bureau: Galderma, SmartPractice, Valeant; Grant/ Research Support: AbbVie, Allergan, Inc., Amgen Inc., Anacor Pharmaceuticals, Inc., Bayer, Celgene Corporation, Centocor, Inc., Chugai Pharma USA, Inc., Dow Chemical Company, Eli Lilly and Company, Galderma, Genentech, Inc., Innovaderm Research Inc., Janssen Biotech, Inc., Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Onset Dermatologics, LLC, Pfizer Inc., Precision Dermatology, Regeneron Pharmaceuticals, Inc., SmartPractice, Taisho Pharmaceutical Co., Ltd., Taro Pharmaceutical Industries Ltd., Valeant. Christopher B. Zachary, MBBS, FRCP, Consultant: Kythera Biopharmaceuticals, Inc., Sciton, Inc., Solta Medical; Scientific Advisory Board: Sciton and ZELTIQ Aesthetics, Inc. Address reprint requests to: Christopher B. Zachary, MBBS, FRCP, Dermatology, UC Irvine Health, 118 Med Surge I, Irvine, CA 92697, [email protected]

Highlights of Skin Disease Education Foundation’s 40th Annual Hawaii Dermatology Seminar • globalacademycme.com/dermatology 

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Update on TNF Inhibitors in Dermatology Jeffrey M. Sobell, MD*

Abstract

Emerging data describe new potential indications for tumor necrosis factor (TNF) inhibitors in dermatology, including pediatric psoriasis and hidradenitis suppurativa. New biosimilar TNF agents are in late stages of development and may be available in the United States in the near future. Biosimilar agents are similar but not identical to available TNF inhibitors, and approval requires extensive analytic, toxicity, pharmacokinetic, pharmacodynamic, and clinical testing. Semin Cutan Med Surg 35(supp6):S104-S106 © 2016 published by Frontline Medical Communications

Keywords Biosimilars; hidradenitis suppurativa; pediatric psoriasis; psoriasis; TNF inhibitors

T

umor necrosis factor (TNF) inhibitors have been approved for the treatment of adult patients with psoriasis for a dozen years, starting with etanercept and followed by infliximab and adalimumab. Current evidence also suggests that TNF inhibitors can be safe and effective for pediatric patients, and new biosimilars are also in late stages of development. Finally, the TNF inhibitor adalimumab was recently approved for a new dermatologic indication, hidradenitis suppurativa.

Pediatric Psoriasis

Psoriasis is relatively common in the pediatric population. For example, approximately 40% of adults with psoriasis report onset during childhood.1 The use of etanercept for pediatric psoriasis was initially evaluated in a phase III trial (n=211) that included a 12-week double-blind treatment period, followed by 24 weeks of open-label treatment and a 12-week double-blind withdrawal period.2 Enrolled subjects were aged 4 to 17 years and had moderate to severe psoriasis. Etanercept dosing was weight based (0.8 mg/kg once weekly). At week 12, among subjects treated with etanercept, 57% had at least 75% improvement on the Psoriasis Area Severity Index (PASI 75), and 27% had at least * Assistant Professor of Dermatology, Tufts University School of Medicine; Director, Psoriasis Treatment Center, SkinCare Physicians, Chestnut Hill, Massachusetts Publication of this CME/CE article was jointly provided by Rutgers, The State University of New Jersey, and Global Academy for Medical Education, LLC, with Skin Disease Education Foundation (SDEF) and is supported by educational grants from AbbVie Inc., Bayer Healthcare, Merz North America Inc., and Valeant Pharmaceuticals North America LLC. Dr Sobell has received an honorarium for his participation in this activity. He acknowledges the editorial assistance of Josh Kilbridge, medical writer, and Global Academy for Medical Education in the development of this continuing medical education journal article. Jeffrey M. Sobell, MD: Grant/Research Support: Amgen Inc., Celgene Corporation, Eli Lilly and Company, Janssen Biotech, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation; Consultant: AbbVie, Amgen, Celgene, Eli Lilly, Janssen; Speakers Bureau: AbbVie, Amgen, Celgene, Janssen, Novartis. Address reprint requests to: Jeffrey M. Sobell, MD, Tufts University School of Medicine, 145 Harrison Ave, Boston, MA 02111, [email protected]

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90% improvement (PASI 90) (compared to 11% and 7% with placebo, respectively; P