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CELEBRATING

EXCELLENCE IN DERMATOL

1938-2013

ADVANCE PROGRAM

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CONTINUING MEDICAL EDUCATIONINFORMATIONMISSIONThe purpose of the American Academy of Dermatology (AAD)CME Program is to provide members with opportunities forlife-long learning and assistance in fulfilling their maintenance

of certification and licensure requirements, thereby promotingexcellence in the provision of dermatologic care.

DEFINITION OF CONTINUING MEDICAL EDUCATIONContinuing medical education consists of educational activitiesthat serve to maintain, develop, or increase the knowledge, skills,and professional performance and relationships that a physicianuses to provide services for patients, the public, or the profession.The content of CME is that body of knowledge and skillsgenerally recognized and accepted by the profession as withinthe basic medical sciences, the discipline of clinical medicine, andthe provision of health care to the public.Source: www.accme.org

COMMERCIAL BIAS

A personal judgment in favor of a specific proprietary businessinterest of a commercial interest.Source: www.accme.org

SCIENTIFIC ASSEMBLY COMMITTEE*As of the April 20-21, 2012 planning meeting

Janet A. Fairley, MD;Chair

Ilona J. Frieden, MD

Joan Guitart, MD

M. Christine Lee, MD

Henry W. Lim, MD

Allison Vidmos, MD, RPh

Daniel M. Siegel, MD;President

Dirk Michael Elston, MD;President-Elect

Suzanne Olbricht, MD;Secretary-TreasurerRoy Mitchell Colven, MD;Chair, Needs Assessment and OutcomesCommittee

Scott M. Dinehart, MD;Chair, Named LectureshipTask Force

Tammie C. Ferringer, MD;Chair, Poster Exhibits Task Force

Robert S. Kirsner, MD, PhD;Chair, Council On Education andMaintenance of Certification

LEARNER BILL OF RIGHTSAAD recognizes that you are a life-long learner who has chosento engage in continuing medical education to identify or fill agap in knowledge or skill and to attain or enhance a desiredcompetency. As part of AADs duty to you as a learner, youhave the right to expect that your continuing medical education

experience with AAD includes the following.

Content that: Promotes improvements or quality in healthcare. Is current, valid, reliable, accurate and evidence-based. Addresses the stated objectives or purpose. Is driven and based on independent survey and analysis of

learner needs, not commercial interests. Has been reviewed for bias and scientific rigor. Offers balanced presentations that are free of commercial bias. Is vetted through a process that resolves any conflicts of

interest of planners and faculty. Is evaluated for its effectiveness in meeting the identified

educational need.

A learning environment that: Is based on adult learning principles that support the use ofvarious modalities.

Supports learners abilities to meet their individual needs. Respects and attends to any special needs of the learners. Respects the diversity of groups of learners. Is free of promotional, commercial, and/or sales activities.

Disclosure of: Relevant financial relationships that planners, teachers, and

authors have with commercial interests related to the contentof the activity.

Commercial support (funding or in-kind resources) of thisactivity.

American Academy of Dermatology930 East Woodfield Road, Schaumburg, Illinois 60173

Phone: 847.330.0230 Fax: 847.330.1090 Website: www.aad.org

2012 American Academy of Dermatology, Schaumburg, IllinoisNo part of this publication may be reproduced without the prior writtenpermission of the American Academy of Dermatology.

REGISTER FOR THE MEETING AND MAKE HOTEL RESERVATIONS ONLINE AT

WWW.AAD.ORG

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For more information, visitwww.aad.org/meetings

CELEBRATING

EXCELLENCE IN DERMATOLOGY

1938-2013

Join in celebrating the Academys 75th anniversary in 2013. Growing from

463 members in 1938 to more than 18,000 members today, the Academy

continues to provide programs and services that lead the specialty and enrichthe lives of those served.

Interactive 75th Anniversary Timeline Exhibit Lobby C/D

Visit this informative exhibit during the Annual Meeting to view the pivotal events

and achievements that have shaped the AAD and the specialty of dermatology

over the past 75 years.

Reception Row Events Friday, March 1, 2013 from 5 to 6:30 p.m.Location TBD

International Members Reception

Young Physician/New Member Reception

Residents Reception

Presidents Gala Saturday, March 2, 2013, Time TBD Invitation only

Loews Miami Beach Hotel, Americana Ballroom

Te Festivities Begin in 2013Be part of the AADs 75th anniversary celebration!

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PRESIDENTS MESSAGE

A handful of historyI love history. And as we celebrate the AADs 75th Anniversary during this 71st Annual Meeting in Miami, its also worth reflectingon the history of our meetings, events that have become the heart and soul of this organization. In point of fact, the program bookyoure reading now and AAD meetings have their own interesting history.

The very first program book for the Annual Meeting in St. Louis in 1938 was not much larger than a postcard collection. Itcontained a mere six pages for the entire scientific program (and one of those pages was blank, for notes). By the second meetingin Philadelphia, we more than doubled that number. Thats right 13 full pages of scientific program. By the third meeting inChicago, that number jumped to 19, then 25 pages for the 4th meeting.

By 1954, the scientific program book had grown to 160 pages and was actually called too obese to be a pocket guide any longer.

Streamlining processes and advances in publishing would eventually improve the book (now available in many handy formats), but ithas never stopped never could stop an ever-expanding growth of dermatology sessions and events.

As the program grew, so did attendance, increasing steadily with each new meeting. Fifty years ago, in 1962, then president J.Walter Wilson, MD, proclaimed that with 21 meetings under its belt, AAD meetings had officially come of age, and he expressedhis astonishment and pride about the astounding attendance in Chicago no less than 1,550 were present! Dr. Wilson addedthat he believed people were coming to the Academys meetings not because of loyalty or a sense of duty. Rather, he said,members truly like to attend and find themselves aware after each reunion that a full measure of value has been received.True 50 years ago. Just as true today.

What makes todays program book so thick, rich, and diverse is the commensurate growth of AAD members and meetingattendees, right along with our growth of and thirst for knowledge. Fifty years ago we thought 1,550 was an astoundingnumber and we were damned proud of it. The last time we visited Miami our attendance-breaking number was more than19,000. As president of this organization at this time, I couldnt be prouder of how much weve grown.

Whatever the attendance numbers are for the 71st Annual Meeting in Miami, they will be spectacular numbers, far beyond what thisorganization might have dreamed of back in 1938 in St. Louis. We continue to smash attendance records on a pretty regular basisand in a difficult economy to boot.

So, as you look through these pages, remember there were once only six pages of dermatology scientific sessions in the programbook, amounting to little more than a dozen individual sessions. Now there are more than 200 pages, with over 375 sessions to choosefrom an extraordinary compendium of progress.

I would never call this program book obese, but it sure has become meaty. And with its expansive offering of knowledge,both new and passed on, its yet another document of dermatology history in the making, whether you view it on paper oryour favorite digital device!

Sincerely,

Daniel M. Siegel, MD, FAADPresident, American Academy of Dermatology

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isZeinObagi, MD

Dr. Obagi has no affiliation with Obagi Medical Products.He resigned as an officer and director in 2006 to

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Raising the Bar for Skin HealthDr. Zein Obagi has a history of advancing the science of skincare. And hes done it again, with ZO Medical,

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ZO Skin Health, Inc. and Dr. Obagi have no business relationship with Obagi MedicalProducts, and Obagi Medical Products does not sell or endorse using any ZO product.Todays Obagi Nu-Derm, the Obagi Blue Peelkit, and other Obagiproducts areproduced and marketed by Obagi Medical Products. Obagi, Obagi Nu-Derm,Obagi Blue Peel, Exfoderm, and Blenderare registered trademarks of Obagi

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CHAIRS MESSAGE

Continuing medical education. CME. Its one of those phrases that is so commonly used that it starts to lose its full meaning.

But there is real meaning in CME. Obviously medical education is something dermatologists need and desire, but theprefacing word continuing suggests something ongoing. One definition of continue is to persist in an activity orprocess. I like that definition because it contains the word persist, suggesting that we cannot allow ourselves to letup; we must be dogged in our pursuit of education. Wherever you are at in your medical education, whether you are inresidency or in a private or group practice you will always be continuing your dermatology education, because theknowledge base changes from year to year, and perhaps even more rapidly than that.

There is no better place to continue to soak in the vast amount of information currently available than through theAADs 71stAnnual Meeting in Miami Beach. Its an amazing area, rich with diversity, culture, and architecture, and set within

a geographical location that can often resemble a tropical paradise. On top of all that, we have strong program and Improud to be chair for such an exciting and diverse event.

This years Plenary boasts a highly-anticipated group of lectures featuring some of the pre-eminent names in dermatology and willfeature updates on the epidemiology and biology/treatment of melanoma fast moving areas in our specialty.

Michael E. Bigby, MD, is presenting the Clarence S. Livingood, MD, Lectureship, and Im looking forward to his talk, Tamingthe Dragon, wherein he will discuss the true meaning and purpose of evidence-based medicine.It is fitting that one metaphor leads to another as Hensin Tsao, MD, PhD, presents the 2013 Marion B. Sulzberger MemorialLectureship, Melanoma and Its Metaphors. Dr. Tsao believes that exploring melanoma in the context of familiarmetaphors reduces the complexity of its natural biology into simple and comprehensible terms.

The Lila and Murray Gruber Memorial Cancer Research Award and Lectureship will be Public Health Science will CutMelanoma Deaths in Half, to be presented by Harold E. Varmus, MD. Dr. Varmus believes that in the absence of a cure formetastatic disease, efforts should focus on epidemiologic principles to advance the science around melanoma.

Jouni J. Uitto, MD, PhD, will be presenting the 2012 Eugene J. Van Scott Award for Innovative Therapy of the Skin and PhillipFrost Leadership Lecture on progress in genodermatoses. He will be providing some exciting information about the recentprogress in molecular genetics of heritable skin diseases, resulting in improved diagnosis with prognostic implications.

I believe the best Plenary sessions include one talk that is somewhat outside the realm of dermatology and serves to amuse,inspire and allow dermatologists to think about science in new ways. This year, Paul Stamets, a mycologist, will give us awhole new and interesting perspective on the world of fungi.

Stamets is not only a mushroom expert who has authored several books on mycology, but a true visionary who hasdiscovered and coauthored four new species of mushrooms and pioneered countless techniques in the field of edible andmedicinal mushroom cultivation.

Additionally, youll find within these pages five days of diverse sessions covering all aspects and facets of dermatology.Im pleased to see an increase in the number of MOC sessions offered, as these have been increasingly popular withattendees. Likewise, the Academy is ramping up its offerings of live demonstrations and adding more forums, increasingyour educational opportunities.

Enjoy your continuing medical education!

Sincerely,

Janet A. Fairley, MD, FAADChair, Scientific Assembly Committee

6 | AMERICAN ACADEMY OF DERMATOLOGY 71ST ANNUAL MEETING

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TABLE OF CONTENTS

8 | AMERICAN ACADEMY OF DERMATOLOGY 71ST ANNUAL MEETING

AAD Meeting Policies Alcoholic Beverages ...............................................................37 Age Limits ..............................................................................37 Camera/Video Recording ......................................................37

Cell Phones ............................................................................37 Official Language ...................................................................37 Smoking .................................................................................37 Ticketed Session Admittance/Walk-Ins ..................................37

AAD Staff Creative and Publishing .........................................................37 Education ...............................................................................37 Meetings and Conventions ....................................................37

Chairs Message ..............................................................................6

Charitable Contribution ................................................................33

Continuing Medical Education Accreditation ..........................................................................13 CME Credit Information .........................................................13 Commercial Bias ......................................................................2

Commercial Support Disclosure ............................................13 Content Validation .................................................................13 Definition of .............................................................................2 Disclaimer ...............................................................................13 Disclosures ..........................................................................1-12 Independence in CME ...........................................................12 Mission .....................................................................................2 Outcomes Measurement .......................................................13 Resolutions of Conflicts of Interest ........................................12 Statement of Need ................................................................11 Target Audience Learning Objectives ...................................11 Unapproved Use Disclosure...................................................12

General Information Badge Information .................................................................32 Badges, Tickets and Vouchers ...............................................31

Certificate of Meeting Attendance ........................................33 Letters of Invitation ................................................................32 Meeting Location ...................................................................27 Registration .......................................................................27-31

Honors and Awards............................................................170-176

Hotel and Travel Information Air Travel ................................................................................33 Car Rental ..............................................................................33 Hotel Accommodations and Reservations.............................32 Hotel Cancellations ................................................................32

Important Dates and Times.........................................................26

Indices Invited Faculty .................................................................97-206 Subject ............................................................................77-194

Learner Bill of Rights ......................................................................2

Mobility Services ...........................................................................36

On-Site Services and Exhibits AAD Bistro .............................................................................36 Academy offices/Exhibits .......................................................34

Attendance Verification .........................................................34

Attendee/Exhibitor Registration ............................................34

Business Center ......................................................................35

Child Care Services ................................................................36

Electronic Posters ...........................................................35, 146

First Aid/Nursing Mothers .....................................................36

Information Desks ..................................................................36

Mingle Zones .........................................................................35

Optional Activities/Tours ........................................................36

Press Registration ..................................................................35

Speaker Ready Room.............................................................35

Technical Exhibits ....................................................35, 149-168

Plenary Session

Business and Bagels ...............................................................93

Clarence S. Livingood, MD Award and Lectureship ..............93

Eugene J. Van Scott Award for Innovative

Therapy of the Skin and Phil lip Frost Leadership Lecture .....95

Guest Speaker ........................................................................95 Lila and Murray Gruber Memorial Cancer

Research Award and Lectureship...........................................94

Marion B. Sulzberger Memorial Award and Lectureship ......94

President Address ..................................................................94

President Elect Address .........................................................94

Welcome ................................................................................93

Presidents Message .................................................................. 4

Program Overview ..................................................................15-24

Registration Information

Categories, Access, and Fees ................................................29

Cancellations ..........................................................................31

Confirmations and Changes ..................................................28

Corrections .............................................................................31

Instructions .............................................................................28

International Groups ..............................................................32

Member ..................................................................................29

Non-Member..........................................................................29

Session Categories, Access and Fees..........................................29

Session Ticket Cancellations........................................................31

Spouse / Guest ..............................................................................34

Scientific Assembly Committee...................................................11

Scientific Sessions

Friday, March 1..................................................................41-62

Friday/Saturday, March 1/2 ...............................................63-65

Saturday, March 2 .............................................................66-87

Sunday, March 3 ..............................................................88-105

Monday, March 4 ..........................................................106-126 Tuesday, March 5 ..........................................................127-142

Shuttle Bus Services .....................................................................36

Whats New ...................................................................................40

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Aczone

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Aczone PI

INDICATIONS AND USAGEACZONEGel, 5%, is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATIONFor topical use only. Not for oral, ophthalmic, or intravaginal use.After the skin is gently washed and patted dry, apply approximately a pea-sized amount ofACZONEGel, 5%, ina thin layer to the acne affected areas twice daily. Rub inACZONEGel, 5%, gently and completely.ACZONEGel,5%, is gritty with visible drug substance particles. Wash hands after application ofACZONEGel, 5%.If there is no improvement after 12 weeks, treatment withACZONEGel, 5%, should be reassessed.

CONTRAINDICATIONSNone.

WARNINGS AND PRECAUTIONS

Hematological EffectsOral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PDdeficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.

There was no evidence of clinically relevant hemolysis or anemia in patients treated withACZONEGel,5%, including patients who were G6PD deficient. Some subjects with G6PD deficiency usingACZONEGeldeveloped laboratory changes suggestive of mild hemolysis.If signs and symptoms suggestive of hemolytic anemia occur,ACZONEGel, 5% should be discontinued.ACZONEGel, 5% should not be used in patients who are taking oral dapsone or antimalarial medicationsbecause of the potential for hemolytic reactions. Combination ofACZONEGel, 5%, with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in pat ients with G6PD deficiency.

Peripheral NeuropathyPeripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. Noevents of peripheral neuropathy were observed in clinical trials with topicalACZONEGel, 5% treatment.

SkinSkin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous andexfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types ofskin reactions were not observed in clinical trials with topical ACZONEGel, 5% treatment.

ADVERSE REACTIONSClinical Studies ExperienceBecause clinical trials are conducted under prescribed conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may notreflect the rates observed in practice.Serious adverse reactions reported in patients treated withACZONEGel, 5%, during clinical trials included butwere not limited to the following: Nervous system/Psychiatric Suicide attempt, tonic clonic movements.

Gastrointestinal Abdominal pain, severe vomiting, pancreatitis. Other Severe pharyngitisIn the clinical trials, a total of 12 out of 4032 patients were reported to have depression (3 of 1660 treated withvehicle and 9 of 2372 treated withACZONEGel, 5%). Psychosis was reported in 2 of 2372 patients treatedwith ACZONEGel, 5%, and in 0 of 1660 pa tients treated with vehicle.Combined contact sensitization/irritation studies with ACZONEGel, 5%, in 253 healthy subjects resulted inat least 3 subjects with moderate erythema.ACZONEGel, 5%, did not induce phototoxicity or photoallergy inhuman dermal safety studies.ACZONEGel, 5%, was evaluated for 12 weeks in four controlled studies for local cutaneous events in 1819patients. The most common events reported from these studies include oiliness/peeling, dryness, and erythema.One patient treated with ACZONEGel in the clinical trials had facial swelling which led to discontinuation

of medication.In addition, 486 patients were evaluated in a 12 month safety study. The adverse event profile in this study wasconsistent with that observed in the vehicle-controlled studies.

Experience with Oral Use of DapsoneAlthough not observed in the clinical trials withACZONEGel (topical dapsone) serious adverse reactions havebeen reported with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy(motor loss and muscle weakness), and skin reactions (toxic epidermal necrolysis, erythema multiforme,morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria).

DRUG INTERACTIONS

Trimethoprim-SulfamethoxazoleA drug-drug interaction study evaluated the effect of the use ofACZONEGel, 5%, in combination with doublestrength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemiclevels of TMP and SMX were essentially unchanged. However, levels of dapsone and its metabolites increasedin the presence of TMP/SMX. Systemic exposure (AUC0-12) of dapsone and N-acetyl-dapsone (NAD) wereincreased by about 40% and 20% respectively in the presence of TMP/SMX. Notably, systemic exposure(AUC0-12) of dapsone hydroxylamine (DHA) was more than doubled in the presence of TMP/SMX. Exposurefrom the proposed topical dose is about 1% of that from the 100 mg oral dose, even when co-administeredwith TMP/SMX.

Topical Benzoyl PeroxideTopical application of ACZONEGel followed by benzoyl peroxide in subjects with acne vulgaris resulted in atemporary local yellow or orange discoloration of the skin and facial hair (reported by 7 out of 95 subjects in aclinical study) with resolution in 4 to 57 days.

Drug Interactions with Oral DapsoneCertain concomitant medications (such as rifampin, anticonvulsants, St. Johns wort) may increase theformation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsonetreatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood ofhematologic reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects: Pregnancy Category CThere are no adequate and well controlled studies in pregnant women. Dapsone has been shown to have anembryocidal effect in rats and rabbits when administered orally in doses of 75 mg/kg/day and 150 mg/kg/day(approximately 800 and 500 times the systemic exposure observed in human females a s a result of use of themaximum recommended topical dose, based on AUC comparisons), respectively. These effects were probablysecondary to maternal toxicity.ACZONEGel, 5%, should be used during pregnancy only if the potential benefitjustifies the potential risk to the fetus.

ACZONE(dapsone) Gel 5%

Nursing MothersAlthough systemic absorption of dapsone following topical application ofACZONEGel, 5%, is minimal relative tooral dapsone administration, it is known that dapsone is excreted in human milk. Because of the potential for oraldapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursingor to discontinue ACZONEGel, 5%, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and efficacy was evaluated in 1169 children aged 12-17 years old treated withACZONEGel, 5%, in theclinical studies. The adverse event rate forACZONEGel, 5%, was similar to the vehicle control group. Safetyand efficacy was not studied in pedia tric patients less than 12 years of age, thereforeACZONEGel, 5%, is notrecommended for use in this age group.

Geriatric UseClinical studies of ACZONEGel, 5%, did not include sufficient number of patients aged 65 and over todetermine whether they respond differently from younger pat ients.

G6PD DeficiencyACZONEGel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical studyof 64 patients with G6PD deficiency and acne vulgaris. Subjects were Black (88%), Asian (6%), Hispanic (2%)or of other racial origin (5%). Blood samples were taken at Baseline, Week 2, and Week 12 during both vehicleand ACZONEGel, 5% treatment periods. There were 56 out o f 64 subjects who had a Week 2 blood drawand applied at least 50% of treatment applications.ACZONEGel was associated with a 0.32 g/dL drop inhemoglobin after two weeks of treatment, but hemoglobin levels generally returned to baseline levels at Week 12.There were no changes from baseline in haptoglobin or lactate dehydrogenase duringACZONEor vehicletreatment at either the 2-week or 12-week time point.The proportion of subjects who experienced decreases in hemoglobin1 g/dL was similar between ACZONEGel, 5% and vehicle treatment (8 of 58 subjects had such decreases duringACZONEtreatment comparedto 7 of 56 subjects during vehicle treatment a mong subjects with at least one on-treatment hemoglobinassessment). Subgroups based on gender, race, or G6PD enzyme activity did not display any differences inlaboratory results from the overall study group. There was no evidence of clinically significant hemolytic anemiain this study. Some of these subjects developed laboratory changes suggestive of mild hemolysis.

OVERDOSAGEACZONEGel, 5%, is not for oral use. If oral ingestion occurs, medical advice should be sought.

HOW SUPPLIED/STORAGE AND HANDLINGACZONE(dapsone) Gel, 5%, is supplied in the following size t ubes: Professional Sample: 3 gram laminate tube (3). Commercially: 30 and 60 gram laminate tubes (3).

2012 Allergan, Inc., Irvine, CA 92612, U.S.A.marks owned by Allergan, Inc.

U.S. Patents 5,863,560; 6,060,085; and 6,620,435Made in the U.S.A.

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CME INFORMATIO

ADVANCE PROGRAM

|For the latest Program Book information please refer to www.aad.org

2013 ANNUAL MEETINGDIRECTLY SPONSORED BYTHE AMERICAN ACADEMY OF DERMATOLOGY

STATEMENT OF NEED

The American Academy of Dermatologys Annual Meeting isplanned to comprehensively address the nine content areas withinthe Dermatologic Core Curriculum and provide dermatologistsand other dermatology health care professionals with high qualityeducational opportunities for the optimization of dermatologicknowledge, competence, and performance.

TARGET AUDIENCEThe primary target audience of the American Academy ofDermatologys Annual Meeting is its members. Secondary audiencesfor the Academys Annual Meeting include dermatology residents andother dermatology health care professionals.

GLOBAL LEARNING OBJECTIVESThis comprehensive meeting provides learners with opportunities

Review and apply basic knowledge and skills in medicaldermatology, dermatologic surgery, pediatric dermatology, andermatopathology.

Update their knowledge about recent advances in the diagnomanagement and treatment of diseases of the skin, hair, nails,and mucous membranes.

Assess the relationship of evidence-based diagnostic approacand therapies with new dermatologic treatment development

Self-assess current practice management skills and developstrategies for improving these skills.

Develop new skills to improve their everyday practice ofdermatology.

NOTE:Each session has its own specific learning objectives thaare included within the scientific sessions.

DISCLOSURESPLANNER DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIP(S)The following Scientific Assembly Committee members reported they have no relationship(s) with commercial interest(s) to disclose relevato the content of this CME activity:

Roy Mitchell Colven, MD Dirk Michael Elston, MD

Janet A. Fairley, MD Tammie C. Ferringer, MD

Allison Therese Vidimos, MD, RPh Suzanne Olbricht, MD

The following Scientific Assembly Committee members reported they do have relationship(s) with commercial interest(s) to be disclosed to learner

PLANNER ROLE COMMERCIAL INTEREST

Scott M. Dinehart, MD Investigator Grants Abbott Laboratories

Ilona J. Frieden, MD Honoraria Consultant Pierre Fabre Dermo-Cosmtique USHonoraria Advisory Board TOPAZ Pharmaceuticals, Inc.

Joan Guitart, MD Honoraria Consultant Bristol-Myers Squibb, Excaliard Pharmaceuticals, Inc., Galderma, L.P., Genzyme,Millennium Pharmaceuticals, Seattle Genetics Consultant

Honoraria Advisory Board Astellas

Grants Investigator Eisai, YauponRobert S. Kirsner, MD, PhD Grants Investigator Advanced Biohealing, Healthpoint, Tissue Repair Company

Honoraria Advisory Board Molynecke, National Healing Board, OrganogenesisHonoraria Other GlaxoSmithKlineAdvisory Board No Compensation Received Mosaic

M. Christine Lee, MD Equipment Investigator Alma, CuteraHonoraria Investigator Laserscope/IridexGrants Investigator Lumenis

Henry W. Lim, MD Honoraria Consultant Clinuvel, La Roche-Posay, Procter and Gamble

Grants Investigator Clinuvel, Estee Lauder

Daniel M. Siegel, MD Stockholder Other DermFirst

Honoraria Consultant Compulink, Dusa Pharmaceuticals, Inc., Leerink Swan, LEO Pharma US, MakuCeInc., Meda Pharmaceuticals, Inc., Melasciences

Other Royalty ElsevierNo Compensation Received Consultant Encite, MDSolarSciences CorporationGrants Investigator The Este Lauder Companies, Inc.Stock Options Consultant Logical ImagesInvestigator No Compensation Received Dermapen, Michelson Diagnostics Ltd.Advisory Board No Compensation Received Click Diagnostics, Michelson Diagnostics Ltd., VivacareAdvisory Board Honoraria Biopelle, Inc., Galderma Laboratories, L.P., Genentech, Inc., LEO Pharma, US, M

LabsAdvisory Board Stock Photomedex

Advisory Board Stock Options Michelson Diagnostics Ltd, Modernizing Medicine, Quinnova Pharmaceuticals,Inc., Remote Derm

Stockholder No Compensation Received A.P. Pharmaceutical, Adamis Pharmaceuticals, Affymetrix, Astellas Pharma, CelldClinuvel, Colgate-Palmolive, DuPont, GlaxoSmithKline, Healthgate Data Corp,Ibis Technologies, Insmed Incorporated, Life Technologies, Lumenis, MylanTechnologies, Inc., Pfizer, Inc., Senetek PLC, XOMA (US) LLC, Zoll

Honoraria Speaker Genentech, Inc., LEO Pharma, US

Intellectual Property Rights Founder Dantech Systems

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CME INFORMATION

12 | AMERICAN ACADEMY OF DERMATOLOGY 71ST ANNUAL MEETING

FACULTY DISCLOSURE OF RELEVANT FINANCIALRELATIONSHIP(S)

It is the policy of AAD that all faculty participating in a CME-certified activity are required to disclose to AAD and to learnersrelevant financial relationships that they or their first-degreerelative (spouse, parent, sibling, or child) have with any commercialinterests. Relevant financial relationships1include financialrelationships in any amount occurring within the past 12 monthsthat create a conflict of interest2. Typically, such relationshipswould be with companies that sell health care products or servicesthat are consumed by or used in the treatment of patients. Theintent of this disclosure is not to prevent participation in CME-certified educational activities by individuals with a relevantfinancial relationship with commercial interest(s), but rather toprovide learners with information on which they can make theirown determination whether or not said relationship(s) influencedthe content of the educational activity.

Session Director and faculty disclosure information is located withinthe Onsite Program Book after the scientific schedule. Faculty havebeen asked to also make a verbal disclosure at the start of theirpresentations supplemented by a disclosure slide in order to verifythe accuracy of the disclosure information printed in the OnsiteProgram Book and ensure their disclosure information is shared withthe learners PRIOR to the presentation taking place.

RESOLUTION OF CONFLICTS OF INTERESTIn accordance with the ACCME Standards for Commercial Supportof CME, the American Academy of Dermatology has implementedmechanisms, prior to the planning and implementation of thisCME activity, to identify and mitigate conflicts of interest for allindividuals in a position to control the content of this CME activity.

UNAPPROVED USE DISCLOSUREThe American Academy of Dermatology requires CME faculty(speakers) to disclose to attendees when products or proceduresbeing discussed are off-label (not approved for the indicationsbeing discussed), unlabeled (not approved for any indications),

experimental, and/or investigational (not FDA approved); andany limitations on the information that is presented, such as data

that are preliminary or that represent ongoing research, interimanalyses, and/or unsupported opinion. This information is intendedsolely for continuing medical education and is not intendedto promote off-label use of these products/procedures. If youhave questions, contact the medical affairs department of themanufacturer for the most recent approval information. Faculty atthis meeting will be discussing information about pharmaceuticalagents that is outside of U.S. Food and Drug Administrationapproved labeling.

INDEPENDENCE IN CMEThe mission of the Academys continuing medical educationprogram is to improve patient care and health care outcomesby maintaining, developing, and enhancing medical knowledge,patient care, interpersonal and communication skills, and

professionalism. As a provider accredited by the AccreditationCouncil for Continuing Medical Education (ACCME) and in supportof this mission, the Academy is dedicated to providing continuingmedical education that is independent, fair, balanced, objective,and free of commercial bias.

The Academy employs several strategies to ensure these standardswill be met. The planning committee members submit andconsider their own disclosure information and recuse themselvesfrom planning educational activities should they have conflictsrelated to the subject area presented. When developing aneducational program, the planning committee reviews applicationsand disclosure forms, along with needs assessment and evaluativedata from past activities in order to develop programming.Potential participants are sent detailed guidelines that provide

direction on necessary components to ensure independence incontinuing medical education activities and to resolve conflict.

The following Leadership Development Steering Committee members reported they have no relationship(s) with commercial interest(s) todisclose relevant to the content of this CME activity:

Erin G. Adams, MD Tammie Ferringer, MD

Jennifer Lucas, MD Mary E. Maloney, MD

Margaret E. Parsons, MD Jack S. Resneck Jr., MD

Sabra Sullivan MD, PhD Marta Jane VanBeek, MD

The following Leadership Development Steering Committee members reported they do have relationship(s) with commercial interest(s) to be

disclosed to learners:

PLANNER ROLE COMMERCIAL INTEREST

Ilona J. Frieden, MD Honoraria Consultant Pierre Fabre Dermatology

Honoraria Advisory Board TOPAZ Pharmaceuticals, Inc.

Elizabeth ShannonMartin, MD

Honoraria Speaker Medicis Pharmaceutical Corporation, Promius Pharma, LLC

Barbara M. Mathes, MD Consultant Fees Astellas Pharma US, Inc., Johnson & Johnson Consumer Products Company

Other Fees Valeant Pharmaceuticals International

The staff involved with this CME activity and all content validation/peer reviewers of this CME activity have reported no relevant financialrelationships with commercial interest(s).

1Relevant Financial Relationships:The ACCME defines relevant financial relationships as financial relationships in any amount occurringwithin the past twelve months that create a conflict of interest. Source: www.accme.org.

2Conflict of Interest:When an individuals interests are aligned with those of a commercial interest the interests of the individual are inconflict with the interests of the public. Source: www.accme.org.

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CME INFORMATIO

ADVANCE PROGRAM

|For the latest Program Book information please refer to www.aad.org

CONTENT VALIDATIONAcademy-sponsored educational activities are designed topromote improvements or quality in health care and not promotea specific proprietary business interest or a commercial interest.Presentations and related materials must be based on scientificmethods generally accepted by the medical community.

Presentations should be evidence-based and discuss the validityof the evidence upon which they base the opinion(s). (See Sackettet al, BMJ 1996;312:71-2.) This ensures the audience that therecommendations are supported by the evidence and contributesto management of any potential conflicts of interest. Further, if thepresentation includes discussion of unlabeled or investigationaluse of a commercial product, this also must be disclosed to theparticipants. CME must give a balanced view of therapeuticoptions. Use of generic names will contribute to this impartiality.

If CME educational material or content includes trade names, tradenames from several companies should be used where available,as opposed to using trade names from just a single company.Educational materials such as slides, abstracts, and handoutscannot contain any advertising or product-group messages.

OUTCOMES MEASUREMENTSeveral methods of evaluation are utilized in assessing theeducational program. Session directors, speakers, attendees, andformal observers are all given the opportunity to evaluate theeducational content and speaker performance. Included in thisprocess are measures to rate the success of the Academys policiesregarding independence in continuing medical education activitieswith particular focus on the absence of commercial bias.

In addition, the Academy may review speaker presentationsstored on the meeting servers to collect aggregate data regardingdisclosure. These data are only used to determine effectivenessof the Academys policies and procedures regarding disclosure.Should it be determined that a member of the Academys

educational program violated the Academys Policy to EnsureIndependence in Continuing Medical Education, the individualmay not be asked to participate in future educational programs.

DISCLAIMERThe American Academy of Dermatology is not responsible forstatements made by faculty. Statements or opinions expressedin this program reflect the views of the faculty and do not reflectthe official policy of the American Academy of Dermatology.The information provided at this CME activity is for continuingeducation purposes only and is not meant to substitute for theindependent medical judgment of a health care provider relativeto the diagnostic, management, and treatment options of aspecific patients medical condition.

ACCREDITATIONThe American Academy of Dermatology is accredited by theAccreditation Council for Continuing Medical Education to provcontinuing medical education for physicians.

AMA PRA CATEGORY 1 CREDITTMDESIGNATIONThe American Academy of Dermatology designates this liveactivity for a maximum of 45AMA PRA Category 1 CreditsTM.Physicians should claim only the credit commensurate with theextent of their participation in the activity.

AAD RECOGNIZED CREDITThe American Academy of Dermatologys Annual Meeting isrecognized by the American Academy of Dermatology for 45AAD Recognized Creditsand may be used toward the AmericaAcademy of Dermatologys Continuing Medical Education Awa

All Annual Meeting activities, unless otherwise specified, areapproved for direct-sponsored AAD Recognized Credit.

WHAT YOU NEED TO DO TO RECEIVECME CREDITCME credit is awarded based on actual participation in thelearning activities. An overall evaluation form and CME credit cform will be provided in the registration bag distributed on-siteregistration. New this year, all attendees will be able to complet

their session evaluations*and claim CME credits online using thfollowing link www.aad.org/evals. Please see page 40 for detailinstructions.

CME credits can also be claimed online at www.aad.org/cme/claThe online claim system is available for four weeks post meetingCredit is calculated on a -hour basis and will be reflected onmember transcripts within four to six weeks after the meeting.

*There will be a limited amount of paper evaluations located at easession room for those attendees who do not wish to completesession evaluations online. Hard copy CME claim forms will still bedistributed in the convention office located in Hall D (CC). Should

you decide to complete a hard copy CME claim form or sessionevaluation form, you can drop them into the boxes labeled CMEEvaluations throughout the duration of the meeting.

NON-MEMBER PHYSICIAN CME CREDITCERTIFICATENon-member physicians who attend the meeting can receive aCME Credit certificate which includes documentation of the totCME credits claimed. If you are a physician and would like toreceive a CME Credit certificate, please submit a copy of the CClaim Form and check yes where asked if you would like toreceive the CME Certificate.

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Phytoceuticals

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PROGRAM OVERVIEW

ADVANCE PROGRAM

|

FRIDAY, MARCH 1

Course 7 a.m. to 9 a.m.C03A Basic Self-Assessment of Dermatopathology ..............43

Focus Sessions 7:15 a.m. to 8:45 a.m.U001 Vulvar Disease: What do you know? An Overview ......43U002 The Tzanck Smear Test:

Reintroducing Our Good Old Fr iend ...........................43U003 Psychodermatology: Not Just a Delusion Bugs,

Trichotillomania, and the Morgellons Debate ..............43U004 Ten Tumors You Dont Want to Miss! Management

of Uncommon Tumors in the Mohs Surgical Unit ........43U005 Cutaneous Issues in Pediatric Oncology ......................44U006 Reconstruction in Dermatologic Surgery:

An Introductory and Review Session ............................44U007 Captain Cook and the Dawn of Pacific Dermatology .44U008 Novel Therapies to Treat Chronic Pruritus ...................44

U009 Procedural Safety in Dermatology ...............................44U010 Numerous and Large Cafe Au Lait Macules: Evaluation

and Management of NF1 and Related Disorders ........44U011 Building Beauty: Understanding Facial Proportions,

Phi, and Use of Volumizing Soft Tissue Fillers ..............44U012 Merkel Cell Carcinoma: Practical Tips and Advances

in Management ............................................................45U013 Great Mimickers Beyond Syphilis .................................45U014 Treatment and Prevention of Actinic Keratoses and

other Non-Melanoma Skin Cancers .............................45U015 Past, Present, and Pearls of Treatment of

Autoimmune Bullous Disease.......................................45U016 Diagnosis and Management of Unusual Skin Tumors ..45

U017 A Primer of Pharmaceutical Advertising:Sometimes its Just Wrong ...........................................45

U018 Current Issues in Geriatric Dermatology ......................45

Symposia 9 a.m. to 12 p.m.S001 Therapeutic Hotline......................................................46

S002 Alopecia: Work-Up and Treatment...............................46S003 Melanoma Update .......................................................46S004 Resident Jeopardy .......................................................46S005 Key Surgical Principles We All Should Know................46S006 Common, Challenging and Controversial Short Topics

in Patient Management ................................................46S007 Acne and Rosacea ........................................................46

Courses 9 a.m. to 12 p.m.C001 Live Demonstration: Head and Neck Anatomy:

Cadaver Prosection .....................................................C002 Coding, Documentation and Practice Management ..

Courses 9 a.m. to 5 p.m.C004 Advanced Dermoscopy ..............................................C005 Pediatric Dermatology ................................................

Course 9:30 a.m. to 11 a.m.C03B Basic Self-Assessment of Dermatopathology ............

Discussion Group 10 a.m. to 12 p.m.D001 Defect Rounds ............................................................

Forums 10 a.m. to 12 p.m.

F001 Skin Signs of Internal Disease:Case-Based Challenges ...............................................F002 Practical Management of Atypical

Melanocytic Lesions ....................................................F003 Managing Group Dynamics, Part 1: Dream Team or

I Want to Scream Team...........................................F004 Hot Topics in Melanoma.............................................

F005 Cutaneous Lymphoma CPC: A Practical Approach ....F006 How to Have an Unforgettably Positive Office Visit ...

F007 Recent Developments in Dermatopathology:What Has Happened Since You Last Checked ...........

F008 Medical Dermatology Challenge: Complex Casesfrom the Collection of Dr. Samuel Moschella .............

F009 Medical Dermatology in Multicultural Skin .................F010 Managing Hair Loss Made Easy ..................................F011 Merkel Cell Carcinoma: Diagnosis, Management

and Controversies ......................................................F012 Aesthetic Dermatologic Complications ......................

F013 Wounded Warrior Traumatic Injuries ..........................F014 Surgical Cases We Wish We Could Do Over .............

Workshop 10 a.m. to 12 p.m.W001 MOC Self-Assessment: Dermatopathology ................

Course 12:30 p.m. to 2:30 p.m.C03C Basic Self-Assessment of Dermatopathology ...........

Restricted Session open to dermatologists and adjunct (researcher,

corporate) members. A ticket is required for admittance only for

workshops and courses

Practice Management Session open to eligibleoffice staff/registered nurses

Patient Safety Session

Audience Response System Session

MO

C

This activity has been approved or is pending approval by theABD to satisfy component 2 of MOC

Leadership Institute addresses leadership competenciesspecific to dermatologists

Health Information Technology Session

Evidence-Based Practice Session

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PROGRAM OVERVIEW

16 | AMERICAN ACADEMY OF DERMATOLOGY 71ST ANNUAL MEETING

Discussion Group 1 p.m. to 3 p.m.D002 Best Practice for Teaching in the Clinic ........................54

Workshop 1 p.m. to 3 p.m.W002 MOC Self-Assessment: Pediatric Dermatology ...........54

Forums 1 p.m. to 3 p.m.F015 Epidermolysis Bullosa: Cases and Discussion ..............55F016 Atypical Wound Diagnosis and Management ..............55F017 Managing Group Dynamics, Part 2: Politics, People

and Performance in Organizations ...............................55F018 Nailing Onychomycosis ................................................55

F019 Fractional Laser and Light Based Technologies ...........55F020 Management of the Vitiligo Patient .............................55

F021 Use of Physician Extenders ..........................................55F022 Half-Truths, Lies, and Statistics: Understanding

Medical Statistics for the Practitioner ..........................55

F023 Aesthetic and Surgical Procedures in Latin America ...56F024 Examining in Dermatology Clinic: Beyond the Skin .....56F025 Skin Cancer Viruses: Bench to Bedside ........................56F026 The Future of Dermatology: What Changes

are Coming and How Can We Prepare? ......................56

Courses 2 p.m. to 5 p.m.C006 Live Demonstration: Advanced Botulinum Toxin .........56C007 Translating Evidence into Practice:

Psoriasis Guidelines ......................................................57

Symposia 2 p.m. to 5 p.m.S009 Consultative Dermatology for

the Hospitalized Patient ...............................................57S010 Hot Topics ....................................................................57

S011 Clinical Issues in Medical Dermatology........................57S012 Cutaneous Complications in Oncology and

Bone Marrow Transplant Patients ................................58S013 Reflectance Confocal Microscopy:

Current and Future .......................................................58S014 Nails .............................................................................58

S015 Cosmetics .....................................................................58

Discussion Group 3:30 p.m. to 5:30 p.m.D003 Cutaneous Mucinosis ...................................................59

Forums 3:30 p.m. to 5:30 p.m.F027 Burning Mouth Syndrome:

Whats New in Fire Fighting? .......................................59

F028 The Red Face: To Patch or Not to Patch? ....................59F029 Sclerosing Skin Conditions State of the Art

Diagnosis Evaluation and Therapy ...............................59F030 Vitiligo: Therapeutic Challenges

(Medical and Surgical) ..................................................60 F031 Medication Monitoring and Complications .................60 F032 Apps for Derm..............................................................60F033 Pediatric Psoriasis: Systemic Therapy and Beyond ......60F034 Pregnancy Dermatoses: Moving Towards

a Better Understanding ................................................60 F035 Medium and Deep Chemical Peeling in 2013 .............60F036 Lumps and Bumps in Children .....................................60

Course 3 p.m. to 5 p.m.C03D Basic Self-Assessment of Dermatopathology ..............61

Workshops 3:30 p.m. to 5:30 p.m.

W003 MOC Self-Assessment: Acne .......................................61W004 Dermoscopy Cases .......................................................62

FRIDAY, SATURDAY, MARCH 1, 2Symposium 9 a.m. to 5 p.m.S008 Gross and Microscopic Dermatology ..........................62

Courses 9 a.m. to 5 p.m.C008 Structure and Function of the Skin...............................64C009 Dermatology Review ....................................................65

SATURDAY, MARCH 2Poster Discussion 7:15 a.m. to 8:45 a.m.

TBD ...............................................................................68

Focus Sessions 7:15 a.m. to 8:45 a.m.U019 The Management of TEN/SJS: The US Army

Burn Unit Experience ...................................................68U020 Hyperhidrosis and Hypertrichosis in Children

and Adolescents ...........................................................68U021 Full Facial Approach with Botulinum Toxin and Fillers:

Cases From a European Practice .................................68U022 Dermatoscopy Beyond Pigmented Lesions .................68U023 Molecular Diagnostics in Dermatopathology:

Melanoma and other Applications ...............................69U024 Cutaneous Lupus and Dermatomyositis: Management

Pearls and Pitfalls for the General Dermatologist ........69U025 Facing Facial Dermatoses ............................................69U026 Hair Transplantation .....................................................69

Restricted Session open to dermatologists and adjunct (researcher,corporate) members. A ticket is required for admittance only for

workshops and courses

Practice Management Session open to eligibleoffice staff/registered nurses

Patient Safety Session

Audience Response System Session

MO

C

This activity has been approved or is pending approval by theABD to satisfy component 2 of MOC

Leadership Institute addresses leadership competenciesspecific to dermatologists

Health Information Technology Session

Evidence-Based Practice Session

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IMPORTANT SAFETY INFORMATIONSERIOUS INFECTIONSPatients treated with Enbrel (etanercept) are at increased risk for developing seriousinfections that may lead to hospitalization or death. Most patients who developed theseinfections were taking concomitant immunosuppressants such as methotrexate orcorticosteroids or were predisposed to infection because of their underlying disease. ENBRELshould not be initiated in the presence of sepsis, active infections, or allergy to ENBREL orits components. ENBREL should be discontinued if a patient develops a serious infectionor sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of

latent TB. Patients with TB have frequently presented with disseminated or extrapulmonarydisease. Patients should be tested for latent TB before ENBREL use and periodically duringtherapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasivefungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergill osis,blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungalinfections may present with disseminated, rather than localized, disease. Antigen andantibody testing for histoplasmosis may be negative in some patient s with activeinfection. Empiric antifungal therapy should be considered in patients at risk for invasivefungal infections who develop severe systemic illness, and 3) Bacterial, viral, and otherinfections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with ENBREL should be carefully considered prior toinitiating therapy in patients 1) with chronic or recurrent infecti on, 2) who have beenexposed to TB, 3) who have resided or traveled in ar eas of endemic TB or endemic mycoses,or 4) with underlying conditions that may predispose them to infections such as advancedor poorly controlled diabetes. Patients should be closely monitored for the development

of signs and symptoms of infection during and after treatment with ENBREL, includingthe possible development of TB in patients who tested negative for latent TB prior toinitiating therapy.

MALIGNANCIESLymphoma and other malignancies, some fatal, have been reported in children andadolescent patients treated with tumor necrosis factor (TNF) blocker s, including ENBREL.

In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to controlpatients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients. Therole of TNF blocker therapy in the development of malignancies is unknown.

Cases of acute and chronic leukemia have been reported in association with postmarketing TNFblocker use in RA and other indications. The risk of leukemia may be higher in patients with RA(approximately 2-fold) than the general population.

Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with

TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patientsat increased risk for sk in cancer.

Pediatric PatientsIn patients who initiated therapy at 18 years of age, approximately half of the reportedmalignancies were lymphomas (Hodgkins and non-Hodgkins lymphoma). Other cases includedrare malignancies usually associated with immunosuppression and malignancies that are notusually observed in children and adolescents. Most of the patients were receiving concomitantimmunosuppressants.

NEUROLOGIC EVENTSTreatment with TNF-blocking agents, including ENBREL, has been associated with rare(< 0.1%) cases of new onset or exacerbation o f central nervous sys tem demyelinating disorders,some presenting with mental status changes and some associated with permanent disability,and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis,optic neuritis, multiple sclerosis, Guillain-Barr syndromes, ot her peripheral demyelinatingneuropathies, and new onset or exacerbation of seizure disorders have been reported inpostmarketing experience with ENBREL therapy. Prescribers should exercise caution inconsidering the use of ENBREL in patients with preexisting or recent-onset central or peripheralnervous system demyelinating disorders.

CONGESTIVE HEART FAILURECases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have beenreported in patients taking ENBREL. Caution should be used when using ENBREL in patientswith CHF. These patients should be carefully monitored.

HEMATOLOGIC EVENTSRare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causarelationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL inpatients who have a previous history of significant hematologic abnormalities. Advise patientsto seek immediate medical at tention if they develop signs or symptoms of blood dyscrasias orinfection. Consider discontinuing ENBREL if significant hematologic abnormalities are conf irmed.

HEPATITIS B VIRUS REACTIVATIONUse of TNF blockers, including ENBREL, has been associated with reactivation of hepatitis Bvirus (HBV) in chronic carriers of this virus. The majority of these report s occurred in patientson concomitant immunosuppressive agents, which may also contribute to HBV reactivation.Exercise caution when considering ENBREL in patients identified as carriers of HBV.

ALLERGIC REACTIONSAllergic reactions have been reported in < 2% of patients in clinical trials of ENBREL.

IMMUNIZATIONSLive vaccines should not be administered to patients on ENBREL. JIA patients, if possible, shouldbe brought up to date with all immunizations prior to initiating ENBREL. In patients with exposureto varicella virus, consider temporary discontinuation of E NBREL and prophylactic treatment withVaricella Zoster Immune Globulin.

AUTOIMMUNITYAutoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmunehepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-likesyndrome or autoimmune hepatitis develops.

WEGENERS GRANULOMATOSIS PATIENTSThe use of ENBREL in patients with Wegeners granulomatosis receiving immunosuppressiveagents (e.g., cyclophosphamide) is not recommended.

MODERATE TO SEVERE ALCOHOLIC HEPATITISBased on a s tudy of patients treated for alcoholic hepatitis, exercise caution when using ENBRELin patients with moderate to severe alcoholic hepatitis.

ADVERSE EVENTSThe most commonly reported adverse events in RA clinical trials were injection site reaction,infection, and headache. In clinical trials of all other adult indications, adverse events were

similar to those reported in RA clinical trials.

DRUG INTERACTIONSThe use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended.The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrenttherapy with ENBREL and anakinra is not recommended. Hypoglycemia has been reportedfollowing initiation of ENBREL therapy in patients receiving medication for diabetes, necessitatina reduction in anti-diabetic medication in some of these patients.

References: 1. Data on file, Amgen. 2.Gottlieb AB, Matheson RT, Lowe N, et al. A randomized trial of etanercept as monotherapy

for psoriasis.Arch Dermatol. 2003;139:1627-1632. 3.Papp KA, Tyring S, Lahfa M, et al; for the Etanercept Psoriasis Study Group.

A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermato

2005;152:1304-1312. 4.Leonardi CL, Powers JL, Matheson RT, et al; for the Etanercept Psoriasis Study Group. Etanercept as

monotherapy in patients with psoriasis. N Engl J Med. 2003;349:2014-2022. 5.Tyring S, Gottlieb A, Papp K, et al. Etanercept

and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet.

2006;367:29-35. 6.Moore A, Gordon KB, Kang S, et al. A randomized, open-label trial of continuous versus interrupted etanercept

therapy in the treatment of psoriasis.J Am Acad Dermatol. 2007;56:598-603. 7.Enbrel (etanercept) Prescribing Information,

Immunex Corporation, Thousand Oaks, Calif. December 2011. 8.Gordon KB, Gottlieb AB, Leonardi CL, et al; for the EtanerceptPsoriasis Study Group. Clinical response in psoriasis patients discontinued from and then reinitiated on etanercept therapy.

J Dermatolog Treat. 2006;17:9-17.

Please see Brief Summary of Prescribing Information on following pages.

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SEEthe long-term

SEE the long-term safety profile Safety data from 7 PsO trials that included 4,410 patients1-6

1,174 patients with 3 years of continuous exposure1

Serious adverse event rates studied through 3 years of continuous treatment1

SEE the long-term, recapturable efficacy Sustained efficacy for up to 2.5 years1

In clinical trials, nearly half of patients saw significant improvement intheir moderate to severe plaque psoriasis symptoms at 3 months ofusing ENBREL. Overall, 3 out of 4 patients saw improvement at 3 months1,7

ENBREL recaptured almost all of its initial response following suspensionof treatment for up to 5 months1,7,8

Please see Important Safety Information on previous page.

Please see Brief Summary of Prescribing Information on following pages.

SEE the long-term experience 18 years of clinical experience in rheumatoid arthritis (RA)1,7*

13 years of postmarketing experience in moderate to severeRA since 19981

7 years of postmarketing experience in moderate to severePsO since 20041

*Initial clinical research in RA patients began in 1993. ENBREL approved for psoriatic arthritis in 2002 and for adultchronic moderate to severe plaque psoriasis in 2004.

These actual ENBREL patients got back to doing many of the things they love

In adult chronicmoderate to severeplaque psoriasis (PsO)

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experience of ENBREL

Important Safety Considerations: ENBREL has been associated withserious and sometimes fatal infections, including opportunistic infect ionsand TB. Malignancies, neurologic events, hematologic events, and hepatitis B reactivation have also been reported.Common adverse reactions:headache, infection, and injection site reaction. ENBREL is contraindicated in patients with sepsis.

Prescription ENBREL is administered by injection.

ENBREL is indicated for:

The treatment of adult patients (18 years or o lder) with chronic moderate to s evereplaque psoriasis who are candidates for systemic therapy or phototherapy.

Reducing signs and symptoms, inhibiting the progression of structural damageof active arthritis, and improving physical function in patients with psoriaticarthritis. ENBREL can be used in combination with methotrexatein patients who do not respond adequately to methotrexate alone.

64923-R4-V1

SAFETY

PROFILE EFFICACY EXPERIENCE

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Enbrel(etanercept) Brief Summary

SEE PACKAGE INSERT FOR FU LL PRESCRIBING INFORMATION

WARNINGSSERIOUS INFECTIONS AND MALIGNANCIES

Patients treated with Enbrel are at increased risk for developing seriousinfections that may lead to hospitalization or death [see Warnings andPrecautions and Adverse Reactions]. Most patients who developed theseinfections were taking concomitant immunosuppressants such asmethotrexate or corticosteroids.

Enbrel should be discontinued if a patient develops a serious infectionor sepsis.

Reported infections include:

Active tubercul osis, includi ng reactivati on of latent tubercul osis. Patien ts

with tuberculosis have frequently presented with disseminated orextrapulmonary disease. Patients should be tested for latent tuberculosisbefore Enbrel use and during therapy. Treatment for latent infectionshould be initiated prior to Enbrel use.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis,candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patientswith histoplasmosis or other invasive fungal infections may present withdisseminated, rather than localized, disease. Antigen and antibodytesting for histoplasmosis may be negative in some patients with activeinfection. Empiric anti-fungal therapy should be considered in patients atrisk for invasive fungal infections who develop severe systemic illness.

Bacterial, viral, and other infections due to opportunistic pathogens,including Legionella and Listeria.

The risks and benefits of treatment with Enbrel should be carefullyconsidered prior to initiating therapy in patients with chronic or recurrentinfection.

Patients should be closely monitored for the development of signs andsymptoms of infection during and after treatment with Enbrel, includingthe possible development of tuberculosis in patients who tested negativefor latent tuberculosis infection prior to initiating therapy.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported

in children and adolescent patients treated with TNF blockers,including Enbrel.

INDICATIONS AND USAGE

Rheumatoid Arthritis

Enbrel is indicated for reducing signs and symptoms, inducing major clinicalresponse, inhibiting the progression of structural damage, and improvingphysical function in patients with moderately to severely active rheumatoidarthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX)or used alone.

Polyarticular Juvenile Idiopathic Arthritis

Enbrel is indicated for reducing signs and symptoms of moderately to severelyactive polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2and older.

Psoriatic Arthritis

Enbrel is indicated for reducing signs and symptoms, inhibiting theprogression of structural damage of active arthritis, and improving physicalfunction in patients with psoriatic arthritis (PsA). Enbrel can be used incombination with methotrexate (MTX) in patients who do not respondadequately to MTX alone.

Ankylosing Spondylitis

Enbrel is indicated for reducing signs and symptoms in patients with active

ankylosing spondylitis (AS).

Plaque Psoriasis

Enbrel is indicated for the treatment of adult patients (18 years or older) withchronic moderate to severe plaque psoriasis (PsO) who are candidates forsystemic therapy or phototherapy.

CONTRAINDICATIONS

Enbrel should not be administered to patients with sepsis.

WARNINGS AND PRECAUTIONS

Serious Infections

Patients treated with Enbrel are at increased risk for developing seriousinfections involving various organ systems and sites that may lead tohospitalization or death.

Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral,parasitic, or other opportunistic pathogens including aspergillosis,blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis,listeriosis, pneumocystosis, and tuberculosis have been reported with TNFblockers. Patients have frequently presented with disseminated rather thanlocalized disease.

Treatment with Enbrel should not be initiated in patients with an activeinfection, including clinically important localized infections. Patients greaterthan 65 years of age, patients with co-morbid conditions, and/or patientstaking concomitant immunosuppressants (such as corticosteroids or

methotrexate), may be at greater risk of infection. The risks and benefits oftreatment should be considered prior to initiating therapy in patients: withchronic or recurrent infection; who have been exposed to tuberculosis; with ahistory of an opportunistic infection; who have resided or traveled in areas ofendemic tuberculosis or endemic mycoses, such as histoplasmosis,coccidioidomycosis, or blastomycosis; or with underlying conditions that maypredispose them to infection, such as advanced or poorly controlled diabetes[see Adverse Reactions].

Patients should be closely monitored for the development of signs andsymptoms of infection during and after treatment with Enbrel.

Enbrel should be discontinued if a patient develops a serious infection orsepsis. A patient who develops a new infection during treatment with Enbrelshould be closely monitored, undergo a prompt and complete diagnosticworkup appropriate for an immunocompromised patient, and appropriateantimicrobial therapy should be initiated.

Tuberculosis

Cases of reactivation of tuberculosis or new tuberculosis infections have beenobserved in patients receiving Enbrel, including patients who have previouslyreceived treatment for latent or active tuberculosis. Data from clinical trialsand preclinical studies suggest that the risk of reactivation of latenttuberculosis infection is lower with Enbrel than with T NF-blocking monoclonalantibodies. Nonetheless, postmarketing cases of tuberculosis reactivationhave been reported for TNF blockers, including Enbrel. Tuberculosis has

developed in patients who tested negative for latent tuberculosis prior toinitiation of therapy. Patients should be evaluated for tuberculosis risk factorsand tested for latent infection prior to initiating Enbrel and periodically duringtherapy. Tests for latent tuberculosis infection may be falsely negative whileon therapy with Enbrel.

Treatment of latent tuberculosis infection prior to therapy with T NF-blockingagents has been shown to reduce the risk of tuberculosis reactivation duringtherapy. Induration of 5 mm or greater with tuberculin skin testing should beconsidered a positive test result when assessing if treatment for latenttuberculosis is needed prior to initiating Enbrel, even for patients previouslyvaccinated with Bacille Calmette-Guerin (BCG).

Anti-tub erculos is therap y should also be conside red prior to initiat ion ofEnbrel in patients with a past history of latent or active tuberculosis in whoman adequate course of treatment cannot be confirmed, and for patients with anegative test for latent tuberculosis but having risk factors for tuberculosisinfection. Consultation with a physician with expertise in the treatment oftuberculosis is recommended to aid in the decision whether initiating anti-

tuberculosis therapy is appropriate for an individual patient.

Tuberculosis should be strongly considered in patients who develop a newinfection during Enbrel treatment, especially in patients who have previouslyor recently traveled to countries with a high prevalence of tuberculosis, or whohave had close contact with a person with active tuberculosis.

Invasive Fungal Infections

Cases of serious and sometimes fatal fungal infections, includinghistoplasmosis, have been reported with TNF blockers, including Enbrel. Forpatients who reside or travel in regions where mycoses are endemic, invasivefungal infection should be suspected if they develop a serious systemicillness. Appropriate empiric antifungal therapy should be considered while adiagnostic workup is being performed. Antigen and antibody testing forhistoplasmosis may be negative in some patients with active infection. Whenfeasible, the decision to administer empiric antifungal therapy in thesepatients should be made in consultation with a physician with expertise in thediagnosis and treatment of invasive fungal infections and should take intoaccount both the risk for severe fungal infection and the risks of antifungaltherapy. In 38 Enbrel clinical trials and 4 cohort studies in all approvedindications representing 27,169 patient-years of exposure (17,696 patients)from the United States and Canada, no histoplasmosis infections werereported among patients treated with Enbrel.

Neurologic Events

Treatment with TNF-blocking agents, including Enbrel, has been associatedwith rare (

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immunosuppressive agents is not recommended. In a study of patients withWegeners granulomatosis, the addition of Enbrel to st andard therapy (includingcyclophosphamide) was associated with a higher incidence of non cutaneoussolid malignancies and was not associated with improved clinical outcomeswhen compared with standard therapy alone [see Drug Interactions].

Use with Anakinra or Abatacept

Use of Enbrel with anakinra or abatacept is not recommended [seeDrug Interactions].

Use in Patients with Moderate to Severe Alcoholic Hepatitis

In a study of 48 hospitalized patients treated with Enbrel or placebo formoderate to severe alcoholic hepatitis, the mortality rate in patients treatedwith Enbrel was similar to patients treated with placebo at 1 month butsignificantly higher after 6 months. Physicians should use caution when usingEnbrel in patients with moderate to severe alcoholic hepatitis.

ADVERSE REACTIONS

Across clinical studies and postmarketi ng experience, the most seriousadverse reactions with Enbrel were infections, neurologic events, CHF, andhematologic events [see Warnings and Precautions]. The most commonadverse reactions with Enbrel were infections and injection site reactions.

Clinical Studies Experience

Adverse Reactions in Adult Patients With Rheumatoid Arthritis, PsoriaticArthritis, Ankylosing Spondylitis, or Plaque Psoriasis

The data described below reflect exposure to Enbrel in 2219 adult patientswith RA followed for up to 80 months, in 182 patients with PsA for up to 24months, in 138 patients with AS for up to 6 months, and in 1204 adult patientswith PsO for up to 18 months.

In controlled trials, the proportion of Enbrel-treated patients who discontinuedtreatment due to adverse events was approximately 4% in the indications studied.

Because clinical trials are conducted under widely varying conditions,adverse reactions rates observed in the clinical trials of a drug cannot bedirectly compared to rates in the clinical trials of another drug and may notpredict the rates observed in clinical practice.

Infections

Infections, including viral, bacterial, and fungal infections, have beenobserved in adult and pediatric pati ents. Infect ions have been noted in all bodysystems and have been reported in patients receiving Enbrel alone or incombination with other immunosuppressive agents.

In controlled portions of trials, the types and severity of infection were similar

between Enbrel and the respective control group (placebo or MTX for RA andPsA patients) in RA, PsA, AS and PsO patients. Rates of infections in RAand PsO patients are provided in Table 3 and Table 4, respectively.Infections consisted primarily of upper respiratory tract infection, sinusitisand influenza.

In controlled portions of trials in RA, PsA, AS and PsO, the rates of seriousinfection were similar (0.8% in placebo, 3.6% in MTX, and 1.4% in Enbrel/Enbrel + MTX-treated groups). In clinical trials in rheumatologic indications,serious infections experienced by patients have included, but are not limitedto, pneumonia, cellulitis, septic arthritis, bronchitis, gastroenteritis,pyelonephritis, sepsis, abscess and osteomyelitis. In clinical trials in PsO,serious infections experienced by patients have included, but are not limitedto, pneumonia, cellulitis, gastroenteritis, abscess and osteomyelitis. The rateof serious infections was not increased in open-label extension trials and wassimilar to that observed in Enbrel- and placebo-treated patients fromcontrolled trials.

In 66 global clinical trials of 17,505 patients (21,015 patient-years of therapy),tuberculosis was observed in approximately 0.02% of patients. In 17,696patients (27,169 patient-years of therapy) from 38 clinical trials and 4 cohortstudies in the US and Canada, tuberculosis was observed in approximately0.006% of patients. These studies include reports of pulmonary andextrapulmonary tuberculosis [see Warnings and Precautions].

Injection Site Reactions

In placebo-controlled trials in rheumatologic indications, approximately 37%of patients treated with Enbrel developed injection site reactions. In controlledtrials in patients with PsO, 15% of patients treated with Enbrel developedinjection site reactions during the first 3 months of treatment. All injection sitereactions were described as mild to moderate (erythema, itching, pain,swelling, bleeding, bruising) and generally did not necessitate drugdiscontinuation. Injection site reactions generally occurred in the first monthand subsequently decreased in frequency. The mean duration of injection sitereactions was 3 to 5 days. Seven percent of patients experienced redness ata previous injection site when subsequent injections were given.

Immunogenicity

Patients with RA, PsA, AS or PsO were tested at multiple time points forantibodies to etanercept. Antibodies to the TNF receptor portion or otherprotein components of the Enbrel drug product were detected at least once insera of approximately 6% of adult patients with RA, PsA, AS or PsO. Theseantibodies were all non-neutralizing. Results from JIA patients were similar tothose seen in adult RA patients treated with Enbrel.

In PsO studies that evaluated the exposure of etanercept for up to 120 weeks,the percentage of patients testing positive at the assessed time points of 24,48, 72 and 96 weeks ranged from 3.6%8.7% and were all non-neutralizing.The percentage of patients testing positive increased with an increase in theduration of study; however, the clinical significance of this finding is unknown.No apparent correlation of antibody development to clinical response oradverse events was observed. The immunogenicity data of Enbrel beyond 120weeks of exposure are unknown.

The data reflect the percentage of patients whose test results wereconsidered positive for antibodies to etanercept in an ELISA assay, and arehighly dependent on the sensitivity and specificity of the assay. Additionally,the observed incidence of any antibody positivity in an assay is highlydependent on several factors, including assay sensitivity and specificity,assay methodology, sample handling, timing of sample collection,concomitant medications, and underlying disease. For these reasons,comparison of the incidence of antibodies to etanercept with the incidence ofantibodies to other products may be misleading.

Autoantibodies

Patients with RA had serum samples tested for autoantibodies at multipletime points. In RA Studies I and II, the percentage of patients evaluated forantinuclear antibodies (ANA) who developed new positive ANA (titer 1:40)was higher in patients treated with Enbrel (11%) than in placebo-treatedpatients (5%). The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15%of patients treated with Enbrel compared to 4% of placebo-treated patients)and by Crithidia luciliaeassay (3% of patients treated with Enbrel compared tonone of placebo-treated patients). The proportion of patients treated withEnbrel who developed anticardiolipin antibodies was similarly increased

compared to placebo-treated patients. In RA Study III, no pattern of increasedautoantibody development was seen in Enbrel patients compared to MTXpatients [see Warnings and Precautions].

Other Adverse Reactions

Table 3 summarizes adverse reactions reported in adult RA patients. Thetypes of adverse reactions seen in patients with PsA or AS were similar to thetypes of adverse reactions seen in patients with RA.

Table 3. Percent of Adult RA Patients Experiencing AdverseReactions in Controlled Clinical Trials

Placebo Controlleda

(Studies I, II, and aPhase 2 Study)

Active Controlledb

(Study III)

Placebo(N = 152)

Enbrel c

(N = 349)MTX

(N = 217)Enbrel c

(N = 415)

Reaction Per cent of Patients Percent of Patients

Infectiond(total)Upper Respiratory

Infectionse

Non-upper RespiratoryInfections

Injection SiteReactions

DiarrheaRashPruritusPyrexiaUrticariaHypersensitivity

3930

15

11

9211

5038

21

37

8323

8670

59

18

16195441

8165

54

43

16135221

aIncludes data from the 6-month study in which patients receivedconcurrent MTX therapy in both arms.

bStudy duration of 2 years.cAny dose.dIncludes bacterial, viral, and fungal infections.eMost frequent Upper Respiratory Infections were upper respiratorytract infection, sinusitis, and influenza.

In placebo-controlled PsO trials, the percentages of patients reportingadverse reactions in the 50 mg twice a week dose group were similar to thoseobserved in the 25 mg twice a week dose group or placebo group.

Table 4 summarizes adverse reactions reported in adult PsO patients fromStudies I and II.

Table 4. Percent of Adult PsO Patients Experiencing AdverseReactions in Placebo-Controlled Portions of Clinical Trials

(Studies I & II)

Placebo(N = 359)

Enbrel a

(N = 876)

Reaction Percent of Patients

Infectionb(total)Non-upper Respiratory InfectionsUpper Respiratory Infectionsc

Injection Site ReactionsDiarrheaRashPruritusUrticariaHypersensitivityPyrexia

2814

17

6

2121

2712

17

15

31111

aIncludes 25 mg SC QW, 25 mg SC BIW, 50 mg SC QW, and 50 mg SCBIW doses.

bIncludes bacterial, viral and fungal infections.cMost frequent Upper Respiratory Infections were upper respiratorytract infection, nasopharyngitis and sinusitis.

Adverse Reactions in Pediatric Patients

In general, the adverse reactions in pediatric patients were similar in f requencyand type as those seen in adult patients [see Warnings and Precautions]. Thetypes of infections reported in pediatric patients were generally mild andconsistent with those commo