2019 AMERICAN ACADEMY OF DERMATOLOGYANNUAL MEETING
cp-74265v1_821516_v2.indd 1 1/31/19 2:13 PM
Morbidity and mortality conferences can improve safetyM orbidity and mortality
conferences (MMC) are a staple in anesthesia
and surgery, but rare in dermatology. That difference is dermatology’s loss, said Alice J. Watson, MD, MPH, a dermatologist at Brigham and Women’s Hospital and assistant professor at Harvard Medical School.
“Morbidity and mortality conferences can be a powerful tool to drive safety and quality in your practice. We are not perfect, and the systems we work in are not perfect,” Dr. Watson said. “We all make
mistakes, take shortcuts, and get distracted. There is plenty to work with even if dermatology doesn’t have a lot of mortality.”
Dr. Watson discussed the theory and practice of MMC during Saturday’s “The Revamped Morbidity and Mortality Conference — A Must for All Dermatology Practices” (U035).
She organizes a quarterly dermatology MMC at lunchtime for providers and a breakfast MMC for other staff every six months. Any event that includes food attracts more attendees, she noted, and increased
attendance increases attention and impact.
Near misses are more common than lapses that affect patients and are no less important for lack of immediate patient harm.
“When you reduce near misses, you dramatically reduce the incidence of events that result in harm,” she said. “The more you focus on safety, the more attention people pay to safety. And it is easier to talk about a near miss than the time someone lost a biopsy specimen or misdiagnosed a cancer.”
Regular attention to safety pays off, Dr. Watson added. After more than two years of MMC, Brigham faculty surveys show the percentage of providers from whom they get feedback increased from 7% to 29%. The percentage of providers who believe mistakes will not be held against them jumped from 13% to 60%.
“It doesn’t have to be a disaster to be a useful MMC discussion,” she said. “Safety is about the things that happen every day. It is about raising awareness of safety issues in everything we do.”
Summer in the CityJoin the brightest minds in dermatology for an unforgettable educational experience in New York.
2019 AAD Summer MeetingNew York, New York
July 25–28, 2019NEW YORK HILTON
Alice J. Watson, MD, MPH: “Regular attention to safety pays off.”
Sunday’s Plenary lineup8-11:30 a.m.Ballroom B Paul Nghiem, MD, PhD“Less Toxic, More Effective: A Win-Win for Merkel Cell Carcinoma” Boris D. Lushniak, MD“I Acted and Behold, Service was Joy” Crystal L. Mackall, MD“Engineering T Cells for Cancer Therapy” Robin Farmanfarmaian“Patient Empowerment in the Digital Age” Diane M. Thiboutot, MD“In Search of the Next Isotretinoin” George J. Hruza, MD, MBAPresident-Elect’s Address Suzanne M. Olbricht, MDPresident’s Address
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THAN A MOISTURIZERAmLactin® gently exfoliatesplus deeply hydrates with beneficial levels of lactic acid
Experience the difference at booth #2925
SUNBURN ALERT: This product contains an alpha-hydroxy acid (AHA) that may increase your skin’s sensitivity to sunburn. Be sun smart: Use sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward.
Non-transplant alopecia treatments grow in popularity
T hree minimally invasive procedures are gaining traction for the
management of alopecia. As research continues and evidence mounts, experts discussed three key strategies during Saturday’s “Emerging Non-transplant Procedures and Drug Delivery for the Management of Complex Alopecias” (U034).
Platelet-rich plasma (PRP)PRP is the autologous high concentration of platelets in a small volume of plasma. It’s performed in a 10-minute process that’s comprised of five steps: Collect the blood, centrifuge it, remove platelet-poor plasma (PPP), re-suspend and collect PRP, and inject.
PRP treats hair loss by promoting vascularization and angiogenesis, triggering anagen entry, extending anagen duration, reducing inflammation and oxidative stress, and triggering hair stem cell regeneration. Neil S. Sadick, MD, clinical professor of dermatology at Weill Cornell Medical College in New York,
said the first sign that the treatment is working is that the patient will experience decreased shedding. If the patient hasn’t experienced hair growth by the five- to six-month mark, Dr. Sadick will discuss ending treatment.
See related PRP story in Dermatology World: www.aad.org/dw/monthly/ 2018/may/a-new-spin
MicroneedlingMicroneedling is the practice of wounding the skin to mimic embryonic follicle development and to express nascent follicles. By introducing microscopic punctures to the skin, the follicle infundibulum is dilated, and the patient will experience improved transepidermal and transfollicular delivery of hair growth agents.
Nicole Elaine Rogers, MD, a dermatologist with East Jefferson General Hospital in Metairie, Louisiana, said there is evidence that the process of wounding the skin alone can enhance hair growth. “Alone, it is probably not superior to existing alopecia therapies,” she
said. But in combination, she believes it is probably superior.
See related story in Dermatology World on microneedling: www.aad.org/dw/monthly/2018/september/the-many-uses-of-microneedling
Laser-assisted drug deliveryIn addition to microneedling, transdermal drug delivery treatments can include fractionated lasers. These create small channels through the
stratum corneum to the dermis and can include either ablative lasers or non-ablative lasers.
Sisters Ana Carina Junqueira Bertin, MD, and Ana Lucia Ariano Junqueira, MD, from Clinic 462 in São Paulo, Brazil, use fractional non-ablative lasers in their practice. These act as a wounding source, increase blood flow, impact cytokine expression, induce growth factor changes, and enhance penetration of topical agents.
From left to right: Nicole Elaine Rogers, MD, Neil S. Sadick, MD, Ana Lucia Ariano Junqueira, MD, and Maria K. Hordinsky, MD, share minimally invasive procedures for the management of alopecia.
The American Academy of Dermatology has selected its candidates in this year’s election. The Nominating Committee voted to present the following slate of candidates (listed in random order) to the membership for the 2019 Academy election of officers, directors, and Nominating Committee member representatives.
The election is open through Saturday, March 16. Vote online at www.aad.org/aadelection or from the 2019 AAD Meeting Mobile App.
4 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
Several Th2 cytokines, including IL-13, are key drivers of atopic dermatitis.1
BECOME ANATOPIC DERMATITIS
DETECTIVE
Reference: 1. Gittler JK, Shemer A, Suárez-Fariñas M, et al. J Allergy Clin Immunol. 2012;130(6):1344-1354.
Meeting unmet needs: Seeing patients as individuals
B etter understanding and representation of the variety of skin colors and
structures are needed in clinical studies and treatments. That was the message of the speakers at Saturday’s “Addressing Unmet Needs in Diverse Populations: Therapeutic, Aesthetic, and Investigational Approaches” (U036).
“Dermatologists can be the primary agents of change” by driving more understanding of these unique patient needs, said Hema Sundaram, MA, MD, a dermatologist in Rockville, Maryland. She said many patients with skin of color are experiencing suboptimal access to high quality medical care, lower rates of treatment, and worse treatment outcomes.
Seemal R. Desai, MD, a dermatologist from Plano, Texas, specifically called out three conditions that lack effective treatment in diverse populations: melasma, vitiligo, and psoriasis. Traditional treatments for melasma include topical retinoids, combination therapy, azelaic acid, hydroquinone, and chemical peels. However, he said tranexamic acid is an interesting option for visibly improving melasma because you can treat
for a shorter period of time and not use hydroquinone. He also encouraged further studies on men of color with melasma.
Dr. Desai pointed to the need to stabilize vitiligo, especially in patients from Southeast Asia and India, because they tend to be ostracized as a result of their condition. As a pearl, he suggested oral mini-pulse therapy and prescribing dexamethasone 4 mg daily on two consecutive days per week for eight weeks to get it under control. He said it is safer than prednisone.
“There is very little data on psoriasis for people of color,” he said. “We need more data, so we can offer biologic and topical treatments for these patients.”
Dr. Sundaram said there’s a growing occurrence of skin cancer and cutaneous malignancies in skin of color.
This is leading to increased morbidity and mortality in these patients because it’s usually found later. “There are atypical presentations when compared to what we see in Caucasians,” she said.
She encouraged the development of skin cancer prevention and screening programs specifically tailored for the African-American, Latin, and Asian populations.
For dermatology in particular, she said there are ethnic ideals of beauty that need to be respected.
“What constitutes beauty for Asian, Caucasian, and African-Americans is different,” she said. She questioned whether in the pursuit of the ideal ethnic face, patients are actually being ‘caucasianized,’ and in so doing, creating facial disharmony and dissatisfaction in patients.
Hema Sundaram, MA, MD
The American Academy of Dermatology Poster Exhibits Workgroup is pleased to announce the recipients of the 2019 Poster Awards.
Award nominees are selected and judged from a pool of the highest scoring abstracts submitted for poster presentation.
1st Place8059: Safety of 5a-reductase inhibitors and spironolactone in breast cancer patients receiving endocrine therapiesAuthors: Raquel Rozner, MD, Azael Freites-Martinez, MD, Jerry Shapiro, MD, Eliza B. Geer, MD, Shari Goldfarb, MD, Mario Lacouture, MD
2nd Place8555: Retrospective clinical, molecular, and outcome analysis of Spitzoid melanocytic tumors at a large volume academic medical center: A 10-year experienceAuthors: Sophia Zhang BS, Arivarasan Karunamurthy, MD, Jonhan Ho, MD, MS, Laura Ferris, MD, PhD, Jonathan Lee, MD
3rd Place9798: Hidradenitis Suppurativa is Associated with Increased Odds of Stroke, Coronary Artery Disease, Heart Failure, and PAD: A Population-Based Analysis in the United StatesAuthors: Rachael Ward, BS, MPH, Rayan Kaakati, BS, Tarannum Jaleel, BS, MD, Beiyu Liu, MS, PhD, Cindy Green, PhD
4th Place9824: Prevention of Taxane-Induced Alopecia and Nail ToxicityAuthors: Dustin H. Marks, BS, Azam A. Qureshi, BA, Adam Friedman, MD
Honorable Mention9909: Screening for Second Primary Melanoma in High Risk Patients: A Cost-Effectiveness AnalysisAuthors: Divya Seth, MPH, Margaret Krasne, MPH, Lyndon James, MBBS, MPH, Jane Kim, PhD, Jeremy Bordeaux, MD, MPH
”Be nice” and four more rules for young physicians
A rianne Shadi Kourosh, MD, MPH, a dermatologist
at Massachusetts General Hospital, wants to pass on some sage advice to young physicians. In fact, it’s the same advice she received when she was starting out, and some she wished she would have received.
Here are five pearls she presented during Saturday’s “Young Physician Pearls and Pitfalls: A Survival Guide for the First 10 Years” (F057).
1Protect your eyes. On the surface, this suggestion is literal. You
actually need to wear proper eye protection. But it goes beyond that, said Dr. Kourosh. You need to protect yourself and your ability to do your job in the long term. In this same vein, she recommends getting disability insurance while still a resident; this way, you’ll be locked into lower rates.
2Keep a paper trail. Dr. Kourosh said to document encounters
fairly and accurately. Learn accurate and prudent billing and coding procedures. Use neutral language, such as “declined” instead of “refused,” and record all pertinent discussions. It’s important to protect not only yourself, but your entire team.
3Pace yourself. It can be tempting to go after all of your goals at once,
but make sure to prioritize your health along the way. Sleep, exercise, meditate. Practice self-care habits that work for you, pursue your hobbies, and travel if it appeals to you.
4Be nice. Be a good neighbor to your colleagues. Help when
you can; cover for, support, and defend them. But it goes beyond your colleagues — be a good neighbor for those who work for
you as well. Show your entire team respect.
5Get involved. You can’t change the future of dermatology if you don’t
speak up for what you believe in. Run for office. Serve on
committees. Come to the AADA Legislative Conference.
And if you’re feeling stuck and needing help? The AAD is always available for education, advocation, and other resources and programs.
Young physicians chuckle as Arianne Shadi Kourosh, MD, MPH, tells them they “won’t be 21 forever” and other sage advice.
Several Th2 cytokines, including IL-13, are key drivers of atopic dermatitis.1
BECOME ANATOPIC DERMATITIS
DETECTIVE
Reference: 1. Gittler JK, Shemer A, Suárez-Fariñas M, et al. J Allergy Clin Immunol. 2012;130(6):1344-1354.
Actual COSENTYX patients compensated for their time.
Stay connected
#AAD2019 with the president of #2020 CILAD Madrid
@olzerpa
Blue light and Endothelin are implicated in the pathogenesis of #melasma. That’s just one of the gems from the unmasking facial pigmentation session this morning. Session jam packed! #AAD2019
@MRodriguesMD
Congrats to @DrScottElmanon a great presentation at #AAD2019 on ID-derm related complications related to immunosuppression! Thanks for representing #mgh #dermatology and the #medderm program so well!#dermtwitter
@DrStevenTChen
Exciting session on global dermatology at #AAD2019 with rock stars Toby Maurer @UCSFMedicine Claire Fuller @Fuller9Claire@ILDSDerm Esther Freeman @AADskin@Fogarty_NIH @NIH_NIAMS @GlobalHealthMGH #gloderm
@PeterKilmarx
@juleslipoff Biggest piece of advice for trainees (and myself when stuck)... do everything possible to find, discern etiology and focus treatment to that end (easier said than done). #itch #AAD2019
@DanielButlerMD
Atopic dermatitis is common, even among adults—but childhood disease is likely more persistent than previously thought, Dr. Aaron Drucker said at #AAD2019. @MDEdgeTweets
@jeffbcraven
TODAY’S TOP TWEETS #AAD2019 @AADmember
“Physician burnout is something that you have to fight against. The best way to do it is to develop a sense of gratitude. Every day, I go into the practice being thankful that I have patients who trust me to do a good job.”
Julie Harper, MDBirmingham, Alabama
“Begin with you. You have to think about why you wanted to be a physician. But then you also have to think about what sort of things you want to do for yourself. Make time for yourself, for activities, and broaden your approach to leaving your legacy, not just at work.
Markham Luke, MD, PhDGaithersburg, Maryland
“I think one of the most important things is to be well-rounded and to take time for yourself after work. Stay close to family and friends. Do different things that help you feel more at peace after a long, stressful day, like meditating, working out, and getting proper sleep.
Emily Boes, DOLakewood, Ohio
What have you done to cope with physician burnout?
WATER COOLER
CONNECT FOR TODAY’S TOP POSTS #AAD2019 @AADMember
Share your photos on Instagram to win big at the Annual Meeting!The Instagram Challenge is still on! Submit photos with friends and colleagues and have the chance to win big prizes! Use #AAD2019Challenge to enter.
Why are you voting?DW Election Correspondent Terry Cronin Jr., MD, asked Annual Meeting attendees about the top issues in the field — and snuck in a few Boards questions. Watch at www.aad.org/derm-on-the-street.
• Learn about AAD products and services.
• Demo products such as Simulated Patient Encounters, Digital Derm Coding Consult Pro, and Dermatology Patient Education Digital Subscription.
• Check out the Resident Corner to apply for membership or try out Board Prep Plus.
• Discover new tools in the AADA’s Practice Management Center to help with coding challenges, combating burnout, and meeting HIPAA requirements.
discounts on products. • Explore Preferred Provider
programs.
Explore professional growth resources at AADCareerCompass
Learn about DataDerm™, AAD’s data registry
Hear Dialogues in Dermatology LIVE!’s podcast
Additionally, you can:
AAD Resource CenterThe place to experience, explore, and interact.
HOURS: Sunday-Monday8 a.m.-5 p.m. | Hall D
TARGET AUDIENCEThe educational design of this activity addresses the needs of dermatologists, clinical immunologists, and other clinicians involved in the treatment and management of patients with pustular psoriasis.
EDUCATIONAL OBJECTIVESAfter completing this activity, the participant should be better able to:• Describe the genetic and pathophysiologic
mechanisms that contribute to the development of pustular psoriasis including factors that have informed the development of new therapies
• Comprehensively assess patients with suspected pustular psoriasis based on clinical manifestations, diagnostic criteria, and disease severity
• Describe the mechanistic rationales and clinical evidence for current and emerging biologic therapies for the treatment of generalized pustular psoriasis and palmoplantar pustulosis
• Individualize therapeutic regimens for pustular psoriasis, with a focus on generalized disease subtypes and palmoplantar pustulosis
PROGRAM AGENDA7:00–7:10 Preactivity Questionnaire and
Faculty Introductions 7:10–7:30 Introduction to Pustular Psoriasis
Pathophysiology 7:30–7:50 Evaluating Patients With
Generalized Pustular Psoriasis or Palmoplantar Pustulosis
7:50–8:20 Evolving Therapeutic Approaches for Patients With Pustular Psoriasis
8:20–8:40 Case Study Discussion: Prerecorded Patient Examples
8:40–9:00 Postactivity Questionnaire and Q&A Session
AMERICANS WITH DISABILITIES ACT Event staff will be glad to assist you with any special needs (ie, physical, dietary, etc). Please contact Christa Master prior to the live event at [email protected] program is independent and is not part of the official AAD Annual Meeting, as planned by its Scientific Assembly Committee. This program does not qualify for continuing medical education (CME) credit.
PROGRAM OVERVIEWPustular psoriasis is a relatively rare form of psoriasis and has historically been classified into generalized and localized forms of the disease.1 Generalized pustular psoriasis is characterized by widespread sterile pustules on erythematous skin, recurrent fever, and systemic flushing and malaise.1,2 Palmoplantar pustulosis, a localized form, is characterized by erythema, pruritis, burning, and pain on the palms of the hands and soles of the feet. Recent evidence suggests that IL36RN mutations are the most common genetic aberration linked to pustular psoriasis, with the allelic frequency distinguishing generalized pustular psoriasis from palmoplantar pustulosis; the former shows a 4 to 1 increase versus the latter.3 Whether pustular psoriasis presents as localized or generalized, patients are subject to significant health risks and poor quality of life outcomes due to both skin and systemic manifestations. Patients may be subject to delays in diagnosis, in part because the disease states are relatively rare and there are little solid epidemiologic data.4 Dermatologists are faced with limited guidance on selecting therapies for patients with any of the pustular psoriasis subtypes.1 Biologic agents for pustular psoriasis and palmoplantar pustulosis are being examined in clinical trials. These include some biologics approved for psoriasis as well as agents with novel therapeutic targets, such as an anti-interleukin (IL)-36 receptor antibody.5 This Clinical Issues symposium will use both lecture and faculty discussion among leading dermatology experts to explore many of these issues, with an emphasis on evolving diagnostic and management strategies for generalized pustular psoriasis and palmoplantar pustulosis.
REFERENCES1. Robinson A, Van Voorhees AS, Hsu S, et al. Treatment of pustular
psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2012;67(2):279-288.
2. Fujita H, Terui T, Hayama K, et al. Japanese guidelines for the management and treatment of generalized pustular psoriasis: The new pathogenesis and treatment of GPP. J Dermatol. 2018;45(11):1235-1270.
3. Twelves S, Mostafa A, Dand N, et al. Clinical and genetic differences between pustular psoriasis subtypes. J Allergy Clin Immunol. 2018. [Epub ahead of print.]
4. Benjegerdes KE, Hyde K, Kivelevitch D, Mansouri B. Pustular psoriasis: pathophysiology and current treatment perspectives. Psoriasis (Auckl). 2016;6:131-144.
5. Bachelez H, Choon S, Marrakchi S, et al. Efficacy and safety of BI 655130, an anti-interleukin-36 receptor antibody, in patients with acute generalized pustular psoriasis. Abstract D3T01.1E. EADV Congress; September 12-16, 2018; Paris, France.
This activity is jointly provided by Clinical and Patient Educators Association (CPEA) and Integritas Communications.
This activity is supported by an independent educational grant from Boehringer Ingelheim.
There is no registration fee for attending this program; however, seating is limited. Preregistration does not guarantee seating. We recommend arriving at the symposium location early.
Jeffrey J. Crowley, MD, FAADBakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California
Neil J. Korman, MD, PhDProfessor of Dermatology Department of Dermatology Case Western Reserve University Director, Clinical Trials Unit Clinical DirectorMurdough Family Center for Psoriasis University Hospitals Cleveland Medical Center
Cleveland, Ohio
Abby S. Van Voorhees, MDChair, Department of Dermatology Eastern Virginia Medical School Norfolk, Virginia
Jeffrey J. CrowleyBakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California
Neil J. KormanProfessor of Dermatology Department of Dermatology Case Western Reserve University
Abby S. Van VoorheesChair, Department of Dermatology Eastern Virginia Medical School Norfolk, Virginia
2019 BI PSORIASIS NewsAd R1.indd 1 1/29/19 3:53 PM
PREPARED BY FCB
Job #: 11101394Releasing as: PDFx1a Production: Debi Post X2844
March 2, 2019 at 2:45 PM | Industry Experts Theater | Booth #002
Come Join Our Industry Expert Session and Raise the Bar for Your Patients With Primary Axillary Hyperhidrosis
INDICATION QBREXZATM (glycopyrronium) cloth is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
IMPORTANT SAFETY INFORMATION Contraindications: QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
WARNINGS AND PRECAUTIONSWorsening of Urinary Retention: QBREXZA should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Patients with a history of urinary retention were not included in the clinical studies.
Control of Body Temperature: In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile: Transient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
ADVERSE REACTIONSThe most common adverse reactions seen in ≥2% of subjects treated with QBREXZA were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat
(2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions, including erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.
DRUG INTERACTIONSAnticholinergics: Coadministration of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
INSTRUCTIONS FOR ADMINISTERING QBREXZAInstruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one underarm, ONE TIME. Using the same cloth, apply the medication to the other underarm, ONE TIME. Inform patients that QBREXZA can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
USE IN SPECIFIC POPULATIONSPregnancy: There are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Lactation: There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
Renal Impairment: The elimination of glycopyrronium is severely impaired in patients with renal failure.
Please see Brief Summary of Full Prescribing Information on adjacent page.
QBREXZATM (glycopyrronium) cloth, 2.4%, for topical useThe following is a Brief Summary; refer to Full Prescribing Information for complete product information.
1 INDICATIONS AND USAGEQBREXZA is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
2 DOSAGE AND ADMINISTRATION
For topical use only.
QBREXZA is for topical use in the underarm area only and not for use in other body areas.
QBREXZA is administered by a single-use pre-moistened cloth packaged in individual pouches. QBREXZA should be applied to clean dry skin on the underarm areas only. QBREXZA should not be used more frequently than once every 24 hours.
Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once. Using the same cloth, wipe the other underarm once. A single cloth should be used to apply QBREXZA to both underarms.
Wash hands immediately with soap and water after applying and discarding the QBREXZA cloth. QBREXZA may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Avoid transfer of QBREXZA to the periocular area [see Warnings and Precautions (5.3)].
Do not apply QBREXZA to broken skin. Avoid using QBREXZA with occlusive dressings.
4 CONTRAINDICATIONS
QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA (e.g, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
5 WARNINGS AND PRECAUTIONS5.1 Worsening of Urinary Retention QBREXZA should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop.
Patients with a history of urinary retention were not included in the clinical studies.
5.2 Control of Body Temperature In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
5.3 Operating Machinery or an AutomobileTransient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
6 ADVERSE REACTIONS
The following adverse reactions are described in greater detail in other sections • Worsening of Urinary Retention [see Warnings and Precautions (5.1)]
6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two double-blind, vehicle-controlled clinical trials (Trial 1 [NCT02530281] and Trial 2 [NCT02530294]) of 459 subjects treated with QBREXZA once daily and 232 treated with vehicle, subjects were 9 to 76 years of age, 47% male, and the percentages of White, Black (including African Americans), and Asian subjects were 82%, 12%, and 1%, respectively.
Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with QBREXZA.
Table 1: Adverse Reactions Occurring in ≥2% of Subjects
Adverse ReactionsQBREXZA (N=459)
n (%)
Vehicle (N=232)
n (%)
Dry mouth 111 (24.2%) 13 (5.6%)
Mydriasis 31 (6.8%) 0
Oropharyngeal pain 26 (5.7%) 3 (1.3%)
Headache 23 (5.0%) 5 (2.2%)
Urinary hesitation 16 (3.5%) 0
Vision blurred 16 (3.5%) 0
Nasal dryness 12 (2.6%) 1 (0.4%)
Dry throat 12 (2.6%) 0
Dry eye 11 (2.4%) 1 (0.4%)
Dry skin 10 (2.2%) 0
Constipation 9 (2.0%) 0
Table 2 shows the most frequently reported local skin reactions, which were relatively common in both the QBREXZA and vehicle groups.
Table 2: Local Skin Reactions
Local Skin ReactionsQBREXZA (N=454)a
n (%)
Vehicle (N=231) a
n (%)
Erythema 77 (17.0%) 39 (16.9%)
Burning/stinging 64 (14.1%) 39 (16.9%)
Pruritus 37 (8.1%) 14 (6.1%)
aPatients with a post-baseline local skin reaction assessment
In an open-label safety trial (NCT02553798), 564 subjects were treated for up to an additional 44 weeks after completing Trial 1 or Trial 2. Adverse reactions occurring at a frequency ≥2.0% were: dry mouth (16.9%), vision blurred (6.7%), nasopharyngitis (5.8%), mydriasis (5.3%), urinary hesitation (4.2%), nasal dryness (3.6%), dry eye (2.9%), pharyngitis (2.2%), and application site reactions (pain [6.4%], dermatitis [3.8%], pruritus [3.8%], rash [3.8%], erythema [2.4%]).
7 DRUG INTERACTIONS7.1 AnticholinergicsCoadministration of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects [see Warnings and Precautions (5) and Adverse Reactions (6)]. Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyThere are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In pregnant rats, daily oral administration of glycopyrrolate (glycopyrronium bromide) during organogenesis did not result in an increased incidence of gross external or visceral defects. When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis, no adverse effects on embryo-fetal development were seen. The available data do not support relevant comparisons of systemic glycopyrronium exposures achieved in the animal studies to exposures observed in humans after topical use of QBREXZA.
The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
8.2 LactationThere are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
8.4 Pediatric UseThe safety, effectiveness and pharmacokinetics of QBREXZA have been established in pediatric patients age 9 years and older for topical treatment of primary axillary hyperhidrosis. Use of QBREXZA in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older [see Adverse Reactions (6.1)]. The safety and effectiveness of QBREXZA have not been established in pediatric patients under 9 years of age.
8.5 Geriatric UseClinical trials of QBREXZA did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects.
8.6 Renal ImpairmentThe elimination of glycopyrronium is severely impaired in patients with renal failure.
10 OVERDOSAGE
Because glycopyrronium is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrronium overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. Associated signs and symptoms related to excessive anticholinergic activity may include flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation and light sensitivity due to mydriasis.
In the case of overdose when symptoms are severe or life threatening, therapy may include:
• Managing per standard of care any acute conditions such as hyperthermia, coma, and/or seizures, as applicable, and managing any myoclonic or choreoathetoid movements which may lead to rhabdomyolysis in some cases of anticholinergic overdosage
• Managing severe urinary retention with catheterization if not spontaneously reversed within several hours
• Providing cardiovascular support and/or controlling arrhythmias
• Maintaining an open airway, providing ventilation as necessary
• Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate severe and/or life threatening peripheral anticholinergic effects.
Topical overdosing of QBREXZA could result in an increased incidence or severity of local skin reactions. Administration of QBREXZA under occlusive conditions may result in an increase in anticholinergic effects, including dry mouth and urinary hesitation.
16.2 Storage and HandlingStore at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].
QBREXZA is flammable; keep away from heat or flame.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Worsening of Urinary Retention Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder). Instruct patients to discontinue use and consult a physician immediately should any of these signs or symptoms develop.
Control of Body Temperature (Risk of Overheating or Heat Illness) In the presence of high ambient temperature, heat illness due to decreased sweating can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile Transient blurred vision may occur with QBREXZA. If this occurs, instruct patients to contact their healthcare provider, discontinue use of QBREXZA and avoid operating a motor vehicle or other machinery, or performing hazardous work until symptoms resolve.
Instructions for Administering QBREXZA It is important for patients to understand how to correctly apply QBREXZA (see Patient Information).
• Instruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one underarm, ONE TIME.
• Using the same cloth, apply the medication to the other underarm, ONE TIME.
• Inform patients that QBREXZA can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
• Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
• Remind patients not to apply QBREXZA to other body areas or to broken skin. Instruct patients to avoid using QBREXZA with occlusive dressings.
• QBREXZA is flammable; avoid use near heat or flame.
March 2, 2019 at 2:45 PM | Industry Experts Theater | Booth #002
Come Join Our Industry Expert Session and Raise the Bar for Your Patients With Primary Axillary Hyperhidrosis
INDICATION QBREXZATM (glycopyrronium) cloth is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
IMPORTANT SAFETY INFORMATION Contraindications: QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
WARNINGS AND PRECAUTIONSWorsening of Urinary Retention: QBREXZA should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Patients with a history of urinary retention were not included in the clinical studies.
Control of Body Temperature: In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile: Transient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
ADVERSE REACTIONSThe most common adverse reactions seen in ≥2% of subjects treated with QBREXZA were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat
(2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions, including erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.
DRUG INTERACTIONSAnticholinergics: Coadministration of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
INSTRUCTIONS FOR ADMINISTERING QBREXZAInstruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one underarm, ONE TIME. Using the same cloth, apply the medication to the other underarm, ONE TIME. Inform patients that QBREXZA can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
USE IN SPECIFIC POPULATIONSPregnancy: There are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Lactation: There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
Renal Impairment: The elimination of glycopyrronium is severely impaired in patients with renal failure.
Please see Brief Summary of Full Prescribing Information on adjacent page.
QBREXZATM (glycopyrronium) cloth, 2.4%, for topical useThe following is a Brief Summary; refer to Full Prescribing Information for complete product information.
1 INDICATIONS AND USAGEQBREXZA is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
2 DOSAGE AND ADMINISTRATION
For topical use only.
QBREXZA is for topical use in the underarm area only and not for use in other body areas.
QBREXZA is administered by a single-use pre-moistened cloth packaged in individual pouches. QBREXZA should be applied to clean dry skin on the underarm areas only. QBREXZA should not be used more frequently than once every 24 hours.
Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once. Using the same cloth, wipe the other underarm once. A single cloth should be used to apply QBREXZA to both underarms.
Wash hands immediately with soap and water after applying and discarding the QBREXZA cloth. QBREXZA may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Avoid transfer of QBREXZA to the periocular area [see Warnings and Precautions (5.3)].
Do not apply QBREXZA to broken skin. Avoid using QBREXZA with occlusive dressings.
4 CONTRAINDICATIONS
QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA (e.g, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
5 WARNINGS AND PRECAUTIONS5.1 Worsening of Urinary Retention QBREXZA should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop.
Patients with a history of urinary retention were not included in the clinical studies.
5.2 Control of Body Temperature In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
5.3 Operating Machinery or an AutomobileTransient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
6 ADVERSE REACTIONS
The following adverse reactions are described in greater detail in other sections • Worsening of Urinary Retention [see Warnings and Precautions (5.1)]
6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two double-blind, vehicle-controlled clinical trials (Trial 1 [NCT02530281] and Trial 2 [NCT02530294]) of 459 subjects treated with QBREXZA once daily and 232 treated with vehicle, subjects were 9 to 76 years of age, 47% male, and the percentages of White, Black (including African Americans), and Asian subjects were 82%, 12%, and 1%, respectively.
Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with QBREXZA.
Table 1: Adverse Reactions Occurring in ≥2% of Subjects
Adverse ReactionsQBREXZA (N=459)
n (%)
Vehicle (N=232)
n (%)
Dry mouth 111 (24.2%) 13 (5.6%)
Mydriasis 31 (6.8%) 0
Oropharyngeal pain 26 (5.7%) 3 (1.3%)
Headache 23 (5.0%) 5 (2.2%)
Urinary hesitation 16 (3.5%) 0
Vision blurred 16 (3.5%) 0
Nasal dryness 12 (2.6%) 1 (0.4%)
Dry throat 12 (2.6%) 0
Dry eye 11 (2.4%) 1 (0.4%)
Dry skin 10 (2.2%) 0
Constipation 9 (2.0%) 0
Table 2 shows the most frequently reported local skin reactions, which were relatively common in both the QBREXZA and vehicle groups.
Table 2: Local Skin Reactions
Local Skin ReactionsQBREXZA (N=454)a
n (%)
Vehicle (N=231) a
n (%)
Erythema 77 (17.0%) 39 (16.9%)
Burning/stinging 64 (14.1%) 39 (16.9%)
Pruritus 37 (8.1%) 14 (6.1%)
aPatients with a post-baseline local skin reaction assessment
In an open-label safety trial (NCT02553798), 564 subjects were treated for up to an additional 44 weeks after completing Trial 1 or Trial 2. Adverse reactions occurring at a frequency ≥2.0% were: dry mouth (16.9%), vision blurred (6.7%), nasopharyngitis (5.8%), mydriasis (5.3%), urinary hesitation (4.2%), nasal dryness (3.6%), dry eye (2.9%), pharyngitis (2.2%), and application site reactions (pain [6.4%], dermatitis [3.8%], pruritus [3.8%], rash [3.8%], erythema [2.4%]).
7 DRUG INTERACTIONS7.1 AnticholinergicsCoadministration of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects [see Warnings and Precautions (5) and Adverse Reactions (6)]. Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyThere are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In pregnant rats, daily oral administration of glycopyrrolate (glycopyrronium bromide) during organogenesis did not result in an increased incidence of gross external or visceral defects. When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis, no adverse effects on embryo-fetal development were seen. The available data do not support relevant comparisons of systemic glycopyrronium exposures achieved in the animal studies to exposures observed in humans after topical use of QBREXZA.
The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
8.2 LactationThere are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
8.4 Pediatric UseThe safety, effectiveness and pharmacokinetics of QBREXZA have been established in pediatric patients age 9 years and older for topical treatment of primary axillary hyperhidrosis. Use of QBREXZA in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older [see Adverse Reactions (6.1)]. The safety and effectiveness of QBREXZA have not been established in pediatric patients under 9 years of age.
8.5 Geriatric UseClinical trials of QBREXZA did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects.
8.6 Renal ImpairmentThe elimination of glycopyrronium is severely impaired in patients with renal failure.
10 OVERDOSAGE
Because glycopyrronium is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrronium overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. Associated signs and symptoms related to excessive anticholinergic activity may include flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation and light sensitivity due to mydriasis.
In the case of overdose when symptoms are severe or life threatening, therapy may include:
• Managing per standard of care any acute conditions such as hyperthermia, coma, and/or seizures, as applicable, and managing any myoclonic or choreoathetoid movements which may lead to rhabdomyolysis in some cases of anticholinergic overdosage
• Managing severe urinary retention with catheterization if not spontaneously reversed within several hours
• Providing cardiovascular support and/or controlling arrhythmias
• Maintaining an open airway, providing ventilation as necessary
• Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate severe and/or life threatening peripheral anticholinergic effects.
Topical overdosing of QBREXZA could result in an increased incidence or severity of local skin reactions. Administration of QBREXZA under occlusive conditions may result in an increase in anticholinergic effects, including dry mouth and urinary hesitation.
16.2 Storage and HandlingStore at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].
QBREXZA is flammable; keep away from heat or flame.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Worsening of Urinary Retention Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder). Instruct patients to discontinue use and consult a physician immediately should any of these signs or symptoms develop.
Control of Body Temperature (Risk of Overheating or Heat Illness) In the presence of high ambient temperature, heat illness due to decreased sweating can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile Transient blurred vision may occur with QBREXZA. If this occurs, instruct patients to contact their healthcare provider, discontinue use of QBREXZA and avoid operating a motor vehicle or other machinery, or performing hazardous work until symptoms resolve.
Instructions for Administering QBREXZA It is important for patients to understand how to correctly apply QBREXZA (see Patient Information).
• Instruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one underarm, ONE TIME.
• Using the same cloth, apply the medication to the other underarm, ONE TIME.
• Inform patients that QBREXZA can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
• Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
• Remind patients not to apply QBREXZA to other body areas or to broken skin. Instruct patients to avoid using QBREXZA with occlusive dressings.
• QBREXZA is flammable; avoid use near heat or flame.
12 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
Knocking down morbidity and mortality in pediatric dermatology
A dverse events are part and parcel of the practice of medicine, including
pediatric dermatology. But not all adverse events are created equal. Some are inherent risks of illness and all but impossible to avoid. And some adverse events are the result of errors in diagnosis or treatment, errors that can be avoided.
“There is always room for practice improvement, including in adult, pediatric, surgical, and dermatopathology aspects of dermatology,” said
Carrie C. Coughlin, MD, assistant professor of medicine at Washington University. “The only way we can avoid making the same mistakes or producing the same adverse outcomes is to evaluate events that have happened and use them as teaching points going forward.”
On Friday, Dr. Coughlin moderated “Pediatric Dermatology M&M,” a case-based session that focused on evaluating gaps in communication that can lead to error, learning to distinguish adverse events that are risks of therapy or disease and those that result from error, and discussing strategies for handling and coping with adverse events.
The blameless environmentFour cases explored complications encountered while caring for children in both inpatient and outpatient settings. The key, Dr. Coughlin said, is to create a blameless
environment in which all physicians can learn and improve their own practice. Look for common issues associated with melanocytic lesions in children, infectious complications, and non-accidental trauma, what patients and child safety experts more commonly call child abuse.
The ultimate goal is to improve patient outcomes by improving the care dermatologists deliver in every practice setting.
“These cases are representative of the patients we see both in the outpatient setting and in the hospital,” Dr. Coughlin said. “What is important is exploring how adverse events could be avoided or mitigated. This is information you can use to improve practice quality tomorrow.”
Practical pearlsMelanoma is far less common in children than in adults, but still an important diagnosis to make correctly. Often, the
key is distinguishing between a benign Spitzoid lesion and melanoma. The distinction is not always obvious, especially as melanoma can present differently in children, tweens, and adolescents.
Infectious complications are an everyday occurrence in the inpatient setting. Fungal infections are less common than bacterial infections in most pediatric units, but morbidity and mortality that result from fungal infections can be high without prompt diagnosis and management.
A heightened alertDermatologists are often involved when children are evaluated for non-accidental trauma. It is important to maintain a high index of suspicion when examining children with skin trauma. Even the most plausible tale of accident or denial of any known exposure may turn out to be a case of neglect or intentional harm.
Get your copy of the 2019 Onsite Meeting Guide to find vital meeting information such as:• Key elements• Daily highlights• AAD honors and
awards• Education
information
• Social media platforms
• Exhibit Hall floor plan and exhibitor lists
• Convention center maps
Carrie C. Coughlin, MD
Available in racks throughout the Walter E. Washington Convention Center
Brought to you byBe the first to know. Find out more at
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Dermpath Lab of Central States ................... 1818
▼To Hall D
(shown at right)Map sponsored by AbbVie
Exhibit Hall HoursSUNDAY: 10 a.m.-3 p.m.Unoppossed hours: 12-1 p.m.
Data current as of Jan. 10, 2019.
15DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
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Hall C Entrance
IndustryExpertsTheater
AAD Food Court
002
Hall B Entrance Hall A Entrance
INDUSTRY EXPERTS THEATERThese unique sessions provide exhibiting companies the opportunity to present new research findings on products; conduct demonstrations, detail products, and highlight new products. These sessions are solely promotional and are not eligible for continuing medical education credit.
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Hall C Entrance
IndustryExpertsTheater
AAD Food Court
002
Hall B Entrance Hall A Entrance
Hall D
▼TO AAD CONNECTION(Poster Exhibits, Resource Center, Networking Lounge)
DermTec, Inc. ............................................. 2861
These SkinMedica® products are intended to meet the FDA’s defi nition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements have not been evaluated by the FDA.
BLUE LIGHT EXPOSUREIS HERE TO STAYBUT WITH THE LUMIVIVE™ SYSTEM, SKIN DAMAGE DOESN’T HAVE TO
LUMIVIVE™ System helps your patients
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These SkinMedica® products are intended to meet the FDA’s defi nition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements have not been evaluated by the FDA.
BLUE LIGHT EXPOSUREIS HERE TO STAYBUT WITH THE LUMIVIVE™ SYSTEM, SKIN DAMAGE DOESN’T HAVE TO
LUMIVIVE™ System helps your patients
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20 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
PEARLS FROM MEMBERSSylvia Hsu, MDProfessor and Chair, Department of Dermatology, Temple University Lewis Katz School of Medicine
Potential for medical error
There are no particular conditions that have the
highest potential for medical errors. Rather, based on over two decades of my medical dermatology referral practice, there is one particular type of medical error that does stand out, which I call ‘answer key bias.’ However, the term in the literature is ‘blind obedience.’ This is a type of medical error that occurs when the practitioner places undue reliance on test results. I call it answer key bias because all too often the dermatologist treats the biopsy report as the answer key, rather than examining the patient and asking oneself if the histopathological diagnosis makes sense.”
“Eat, meet, and network at the AAD Food Court11 a.m. -2:30 p.m. Sunday.AAD Exhibit Floor located at the back of Hall C
International food stands offering a variety of healthy and delicious options. Ample seating available. Cash or credit accepted.
Dr. Wolf draws attention to two mystery skin disorders that Sherlock Holmes diagnosed in two of his short stories.
Can the classic detective Sherlock Holmes teach dermatologists a thing or two? The
answer is yes, according to John E. Wolf Jr., MD, MA, professor and chairman of the
department of dermatology at Baylor College of Medicine. Dr. Wolf led the Friday session
“The Game’s Afoot: Sherlock Holmes & The Art of Dermatologic Diagnosis.”
“The Adventure of the Blanched Soldier:” This scaly, white skin condition observed by Sherlock Holmes could be:• Tinea versicolor• Vitiligo• Leprosy• Pityriasis Alba
“The Adventure of the Lion’s Mane:” This condition observed in Sherlock Holmes’ story could be:• A deadly
encounter with a jellyfish (Cyanea capilata, the largest jellyfish in the world found in the deep, cold waters of the North Sea and the English Channel. Death is rare in healthy victims).
• An encounter with a Portuguese man o’ war.
“The temptation to form premature theories upon insufficient data is the bane of our profession.”
Sherlock Holmes, “The Adventure of the
Dying Detective”
T he literary chronicles of Holmes’ adventures hold many references
to dermatologic disorders and even more insights into the crucial art of observation and detection. The session looked at both Holmes’ literature and science, including specific diseases. Dr. Wolf offered clues in this audience participation session. Two of Holmes’ classic short stories, “The Adventure of the Blanched Soldier” and “The Adventure of the Lion’s Mane,” were a focus of Dr. Wolf ’s lessons in the Sherlockian principles of detection and applying these principles to the diagnosis of a wide variety of skin disorders.
“The world is full of observations. Yet, sometimes we look at something and don’t really know what’s there,” Dr. Wolf said. “We look at it, not for it. That’s an important lesson.”
Early clues to dermatologic diagnosis
Download the new AAD Meeting Mobile App
Session scheduleList of sessions by day, type, category, and speaker. Bookmark sessions you like, take notes, or access session handouts. ExhibitorsView the exhibit hall floor plan and search by name or category. Interactive maps, explore floor plans for session rooms, events, and other areas.
EventsFind details on specific events, such as Council, Committee, or Task Force meetings, Affiliate and
Reunion Groups, Industry Expert Sessions, and Industry Non-CME (INC) Programs.
Audience participationAccess Audience Response System sessions and provide feedback via your mobile device.
E-postersAccess e-posters and search by author, title, category, keyword, or poster number.
Vote Cast your ballot for AAD leadership.
NetworkLook up and message colleagues to make connections or stay in touch.
Find the most up-to-date information at the AAD Meeting Mobile App. The app’s real-time functionality is easy to navigate and includes countless features, including the following:
Download the AAD Meeting Mobile App now in the App Store or on Google Play by searching for “AAD Meetings.” For more information on the app, visit www.aad.org/mobile. For anyone using a platform other than iOS or Android, there will also be a mobile website with limited functionality. Mobile App assistance is available at the Walter E. Washington Convention Center in the Connection, Hall D
FAQs
Schedule Exhibitors
Maps
Speakers
CME/Evaluations
Event Listing SearchAudience Response
2019 AAD Annual MeetingWashington, D.C. • March 1–5, 2019
Additionally, you can:
EXPERIENCE • EXPLORE • INTERACTat the
AAD Resource Center in Hall D
✓ ✓
✓✓
✓✓
• Learn about dermatology’s premier clinical data registry, AAD’s DataDerm™.
• AADA’s Practice Management Center has new tools for 2019! Access content to help with coding challenges, combating burnout, and meeting HIPAA requirements.
• FREE professional headshots taken courtesy of AADCareerCompass. Plus, come take your #AAD2019 selfie!
• Don’t forget our expert staff and Preferred Providers will be on-hand to assist you.
• Receive personalized demos on products such as Dermatology Patient Education Digital subscription, Digital Derm Coding Consult Pro, Board Prep Plus, and Simulated Patient Encounters.
• 10% off select AAD products.
• 20% off one AAD product, see coupon below.
SHOP & SAVEWHAT’S NEW
SAVE AT THE AAD RESOURCE CENTER
20% OFFONE AAD PRODUCT*
* Offer only valid at the AAD Resource Center 3/1/19 – 3/4/19. Present this coupon at time of purchase. Coupon may only be used once and cannot be used on already discounted or previously purchased items. Discount excludes taxes, shipping and handling, meeting registration, membership dues, packs and bundles, JAAD subscription and third-party products. AMRC19
Present this coupon and get
Friday, March 1 – Monday, March 48 a.m. – 5 p.m. daily
• Learn about dermatology’s premier clinical data registry, AAD’s DataDerm™.
• AADA’s Practice Management Center has new tools for 2019! Access content to help with coding challenges, combating burnout, and meeting HIPAA requirements.
• FREE professional headshots taken courtesy of AADCareerCompass. Plus, come take your #AAD2019 selfie!
• Don’t forget our expert staff and Preferred Providers will be on-hand to assist you.
• Receive personalized demos on products such as Dermatology Patient Education Digital subscription, Digital Derm Coding Consult Pro, Board Prep Plus, and Simulated Patient Encounters.
• 10% off select AAD products.
• 20% off one AAD product, see coupon below.
SHOP & SAVEWHAT’S NEW
SAVE AT THE AAD RESOURCE CENTER
20% OFFONE AAD PRODUCT*
* Offer only valid at the AAD Resource Center 3/1/19 – 3/4/19. Present this coupon at time of purchase. Coupon may only be used once and cannot be used on already discounted or previously purchased items. Discount excludes taxes, shipping and handling, meeting registration, membership dues, packs and bundles, JAAD subscription and third-party products. AMRC19
Present this coupon and get
Friday, March 1 – Monday, March 48 a.m. – 5 p.m. daily
REFERENCES: 1. Takikawa M, Inoue S, Horio F, Tsuda T. Dietary anthocyanin-rich bilberry extract ameliorates hyperglycemia and insulin sensitivity via activation of AMP-activated protein kinase in diabetic mice. J Nutr. 2010;140(3):527-533. 2. Morgan N. What you need to know about xerosis in patients with diabetic feet. Wound Care Advisor. https://woundcareadvisor.com/what-you-need-to-know-about-xerosis-in-patients-with-diabetic-feet_vol2-no4/. Accessed June 25, 2018.
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T GET YOUR PERSONAL DOWNLOAD OF TODAY’S PROGRAMINVITATIONS, PRESCRIBING INFORMATION AND MORE.
This just in – latest of the late-breaking research
Highlights from “Late-breaking Research: Clinical Trials” (S034) During her late-breaking presentation, Dedee Murrell, MD, head of dermatology at The St. George Hospital Clinical School and the University of New South Wales in Sydney, Australia, shared her research in treating patients with pemphigus and avoiding adverse events associated with the prolonged use of corticosteroids.
“Pemphigus patients want to quickly control the disease with minimal or no corticosteroids or their associated toxicities,” Dr. Murrell said. “Principia’s oral BTK inhibitor, acting as an immune modulator, demonstrated positive phase I and II clinical results.”
Elena Peeva, MD, MSc, FACR, from Pfizer presented research on oral Janus Kinase inhibitors PF-06700841 and PF-06651600. Her work studied the clinically evident therapeutic effect in patients with alopecia areata at four and six weeks and the greater efficacy in patients with a shorter duration of their current alopecia episode over 24 weeks.
“In alopecia areata, oral JAK3 and TYK2/JAK1 inhibitors (PF-06651600 and PF-06700841, respectively) demonstrated onset of effect by six weeks. In a disease-episode shorter than 3.5 years, it was associated with greater 24-week response,” Dr. Peeva said.
In presenting his research of a phase IIb study of bimekizumab in providing “lasting relief” for patients with psoriasis, Andrew Blauvelt, MD, MBA, president of Research Excellence & Personalized Patient Care in Portland, Oregon, said results of his 60-week study yielded positive results.
“This demonstrates the value of the unique dual neutralization of IL-17F, along with IL-17A, and its potential to provide meaningful and lasting skin clearance for psoriasis and other inflammatory diseases,” he said.
In another study of psoriasis, Joel Gelfand, MD, MSCE, a dermatologist with Penn Medicine in Philadelphia, presented his findings on the safety of IL-17A inhibition in reducing the risk of cardiovascular disease.
Psoriasis increases the risk of cardiovascular inflammation and cardiovascular events. Specifically, his results showed that secukinumab has a neutral impact on aortic vascular inflammation and CV biomarkers.
Alice Gottlieb, MD, PhD, a dermatologist at New York Medical College, released the findings of her phase II study for novel therapy bermekimab in patients with hidradenitis suppurativa.
“Bermekimab findings in moderate-to-severe hidradenitis suppurativa show treatment is effective even in patients failing current approved biological therapy, and provides unprecedented reduction in severe pain associated with the disease,” Dr. Gottlieb said.
Similarly, Ted Lain, MD, a dermatologist in Pflugerville, Texas, shared two phase III studies of KX2-391 ointment with short five-day self-treatment for actinic keratosis.
His research yielded excellent efficacy and safety results. KX2-391 may be a valuable alternative treatment for AK patients, if approved, Dr. Lain said.
Highlights from Late-breaking Research: Clinical Studies/Pediatric” (F078)
John Barbieri, MD, a dermatologist in Mason, Ohio, was among the speakers to showcase his research in the Saturday afternoon session. His research, spanning 2008 to 2016, studied the use of antibiotics in dermatology surgery.
“We found that antibiotic use associated with dermatologic procedures is increasing, and there is significant geographic variation, suggesting there may be opportunities to improve use of prophylactic antibiotics associated with procedures,” Dr. Barbieri said.
Lawrence F. Eichenfield, MD, a professor and dermatologist with the University of California, San Diego School of Medicine and Rady Children’s Hospital in San Diego, presented his research on molluscum contagiosum, a common and highly contagious skin infection for which there are no FDA-approved treatments. Current unapproved methods of treatment have significant limitations, including pain, scarring, and unproven efficacy. Many are unsuitable for use in children.
“Verrica has formulated VP-102, a consistent, stable cantharadin product, and has now completed two parallel vehicle-controlled studies that show the efficacy and good tolerability,” Dr. Eichenfield said. “Having an FDA-approved therapy that can minimize molluscum infection would be very helpful for our patients and families.”
Two Saturday afternoon late-breaking sessions put a spotlight on the latest groundbreaking observations in clinical trial research and pediatric clinical studies. These unpublished results offer critical data and information in recent investigations and clinical practice.
REFERENCES: 1. Takikawa M, Inoue S, Horio F, Tsuda T. Dietary anthocyanin-rich bilberry extract ameliorates hyperglycemia and insulin sensitivity via activation of AMP-activated protein kinase in diabetic mice. J Nutr. 2010;140(3):527-533. 2. Morgan N. What you need to know about xerosis in patients with diabetic feet. Wound Care Advisor. https://woundcareadvisor.com/what-you-need-to-know-about-xerosis-in-patients-with-diabetic-feet_vol2-no4/. Accessed June 25, 2018.
Developed with dermatologists for individuals with diabetes to help moisturize and soothe dry skin.
Bilberry• Has antioxidant properties1
• Is a source of lactic and ascorbic acid
Urea• Helps facilitate exfoliation2
• Helps moisturize and promote smoother skin
DRY TO VERY DRY SKIN
AND HELP
RESTORERELIEVE
Formulated with ceramides 1, 3, & 6-ll to help repair and restore the natural skin barrier, CeraVe offers over 70 different skincare products.
VISIT BOOTH #3337 TO SEE MORE.
COME FOR THE DATA STAY FOR THE RESULTSMEET TALTZ AT BOOTH 2751
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Learn about the Taltz Savings Card Program at taltz.com/hcp
If you are a US medical doctor with an active state license number, the value of the food, beverage, and/or educational item that you receive when attending this program may be disclosed on Eli Lilly and Company’s Physician Payment Registry and/or the National Physician Payment Transparency Program (NPPTP) Open Payments report under the federal Sunshine Act as a transfer of value made to you by Lilly. As a result of enacted state regulations, food and beverages will not be provided to healthcare professionals licensed in the states of Minnesota, Massachusetts, and Vermont. Additionally, educational items will not be provided to healthcare professionals licensed in Minnesota. Federal Veterans Affairs (VA) regulations and several states also prohibit state/government employees from receiving or being provided gift items, which may include educational materials and meals. Please consult your state regulations and ethics laws to see if such prohibition would apply to you. This medical presentation is intended only for invited healthcare professionals for whom the information to be presented is relevant to their practice. We regret that spouses or other guests cannot be accommodated. This is a promotional program and no continuing medical education (CME) credits are offered.
