AAD Winter 2014 Meeting Highlights
At last month’s annual meeting of the American Academy of Dermatology (AAD) in Denver, CO, the convention center buzzed with new drug approvals, research updates, clinical pearls and predictions for the road ahead for dermatology as a specialty. More than 16,900 people were in attendance, including about 8,942 medical personnel, according to AAD.
“We have had lots of challenges, but we have dealt with them effectively, and unity within our specialty has been key,” said Dirk Elston, MD, immediate past president of the Academy and managing director of the Ackerman Academy of Dermatopathology, in New York. “We have completely revamped our communications unit and our state society liaison program within the Academy structure because we recognize the importance of our communications to the public, to legislators, to policy makers and to our own members, as well as recognizing the importance of our state societies. Healthcare challenges arise in one state, and then the issue pops up in another state. We can play a valuable role in coordinating with the states to address challenges as they arise.”
Among the changes dermatologists are dealing with are the implementation of the Affordable Care Act, new models for reimbursement and delivery of care, the need to collect data to demonstrate dermatologists’ value and the image enhancement of the specialty, said Dr. Elston. He added that he departs office feeling positive about his accomplishment and the AAD’s ability to confront difficult problems in the future.
New AAD President, Vice President and Board Members Take Office
Brett Coldiron, MD, a dermatologist in private practice in Cincinnati, took over the office of AAD president from Dr. Elston during the 2014 meeting in Denver. Dr. Coldiron spoke of his passion for patients during his speech.
“As long as we stay focused on what is best for our patients, we will persevere and we will come out through this maelstrom of change,” he said. “There are some definite hurdles, but we have a unique skill set and we are valuable. As long as we stay united and support one another, I think we will do okay. We are a very small specialty, and we can’t afford any division in our ranks.”
He highlighted key areas he sees as critical for dermatologists and he encouraged all members of the Academy to get involved and take action. Changes resulting in the tightening of insurance company networks, the effects of the health reform bill threaten both patient access to healthcare and the ability for 1- to 2-person practices to survive.
He also emphasized the need for data registries to show that dermatology is effective and cost-efficient. “This seems obvious to us, but payers and the government are demanding hard data,” Dr. Coldiron said, adding that data registries are expensive to set up and maintain.
He issued a call to action for dermatologists to become more active politically, support their specialty’s activities, and consider personal donations to their local representatives. He also stressed the importance of joining the American Medical Association “so that dermatologists can continue to have representation in the house of medicine and at key committees.”
Finally, he noted that the AAD must continue to work on specialty positioning. He called for a publicity campaign “to burnish the image of our specialty. This will also be very expensive and an investment we should consider. This type of activity is not currently in our budget but could be funded by a special assessment dues increase.”
“The Academy will continue to do its part as the parent organization for all of dermatology,” said Dr. Coldiron, but he noted that the effort must be collective. “We are going to need to pull together or we are going to be greatly diminished as a specialty.”
Elise A. Olsen, MD, FAAD, a professor of dermatology at Duke University School of Medicine in Durham, NC, took office as vice president of the AAD and will hold office for 1 year. Dr. Olsen received her medical degree from Baylor College of Medicine in Houston, TX. She did an internal medicine residency training at the University of North Carolina at Chapel Hill and a dermatology residency at Duke University School of Medicine in Durham, NC, where she serves as a professor. Dr. Olsen is a past member of the Academy’s board of directors and the Journal of the American Academy of Dermatology editorial board and is the current chair of the Academy’s patient advocacy task force.
Kevin D. Cooper, MD, FAAD; Jane M. Grant-Kels, MD, FAAD; Neal D. Bhatia, MD, FAAD; and Sheila Fallon Friedlander, MD, FAAD, began 4-year terms as members of the board of directors of the AAD at the conclusion of the 2014 annual meeting.
Mark G. Lebwohl, MD, Named AAD President-Elect
Mark G. Lebwohl, MD, was named president-elect of the AAD during the last day of the annual meeting on March 25. He will hold the office of president for 1 year.
“My position at the AAD will allow me to serve as an even more effective advocate for our patients,” said Dr. Lebwohl, Sol and Clara Kest Professor of Dermatology and Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai. “Quality patient care will be the focus of my presidency.”
Dr. Lebwohl completed residencies in internal medicine and dermatology at Mount Sinai and has been practicing dermatology since 1983. He has developed Mount Sinai’s Dermatology Department into one of the largest in the nation with more than 40 full-time faculty members and nearly 250 voluntary faculty members. Dr. Lebwohl has chaired numerous symposia and has written, edited or co-edited more than 10 books including the first atlas devoted entirely to cutaneous manifestations of systemic disease, as well as the leading book on dermatologic therapy, Treatment of Skin Disease. He has authored or co-authored more than 500 publications including peer-reviewed articles, invited articles and book chapters. Chairman of the Medical Board of the National Psoriasis Foundation (term 2002-2014), Dr. Lebwohl is also the founding editor of Psoriasis Forum.
Hot Topics & Late Breaking News
The “Hot Topics” symposium, which took place from 2 pm to 5 pm Friday, March 21 at the annual meeting was standing room only. David Eric Cohen, MD, moderated the session presentations, which reviewed new and emerging therapies for the treatment of a range of dermatological diseases, such as contact dermatitis, melanoma and non-melanoma skin cancers, acne and rosacea and skin and psoriasis. The session also covered numerous aesthetic challenges in clinical practice, such as working with filler and toxins, and advanced lasers and devices.
Bruce Elliot Strober, MD, PhD, concluded the session by talking about current and future promising applications of biologics for dermatologic patients – a much talked about topic of the annual meeting. “There are going to be a lot of new drugs. Right now we have 4 approved biologic agents for the treatment of psoriasis, and I am not kidding when I tell you in about 5 years that number will at least double, and maybe be as high as 10 approved biologics as a many as 2 or perhaps 3 small molecules — FDA approved. So we are looking at about 13 therapeutics,” he said, in addition to biosimilars. “So it will be a complex treatment landscape.” Look for more on Dr. Strober’s insights on biologics in future issues of The Dermatologist.
The Plenary Session
The plenary session is always a highlight of the annual meeting. This year the session was held Sunday, March 23 from 8:00 am to 12:00 pm in the Bellco Theatre. Jack S. Resneck, Jr., MD, presented the Clarence S. Livingood, MD, Lecture, “The Future of Our Specialty in a Time of Unprecedented Change,” and echoes Dr. Coldiron’s message for the specialty to unite. I want to see us thrive,” Dr. Resneck said. “We have a lot of control over our destiny, but we have a lot of work to do over the next few years.”
He noted that government, private insurers, employers and patients will continue to push back on healthcare cost increases. The key to meeting those demands is collecting data to quantify quality and cost improvements, he said.
Anthony Eugene Oro, MD, PhD, presented “Heal Thyself: Using Stem Cell Biology for Skin Diseases,” this year’s Marion B. Sulzberger, MD, Memorial Lecture. Lynda Chin, MD, broke down the complexities of cancer with The Lila and Murray Gruber Memorial Cancer Research Lecture on “Genomic Medicine: Transforming Research and Patient Care.”
Ervin H. Epstein, Jr., MD, the presented the Eugene J. Van Scott Award for Innovative Therapy of the Skin and Phillip Frost Leadership Lecture, “Thwacking the Hedgehog.” The lecture touched on Gorlin syndrome and the development of a molecularly targeted anti-basal cell carcinoma therapy.
AID Supports Magic Wand Initiative
Advancing Innovation in Dermatology (AID) will donate $50,000 to support the Magic Wand Initiative. The announcement was made at the organization’s reception in Denver before the start of the annual American Academy of Dermatology Meeting. According to Rox Anderson, MD, founder of AID, the Magic Wand Initiative seeks to empower research teams led by clinical dermatologists — matching clinical problems worth solving with the know-how to do so.The program is meant to catalyze the development of new drugs, medical devices and diagnostics to advance the care of skin diseases and conditions, he says.
The $50,000 contribution will support the Magic Wand project, “Identifying and validating reliable testing modalities to establish an objective ‘gold standard’ diagnostic tool for cellulitis,” led by Daniela Kroshinsky, MD, MPH, assistant professor in dermatology, Harvard Medical School, and director of pediatric dermatology and director of inpatient dermatology, education and research, at Massachusetts General Hospital (MGH) and MassGeneral Hospital for Children.
“The Magic Wand project empowers clinical dermatologists to launch, and then lead research with practical impact. In less than a year, this pilot project at MGH in Boston has stimulated a lot of creativity. The misdiagnosis of cellulitis is one example of a major clinical and financial challenge that needs a little magic, in the form of Dr. Daniela Kroshinsky,” explains Dr. Anderson, who professor in dermatology at Harvard Medical School, director of the Wellman Center for Photomedicine at MGH, and adjunct professor of Health Sciences at MIT.
“Dr. Anderson has long been an advocate for research teams at medical centers addressing unmet needs in health,” says William Ju, MD, president of AID. “We are delighted to support the Magic Wand Initiative as an important and exciting opportunity to help scientific discoveries and inventions form the basis of the next generation of dermatology products and platforms.”
The Magic Wand Initiative has been launched at the MGH at the Department of Dermatology and Wellman Center of Photomedicine, which have both an existing community of contributors and collaborators and a highly successful track record of inventions that have become leading products in dermatology.
Positive Phase II Results for Novel Acne Treatment
Phase II study results for Novan Therapeutics’ topical SB204 drug candidate for the treatment of acne vulgaris positive showed statistically significant reductions in both the primary and secondary endpoints for lesion types at the 12-week time point. In the Phase II double blind, vehicle-controlled, dose-ranging study 150 subjects with acne were randomized evenly to 1% SB204, 4% SB204, or vehicle gel and treated for 12 weeks. SB204 demonstrated good cutaneous tolerability with no reported serious adverse events.
At 4 weeks, the 4% dose of SB204 demonstrated a statistically significant reduction in both noninflammatory and inflammatory lesions compared to vehicle (P≤ 0.05, intent-to-treat analysis). Statistically significant reductions were also observed in both the primary and secondary endpoints for lesion types at the 12-week time point.
“The results from this Phase II study exceeded our expectations,” said Nate Stasko, Novan’s President. “This data enables us to move forward with late stage clinical development for a fast acting, first-in-class new drug for acne. Our goal is to continue to build value into the platform and execute a financing strategy to rapidly advance SB204 towards commercialization.”
Positive Results of Phase III Trials for Papulopustular Rosacea Treatment
The results of two pivotal phase III trials of ivermectin 1% (Galderma Laboratories, L.P.), an investigational drug being evaluated for the treatment of papulopustular (inflammatory) rosacea, were presented at a Late-Breaking session of the 72nd annual meeting of AAD.
The results of the studies, in which 910 subjects applied ivermectin 1% cream once daily for 12 weeks, demonstrate that ivermectin is safe and effective.
Both pivotal studies of ivermectin 1% cream significantly met their co-primary efficacy endpoints of treatment success as defined by Investigator Global Assessment (IGA) rating of clear skin, and change in inflammatory lesion count. In the studies, ivermectin 1% showed comparable tolerability and safety to its vehicle. Onset of treatment effect was observed at week 4 in both studies.
Both pivotal studies were Phase III randomized, double-blind, 12-week vehicle controlled parallel-group studies assessing the efficacy and safety of ivermectin 1% cream in subjects with papulopustular rosacea. Both pivotal studies met their co-primary efficacy endpoints. The effect was significant (P<0.001) in all primary and sensitivity analyses at Week 12 (ITT-LOCF). Onset of treatment effect was observed at week 4 in each study. The first co-primary endpoint of was success rate (percent of subjects rated clear or almost clear on the IGA rating scale) at Week 12. In Study 1, 173 subjects (38.4%) were assessed as success with ivermectin 1% versus 27 subjects (11.6%) with vehicle (p<0.001). Statistical significance was observed from Week 4 with success in 49 (10.9%) and 13 (5.6%) patients for ivermectin 1% and vehicle, respectively. The results were consistent between the studies.
The second co-primary endpoint was reduction in inflammatory lesions, and both studies also demonstrated that ivermectin 1% was significantly superior to vehicle in reducing lesion counts, with statistical significance apparent at week 2 and continuing for the duration of the study. Trial patients using ivermectin 1% also showed an average reduction of more than 20 lesions versus a reduction of 12 and 13 lesions respectively in the control groups.
In both studies, ivermectin 1% showed comparable tolerability and safety to the control group vehicle. There were no treatment-related serious AEs. The most common related AE in Study 1 was sensation of skin burning (1.8% in ivermectin 1%, 2.6% for vehicle) and the most common related AEs in Study 2 were pruritus and dry skin (0.7% and 0.9% respectively).
Positive Phase III Data for Plaque Psoriasis Treatment Released
Phase III results from several studies show secukinumab (AIN457, Novartis), a selective interleukin-17A (IL-17A) inhibitor, met both co-primary endpoints at Week 12 based on Psoriasis Area and Severity Index (PASI) 75 and Investigator’s Global Assessment modified 2011 (IGA mod 2011) 0/1 response rates compared to placebo.
Results from the FEATURE (First study of sEcukinumAb in prefilled syringes in subjecTs with chronic plaqUe-type psoriasis REsponse) and JUNCTURE (Judging the efficacy of secUkinumab in patients with psoriasis using autoiNjector: a Clinical Trial evalUating treatment REsults) studies also demonstrated skin clearance at Week 12 based on PASI 90 response rates compared to placebo, usability and acceptability of the secukinumab pre-filled syringe (PFS) and autoinjector pen (AI), and an approximately 50% mean decrease in PASI scores from baseline by Week 3 (300mg) and Week 4 (150mg).
FEATURE results showed the efficacy of secukinumab 300mg and 150mg based on a statistically significant higher proportion of patients who achieved a PASI 75 response at Week 12 compared with placebo patients: 75.9% (300 mg) and 69.5% (150 mg) versus 0% for placebo (p <.0001). On the co-primary endpoint, the efficacy of secukinumab 300mg and 150mg was shown based on a statistically significant higher proportion of patients who achieved an IGA mod 2011 0/1 response at Week 12 compared with placebo: 69.0% (300mg) and 52.5% (150mg), versus 0% for placebo (p <.0001).
Results from JUNCTURE also showed the efficacy of secukinumab 300mg and 150mg based on a statistically significant higher proportion of patients who achieved a PASI 75 response at Week 12 compared with placebo: 86.7% (300mg) and 71.7% (150mg), versus 3.3% for placebo (p <.0001). On the co-primary endpoint, the efficacy of secukinumab 300mg and 150mg was shown based on a statistically significant higher proportion of patients who achieved an IGA mod 2011 0/1 response at Week 12 compared with placebo: 73.3% (300mg) and 53.3% (150mg), versus 0% placebo (p <.0001).
Additionally, more secukinumab patients in both studies experienced an improvement in PASI of greater than or equal to 90% (PASI 90) from baseline as compared to placebo, which is a higher standard of skin clearance compared to PASI 75.
In FEATURE (n=177), the most common adverse events (AEs) in any treatment group including placebo were diarrhea, nasopharyngitis and headache. In JUNCTURE (n=182), the most common AEs in any treatment group including placebo were nasopharyngitis, headache, pruritus and hypertension.