Data Show Impact of Dupilumab on Patients with Coexistent Atopic Diseases

New data highlights the potential impact of treatment with dupilumab (Dupixent, Sanofi/Regeneron) in children and adults with coexistent atopic diseases. In children, the presence of allergic rhinitis (AR) is shown not to impede dupilumab efficacy, while in adults, dupilumab may improve skin symptoms, as well as asthma and sinonasal symptoms.

Presented by Lisa A. Beck, MD, FAAAAI at the Annual Meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI), data from a double-blind, 16-week, phase 3 trial involving 367 children aged 6–11 years show a similar rate of response to dupilumab plus topical corticosteroids (TCS), as measured by disease severity scores including Investigator Global Assessment (IGA), Eczema Area and Severity Index, and Peak Pruritus Numerical Rating Scale, regardless of the presence or absence of AR. Establishing efficacy of dupilumab in those children with and without AR, “is important,” says Dr. Beck. “This age group is really enriched for having allergic comorbidities like allergic rhinitis, asthma, food allergy, eosinophilic esophagitis. These comorbidities are more commonly seen in these younger age groups, than in adults with atopic dermatitis, which are even more common when their atopic dermatitis is more severe.”

Dr. Beck also co-authored an analysis recently published in JACI In Practice showing that dupilumab significantly improved signs and symptoms of AD as well as asthma and sinonasal patient-reported outcomes in adult patients with moderate-to-severe AD who suffered from these comorbid conditions.

“We took four adult pivotal trials and looked at how many subjects reported a history of asthma or sinonasal conditions. We found about 19 percent of the patients reporting asthma and about 48 percent reporting sinonasal conditions, which included a variety of different conditions, including allergic rhinitis,” As an aside, Dr. Beck notes that children with AD more commonly report sinonasal conditions (62 percent), which is considerably higher than 48 percent in this adult trial. “In general, as you get a little older, the comorbid atopic conditions in adults are a little less frequent than they are in children. But the point here is you might use one drug to treat all of allergic conditions,” she says.

Dr. Beck notes that the findings point to the potential to improve patient care by considering a treatment like dupilumab that may address multiple coexistent atopic diseases. Although the direct cost of dupixent therapy may be higher than alternatives, she says, the ability to target more than one condition with a single agent makes it more cost-effective.

“It’s important to note that what is an appropriate readout for disease improvement in one patient may not be the most appropriate readout for another patient,” Dr. Beck says. “The goal would be, that if someone has four allergic diseases, but none of them would fulfill the severity metrics to get insurance approval for dupilumab, that the combined impact of those four diseases would be considered. Although each one of the currently available non-biologic treatments for these common allergic diseases are individually not very expensive, collectively they can add up to a considerable expense, since they are directed at the specific allergic disease and have little effect on other allergic conditions. Additionally, these drugs are typically administered by a number of different physicians, meaning these patients are having to see more physicians, pay more healthcare costs for these visits, which also leads to lost work or school time. Alternatively, you could potentially have one provider taking care of all of these diseases.”

Two-Year Data for Tremfya in PsA

Long-term data from the Phase 3 DISCOVER-2 study show continued benefit for Tremfya (guselkumab) for up to two years in adults with active psoriatic arthritis. Previous data demonstrated skin clearance, joint symptom relief, and safety for Tremfya through 24 weeks and one year (Week 52) in adults with PsA. Effects of Temfya at Week 24 on physical function, physical aspects of health-related quality of life, and resolution of enthesitis and dactylitis were also seen through Week 100. These data were presented virtually in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference.

Week 100 findings show that, among randomized patients, 76 percent of those receiving Tremfya every four weeks and 74 percent of those receiving Tremfya every eight weeks achieved at least 20 percent improvement in the American College of Rheumatology (ACR 20) response criteria. Robust joint and skin response rates and mean improvements from baseline in outcome measures were maintained through two years, and approximately 90 percent of patients randomized to Tremfya continued treatment through Week 100.

No new safety signals were observed in the safety analysis conducted through Week 112. Tremfya safety in patients with active PsA through two years was comparable to safety at six months and one year and generally consistent with Tremfya safety in patients with moderate to severe plaque PsO.

Among patients who had clinically meaningful PsO at baseline, 62 percent of patients receiving Tremfya every four weeks and 55 percent of those receiving Tremfya every eight weeks achieved complete skin clearance as measured by the Investigator Global Assessment (IGA) score of 0.

New AAD Leaders Take Office

Kenneth J. Tomecki, MD, FAAD is now president of the American Academy of Dermatology (AAD).

During his one-year term, Dr. Tomecki (pictured left) will also hold the same position for the American Academy of Dermatology Association, a sister organization to the AAD that focuses on government affairs, health policy, and practice information.

Neal Bhatia, MD, FAAD (pictured right) also begins his term as vice-president of the AAD.

“The AAD made great strides during the pandemic to meet members’ unprecedented needs,” Dr. Tomecki says. “I look forward to continuing this work and keeping a pulse on how the pandemic continues to impact our members and the specialty, and the way we practice dermatology. Overall, in addition to paying special attention to member needs, patient care will always be my primary focus.”

Dr. Tomecki currently serves the AAD as an editorial board member for the Journal of the American Academy of Dermatology. Before that, he served as an assistant editor of JAAD and, most recently, as AAD vice president and a member of the board of directors. Dr. Tomecki is former vice president of the International Society of Dermatology and former vice president of the American Dermatological Association.

Dr. Bhatia is the director of clinical dermatology at Therapeutics Clinical Research in San Diego, and serves as chief medical editor of Practical Dermatology® magazine. He previously served the AAD as a member of the board of directors. Dr. Bhatia is the current secretary-treasurer of the Noah Worcester Dermatological Society and current president of the Pacific Dermatologic Association.

NRS Launches Updated Version of “Understanding Rosacea” for Patients

The National Rosacea Society updated its most popular educational booklet, “Understanding Rosacea,” to incorporate the updated standard classification and pathophysiology of rosacea, developed by a consensus committee and review panel of 28 rosacea experts worldwide and published in the Journal of the American Academy of Dermatology.

The booklet includes an overview of the diagnostic, major and secondary features of rosacea, along with photos to help patients identify the signs and symptoms of the disorder. It also provides information about the potential causes of rosacea, medical treatments and skin care, tips to avoid environmental and lifestyle triggers and how to effectively manage living with the disease.

Visit rosacea.org to order bulk quantities for use as handouts to patients.

The new booklet was made possible by a grant from LEO Pharma.

CLOSE UP with Luis Ruben Soenksen, PhD

Machine learning and artificial intelligence can inform the early detection of melanoma, but many systems have fallen short largely because they evaluate each lesion individually for suspicious features. In clinical practice, however, dermatologists compare multiple lesions from an individual patient to determine whether they are cancerous—a method commonly known as the “ugly duckling” criteria.

A newly developed system for identifying suspicious skin lesions based on convolutional deep neural networks (CDNNs) incorporates an “ugly duckling” metric that is capable of matching the consensus of three dermatologists 88 percent of the time.

Luis Ruben Soenksen, PhD, a postdoctoral fellow at the Wyss Institute for Biologically Inspired Engineering at Harvard University in Boston, and colleagues recently described the new method in Science Translational Medicine. Here, Soenksen discusses the new system’s potential to scale melanoma screening and save more lives.

(The new CDNN’s source code is openly available on GitHub.)

Why is this topic important to study?

Luis Ruben Soenksen, PhD: The burden of skin cancer can be largely addressed by early-stage identification of suspicious pigmented lesions (SPLs) in primary care settings, both reducing mortality and treatment cost. However, the issue is that conducting large-scale screening of SPLs is currently limited by the capacity of healthcare systems and dermatological professionals to perform direct visual inspections to detect these suspicious lesions.

Describe the research and your findings.

Dr. Soenksen: The goal of our study was to demonstrate the feasibility of using deep convolutional neural networks to detect and classify SPLs from wide-field input images in an automated way that could be deployed at scale. Our system formalizes the process of identifying dermatological “oddness” in a way that is inspired by clinical practice, but in a less subjective way than the current standard of care. Suspiciousness identification requires observation and feature extraction of multiple lesions at the same time, which is actually the most common and natural way dermatologists have to accurately evaluate patients in their daily practice.

It is not surprising that automating such processes can be thought of as a valuable method to scale melanoma screening. We believe our system is both useful and innovative because we designed it to emulate “dermatological intuition,” which starts with wide-field observations to guide patient referral of suspicious lesions considering the patient-independent probability of each lesion being malignant, as well as the ugly duckling criteria mostly overlooked by other clinical artificial intelligence (AI) and machine learning systems. Furthermore, we proposed (for the first time) a formal description of such ugly duckling criteria as a patient-dependent probability of lesion suspiciousness given the disparities to all observable lesions in the field of view of a dermatologist, which we hope will inform the development of better dermatological assessment tools in the future.

What is the next step?

Dr. Soenksen: Expanding training datasets, inclusion of wider range and representation of skin of color, and prospective evaluation of these tools in actual clinical care is in our sight and something that we all need to pursue in clinical AI research.

GW Dermatology to Expand Telederm

The George Washington University (GW) Department of Dermatology will use a $250,000 grant from Pfizer to expand accessible teledermatology for atopic dermatitis patients in Washington, DC.

The dermatology team at GW, led by Adam Friedman, MD, chair of the Department of Dermatology and professor of dermatology at the GW School of Medicine and Health Sciences (SMHS), will establish a community-based teledermatology “health desk” designed to address atopic dermatitis in Wards 7 and 8.

The health desk will be located at Temple of Praise, a non-denominational church in Ward 7 of Southeast, Washington, DC. The partnership was made possible through facilitation by the Rodham Institute at GW, led by Jehan “Gigi” El-Bayoumi, MD, founding director of the Rodham Institute and professor of medicine at GW’s SMHS.

“While we have been aware of the health disparities in DC, the pandemic and the emphasis on access to virtual health care has made the disparities even more evident,” says Dr. El-Bayoumi. “Community partnerships are incredibly important in the effort to close the gaps and bring timely health care to underserved communities.”

The effort will build upon the GW’s experience delivering teledermatology care via a Zoom-based platform to atopic dermatitis patients in response to the pandemic.