A new, large-scale observational study (TARGET-DERM) is underway that will collect data on patients with atopic dermatitis (AD), vitiligo, hidradenitis suppurativa, and mild psoriasis over 8 years. The study will start with AD and branch to other common inflammatory skin diseases. The first participant was enrolled on January 25, 2019 and the study will span the United States, Canada and Europe to amass as much data as possible on these immune-mediated skin conditions. Participants, recruited from both community and academic dermatology, pediatric, and allergy practices, will provide key information on treatment efficacy and safety, as well as comorbid conditions, along with samples that can be used for translational research. One of the goals of the registry is to improve the understanding of phenotypes and treatment of immune-mediated skin conditions in the real world.
TARGET-DERM will evaluate treatment regimens, uptake of newly approved therapies, patient outcomes, adverse events, predictors of response to therapies, relationship between immune-mediated conditions and comorbid medical conditions, blood and skin samples, patient-reported outcome measures, and outcomes related to patient support programs, as well as examine underrepresented populations in clinical trials.
Experts for each condition are involved in the steering committee and panel. The panel includes James Krueger, MD, PhD, the D. Martin Carter Professor in Clinical Investigations in the department of dermatology at Rockefeller University; Eric Simpson, MD, MCR, professor of dermatology at Oregon Health and Science University; Jonathan Silverberg, MD, PhD, MPH, assistant professor of dermatology, medical social sciences and preventive medicine at Northwestern University; Amy Paller, MD, Walter J. Hamlin Professor of Dermatology and Pediatrics at Northwestern University; John Harris, MD, PhD, associate professor of dermatology at University of Massachusetts; Katrina Abuabara, MD, PhD, assistant professor of dermatology at the University of California San Francisco; Robert Bissonnette, CEO of a dermatology practice and CRO—Innovaderm, in Canada; and Larry Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, vice chair of the department of dermatology, and professor of dermatology and pediatrics at the University of San Diego School of Medicine. The steering committee co-chairs are Diamant Thaci, MD, professor and head of the comprehensive center for inflammation medicine at the University of Lubeck in Germany and Emma Guttman-Yassky, MD, PhD, Sol and Clara Kest Professor of Dermatology and Immunology, and vice chair of the department of dermatology at the Icahn School of Medicine at Mount Sinai.
Dr Guttman-Yassky spoke with The Dermatologist about how this registry will help researchers and dermatologists better understand disease phenotypes, comorbidities, and efficacy of various treatment options.
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Mental Health Burden of AD Deemed Substantial
Comorbidities in Atopic Dermatitis
AD Linked to Cardiovascular Outcomes
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The Dermatologist: What made you decide to co-chair the steering committee for this study and why are you focusing on these immune-mediated conditions?
Dr Guttman-YasskyÂ: There is a mass need to create registries because they are a good way to get more information about patients and patients’ phenotype and, ultimately, improve their treatment. We are excited because the first patient with AD has enrolled in the registry.
Currently, there is a lot of interest in inflammatory skin diseases due to new knowledge on pathogenesis and treatment for several of these conditions. For example, the understanding and treatment of psoriasis has had a revolution in the last few years and there are several large registries for moderate to severe psoriasis.
Other inflammatory skin diseases, including several that are very dear to my heart, such as AD, alopecia areata, vitiligo, and hidradenitis suppurativa, have also had breakthroughs in the understanding and treatment. It is important to capture the effects of new therapies in a registry and help promote newer treatment options. Registries also provide us with a way for capturing real life situations and information regarding what therapies patients are using correctly and how they are responding to treatments.
Additionally, our registries will include minimally invasive biomarkers and samples from patients where we can learn more about the different phenotypes of these diseases. We are starting to learn more about the different phenotypes of AD. For example, we know pediatric patients with AD have a different phenotype from adult patients, and that there are differences in phenotypes between African American patients and European American patients with AD. Recently, we published a paper that showed adult patients aged 65 years and older had a different phenotype than younger patients. This registry will provide us with the opportunity to better understand these differences and how we, as treating dermatologists, can accommodate differences in phenotype and therapeutic response into the treatment of our patients in the future.
The Dermatologist: How are you recruiting your participants and how are you going to evaluate your data?
Dr Guttman-Yassky: We will be recruiting participants from multiple dermatology and pediatric dermatology offices in academic institutions and private practices, although we will also open recruitment up to some pediatricians and allergists as well as primary care physicians. We are recruiting from both private practice and academic institutions in order to understand the differences between these different treatment settings. I think it is important to understand differences in these treatment settings because we will have a good representation of patients.
The Dermatologist: Why did you decide to partner with TARGET for the registry?
Dr Guttman-Yassky: We are happy to work with TARGET because they are distinguished in the medical field and have a good track record for developing registries in infectious diseases and gastrointestinal fields, including several autoimmune diseases. They are experienced in biomedical informatics, biostatistics, and epidemiology, including founders with expertise and professorships in these diseases. Â This collaborative approach is furthered through a formal relationship with the FDA, through a CRADA between TARGET and CDER. Together, this group of stakeholders is able to curate regulatory grade data and connect it longitudinally to patient-reported outcomes and treatment responses to accelerate innovation in immune-mediated inflammatory skin conditions.
The Dermatologist: Why is it important to have this registry for understanding treatment options, adverse events, and also comorbidities?
Dr Guttman-Yassky: This registry is a wonderful opportunity to answer questions, such as the link between AD and cardiovascular diseases, or other comorbidities. We want to understand the disease phenotypes in order to understand the association between these diseases. For example, many patients with AD also have alopecia areata. Likewise, many patients with alopecia areata have vitiligo. Understanding the comorbidities, or cooccurrence, of these diseases and how the different phenotypes will respond to different therapies is important for us to be able to formalize treatment for these diseases.
For more information about TARGET-Derm, please visit Information https://targetpharmasolutions.com/focus-area/immune-mediated-inflammatory-skin-conditions-derm.
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