Published On: 11/28/2020
TARGET-DERM Objectives Published in BMJ Open
An international, observational AD cohort to follow natural history and treatment course
Atopic dermatitis (AD), more commonly known as eczema, is a chronic condition that waxes and wanes over time, often over a lifetime. AD is thought to be caused by a disordered immune system, gene mutations and/or environmental factors.
As new topical and systemic treatments become available for AD, researchers are looking at ways to better understand how treatments are being used in the real world, how effective they are, and their long-term safety, particularly among patient populations underrepresented in clinical trials. Target RWE recently published the objectives of its ongoing longitudinal, observational dermatology study, TARGET-DERM, in the peer-reviewed publication, BMJ Open.
“Despite being one of the leading contributors to non-fatal disease burden worldwide, atopic dermatitis is not well understood in terms of long-term disease control,” said Julie Mallory Crawford, MD, Senior Director of Scientific & Medical Affairs, Target RWE, and co-author on the publication. “We are working with a steering committee of global dermatology experts to collect and analyze data related to AD to better understand the comparative effectiveness and long-term safety of treatments.”
TARGET-DERM generates real-world data on the long-term effectiveness and safety of treatments both currently on the market and new treatments that will be introduced over the next few years. Patients with physician-diagnosed AD receiving prescription treatment (topical or systemic) are enrolled at academic and community clinical centers across the U.S., with plans to expand to Europe and Canada by the end of 2020. Up to three years of retrospective medical records, five years of prospective medical records, and optional biospecimen samples and patient reported outcomes are collected. The study’s primary aims include characterization of AD treatment regimens, evaluation of response to therapy, and description of adverse events.
“Practical, real-world studies that capture long-term changes in atopic dermatitis disease activity and management are needed and can provide complementary data to clinical trials that have strict protocols and may eliminate many people from inclusion. These clinical trial participants may not be representative of the general AD population,” said Dr. Crawford. “Additionally, since most trials make comparisons between active ingredients and placebo, more data from direct comparisons between therapies (both new and conventional) are needed.”
TARGET-DERM serves as a core resource for partners to understand real-world treatment patterns and disease comorbidities, and to perform translational studies using data linked to patient reported outcomes and biospecimen samples. TARGET-DERM is a cooperative consortium of principal investigators from academic institutions and community sites. It is based on a successful model from prior Target RWE studies used to inform the natural history of disease and comparative effectiveness for several gastrointestinal diseases, starting with hepatitis C.
“The ultimate goal is to improve care for patients with AD,” said Dr. Crawford.
About Target RWE
Target RWE is a leading health evidence solutions company that generates innovative real-world evidence (RWE) and provides scientific intelligence tools and solutions for pharmaceutical, biotechnology, and other healthcare partners. Specifically designed to address the complexities of the natural history of disease, the drug development process and treatments in real-world settings, Target RWE builds regulatory-grade clinical data sets and applies state of the science epidemiologic methods to produce RWE about patients with specific conditions, symptoms, and therapies used in usual clinical practice.
Target RWE's regulatory-grade data sets and evidence, modern epidemiological methods, and sound scientific principles rendered as software can be utilized to better health outcomes, inform patient health guidelines, and improve overall quality of care. For more information, visit www.targetrwe.com.
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