Newswise — BOSTON, Dec. 12, 2023 /PRNewswire/ -- Researchers from Analysis Group, a global leader in health economics and outcomes research (HEOR), have coauthored a follow-up analysis of patient-reported outcomes (PROs) that evaluated outcomes three years after initiation of dupilumab among adults with atopic dermatitis (AD). The study, published in the journal Dermatology and Therapy, extends the one-year results of the previously published RELIEVE-AD study in JAMA Dermatology, which was based on a groundbreaking method for generating real-world data (RWD).
The study methodology, Longitudinal Surveys of Patients with Recruitment Through Patient Support Programs (LEAP), represents an advance over other RWD approaches, as it engages patients in patient support programs from the time of treatment initiation and tracks individual patient responses to follow-up surveys administered at pre-defined time intervals. This approach provides a true baseline against which to compare longitudinal data over time. This latest edition of the study provides RWD generated through an online survey given at 30–36 months after initiation of treatment, adding to the existing body of data collected at one, two, three, six, nine, and 12 months.
"Generating real-world data is particularly challenging for conditions like atopic dermatitis that require long-term therapy extending beyond the initial study period. For such chronic conditions, it is important to determine whether long-term treatment creates sustained benefits from the patient's perspective," said the study's senior author, Dr. Alexa B. Kimball, President and CEO at Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center and Professor of Dermatology at Harvard Medical School. "With the LEAP methodology, we were able to effectively identify and evaluate flare-ups, fluctuations in symptoms, and a host of other invaluable RWD points tied to a true baseline with impressive patient participation and, over time, retention."
"While clinical trials remain the gold standard for product approval, they are widely recognized as lacking the type of RWD that regulators, payers, clinicians, and patients want, or require, after a drug's approval," said study investigator Min Yang, Vice President at Analysis Group. "LEAP was created to address this problem by generating patient-centric data early after a launch, grounded by a baseline tied to the clinical trial with the ability for longitudinal follow-up and strong retention rates. It's exciting to be at the forefront of efforts to fill such an important gap, along with Sanofi and Regeneron HEOR researchers, and the clinical experts who were so integral to the success of the LEAP approach."
While the methodology, first published in 2021 by JAMA Dermatology following rigorous peer review, was used to better understand patient outcomes with dupilumab – a monoclonal antibody used to treat diseases such as uncontrolled moderate-to-severe AD, certain types of uncontrolled moderate-to-severe asthma, and inadequately controlled chronic rhinosinusitis with nasal polyposis – LEAP is widely applicable across many diseases and condition types.
"Collecting and synthesizing RWD to generate high-quality evidence is a complex and challenging process, especially when regulators, payers, and clinicians are interested in patient-reported outcomes about diseases and associated therapies," commented coauthor Eric Q. Wu, Managing Principal at Analysis Group. "Leveraging manufacturers' programs, such as patient support programs, has proven to be a breakthrough solution for generating early and long-term high-quality RWD."
The study, "Long-Term Effectiveness of Dupilumab in Patients with Atopic Dermatitis: Results up to 3 Years from the RELIEVE-AD Study," was published in August by Dermatology and Therapy. In addition to Dr. Kimball, Dr. Yang, and Dr. Wu, investigators included Dr. Bruce Strober of the Yale School of Medicine; Manager Bruno Martins of Analysis Group; Gaëlle Bégo-Le-Bagousse, Chien-Chia Chuang, and Debra Sierka of Sanofi; and Zhixiao Wang, Brad Shumel, Jingdong Chao, and Dimittri Delevry of Regeneron Pharmaceuticals. Funding was provided by Sanofi and Regeneron.
To learn more about Analysis Group's HEOR capabilities, visit www.analysisgroup.com/
About Analysis Group's HEOR, Epidemiology & Market Access Practice
Founded in 1981, Analysis Group is one of the largest international economics consulting firms, with more than 1,200 professionals across 14 offices. Analysis Group's health care experts apply analytical expertise to health economics and outcomes research (HEOR), clinical research, market access and commercial strategy, and health care policy engagements, as well as drug safety-related engagements in epidemiology. Analysis Group's internal experts, together with our network of affiliated experts from academia, industry, and government, provide our clients with exceptional breadth and depth of expertise and end-to-end consulting services globally.
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