Analysis Group Researchers Demonstrate a Highly Effective New Real-World Data Generation Method

JAMA Dermatology publishes study results showing that treatment outcomes as reported by patients mirror those indicated in clinical trials

Date:January 19, 2022
Location:Boston, MA
Contact:Eric Seymour
+1 978 273 6049

Analysis Group, a global leader in health economics and outcomes research (HEOR), announced that its groundbreaking method for generating real-world data (RWD) has proven both effective and repeatable. Following rigorous peer review, JAMA Dermatology published a paper introducing the new method, which was used to study dupilumab patient outcomes, including measures of quality of life, in a clinical setting.

By inviting adult patients who voluntarily joined the dupilumab patient support program (PSP) soon after they were prescribed with the treatment, the study team was able to establish true baseline values for patient-reported outcomes. Enrolled patients completed surveys at 1, 2, 3, 6, 9, and 12 months after treatment initiation. This process allowed for early evidence generation directly from the patient’s perspective.

“Capturing baseline data at medication start overcomes a common challenge affecting effectiveness assessments in clinical practice,” said the study senior author Alexa B. Kimball, M.D., M.P.H., President and CEO with Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center. “Faster access to reliable data from the clinical setting can enhance clinicians’ effective management of diseases with newer treatments.”

“Data sources are the biggest challenge for early real-world evidence generation post-product launch,” explained study investigator Min Yang, M.D., Ph.D., a Vice President with Analysis Group. “Claims databases can’t provide data directly from the patient’s perspective, and working with medical centers to establish registries or access electronic medical data can take many years and require significant manpower. Even then, those data are usually not a sufficient reflection of patients’ quality of life following treatment.” Dr. Yang then explained, “This study, jointly designed and executed by Analysis Group and Sanofi and Regeneron HEOR researchers, along with close collaboration among the clinical experts, offered a unique approach to overcoming these challenges.”

“Years of work have gone into solving complex issues that arise from being so close to patients to generate quality RWD in this way,” commented Eric Wu, Ph.D., a Managing Principal with Analysis Group. “We’ve undergone the training needed to effectively manage patient requests during the study in a timely fashion. Running these types of studies also requires considerable governance structures, with the feedback and guidance of clinicians and pharma companies.”

While this method of generating RWD was used to better understand patient outcomes with dupilumab – a monoclonal antibody used to treat diseases such as uncontrolled moderate-to-severe eczema (atopic dermatitis), certain types of uncontrolled moderate-to-severe asthma, and inadequately controlled chronic rhinosinusitis with nasal polyposis – the method is widely applicable across many diseases and condition types. However, researchers should be mindful of the unique patient recruitment channel through the PSP, in order to minimize potential selection bias.

The study, “Treatment Outcomes Associated with Dupilumab Use in Patients with Atopic Dermatitis: 1-Year Results From the RELIEVE-AD Study,” was published in December by JAMA Dermatology. In addition to Dr. Yang, investigators included Dr. Bruce Strober of the Yale University School of Medicine; Dr. Kimball of Beth Israel Deaconess Medical Center; Jessie Wang, Ph.D., of Analysis Group; Usha G. Mallya, Ph.D., and Sohini Ganguli, Pharm.D., former employees, and Debra Sierka, Pharm.D., of Sanofi; and Abhijit Gadkari, Ph.D., former employee, and Dimittri Delevry, Pharm.D., of Regeneron Pharmaceuticals Inc. Funding was provided by Sanofi and Regeneron.

Further details of the RELIEVE-AD study’s methodology and its long-term results will be exhibited at the American Academy of Dermatology Annual Meeting in March 2022, including:

  • Long-Term Dupilumab Effectiveness on Health-Related Quality of Life and Work Productivity in Atopic Dermatitis
  • Early and Sustained Improvement in Atopic Dermatitis Disease Control and Treatment Satisfaction with Dupilumab in Clinical Practice
  • Dupilumab Decreases Concomitant Therapy Use in Adults with Atopic Dermatitis
  • Dupilumab Improves Patient-Reported Outcomes Among Adults with Moderate-to-Severe Atopic Dermatitis in Clinical Practice

To learn more about Analysis Group’s HEOR capabilities, visit

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About Analysis Group’s HEOR Practice

Founded in 1981, Analysis Group is one of the largest international economics consulting firms, with more than 1,000 professionals across 14 offices. Analysis Group’s health care experts apply analytical expertise to health economics and outcomes research, 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 its 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.