Treatment Outcomes Associated with Dupilumab Use in Patients with Atopic Dermatitis: 1-Year Results From the RELIEVE-AD Study

JAMA Dermatology, 2021

Real-world data (RWD) on patient-reported outcomes are important tools for assessing the effectiveness of a pharmaceutical treatment. Accessing these data, however, can be challenging, since they are typically unavailable in existing data settings, and creating registries or accessing electronic medical records can be both time- and labor-intensive. To overcome this gap, an Analysis Group team led by Vice President Min Yang partnered with researchers from Sanofi, Regeneron Pharmaceuticals, the Yale School of Medicine, and Harvard Medical School/Beth Israel Deaconess Medical Center to pioneer a novel method for generating early RWD for stakeholders (pharmaceutical companies, clinicians, patients, payers) with faster access to reliable data (including quality of life and productivity) from the clinical setting.

The study enrolled adult patients with atopic dermatitis (AD) who were members of a patient support program for dupilumab – a monoclonal antibody used to treat AD, certain types of uncontrolled moderate-to-severe asthma, and inadequately controlled chronic rhinosinusitis with nasal polyposis. With the establishment of a patient cohort before they started on treatment, true baseline values for patient outcomes were made possible. Members of the cohort then completed surveys at 1, 2, 3, 6, 9, and 12 months after treatment initiation. This process allowed for early real-world evidence (RWE) generation directly from the patient’s perspective.

The results were published in JAMA Dermatology. While the study focused on patient outcomes with dupilumab, the researchers emphasized that the RWD generation method was capable of wide application across a number of diseases and condition types.

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Strober B, Mallya UG, Yang M, Ganguli S, Gadkari A, Wang J, Sierka D, Delevry D, Kimball AB