Analysis Group Study Provides Patient-Reported Outcomes in Support of Labeling Claims for Plaque Psoriasis Treatment Risankizumab
Date:January 12, 2021
Analysis Group, a global leader in health economics and outcomes research (HEOR), announced the publication of a study focusing on patient-reported outcomes (PROs) such as symptoms, health-related quality of life (HRQL), and mental health among patients with moderate to severe psoriasis. The analysis, published in JAMA Dermatology, provided critical evidence from clinical trials on the benefits of an investigational treatment from the patient’s perspective and supported the inclusion of such benefits in the approved product label by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada.
As the demand to demonstrate the value of novel therapies from a patient’s perspective grows, regulatory bodies around the world are urging drug sponsors to include this vital information when designing a clinical trial and submitting for product approval. A team of researchers from Analysis Group including Managing Principal Eric Wu, Vice President Min Yang, and Manager Viviana Garcia-Horton conducted statistical analyses of PROs captured in risankizumab Phase 3 clinical trials to demonstrate treatment efficacy from a patient’s perspective. Several PRO instruments were included in a pair of Phase 3 replicate clinical trials, including the Psoriasis Symptom Scale (PSS), the Dermatology Life Quality Index (DLQI), and the Hospital Anxiety and Depression Scale. Data showed significantly improved symptoms of moderate to severe psoriasis, improved HRQL, and reduced psychological distress compared with ustekinumab or placebo.
“In the era of patient-centered care, the use of PRO instruments in clinical trials is an important method to assess treatment efficacy from a patient’s perspective to complement and supplement traditional outcomes measured using biomarkers or physicians’ assessments,” said Dr. Yang. “Careful planning is critical during the protocol design phase to ensure the right instruments are included, and are reflective of the aspects of the disease and treatment that are important from a patient’s perspective.”
The study, “Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis,” was published in the October 2020 issue of JAMA Dermatology. Coauthors include Matthias Augustin of University Medical Center Hamburg; Jo Lambert of Ghent University Hospital; Kenneth B. Gordon of the Medical College of Wisconsin; Ziqian Geng and Avani Joshi of AbbVie; and Elizabeth H. Z. Thompson, Carla Zema, and Joaquin M. Valdes, formerly of AbbVie. Funding was provided by AbbVie.
To learn more about Analysis Group’s HEOR capabilities, visit www.analysisgroup.com/healthoutcomes
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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.