Analysis Group Team’s Study Comparing Patient-Reported Outcomes of Psoriasis Therapies Provides Data Critical to Successful Regulatory Submissions
January 12, 2021
As demand to demonstrate the value of therapies from patients’ perspectives grows, regulatory bodies around the world have urged drug sponsors to include such information when designing a clinical trial and submitting for product approval. A team of Analysis Group researchers, including Managing Principal Eric Wu, Vice President Min Yang, and Manager Viviana Garcia-Horton, has conducted statistical analyses of patient-reported outcomes (PROs) to demonstrate treatment efficacy from a patient’s perspective.
“Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis: The UltIMMa-1 and UltIMMa-2 Randomized Clinical Trials,” published in JAMA Dermatology, compares PROs that captured psoriasis symptoms, health-related quality of life (HRQL), and mental health among patients with moderate to severe psoriasis who were administered risankizumab, ustekinumab, or a placebo. This study provides critical evidence from clinical trials and supports the inclusion of such benefits in the approved product labels by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada.
Several PRO instruments were included in a pair of AbbVie’s 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. According to Dr. Yang, “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.”