Evidence for Model-Based Dose Response for Biological Products for Rheumatoid Arthritis and Psoriasis

• Activity Number: 372
• Type: Contributed
• Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Anindita Banerjee* and Joseph Wu and Bo Jin and Steven Martin
• Companies: Pfizer Inc. and Pfizer Inc. and Pfizer Inc. and Pfizer Inc.
• Keywords: meta-analysis ; dose response ; emax model ; biologics ; rheumatoid arthritis ; psoriasis

Abstract

Model-based drug development has become a popular approach to designing and analyzing dose-finding trials for biological products indicated for inflammatory diseases such as rheumatoid arthritis and psoriasis. There has been a number of drugs assessed and approved for these indications. Primary endpoints for these therapeutic areas are mostly binary response variables such as ACR20 and PSAI75 respectively and they may present a challenge for understanding the true dose response within a single trial. Model-based meta-analysis provides an invaluable statistical tool for synthesizing evidences across many trials. In this context it allows us to understand the meta-analytic dose response model for these key inflammatory diseases. We will present results of a meta-analysis that is based on a broad set of dose-ranging phase II trials with at least three active doses. We explore different dose response models including the Emax model for these inflammatory diseases. Distributions of model parameters across studies will be presented and implications for designing trials for innovative biological product will be discussed in the context of rheumatoid arthritis and psoriasis.