Immunomedics, Inc. And UCB Announces Results Of Epratuzumab Phase IIB Data

Immunomedics, Inc. and UCB announced data, that supported the BILAG-based Combined Lupus Assessment (BICLA) as a clinically meaningful composite measure of systemic lupus erythematosus (SLE) disease activity. The EMBLEM study was designed to evaluate the efficacy and safety of the investigational product epratuzumab (in combination with immunosuppressants) in SLE, identify an optimal dose and regimen for further studies, and assess the performance of the new BILAG-based Combined Lupus Assessment (BICLA) composite endpoint. The BICLA was developed based on input from a panel that evaluated the characteristics of disease activity indices (DAIs) commonly used in SLE trials and previous experience with DAIs to evaluate the efficacy of epratuzumab in clinical trials. In the EMBLEM study, all epratuzumab doses, which ranged from 200mg to 3600mg dose administered during one 12-week treatment cycle, had numerically superior BICLA response rates compared to placebo at week 12. For patients receiving epratuzumab at a cumulative dose of 2400mg there was meaningful and statistically reductions in disease activity. The results from the EMBLEM study demonstrated that the BICLA, whose components require clinical assessment, physician assessment, laboratory assessment, and recording of medication use, is a sensitive, clinically meaningful composite measure of SLE disease activity and may help to guide the design of future trials in SLE.