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Immunomedics Reports Clinically Meaningful Improvements for Lupus Patients Treated with Epratuzumab

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Immunomedics, Inc. (Nasdaq: IMMU), today announced that patients receiving epratuzumab reported clinically meaningful improvements in health-related quality of life (HRQoL) that were sustained over approximately 4 years of treatment.

The study is the extension arm of the two ALLEVIATE trials, with 29 ALLEVIATE patients enrolled in the extension study to receive two infusions of 360 mg/m^2 epratuzumab on day 1 and day 8 of 12-week cycles. Immunomedics has licensed the rights to the development and commercialization of epratuzumab to UCB in all autoimmune diseases. The effect of epratuzumab on HRQoL was measured using the 36-item Short Form Health Survey (SF-36).

SF-36 evaluates eight domains - physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). These domains are grouped into two summary scores, Physical and Mental Component Summary scores, PCS and MCS, respectively. Mean changes for PCS and MCS and each domain score were compared with baseline values in the ALLEVIATE trials and at the screening of the extension study. Minimum clinically important difference (MCID) for PCS and MCS is defined as improvements of 2.5 points or more, and 5.0 points or better for the eight domains.

Posted-In: News FDA


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