Immunomedics, Inc.
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.
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