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Epratuzumab Phase IIb Data Presented at ACR Show Pipeline Drug had Positive Effect in Patients Suffering From Moderate to Severe Systemic Lupus Erythematosus
Date:11/9/2010

for at least 5 and 28 days, respectively, prior to first study drug infusion. Primary endpoint was responder rate on a combined index of clinical disease activity at week 12 (defined as reduction of all baseline (BL) BILAG 2004 A to B/C/D and BL BILAG B to C/D, no BILAG worsening in other organ systems, and no deterioration in SLEDAI or physician global assessment [VAS]), with no CS, IS and antimalarials increase over BL dose. The study was not powered to detect statistical differences between treatment arms.

By week 12 (see table) combined responder index rates were higher in all epratuzumab groups than in the placebo group, reaching statistical significance in the epratuzumab 600mg weekly group (2400mg cumulative) and the combined group of all 74 patients who received a cumulative dose of 2400mg (600mg weekly and 1200mg every other week).Dose regimenPBO
(n=38)Emab cd
200mgEmab cd
800mgEmab cd 2400mgEmab cd
3600mg100mg
EOW
(n=39)400mg
EOW
(n=38)600mg
weekly
(n=37(a))1200mg
EOW
(n=37)Combined
group
(n=74)1800mg
EOW
(n=38)Responders n (%)

8 (21.1)

12 (30.8)

10 (26.3)

17 (45.9)

15 (40.5)

32 (43.2)

9 (23.7)Odds ratio1.7

(0.6-4.7)

1.3

(0.5-3.9)

3.2

(1.1-8.8)

P=0.03(b)

2.6

(0.9-7.1)

P=0.07 (b)

2.9

(1.2-7.1) p=0.02 (b)

1.2

(0.4-3.4)Table - Combined responder index, week 12 (ITT population)Emab = epratuzumab

(a) 2 patients randomized but never received drug

(b) p values not adjusted for multiple comparisonsAdditionally, by Week 12, more patients in the epratuzumab 600mg weekly group, compared with placebo, had an improvement from BILAG A/B to BILAG D in the 6 body systems, indicating no
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