|
Characteristics
|
Whole cohort (n=1202)
|
Epratuzumab plus standard of care (n=792)
|
Standard of care only (n=410)
|
|---|
|
Age group (years)
| | | |
|
<35
|
348 (29.0%)
|
224 (28.3%)
|
124 (30.2%)
|
|
35–55
|
664 (55.2%)
|
436 (55.1%)
|
228 (55.6%)
|
|
>55
|
190 (15.8%)
|
132 (16.7%)
|
58 (14.2%)
|
|
Female
|
1131 (94.1%)
|
739 (93.3%)
|
392 (95.6%)
|
|
Disease duration (years)
|
5.58 (1.92, 12.7)
|
5.75 (1.92, 12.7)
|
5.46 (1.83, 11.9)
|
|
ACR/SLICC-DI
|
0 (0, 2)
|
0 (0, 2)
|
0 (0, 2)
|
|
SLEDAI-2K
|
10 (8, 12)
|
10 (8, 12)
|
10 (8, 12)
|
|
nBILAG-2004 score median (IQR)
|
20 (16, 24)
|
20 (16, 24)
|
20 (16, 24)
|
|
BILAG-2004 A or B system score
| | | |
|
Constitutional
|
117 (9.73%)
|
74 (9.34%)
|
43 (10.5%)
|
|
Mucocutaneous
|
990 (82.4%)
|
653 (82.5%)
|
337 (82.2%)
|
|
Neuropsychiatric
|
50 (4.16%)
|
36 (4.55%)
|
14 (3.41%)
|
|
Musculoskeletal
|
1126 (93.7%)
|
741 (93.6%)
|
385 (93.9%)
|
|
Cardiorespiratory
|
132 (11.0%)
|
89 (11.2%)
|
43 (10.5%)
|
|
Gastrointestinal
|
23 (1.91%)
|
13 (1.64%)
|
10 (2.44%)
|
|
Ophthalmological
|
15 (1.25%)
|
10 (1.26%)
|
5 (1.22%)
|
|
Renal
|
91 (7.57%)
|
62 (7.83%)
|
29 (7.07%)
|
|
Haematological
|
12 (1.00%)
|
9 (1.14%)
|
3 (0.73%)
|
|
Serology
| | | |
|
Anti-Ro
|
571 (48.2%)
|
373 (47.8%)
|
198 (49.0%)
|
|
Anti-RNP
|
353 (29.8%)
|
235 (30.1%)
|
118 (29.2%)
|
|
Anti-dsDNA
|
334 (28.2%)
|
211 (27.1%)
|
123 (30.4%)
|
|
Anti-Smith (Sm)
|
311 (27.3%)
|
204 (26.2%)
|
107 (26.5%)
|
|
Low C3 level
|
395 (33.4%)
|
257 (33.0%)
|
138 (34.2%)
|
|
Low C4 level
|
482 (40.8%)
|
320 (41.1%)
|
162 (40.1%)
|
|
Baseline steroid use
|
1129 (93.9%)
|
757 (95.6%)
|
372 (90.7%)
|
|
Baseline steroid dose (mg/day)
|
10 (5, 15)
|
10 (5, 15)
|
10 (5, 15)
|
|
Concomitant therapy
| | | |
|
Anti-malarial
|
884 (73.5%)
|
595 (75.1%)
|
289 (70.5%)
|
|
Methotrexate
|
251 (20.9%)
|
165 (20.8%)
|
86 (21.0%)
|
|
Leflunomide
|
37 (3.08%)
|
37 (3.08%)
|
37 (3.08%)
|
|
Azathioprine
|
321 (26.7%)
|
321 (26.7%)
|
321 (26.7%)
|
|
Mycophenolate mofetil
|
143 (11.9%)
|
88 (11.1%)
|
55 (13.4%)
|
|
Drop out from trial
|
385 (32.0%)
|
259 (32.7%)
|
126 (30.7%)
|
|
Withdrawal (lack of efficacy)
|
174 (14.5%)
|
115 (14.5%)
|
59 (14.4%)
|
|
Withdrawal (adverse events)
|
78 (6.49%)
|
52 (6.57%)
|
26 (6.34%)
|
- Values are n (%) or median (IQR) as appropriate
