Table 2.
Baseline patient demographic and disease characteristicsa
| SAD | MAD | ||||||
|---|---|---|---|---|---|---|---|
| Demographics and disease characteristics | Placebo (n = 6) |
All pateclizumab (n = 24) |
Placebo (n = 7) |
1.0 mg/kg SC (n = 8) |
3.0 mg/kg SC (n = 16) |
5.0 mg/kg IV (n = 4) |
All pateclizumab (n = 28) |
| Demographics | |||||||
| Sex, female:male | 6:0 | 20:4 | 7:0 | 6:2 | 14:2 | 3:1 | 23:5 |
| Median age, years (range) | 57 (25 to 69) |
57.5 (35 to 75) |
57 (29 to 69) |
56 (41 to 73) |
56 (23 to 70) |
54 (48 to 61) |
57 (23 to 73) |
| Race, white:black | 5:1 | 23:1 | 7:0 | 7:1 | 16:0 | 3:1 | 26:2 |
| Region, USA:Hungary | All USA | All USA | 3:4 | 6:2 | 5:11 | 2:2 | 13:15 |
| Disease characteristics | |||||||
| Median disease duration, years | 3 | 5 | 5.4 | 9 | 7.5 | 7 | 8 |
| RF- and anti-CCP-positive (%) | 17 | 67 | 71.4 | 87.5 | 87.5 | 50.0 | 82.1 |
| Concomitant medications (%) | |||||||
| Prior anti-TNF-α | 33 | 33 | 0 | 25 | 19 | 0 | 18 |
| MTX | 67 | 63 | 29 | 13 | 44 | 50 | 36 |
| Leflunomide | 0 | 4 | 43 | 38 | 6 | 25 | 18 |
| Steroids | 33 | 25 | 57 | 50 | 69 | 75 | 54 |
| Median CRP, mg/dl (IQR) | 0.2 (0.1 to 1.1) |
0.7 (0.0 to 6.2) |
1.6 (1.2 to 3.3) |
2.1 (1.1 to 4.6) |
1.6 (0.9 to 4.5) |
3.7 (0.9 to 4.4) |
2 (0.9 to 4.6) |
| Median ESR, mm/hour (IQR) | 25.5 (12 to 48) |
27 (2 to 59) |
34 (24 to 65) |
42.6 (14 to 86) |
31 (11 to 97) |
39.5 (22 to 66) |
30.5 (11 to 97) |
| Median SJC (range) | 12 (6 to 26) |
14.5 (0 to 34) |
6 (5 to 12) |
13 (6 to 23) |
7 (5 to 35) |
12 (5 to 45) |
10.5 (5 to 45) |
| Median TJC (range) | 19 (12 to 38) |
27.5 (0 to 66) |
11 (5 to 33) |
22 (5 to 60) |
20 (7 to 65) |
30 (12 to 56) |
19.5 (5 to 65) |
| Median baseline DAS28-CRP (IQR) | 4.8 (4.6 to 5.5) |
5.4 (2.19 to 7.2) |
5.7 (3.9 to 6.0) |
6.0 (4.8 to 7.9) |
5.4 (4.0 to 7.5) |
5.7 (4.2 to 7.0) |
5.6 (3.9 to 7.9) |
aCCP = cyclic citrullinated peptide; CRP = C-reactive protein; DAS28-CRP = Disease Activity Score in 28 joints, C-reactive protein; ESR = erythrocyte sedimentation rate; IV = intravenously; MAD = multiple ascending dose; MTX = methotrexate; RA = rheumatoid arthritis; RF = rheumatoid factor; SAD = single ascending dose; SC = subcutaneously; SJC = swollen joint count; TJC = tender joint count.