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) |