Skip to main content

Advertisement

Springer Nature is making SARS-CoV-2 and COVID-19 research free. View research | View latest news | Sign up for updates

Table 2 Baseline patient demographic and disease characteristicsa

From: Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial

  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)
  1. 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.