Table 3.
Variable | Placebo (n=556) |
Sirukumab*† | ||
50 mg q4w (n=663) |
100 mg q2w (n=662) |
Combined (n=1325) |
||
Mean duration of follow-up, weeks | 36.18 | 45.76 | 45.12 | 45.44 |
Mean number of study agent administrations | 17.45 | 21.88 | 21.56 | 21.72 |
Patients with ≥1 AE, n (%) p Value versus placebo |
364 (65.5) | 528 (79.6) <0.001 |
531 (80.2) <0.001 |
1059 (79.9) <0.001 |
Patients with ≥1 SAE, n (%) p Value versus placebo |
38 (6.8) | 73 (11.0) 0.012 |
65 (9.8) NS |
138 (10.4) 0.015 |
Patients with ≥1 AE that caused study agent discontinuation, n (%) p Value versus placebo |
18 (3.2) | 53 (8.0) <0.001 |
51 (7.7) <0.001 |
104 (7.8) <0.001 |
Patients with ≥1 serious infection, n (%) p Value versus placebo |
10 (1.8) | 27 (4.1) 0.021 |
22 (3.3) NS |
49 (3.7) 0.031 |
Patients with ≥1 injection site reaction, n (%) p Value versus placebo |
14 (2.5) | 71 (10.7) <0.001 |
108 (16.3) <0.001 |
179 (13.5) <0.001 |
Patients with ≥1 MACE, n (%) p Value versus placebo‡ |
2 (0.4) | 8 (1.2) NS |
3 (0.5) NS |
11 (0.8) NS |
Patients with ≥1 malignancy, n (%) p Value versus placebo‡ |
2 (0.4) | 2 (0.3) NS |
5 (0.8) NS |
7 (0.5) NS |
Patients with ≥1 GI perforation, n (%) p Value versus placebo‡ |
1 (0.2) | 1 (0.2) NS |
0 NS |
1 (0.1) NS |
Death, n (%) p Value versus placebo‡ |
1 (0.2) | 7 (1.1) NS |
3 (0.5) NS |
10 (0.8) NS |
Events of ≥5% frequency in any sirukumab group, n (%) | ||||
Alanine aminotransferase increased p Value versus placebo |
25 (4.5) | 102 (15.4) <0.001 |
124 (18.7) <0.001 |
226 (17.1) <0.001 |
Aspartate aminotransferase increased p Value versus placebo |
19 (3.4) | 58 (8.7) <0.001 |
82 (12.4) <0.001 |
140 (10.6) <0.001 |
Upper respiratory tract infection p Value versus placebo |
63 (11.3) | 65 (9.8) NS |
66 (10.0) NS |
131 (9.9) NS |
Injection site erythema p Value versus placebo |
6 (1.1) | 50 (7.5) <0.001 |
80 (12.1) <0.001 |
130 (9.8) <0.001 |
Nasopharyngitis p Value versus placebo |
57 (10.3) | 62 (9.4) NS |
56 (8.5) NS |
118 (8.9) NS |
Leucopaenia p Value versus placebo |
7 (1.3) | 37 (5.6) <0.001 |
37 (5.6) <0.001 |
74 (5.6) <0.001 |
Bronchitis p Value versus placebo |
27 (4.9) | 39 (5.9) NS |
31 (4.7) NS |
70 (5.3) NS |
Neutropaenia p Value versus placebo |
5 (0.9) | 38 (5.7) <0.001 |
29 (4.4) <0.001 |
67 (5.1) <0.001 |
Hypertension p Value versus placebo |
21 (3.8) | 28 (4.2) NS |
33 (5.0) NS |
61 (4.6) NS |
Headache p Value versus placebo |
22 (4.0) | 33 (5.0) NS |
26 (3.9) NS |
59 (4.5) NS |
Injection site pruritus p Value versus placebo |
1 (0.2) | 11 (1.7) 0.009 |
41 (6.2) <0.001 |
52 (3.9) <0.001 |
*Includes patients from the placebo group rerandomised to treatment with sirukumab; thus, patients may be represented in >1 treatment group.
†p Values are nominal and from χ2 tests, unless otherwise noted.
‡p Values are nominal and from Fisher’s exact tests.
AE, adverse event; GI, gastrointestinal; MACE, major adverse cardiovascular event; NS, not significant; q2w, every 2 weeks; q4w, every 4 weeks; SAE, serious adverse event.