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. 2017 Aug 30;76(12):2001–2008. doi: 10.1136/annrheumdis-2017-211328

Table 3.

Summary of overall safety through week 52

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.