Table 3 Adverse events through study completion in patients with RA, PsA, and AS who received ≥ 1 administration of IV golimumab*

Patients, N

584

460

204

1248

Mean follow-up, weeks (SD)

95.9 (25.7)

47.2 (13.0)

51.8 (9.0)

70.7 (30.7)

Patient years of follow-up

1077

417

203

1697

Patients who discontinued due to an AE

41 (7.0)

17 (3.7)

4 (2.0)

62 (5.0)

 Patients with ≥ 1 AE

462 (79.1)

234 (50.9)

113 (55.4)

809 (64.8)

 Events/100 patient-years (95% CI)

195.4 (187.2, 204.0)

143.5 (132.3, 155.5)

133.0 (117.6, 149.8)

175.2 (169.0, 181.6)

 Patients with ≥ 1 infection

287 (49.1)

105 (22.8)

67 (32.8)

459 (36.8)

 Events/100 patient-years (95% CI)

59.9 (55.4, 64.7)

34.0 (28.7, 40.1)

49.8 (40.5, 60.5)

52.3 (48.9, 55.9)

 Patients with ≥ 1 SAE

106 (18.2)

24 (5.2)

7 (3.4)

137 (11.0)

 Events/100 patient-years (95% CI)

16.1 (13.8, 18.7)

8.2 (5.6, 11.4)

3.9 (1.7, 7.8)

12.7 (11.0, 14.5)

 Patients with ≥ 1 serious infection

36 (6.2)

10 (2.2)

3 (1.5)

49 (3.9)

 Events/100 patient-years (95% CI)

4.0 (2.9, 5.4)

2.6 (1.3, 4.7)

1.5 (0.3, 4.3)

3.4 (2.5, 4.4)

 Patients with ≥ 1 MACE

9 (1.5)

0

0

9 (0.7)

 Events/100 patient-years (95% CI)

0.8 (0.4, 1.6)

0 (0.0, 0.7)

0 (0.0, 1.5)

0.5 (0.2, 1.0)

 Patients

5 (0.9)

2 (0.4)

0

7 (0.6)

 Events/100 patient-years (95% CI)

0.5 (0.2, 1.1)

0.5 (0.1, 1.7)

0 (0.0, 1.5)

0.4 (0.2, 0.9)

 Patients

5 (0.9)

1 (0.2)

0

6 (0.5)

 Events/100 patient-years (95% CI)

0.5 (0.2, 1.1)

0.2 (0.0, 1.3)

0 (0.0, 1.5)

0.4 (0.1, 0.8)

 Patients with ≥ 1 opportunistic infection

4 (0.7)

0

0

4 (0.3)

 Events/100 patient-years (95% CI)

0.4 (0.1, 1.0)

0 (0.0, 0.7)

0 (0.0, 1.5)

0.2 (0.1, 0.6)

 Patients

3 (0.5)

2 (0.4)

1 (0.5)

6 (0.5)

 Events/100 patient-years (95% CI)

0.3 (0.1, 0.8)

0.5 (0.1, 1.7)

0.5 (0.0, 2.7)

0.4 (0.1, 0.8)

 Patients with ≥ 1 infusion reaction

27 (4.6)

4 (0.9)

3 (1.5)

34 (2.7)

 Events/100 patient-years (95% CI)

3.7 (2.7, 5.1)

1.4 (0.5, 3.1)

2.0 (0.5, 5.0)

3.0 (2.2, 3.9)