Table 2 Adverse events in patients with PsA according to age subgroup

Total patient years of exposure

991.3

745.1

246.2

Any AE^a n (%) (95% CI)

171 (34.6) (30.4; 39.0)

124 (32.7) (28.0; 37.7)

47 (40.9) (31.8; 50.4)

Any study treatment-related AE n (%) (95% CI)

84 (17.0) (13.78; 20.6)

69 (18.2) (14.5; 22.5)

15 (13.0) (7.5; 20.6)

Any SAE n (%) (95% CI)

31 (6.3) (4.3; 8.8)

20 (5.3) (3.3; 8.0)

11 (9.6) (4.9; 6.5)

Any study treatment-related SAE n (%) (95% CI)

7 (1.4) (0.6; 2.9)

6 (1.6) (0.6; 3.4)

1 (0.9) (0.0;4.7)

Any AE leading to withdrawal n (%) (95% CI)

43 (8.7) (6.4; 11.5)

37 (9.8) (7.0; 13.2)

6 (5.2) (1.9; 0.9)

Any AE of special interest n (%) (95% CI)

13 (2.6) (1.4; 4.5)

6 (1.6) (0.6; 3.4)

7 (6.1) (2.5; 12.1)

Serious infections and opportunistic infections (with possible relatedness)

6 (1.2) (0.4; 2.6)

5 (1.3) (0.4; 3.1)

1 (0.9) (0.0; 4.7)

CV events

6 (1.2) (0.4; 2.6)

1 (0.3) (0.0; 1.5)

5 (4.3) (1.4; 9.9)

Severe depression including suicidality

1 (0.2) (0.0; 1.0)

1 (0.3) (0.0; 1.5)

0

Malignancies

1 (0.2) (0.0; 1.0)

0

1 (0.9) (0.0; 4.7)

Any neoplasm AE (no lag time) n (%) (95% CI)

10 (2.0) (1.0; 3.7)

4 (1.1) (0.3; 2.7)

6 (5.2) (1.9; 11.0)

Benign neoplasm

4 (0.8) (0.2; 2.1)

3 (0.8) (0.2; 2.3)

1 (0.9) (0.0; 4.7)

Non-melanoma skin cancer

1 (0.2) (0.0; 1.1)

0

1 (0.9) (0.0; 4.7)

Malignancy (excl. non-melanoma skin cancer)

5 (1.0) (0.3; 2.3)

1 (0.3) (0.0; 1.5)

4 (3.5) (1.0; 8.7)

Any neoplasm AE (12-month lag time) n (%) (95% CI)

6 (1.2) (0.4; 2.6)

2 (0.5) (0.1; 1.9)

4 (3.5) (1.0; 8.7)

Benign neoplasm

3 (0.6) (0.1; 1.8)

2 (0.5) (0.1; 1.9)

1 (0.9) (0.0; 4.7)

Malignancy (excl. non-melanoma skin cancer)

3 (0.6) (0.1; 1.8)

0

3 (2.6) (0.5; 7.4)

Death

1 (0.2) (0.0; 1.1)

0

1 (0.9) (0.0; 4.7)