Skip to main content

Table 4 Total number of events of special interest ordered by decreasing frequencies

From: Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs: combined data of more than 15,000 patients from Pharmachild and national registries

 

Pharmachild

N = 2022

BiKeR

N = 1697

Infections:

1523 (75.3%)

1509 (89%)

 Serious/targeted infections (Epstein–Barr virus, cytomegalovirus, papilloma virus, herpes zoster primary and reactivation, and opportunistic infections)

674 (33.3%)

171 (10.1%)

 Tuberculosis

27 (1,3%)

0

 Other infections

822 (40.6%)

1338 (78.8%)

Infusion/injection related reactions:

218 (10.8%)

24 (1.4%)

 Infusion related reaction

144 (7.1%)

11 (0.6%)

 Injection related reaction

74 (3.7%)

13 (0.8%)

Blood cell–related events of special interest (ESI):

188 (9.3%)

90 (5.3%)

 Pancytopenia

6 (0.3%)

65 (3.8%)

 Neutropenia

107 (5.3%)

14 (0.8%)

 Macrophage activation syndrome

75 (3.7%)

11 (0.6%)

 Aplastic anemia

0

0

Autoimmune ESI:

50 (2.5%)

50 (2.9%)

 Inflammatory bowel disease (IBD)

21 (1.1%)

23 (1.3)

 Other autoimmune diseases excluding IBD, uveitis, and demyelinisation disorders

18 (0.9%)

24 (1.4%)

 Lupus erythematosus systemic/lupus-like syndrome

4 (0.2%)

1 (0.1%)

 Optic neuritis

4 (0.2%)

0

 Multiple sclerosis

2 (0.1%)

0

 Demyelination

1 (0.05%)

2 (0.2%)

Malignancies:

16 (0.8%)

13 (0.8%)

 Leukemias

3 (0.1%)

2 (0.2%)

 Lymphomas

2 (0.1%)

5 (0.3%)

 Hematopoietic neoplasms (excluding leukemias and lymphomas)

1 (0.05%)

2 (0.2%)

 Neoplasm (other)

10 (0.5%)

4 (0.2%)

Others ESI:

27 (1.3%)

11 (0.6%)

 Gastrointestinal (GI) ulcer/GI bleed/GI perforation

17 (0.8%)

4 (0.2%)

 Pregnancy

9 (0.4%)

7 (0.4%)

 Congestive heart failure

1 (0.05%)

0

  1. Data are absolute numbers and frequencies (percentage)