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Table 1 Baseline characteristics of 344 patients with systemic autoimmune diseases treated with biological agents

From: Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label

 

n= 344

Females

270 (78%)

Mean age (years)

42.74 ± 0.83

Mean time of follow up (months)

26.76 ± 1.14 (0.5-105)

Autoimmune diseases

 

- Systemic lupus erythematosus

140 (41%)

- Systemic vasculitis

50 (14%)

- Inflammatory myopathies

38 (11%)

- Behçet disease

31 (9%)

- Sjögren syndrome

23 (7%)

- Other diseases*

62 (18%)

Previous therapies (ever exposed)

 

- Oral corticosteroids

332 (97%)

- Methylprednisolone pulses

86 (25%)

- Immunosuppressants

282 (82%)

- Intravenous immunoglobulins

89 (26%)

- Plasma exchange

10 (3%)

- Other therapies

109 (32%)

Cumulated dose/length of previous therapies

 

- Mean length of prednisone therapy (years)

8.04 ± 0.65

- Cumulated dose of cyclophosphamide (gr)

7.18 ± 1.11

- Mean length of mycophenolate (years)

2.20 ± 0.39

- Mean length of azathioprine (years)

1.44 ± 0.35

- Number of previous immunosuppressants

 

> = 3

73 (21%)

> = 4

25 (7%)

Biological agent

 

- Rituximab

264 (77%)

- Infliximab

37 (11%)

- Etanercept

21 (6%)

- Adalimumab

19 (5%)

- Other

3 (1%)

Therapies administered concomitantly

 

- Oral corticosteroids

312 (91%)

- Immunosuppressants

193 (56%)

- Intravenous immunoglobulins

14 (4%)

- Plasma exchange

11 (3%)

Time of exposure to biological (person-years)

 

- Total time

495

- Exposure to rituximab

328

- Exposure to infliximab

52

- Exposure to etanercept

66

- Exposure to adalimumab

30

Retreatment

55 (16%)

Switch

33 (10%)

  1. See the complete list of diseases included in the Methods section.