Table 4

Meta-analysis of adverse events in randomized controlled trials of biological agents in patients with systemic autoimmune diseases

Disease

Patients (n)

Total side effects (n)

Total infections (n)

Severe infections (n)

Placebo

Biologic

Placebo

Biologic

Placebo

Biologic

Placebo

Biologic


Meijer et al [3]

Sjögren síndrome

10

20

4

16

4

11

NS

NS

Dass et al [4]

Sjögren síndrome

9

8

0

4

0

1

0

1

Merrill et al [5]

SLE

88

169

73

139

15

16

15

16

Stone et al [6]

ANCA-vasculitis

98

99

33

31

NS

NS

7

7

Jones et al [7]

ANCA-vasculitis

11

33

NS

NS

7

19

3

7

RITUXIMAB

216

329

110/205

190/296

26/118

47/230

25/206

31/309

HR 1.55 (1.06-2.26)*

HR 0.97 (0.80-1.17)

HR 0.81 (0.45-1.48)

Hoffman et al [8]

Giant cell arteritis

16

28

15

26

9

20

1

3

Salvarani et al [9]

Rheumatic polym.

28

23

5

7

0

1

0

1

Baughman et al [10]

Sarcoidosis

44

89

41

80

32

54

4

10

Mariette et al [11]

Sjögren síndrome

49

54

1

6

0

1

0

1

INFLIXIMAB

137

194

62 (45.2%

119 (61.3%)

41

76

5

15

HR 1.92 (1.20-3.06)*

HR 1.51 (0.92-2.47)

HR 2.21 (0.74-7.96)

Melikoglu et al [12]

Behcet

20

20

0

2

0

0

0

0

Baughman et al [13]

Sarcoidosis

9

9

5

2

2

2

0

0

Sankar et al [14]

Sjögren syndrome

14

14

1

2

1

0

0

0

WGET [15]

ANCA-vasculitis

91

89

51

51

45

44

NS

NS

Mtnez-Taboada et al [16]

Giant cell arteritis

9

8

7

8

4

4

0

0

ETANERCEPT

143

140

64 (44.7%)

65 (46.4%)

52 (36.4%)

50 (35.7%)

0 (0%)

0 (0%)

HR 1.07 (0.65-1.75)

HR 0.97 (0.58-1.63)

Not calculable

TOTAL

496

663

236/485

(48.7%)

374/630

(59.4%)

119/398

(29.9%)

173/564

(30.7%)

30/395

(7.6%)

46/554

(8.3%)

HR 1.54 (1.20-1.97)*

HR 1.04 (0.78-1.39)

HR 1.10 (0.67-1.84)


*P < 0.05; ANCA, anti-neutrophil antibodies; HR, hazard ratio; NS, not specified; SLE, systemic lupus erythematosus.

Díaz-Lagares et al. Arthritis Research & Therapy 2011 13:R112   doi:10.1186/ar3397

Open Data