Skip to main content

Table 1 Study design and baseline characteristics of study participants presented per treatment-control combination

From: Tocilizumab as monotherapy or combination therapy for treating active rheumatoid arthritis: a meta-analysis of efficacy and safety reported in randomized controlled trials

Study

Treatment arms

Design

Study length (weeks)

Enrolled patients (n)

csDMARD-naïve at baseline (yes, no)

Previous biologic therapy (%)

Mean age (years)

Female (%)

Symptom duration (years)

ESR (mm/h)

CRP (mg/l)

DAS28

HAQ

TCZCOMBI vs. TCZMONO

 SURPRISE (2016)

TCZCOMBI

Open label

52

115

No

0

56 (12)

87

4 (3)

41 (28)

12 (15)

5.1 (1)

1.0 (0.7)

 

TCZMONO

111

56 (3)

87

4 (3)

45 (30)

18 (26)

5.3 (1.2)

1.0 (0.7)

 FUNCTION (2015)

TCZCOMBI

Double-blind

52

291

Nof

0

50 (14)

79

6 (6)g

53 (30)

26 (30)

6.7 (1.1)

1.5 (0.6)

 

TCZMONO

292

50 (12)

75

6 (6)g

51 (28)

25 (32)

6.7(1.0)

1.6 (0.7)

 ACT-RAY (2013)

TCZCOMBI

Open-label, double-blindc

24

277

No

0

53 (13)

82

8 (8)

NR

NR

6.3 (1)

1.5 (0.7)

 

TCZMONO

276

54 (12)

79

8 (8)

6.4 (1)

1.5 (0.6)

 ACT-STAR (2013)a

TCZCOMBI

Open-label

24

360

No

67

54 (12)

78

11 (9)

NR

14 (21)

5.5 (1)

NR

 

TCZMONO

163

87

54 (13)

80

14 (10)

19 (33)

6.0 (1)

 CHARISMA (2006)b

TCZCOMBI

Double-blind

16

50

No

14

50 (NR)

78

11 (NR)c

39 (NR)

24 (NR)

6.5 (NR)

NR

 

TCZMONO

52

50 (NR)

73

9 (NR)c

39 (NR)

22 (NR)

6.4 (NR)

TCZCOMBI vs. csDMARD

 FUNCTION (2015)

TCZCOMBI

Double-blind

52

291

No

0

50 (14)

79

6 (6)c

53 (30)

26 (30)

6.7 (1.1)

1.5 (0.6)

 

csDMARD

289

 

50 (13)

80

5 (6)c

50 (27)

23 (27)

6.6 (1.0)

1.5 (0.7)

 ROSE (2012)

TCZCOMBI

Double-blind

24

409

No

38

55 (12)

80

9 (9)

46 (24)

17 (21)

6.5 (1)

4.1 (1.7)h

 

csDMARD

205

38

56 (12)

84

9 (9)

47 (22)

17 (22)

6.6 (1)

4.0 (2.1)h

 LITHE (2011)a

TCZCOMBI

Double-blindd

52

398

No

11

53 (12)

82

9 (NR)

46 (25)

23 (26)

6.6 (1)

1.5 (0.6)

 

csDMARD

393

12

51 (12)

83

9 (NR)

47 (25)

22 (25)

6.5 (1)

1.5 (0.6)

 TOWARD (2008)

TCZCOMBI

Double-blind

24

803

No

NS

53 (13)

81

10 (9)

48 (28)

26 (32)

6.7 (1)

1.5 (0.6)

 

csDMARD

413

54 (13)

84

10 (9)

49 (28)

26 (47)

6.6 (1)

1.5 (0.6)

 OPTION (2008)a

TCZCOMBI

Double-blind

24

205

No

5

51 (12)

85

8 (7)

51 (27)

26 (26)

6.8 (1)

1.6 (0.6)

 

csDMARD

204

9

51 (12)

78

8 (7)

50 (26)

24 (28)

6.8 (1)

1.5 (0.6)

 RADIATE (2008)a

TCZCOMBI

Double-blind

24

170

No

100

54 (13)

84

13 (9)

49 (28)

28 (33)

6.8 (1)

1.7 (0.6)

 

csDMARD

158

53 (13)

79

11 (9)

55 (33)

37 (41)

6.8 (1)

1.7 (0.6)

 CHARISMA (2006)b

TCZCOMBI

Double-blind

16

50

No

14

50 (NR)

78

11 (NR)c

39 (NR)

24 (NR)

6.5 (NR)

NR

 

csDMARD

49

51 (NR)

78

11 (NR)c

43 (NR)

32 (NR)

6.8 (NR)

TCZMONO vs. csDMARD

 FUNCTION (2015)

TCZMONO

Double-blind

52

292

No

0

50 (12)

75

6 (6)c

51 (28)

25 (32)

6.7(1.0)

1.6 (0.7)

 

csDMARD

289

50 (13)

80

5 (6)c

50 (27)

23 (27)

6.6 (1.0)

1.5 (0.7)

 AMBITION (2010)

TCZMONO

Double-blind

24

286

No

8

51 (13)

83

6 (8)

50 (28)

30 (33)

6.8 (1)

1.6 (0.7)

 

csDMARD

284

7

50 (13)

79

6 (8)

49 (26)

31 (34)

6.8 (1)

1.5 (0.6)

 SATORI (2009)

TCZMONO

Double-blind

24

61

No

NS

53 (11)

90

9 (8)

52 (28)

30 (20)

6.1 (1)

NR

 

csDMARD

64

51 (12)

75

9 (7)

52 (24)

32 (26)

6.2 (1)

 SAMURAI (2007)

TCZMONO

Open-labele

52

157

No

NS

53 (12)

80

2 (1)

71 (28)

47 (29)

6.5 (1)

NR

 

csDMARD

145

53 (13)

82

2 (1)

71 (25)

49 (29)

6.4 (1)

 CHARISMA (2006)b

TCZMONO

Double-blind

16

52

No

14

50 (NR)

73

9 (NR)c

39 (NR)

22 (NR)

6.4 (NR)

NR

 

csDMARD

49

51 (NR)

78

11 (NR)c

43 (NR)

32 (NR)

6.8 (NR)

  1. Values are expressed as mean (standard deviation) unless otherwise indicated. aTocilizumab (TCZ) 4 mg + conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) comparator group is excluded in this overview; bTCZ 2 mg, TCZ 4 mg, TCZ 2 mg + csDMARD and TCZ 4 mg + csDMARD comparator groups were excluded; cTCZ was given open-label, treatment with methotrexate (MTX) was double-blind; dfirst-year therapy was double-blind followed by a second year of open-label therapy; eopen-label for clinical efficacy endpoints, single-blind only for radiographic evaluation; fall patients were MTX-naïve, but only approximately 80 % were entirely csDMARD-naïve; gmonths; hHealth Assessment Questionnaire-physical function (HAQ-PF) score. TCZ tocilizumab, ESR erythrocyte sedimentation rate, CRP C-reactive protein, DAS28 Disease Activity Score in 28 joints, NS percentage not specified, NR not reported