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Table 1 Summary of randomized clinical trial data according to author, country, sample characterization, RTX scheme and follow-up, adverse events and main results

From: Is rituximab effective for systemic sclerosis? A systematic review and meta-analysis

Author (year)

Country

Randomization

Sample

(Total / RTX / Control)

Age

(Min-Max/ Mean +/− SD)

Female sex (%)

Follow-up

RTX scheme

AE

Outcomes

Tomographic analysis

Jadad score

Sircar et al. (2018)

India

Yes

60/ 30/ 30

CG: 36.50 ± 9,73

RTX: 34.67 ± 8.13

83

6 months

Two RTX

pulses of 1000 mg at 0 and 15 days i.v, and 1000 mg of RTX after 6 months as maintenance therapy

Yes

 

Skin - mRSS

Lung - FVC (%)

No

3

Time

Control group

RTX group

Control group

RTX group

Start

23.83 ± 9.28

21.77 ± 9.86

59.25 ± 12.96

61.30 ± 11.28

6 months

18.33 ± 7.69 (+)

12.10 ± 10.14 (+)

58.06 ± 111.23

67.52 ± 13.59

Boonstra et al. (2017)

Netherlands

Yes

16/ 8/ 8

CG: 36.6 ± 4.3

RTX: 44.5 ± 5.6

87.5

2 years

1000 mg, two infusions, two weeks apart, and one 1000 mg RTX consolidation treatment once, after 6 months

Yes

 

Skin - mRSS

Lung - FVC (%)

Yes

3

Time

Control group

RTX group

Control group

RTX group

Start

14.0 ± 3.8

16.4 ± 4.4

92.0 ± 6.1

97.9 ± 6.6

12 months (Δ)

- 1.8

- 3.6

+  0.3

+  4.7

24 months (Δ)

- 1.9

- 5.3

- 1.4

+  4.0

Daoussis et al. (2010)

Greece

Yes

14/ 8/ 6

CG: 47.7–68.5/ 56

RTX: 41.0–66.5/ 53

85.7

1 year

Two cycles of RTX. Each cycle consisted of four infusions of 375 mg per m2 of body area, once a week, repeated after 6 months

Yes

 

Skin - mRSS

Lung - FVC (%)

Yes

3

Time

Control group

RTX group

Control group

RTX group

Start

11.5 ± 2.16

13.5 ± 6.9

86.0 ± 19.6

68.1 ± 19.7

12 months

9.7 ± 3.4

8.4 ± 6.5 (+)

81.7 ± 20.7

75.6 ± 19.7 (+)

  1. * Data not reported in article; (+) statistically significant