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Table 4 Summary of non-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 Sample
(Total / RTX / Control)
Age
(Min-Max/ Mean +/− SD)
Female sex (%) Follow-up RTX scheme AE Outcomes Tomographic analysis
Daoussis et al. 2017 Greece 51/ 33/ 18 CG: 52.11 ± 16.10
RTX: 54.3 ± 14.33
80.39 7 years Two or more RTX cycles. Each cycle consisted of four infusions of 375 mg per m2 of body area, once a week, repeated every 6 months. Yes   Skin - mRSS Lung - FVC (%) Yes
Time Control group RTX group Control group RTX group
Start 17.78 ± 9.48 14.72 ± 10.52 77.72 ± 18.29 80.6 ± 21.21
12 months 15.78 ± 9.89 8.83 ± 7.83 (+) 77.18 ± 19.25 83.02 ± 19.05
24 months 13.72 ± 9.67 (+) 5.93 ± 5.15 (+) 77.59 ± 19.45 86.9 ± 20.56 (+)
36 months 15.53 ± 9.53(+) 4.53 ± 5.29 (+)   *
48 months 13.64 ± 8.56(+) 5.37 ± 8.34 (+)   *
7 years * * 61.11 ± 15.73 (+) 91.69 ± 14.81
Bosello et al. 2015 Italy 20/20/0 RTX: 41.4 ± 13.1 85 86 months 1000 mg, two infusions, two weeks apart. Yes Time Skin - mRSS Lung - FVC (%) Yes
Start 22.3 ± 9.5 87.4 ± 19.5
6 months 14.4 ± 8.4(+) 89.0 ± 17.
12 months 11.2 ± 7.5(+) 90.7 ± 17.9 (+)
24 months 9.95 ± 6.0(+) 89.9 ± 21.2
36 months 8.1 ± 5.2(+) 94.0 ± 16.1
48 months 9.8 ± 7.2(+) 95.6 ± 20.7
Lafyatis et al. 2009 USA 15/15/0 RTX: 32.0–57.0/ 45.8 86.66 1 year 1000 mg, two infusions, two weeks apart. Yes Time Skin - mRSS Lung - FVC (%) Yes
Start 20.6 ± 4.4 89.2 ± 10.8  
6 months 20.2 ± 5.5 92.7 ± 10.3  
12 months 21.1 ± 5.2 *  
Melsens et al. 2017 Belgium 17/17/0 RTX: 36.0–69.0/ 51.0 35,3 2 years 1000 mg, two infusions, two weeks apart and 1000 mg, two infusions, two weeks apart, after 6 months. Yes Time Skin - mRSS Lung - FVC (%) Yes
Start 25.5 ± 6.0 93.5 ± 11.3
3 months 18.6 ± 6.5 (+) 90.7 ± 11.6
6 months 14.6 ± 6.2 (+) 93.3 ± 13.4
12 months 10.7 ± 3.5 (+) 95.6 ± 13.5
15 months 9.7 ± 3.5(+) 98.0 ± 13.7 (+)
18 months 9.8 ± 3.8(+) 95.0 ± 15.4
24 months 12.6 ± 5.1(+) 90.5 ± 16.3
Smith et al. 2010 Belgium 8/8/0 RTX: 49.0–57.0 37.5 24 weeks 1000 mg, two infusions, two weeks apart. Yes Time Skin - mRSS Lung - FVC (%) Yes
Start 24.8 ± 3.4 83.9 ± 8.1
12 weeks 19.4 ± 5.4(+) 81.0 ± 17.7
24 weeks 14.3 ± 3.5(+) 77.0 ± 9.8
Smith et al. 2013 Belgium 8/8/0 RTX: 49.0–69.0/ 38.0 37,5 2 years 1000 mg, two infusions, two weeks apart and 1000 mg, two infusions, two weeks apart, after 6 months. Yes Time Skin - mRSS Lung - FVC (%) Yes
Start 24.8 ± 3.4 92.8 ± 8.6
3 months 19.4 ± 5.4(+) 88.5 ± 12.9
6 months 14.3 ± 3.5(+) 88.3 ± 9.3
12 months 10.8 ± 4.6(+) 89.2 ± 13.7
15 months 10.0 ± 2.6(+) 94.4 ± 10.1
18 months 10.8 ± 2.6(+) 89.8 ± 12.0
24 months 13.6 ± 5.6(+) 84.7 ± 13.3 (+)
Bosello et al. 2010 Italy 9/9/0 RTX: 40.9 ± 11.1 88,9 3 years 1000 mg, two infusions, two weeks apart. Yes Time Skin - mRSS Lung - FVC (%) Yes
Start 21.1 ± 9.0 91.6 ± 20.7
3 months 15.2 ± 6.0 *
6 months 12.0 ± 6.1(+) *
12 months 7.0 ± 4.0 *
18 months 7.0 ± 3.5 *
24 months 5.0 ± 2.0 *
36 months 4.0 ± 1.4 96.8 ± 18.9
  1. * Data not reported in article; (+) statistically significant