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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