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 | |||||||||||