Table 1.
Prospective randomized controlled trials comparing rituximab (R) with a classical immunosuppressive regimen (C).
| Studies | Sneller et al. (USA) | De Vita et al. (Italy) |
|---|---|---|
| Methodology | ||
|
| ||
| Sample size (R/C) | 24 (12/12) | 57 (29/28) |
| Design | Prospective RCT Open-label, monocentric |
Prospective RCT Open-label, multicentric |
| Followup duration | M12 | M24 |
| Rituximab | 375 mg/m2 × 4 No GC premedication |
1000 mg × 2 100 mg MP iv before each |
| Other treatments allowed for group R | IS/GC already initiated | Low dosage of GC |
| Effective regimen for group C | IS/GC already initiated ± increase (only PL = 1 at M5) |
GC = 17 or IS = 7 (AZA/CYC) or PL = 5 ± GC |
| Planned sample size | 30 | 124 |
| Limitations | 8-year enrolment Early stop after interim analysis |
86% switch before M2∗
Early stop after interim analysis |
|
| ||
| Patients | ||
|
| ||
| Underlying VHC infection | 24/24 | 53/57 |
| Previous treatments (R versus C) | Unbalanced at randomization GC = 6 versus 3 CYC = 1 versus 0, PL = 2 versus 0 |
Not provided |
|
| ||
| Efficacy | ||
|
| ||
| Primary endpoint | Clinical remission at M6 | Survival of initial treatment at M12 |
| Result (R versus C) | 10/12 (83%) versus 1/12 (8%) | 64% versus 3.5% |
| Response to retreatment | R: 3/3 | R: 5/7 C: 6/8 |
| Time of switch of C to R | After M6 | As soon as failure∗ |
| Number of switches of C to R | 9/12 | 23/28 |
| Response to switch to R | 4/7 (2 lost to followup) | 14/23 |
|
| ||
| Safety | ||
|
| ||
| Infusion-related severe events | 1 serum-infusion reaction | 1 hypotension with angina |
| Viral load of VHC | No difference | Not monitored |
Abbreviations: AZA: azathioprine; CYC: cyclophosphamide; GC: glucocorticoids; IS: immunosuppressive; MP: methylprednisolone; PL: plasmapheresis.