Review Article
The Place of Immunotherapy in the Management of HCV-Induced Vasculitis: An Update
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 |
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Abbreviations: AZA: azathioprine; CYC: cyclophosphamide; GC: glucocorticoids; IS: immunosuppressive; MP: methylprednisolone; PL: plasmapheresis.
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