Table 4.
Effects of Rituximab Therapy in HCV-Related Mixed Cryoglobulinemia.
| Author (year) | N | Population | Treatment | Response |
|---|---|---|---|---|
| Sansonno et al. (2003)111 | 20 | Active MC, refractory to IFN | RTX 375 mg/m2 weekly × 4 FU 12 months (no IS were added) |
CR 80% (reduced cryocrit + clinical improvement) Overall response rate occurred in 5 months Decreased RF, anti-HCV titer and B-cell HCV-RNA increased (×2) in responders, and remained much the same in non-responders |
| Zaja et al. (2003)112 | 12 | Active MC, refractory to CS/IS/IFN/PF 3 pt. had NHL |
RTX 375 mg/m2 weekly × 4 FU response at 6 months with add. 3–28 months FU (low-mod. dose CS are allowed) |
Improved purpura and neuropathy 90–100% Decreased cryocrit, RF and IgM 100% Streroid-sparing effect 100% B-cell depletion in PB (100%), in BM (2/7) Clinical relapse 33% In NHL: 2/3 CR, 1/3 partial response |
| Roccatello et al. (2008)113 | 12 | Active MC, resistance (6), or intolerance (3) to conventional Rx, or significant BM infiltrates (3) | RTX 375 mg/m2 weekly × 4 + add. 2 doses monthly FU at least 18 months (no IS were added) |
Improvement of clinical signs and symptoms Decreased cryocrit, ESR, IgM, and proteinuria HCV-RNA and IgG remained stable BM abnormalities reversed to normal 100% (3/3) |
| Patrarca et al. (2010)114 | 19 | Active MC with CLD (F3-4) intolerant or contraindicated to IFN (15 pt. had cirrhosis, 6 pt. had ascites) | RTX 375 mg/m2 weekly × 4 FU 6–48 months (low-mod. dose CS are allowed) |
Clinical improved (CR 12, partial response 7) 9 negative cryocrit, 5 decreased cryocrit HCV-RNA increased during Rx—3 months after Rx Improved liver synthetic functions and ascites |
| Saadoun et al. (2008)119 | 16 | Active MC, resistance (11) or relapser (5) to previous Peg-IFN or IFN + RBV | RTX 375 mg/m2 weekly × 4, then Peg-IFN 1.5 μg/kg/week + RBV 600–1200 mg/day FU ≥ 6 months after Rx (mean 19.4 months) |
Clinical and immunological improved 93.7% CR 62.5% (all had SVR), clinical relapse 18.8% SVR 68.7% Predictors of CR = shorter vasculitis duration before Rx and lower HCV-RNA at 3 months |
| Terrier et al. (2009)117 | 32 | Active MC - Divided into 2 groups; [A] n = 20, IFN naïve (9), NR or relapser (11); [B] n = 12, failed previous Peg-IFN Rx or IFN intolerant |
[A] RTX 375 mg/m2 weekly × 4 or 100 mg on day 1 and day 15, then Peg-IFN 1.5 μg/kg/week + RBV 600–1200 mg/day for 12 months (range 3–20) [B] RTX alone FU 23 ± 12 months |
SVR; [A] 55%, [B] 0%* Clinical response; [A] = 95%, [B] = 67%* Immunological response; [A] = 100%, [B] = 82%* Clinical relapse; [A] = 15%, [B] 33%* Immunological relapse; [A] = 25%, [B] = 50%* All relapses associated with no SVR 6 pt. had re-Rx by RTX—clinical response 100% *P = ns |
| Dammacco et al. (2010)120 | 37 | Active MC, naïve to IFN/IS - Randomized into 2 groups; [A] n = 22, [B] n = 15 |
[A] RTX 375 mg/m2 weekly × 4 + add. 2 doses 5-monthly, with Peg-IFN alfa-2b 1.5 μg/kg/week or alfa-2a 180 μg/week + RBV for 48 week [B] Peg-IFN + RBV FU 36 months after Rx |
CCR at 12 months; [A] = 54.5%, [B] = 33.3%** CCR at 36 months; [A] = 83.3%(10/12), [B] = 40%(2/5)*** **P < 0.05, ***P < 0.01 Cryoglobulins persisted at 36 months; [A] = 22.7%, [B]33.3% |
| Visentini et al. (2011)138 | 27 | Active MC, resistance (6), or intolerance (3) to | RTX 250 mg/m2 × 2 week | CR 79% Relapse 42% (mean time of relapse 6.5 months) |
MC, Mixed Cryoglobulinemias; RTX, Rituximab; Peg, Pegylated; IFN, Interferon; FU, Follow-Up; CS, Corticosteroid; IS, Immunosuppressive agents; PF, Plasmapheresis; BM, Bone Marrow; PB, Peripheral Blood; CLD, Chronic Liver Disease; NHL, Non-Hodgkin's Lymphoma; SVR, Sustained Virological Response; CR, Clinical Remission; CCR, Complete Clinical Response (disappearance of symptoms, cryoglobulins, serum HCV-RNA, and B-cell clonalities from the blood).