Eradication of hepatitis C virus (HCV) by antiviral therapy is the treatment of choice for mixed cryoglobulinemia secondary to this infection, but many patients fail to achieve sustained viral responses and need second-line treatments. Several studies have demonstrated that the infusion of the anti-CD20 monoclonal antibody rituximab is highly effective for refractory mixed cryoglobulinemia, with a clinical response in approximately 80% of patients, although the relapse rate is high. Virtually all published studies employed a rituximab dosage of 375 mg/m(2) given four times, a schedule used for treating non-Hodgkin's lymphomas. Based on a prior pilot study, we designed a phase II single-arm two-stage study (EUDRACT n. 2008-000086-38) to evaluate the efficacy of a lower dosage of rituximab, 250 mg/m(2) given twice, for refractory mixed cryoglobulinemia. We present here the preliminary results in the first 27 patients enrolled. The overall response rate in 24 evaluable patients was 79%, and the mean time to relapse was 6.5 months, similar to the 6.7 months reported in studies with high-dose rituximab. Side effects were comparable to those seen in patients treated with high-dose. Increase of HCV viral load, reported in some high-dose studies, was not observed in our patients. Low-dose rituximab may provide a more cost/effective and possibly safer alternative for treating refractory HCV-associated mixed cryoglobulinemia. (C) 2011 Elsevier B.V. All rights reserved.

A phase II, single-arm multicenter study of low-dose rituximab for refractory mixed cryoglobulinemia secondary to hepatitis C virus infection / Visentini, Marcella; Serena, Ludovisi; Antonio, Petrarca; Pulvirenti, Federica; Marco, Zaramella; Monica, Monti; Conti, Valentina; Jessica, Ranieri; Colantuono, Stefania; Elisa, Fognani; Alessia, Piluso; Carmine, Tinelli; Anna Linda, Zignego; Mario U., Mondelli; Fiorilli, Massimo; Casato, Milvia. - In: AUTOIMMUNITY REVIEWS. - ISSN 1568-9972. - 10:11(2011), pp. 714-719. [10.1016/j.autrev.2011.04.033]

A phase II, single-arm multicenter study of low-dose rituximab for refractory mixed cryoglobulinemia secondary to hepatitis C virus infection

VISENTINI, MARCELLA;PULVIRENTI, FEDERICA;CONTI, VALENTINA;COLANTUONO, STEFANIA;FIORILLI, Massimo;CASATO, Milvia
2011

Abstract

Eradication of hepatitis C virus (HCV) by antiviral therapy is the treatment of choice for mixed cryoglobulinemia secondary to this infection, but many patients fail to achieve sustained viral responses and need second-line treatments. Several studies have demonstrated that the infusion of the anti-CD20 monoclonal antibody rituximab is highly effective for refractory mixed cryoglobulinemia, with a clinical response in approximately 80% of patients, although the relapse rate is high. Virtually all published studies employed a rituximab dosage of 375 mg/m(2) given four times, a schedule used for treating non-Hodgkin's lymphomas. Based on a prior pilot study, we designed a phase II single-arm two-stage study (EUDRACT n. 2008-000086-38) to evaluate the efficacy of a lower dosage of rituximab, 250 mg/m(2) given twice, for refractory mixed cryoglobulinemia. We present here the preliminary results in the first 27 patients enrolled. The overall response rate in 24 evaluable patients was 79%, and the mean time to relapse was 6.5 months, similar to the 6.7 months reported in studies with high-dose rituximab. Side effects were comparable to those seen in patients treated with high-dose. Increase of HCV viral load, reported in some high-dose studies, was not observed in our patients. Low-dose rituximab may provide a more cost/effective and possibly safer alternative for treating refractory HCV-associated mixed cryoglobulinemia. (C) 2011 Elsevier B.V. All rights reserved.
2011
rituximab; mixed cryoglobulinemia; hcv
01 Pubblicazione su rivista::01a Articolo in rivista
A phase II, single-arm multicenter study of low-dose rituximab for refractory mixed cryoglobulinemia secondary to hepatitis C virus infection / Visentini, Marcella; Serena, Ludovisi; Antonio, Petrarca; Pulvirenti, Federica; Marco, Zaramella; Monica, Monti; Conti, Valentina; Jessica, Ranieri; Colantuono, Stefania; Elisa, Fognani; Alessia, Piluso; Carmine, Tinelli; Anna Linda, Zignego; Mario U., Mondelli; Fiorilli, Massimo; Casato, Milvia. - In: AUTOIMMUNITY REVIEWS. - ISSN 1568-9972. - 10:11(2011), pp. 714-719. [10.1016/j.autrev.2011.04.033]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/377760
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