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

Marcella Visentini, Serena Ludovisi, Antonio Petrarca, Federica Pulvirenti, Marco Zaramella, Monica Monti, Valentina Conti, Jessica Ranieri, Stefania Colantuono, Elisa Fognani, Alessia Piluso, Carmine Tinelli, Anna Linda Zignego, Mario U. Mondelli, Massimo Fiorilli, Milvia Casato

Research output: Contribution to journalArticle

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 375mg/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, 250mg/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 6.5months, similar to the 6.7months 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.

Original languageEnglish
Pages (from-to)714-719
Number of pages6
JournalAutoimmunity Reviews
Volume10
Issue number11
DOIs
Publication statusPublished - Sep 2011

Keywords

  • HCV
  • Mixed cryoglobulinemia
  • Rituximab

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy

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    Visentini, M., Ludovisi, S., Petrarca, A., Pulvirenti, F., Zaramella, M., Monti, M., Conti, V., Ranieri, J., Colantuono, S., Fognani, E., Piluso, A., Tinelli, C., Zignego, A. L., Mondelli, M. U., Fiorilli, M., & Casato, M. (2011). A phase II, single-arm multicenter study of low-dose rituximab for refractory mixed cryoglobulinemia secondary to hepatitis C virus infection. Autoimmunity Reviews, 10(11), 714-719. https://doi.org/10.1016/j.autrev.2011.04.033