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A randomized controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis

Open access
De Vita, S., Quartuccio, L., Isola, M., Mazzaro, C., Scaini, P., Lenzi, M., Campanini, M., Naclerio, C., Tavoni, A., Pietrogrande, M., Ferri, C., Mascia, M. T., Masolini, P., Zabotti, A., Maset, M., Roccatello, D., Zignego, A. L., Pioltelli, P., Gabrielli, A., Filippini, D., Perrella, O., Migliaresi, S., Galli, M., Bombardieri, S., Monti, G.·2012·Arthritis & Rheumatism

Abstract

Objective: To conduct a long‐term, prospective, randomized controlled trial evaluating rituximab (RTX) therapy for severe mixed cryoglobulinemia or cryoglobulinemic vasculitis (CV). Methods: Fifty‐nine patients with CV and related skin ulcers, active glomerulonephritis, or refractory peripheral neuropathy were enrolled. In CV patients who also had hepatitis C virus (HCV) infection, treatment of the HCV infection with antiviral agents had previously failed or was not indicated. Patients were randomized to the non‐RTX group (to receive conventional treatment, consisting of 1 of the following 3: glucocorticoids; azathioprine or cyclophosphamide; or plasmapheresis) or the RTX group (to receive 2 infusions of 1 gm each, with a lowering of the glucocorticoid dosage when possible, and with a second course of RTX at relapse). Patients in the non‐RTX group who did not respond to treatment could be switched to the RTX group. Study duration was 24 months. Results: Survival of treatment at 12 months (i.e., the proportion of patients who continued taking their initial therapy), the primary end point, was statistically higher in the RTX group (64.3% versus 3.5% [P < 0.0001]), as well as at 3 months (92.9% versus 13.8% [P < 0.0001]), 6 months (71.4% versus 3.5% [P < 0.0001]), and 24 months (60.7% versus 3.5% [P < 0.0001]). The Birmingham Vasculitis Activity Score decreased only after treatment with RTX (from a mean ± SD of 11.9 ± 5.4 at baseline to 7.1 ± 5.7 at month 2; P < 0.001) up to month 24 (4.4 ± 4.6; P < 0.0001). RTX appeared to be superior therapy for all 3 target organ manifestations, and it was as effective as conventional therapy. The median duration of response to RTX was 18 months. Overall, RTX treatment was well tolerated. Conclusion: RTX monotherapy represents a very good option for severe CV and can be maintained over the long term in most patients.

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Metadata

Authors
De Vita, S., Quartuccio, L., Isola, M., Mazzaro, C., Scaini, P., Lenzi, M., Campanini, M., Naclerio, C., Tavoni, A., Pietrogrande, M., Ferri, C., Mascia, M. T., Masolini, P., Zabotti, A., Maset, M., Roccatello, D., Zignego, A. L., Pioltelli, P., Gabrielli, A., Filippini, D., Perrella, O., Migliaresi, S., Galli, M., Bombardieri, S., & Monti, G.
Venue
Arthritis & Rheumatism
Publisher
Wiley
Published
2012-02-28
Volume
64
Issue
3
Pages
843-853
ISSN
  • 0004-3591 (ISSN-L)
  • 1529-0131
OpenAlex
W2090887217
Cited by
405
References
17
FWCI
24.99
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: A randomized controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis. https://app.cochat.ai/papers/10.1002/art.34331
The paper
De Vita, S., Quartuccio, L., Isola, M., Mazzaro, C., Scaini, P., Lenzi, M., Campanini, M., Naclerio, C., Tavoni, A., Pietrogrande, M., Ferri, C., Mascia, M. T., Masolini, P., Zabotti, A., Maset, M., Roccatello, D., Zignego, A. L., Pioltelli, P., Gabrielli, A., . . . Monti, G. (2012). A randomized controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis. Arthritis & Rheumatism. https://doi.org/10.1002/art.34331

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.