Dr. De Vita received honoraria from Bristol-Myers Squibb, Glaxo, Roche, and UCB (less than $10,000 each).
A randomized controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis†
Article first published online: 28 FEB 2012
Copyright © 2012 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 64, Issue 3, pages 843–853, March 2012
How to Cite
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. and Monti, G. (2012), A randomized controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis. Arthritis & Rheumatism, 64: 843–853. doi: 10.1002/art.34331
- Issue published online: 28 FEB 2012
- Article first published online: 28 FEB 2012
- Accepted manuscript online: 6 DEC 2011 03:22PM EST
- Manuscript Accepted: 1 DEC 2011
- Manuscript Received: 11 MAR 2011
To conduct a long-term, prospective, randomized controlled trial evaluating rituximab (RTX) therapy for severe mixed cryoglobulinemia or cryoglobulinemic vasculitis (CV).
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.
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.
RTX monotherapy represents a very good option for severe CV and can be maintained over the long term in most patients.