A randomized controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis
Year: 2011
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: Arthritis & Rheumatism
DOI: 10.1002/art.34331
Authors: S. De Vita, L. Quartuccio, M. Isola, C. Mazzaro, P. Scaini, M. Lenzi, M. Campanini, C. Naclerio, A. Tavoni, M. Pietrogrande, C. Ferri, M. T. Mascia, P. Masolini, A. Zabotti, M. Maset, D. Roccatello, A. L. Zignego, P. Pioltelli, A. Gabrielli, D. Filippini, O. Perrella, S. Migliaresi, M. Galli, S. Bombardieri, G. Monti
Institutions: University of Udine, Azienda Ospedaliera Santa Maria Degli Angeli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola, University of Bologna, Azienda Ospedaliero Universitaria Maggiore della Carita, Azienda Sanitaria Locale Salerno, University of Pisa, University of Bergamo, University of Modena and Reggio Emilia, Ospedale San Giovanni Bosco, University of Florence, University of Milan, University of Milano-Bicocca, Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Ospedale D. Cotugno, Ospedale di Circolo di Busto Arsizio
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2090887217