A randomized controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis.
S. De Vita,Luca Quartuccio,Miriam Isola,Cesare Mazzaro,Patrizia Scaini,M. Lenzi,Mauro Campanini,C. Naclerio,Antonio Tavoni,M. Pietrogrande,Clodoveo Ferri,Maria Teresa Mascia,Paola Masolini,Alen Zabotti,M. Maset,Dario Roccatello,Al Zignego,Pietro Pioltelli,Armando Gabrielli,Davide Filippini,Oreste Perrella,S. Migliaresi,Massimo Galli,Stefano Bombardieri,Giuseppe Monti +24 more
TLDR
RTX appeared to be superior therapy for all 3 target organ manifestations, and it was as effective as conventional therapy.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.read more
Citations
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References
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Journal ArticleDOI
Diagnosis, management, and treatment of hepatitis C: An update
TL;DR: This document has been approved by the AASLD, the Infectious Diseases Society of America, and the American College of Gastroenterology.
Journal ArticleDOI
Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis
John H. Stone,Peter A. Merkel,Robert Spiera,Philip Seo,Carol A. Langford,Gary S. Hoffman,Cees G. M. Kallenberg,E. William St. Clair,Anthony M. Turkiewicz,Nadia K. Tchao,Lisa Webber,Linna Ding,Lourdes P. Sejismundo,Kathleen Mieras,David Weitzenkamp,David Ikle,Vicki Seyfert-Margolis,Mark Mueller,Paul Brunetta,Nancy B. Allen,Fernando C. Fervenza,Duvuru Geetha,Karina A. Keogh,Eugene Y. Kissin,Paul A. Monach,Tobias Peikert,Coen A. Stegeman,Steven R. Ytterberg,Ulrich Specks +28 more
TL;DR: Rituximab therapy was not inferior to daily cyclophosphamide treatment for induction of remission in severe ANCA-associated vasculitis and may be superior in relapsing disease.
Journal ArticleDOI
Rituximab versus Cyclophosphamide in ANCA-Associated Renal Vasculitis
Rachel B Jones,Jan Willem Cohen Tervaert,Thomas H. Hauser,Raashid Luqmani,Matthew D. Morgan,Chen Au Peh,Caroline O. S. Savage,Mårten Segelmark,Vladimir Tesar,Pieter van Paassen,D Walsh,Michael Walsh,Kerstin Westman,David Jayne +13 more
TL;DR: A rituximab-based regimen was not superior to standard intravenous cyclophosphamide for severe ANCA-associated vasculitis and was not associated with reductions in early severe adverse events.
Journal ArticleDOI
Mixed cryoglobulinemia: demographic, clinical, and serologic features and survival in 231 patients.
Clodoveo Ferri,Marco Sebastiani,Dilia Giuggioli,M Cazzato,Giovanni Longombardo,Alessandro Antonelli,R Puccini,Claudio Michelassi,Anna Linda Zignego +8 more
TL;DR: Careful patient monitoring is recommended for a timely diagnosis of life-threatening Mixed cryoglobulinemia complications, mainly nephropathy, widespread vasculitis, and B-cell lymphoma or other malignancies.
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