A randomized, controlled, trial of rituximab for treatment of severe cryoglobulinemic vasculitis.

Author(s): De Vita S, Quartuccio L, Isola M, Mazzaro C, Scaini P, Lenzi M, Campanini M, Naclerio C, A T, Pietrogrande M, Ferri C, Mascia M, Masolini P, Zabotti A, Maset M, Roccatello D, Zignego A, Pioltelli P, Gabrielli A, Filippini D, Perrella O, Migliaresi S, Galli M, Bombardieri S, Monti G

Affiliation(s): Rheumatology Clinic, DPMSC, Azienda Ospedaliero-Universitaria "S. Maria della Misericordia", University of Udine, Udine, Italy, Co-ordinating Centre. devita.salvatore@aoud.sanita.fvg.it.

Publication date & source: 2011-12-06, Arthritis Rheum., [Epub ahead of print]

OBJECTIVE: A prospective, long-term randomized controlled trial was designed to support the use of rituximab (RTX) 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. Antiviral therapy had previously failed or was not indicated in patients with hepatitis C virus infection. Patients were randomized in non-RTX Group (conventional treatment, chosen among glucocorticoids, cyclophosphamide or azathioprine, and plasma exchange) or in RTX Group (RTX, 1 gram x2; associated with lower doses of glucocorticoids whenever possible, and with RTX retreatment at relapse). Patients failing treatment in non-RTX Group could be switched to RTX. Study duration was 24 months. RESULTS: Survival of treatment was statistically higher in RTX Group at 12 months (primary end point; 64.3% vs 3.5%, p<0.0001), and also at months +3 (92.9% vs 13.8%, p<0.0001), +6 (71.4% vs 3.5%, p<0.0001) and +24 (60.7% vs 3.5%, p<0.0001). Birmingham vasculitis activity score decreased only after RTX (from 11.9 +/- 5.4 to 7.1 +/- 5.7 at month +2; p< 0.001) up to month +24 (4.4 +/- 4.6; p<0.0001). RTX appeared superior for all the three target organ manifestations, and it was effective as a 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 may be maintained in the long term in most patients. Copyright (c) 2011 by the American College of Rheumatology.