OP0228 Rituximab Monotherapy of Severe Hcv-Related Cryoglobulinemic Vasculitis for More than 2 Years: Follow-Up of A Randomized Controlled Multicentre Study
Authors: L. Quartuccio, F. Zuliani, L. Corazza, P. Scaini, R. Zani, M. Lenzi, A. Tavoni, M. Sebastiani, S. Baldovino, T. Urraro, F. Saccardo, C. Sbreglia, C. Mazzaro, P. Pioltelli, P. Fraticelli, D. Filippini, A. Gabrielli, O. Perrella, S. Scarpato, D. Roccatello, A.L. Zignego, C. Ferri, S. Bombardieri, M. Pietrogrande, M. Galli, G. Monti, S. De Vita
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> Two independent controlled randomized trials demonstrated the efficacy and safety of rituximab (RTX) monotherapy in severe cryoglobulinemic vasculitis (CV) (1, 2), with one reporting a prolonged follow-up (1). <h3>Objectives</h3> To report the very long term efficacy and safety of RTX monotherapy in severe CV since a regimen of RTX monotherapy was maintained after the end of the abovementioned trial (1). <h3>Methods</h3> Long term follow up data of a trial of RTX in severe CV (1) were analysed. During this follow-up, only RTX monotherapy was used. Disease activity at the last follow-up visit, adverse events and survival were registered. Clinical response was evaluated at the last follow-up visit, and was scored as follows: i) complete remission (no activity), partial remission (response &gt;50% of at least one manifestation among glomerulonephritis, severe neuropathy or skin ulcers) (1), and active disease. <h3>Results</h3> After the end of the 2-year controlled trial (1), follow-up data were available in 36 patients undergoing RTX, all HCV positive. The mean follow up after the beginning of RTX therapy (1) was 70.22±20.41 months, including 29 patients followed for more than 4 years (78.4±12.6 months) and 7 patients followed for 2.4-4 years (36.4±6 months). Of them, 3 patients were lost from follow-up shortly after the end of the trial, and 9 patients died. Of the remaining 24 patients, 14/24 (58.3%) showed complete clinical remission at the last follow-up, 6/24 (25%) a partial remission, while 4/24 (16.7%) had an active disease. A first repeated RTX course (1 g two weeks apart) was required in 50% of the patients (12/24), while 25% of the patients (6/24) needed more than one course, for a total of 19 retreatments. Patients were retreated for nephritis (7/19), neuropathy (6/19), skin ulcers (7/19) or diffuse purpura (6/19). Three patients underwent a maintenance RTX regimen, all with 1 g × 2 every 6 months, with a complete and partial remission at the last follow-up noticed in 2/3 and 1/3, respectively. Recurrent infections occurred only in three patients (8%; urinary and upper respiratory), and they were related to persistent hypogammaglobulinemia in 2/3. Death occurred in 9 patients, all showing persistent active disease. <h3>Conclusions</h3> A long-term RTX therapy lasting several years is effective and safe in about two thirds of the patients with severe CV. The advantage of retreatment at relapse regimen instead of a maintenance therapy, and whether this may occur in a further subset of patients, needs further investigation. <h3>References</h3> De Vita S, et al. Arthritis Rheumatol. 2012;64(3):843-53. Sneller MC, et al. Arthritis Rheumatol. 2012;64(3):835-42. <h3>Disclosure of Interest</h3> None declared <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.3872