Rituximab Monotherapy Of Severe Hcv-Related Cryoglobulinemic Vasculitis For More Than 2 Years: Follow-Up Of A Randomized Controlled Multicentre Study
Annals of the Rheumatic Diseases(2014)
摘要
Background 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). Objectives 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). Methods 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 >50% of at least one manifestation among glomerulonephritis, severe neuropathy or skin ulcers) (1), and active disease. Results 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. Conclusions 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. References De Vita S, et al. Arthritis Rheumatol. 2012;64(3):843-53. Sneller MC, et al. Arthritis Rheumatol. 2012;64(3):835-42. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3872
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