SAT0171 RITUXIMAB IN SYSTEMIC AUTOIMMUNE RHEUMATIC DISEASES: ONE CENTER EXPERIENCE OF TREATMENT 515 PATIENTS

Abstract

Background:B cells have important functions in the pathogenesis of systemic autoimmune rheumatic diseases (SARDs).Objectives:The purpose of the research was to study the therapeutic option of Rituximab (RTM), a chimeric anti-CD20 antibody, in SARDs such as ANCA-associated systemic vasculitis (AAV), cryoglobulinemic vasculitis (СV), systemic lupus erythematosus (SLE), systemic sclerosis (SS), primary Sjögren syndrome (pSS) and IgG4-related disease (IgG4-RD).Methods:We present data on efficacy and safety of RTM in 515 patients (pts) with SARDs. 103 pts had AAV (58- granulomatosis with polyangiitis, GPA; 35- microscopic polyangiitis, MPA and 10- eosinophilic granulomatosis with polyangiitis, EGPA), 21 pts had CV, 167- SLE, 90- SS, 100- pSS, 34- IgG4-RD. Characteristics of pts and results of RTM treatment are present in Table. Mean follow-up duration after initiation of RTM was 25- 58 months.Results:The average cumulative RTM dose in all groups exceeded 2.4 g, 71% of pts received repeated RTM courses (0.5-1.0 g) every 4 – 12 months. Complete (good) clinical response was achieved in 70-93% pts, except for the SLE (49%- complete response, 32- incomplete and 19%- no response). Usage of repeated RTM courses increased the clinical efficacy and reduced the risk of recurrence. Despite the fact that the study population included a high percentage of pts with severe or refractory SARDs, total mortality rate was about 6% during the follow-up period, highest in CV and AAV (14-11%). In AAV and SLE infections constitute a significant proportion of serious adverse reactions (10-11%). Late-onset neutropenia was only in pts with AAV (12%) and SLE (3%).Conclusion:Treatment with RTM was highly effective in SARDs. In certain SARDs RTM safety profile of should be considered during treatment planning. Further studies of the targeted anti-B-cell therapy, including RTM efficacy and safety in SARDs, clarification of the indications and optimal RTM regimens are needed.Table.ParametersАAVCVSLESSpSSIgG4-RDGPA, MPAEGPAN pts9310211679010034Age, years41(16-67)50(24-71)53,6 + 2941(18-52)47(17-71)42 + 12,247,4 + 15,9Percentage of females56%90%52%92%75%97%60%Duration of disease, months*14(1-288)11(1-180)72(3-96)18(2-47)70(7-264)90(36-168)24(6-60)Cumulative RTM dose, g*3 (0,5-8)3 (1,5-5,5)4,7 + 3,82,4 (1,8±0,8)2,9(0,5-6)5,5 + 1,54 + 1,5Follow-up duration after the first RTM course, month*37(1–96)36(14-94)52(6-108)38(12-67)27(12-42)58(24-96)25(3-60)Clinical response, %Complete (good)93%90%71%49%70%92,5%77%Incomplete response6%10%29%32%24%6,5%23%No response1%0%-19%6%1%-Relapse8%30%--nd--Glucocorticoids dose, mg/day*:Before RTMAfter RTM30(5–60)5(0-10)20(7,5-50)7,5(5-10)4,4(0-24)1,5(0-4)28(15-40)7,5(5-15)12(0-25)9(0-15)7,5(0-40)1,2510(2,5-40)0,5Immunosuppressants% pts before RTM72%90%38%65%43%44%40%% pts after RTM43%70%5%46%50%8%10%Infusion-related reactions,9%20%24%4%2%10%3%including severe-10%-0,6%1%1%-Pts with serious adverse reactions,26%40%5%14%2%5%3%including: infections,11%10%-10%2%5%3%neutropenia10%20%-3%---Deceased pts during the follow-up11%-14%5%6%2%-*Data are provided in the following format: median & min-max range in the bracketsDisclosure of Interests:None declared