OA03 Are there any differences in the outcomes of treatment of a 12-month course of rituximab BCD020 biosimilar in systemic lupus erythematosus in children with early and late administration of the drug.

Background Juvenile systemic lupus erythematosus (JSLE) is a severe life-threatening disease. The place of rituximab in JSLE management is still undefined. The early biologic intervention might improve disease's outcomes. Aim of study To assess the advantages of early rituximab administration compared with late. Material and methods In the retrospective cohort study the information about 36 JSLE patients, whom rituximab biosimilar BCD020 was initiated were included. All patients were divided in two groups: early start of rituximab (less than six months from onset) and late start (more than one year). We compared initial disease characteristics at onset, on the baseline (BL)—start of rituximab and end of the study—(EOS) - 12 months, and treatment characteristics. Results The time gap between early and late rituximab administration was 19 months. There were no differences in disease profile at onset, except higher SLEDAI and MAS frequency in early rituximab group. Baseline differences were: lower C3, C4, higher SLEDAI and oral daily corticosteroids dosage. At the end of the study, patient whom rituximab was prescribed early had more impressive changes in SLEDAI, e.g. 100% of patients decreased SLEDAI, compared with 79% in late rituximab group. The detailed information about disease activity and treatment outcomes in both groups are in the table. There were no differences in adverse events between groups, except more impressive signs of corticosteroid toxicity in group of late rituximab administration. Conclusion Early administration of rituximab biosimilar made it possible to control the JSLE activity faster and reduce the dose of corticosteroids effectively. There were no differences in adverse events, except signs of corticosteroid toxicity in group of late rituximab initiation. This work was financially supported by the Ministry of Science and Higher Education of the Russian Federation (Agreement No. 075–15-2022–301). Ethics The study was approved by the Ethical Committee of the Saint-Petersburg State Pediatric Medical University (Protocol No1/3 from 11/Jan/2021). There were no violations of patient's rights according to the Declaration of Helsinki. OA03 Table 1. Parameter.  Early start of rituximab (n = 16).  Late start of rituximab (n = 19).  P -value.  Time before rituximab, months  3 (2; 6)  22 (14; 36)  0.00001  SLEDAI, BL, points  22 (15; 26)  10 (6; 16)  0.003  SLEDAI, EOS, points  2 (0; 4)  2 (0; 6)  1.0  SLEDAI changes from BL, points  -18 (-13; -24)  -6 (-14 -14)  0.0006  Patients, improved SLEDAI, %  16 (100)  15 (79)  0.05  SLEDAI changes from BL, %  85 (81; 100)  64 (14; 100)  0.099  Daily corticosteroids, BL, mg/kg  1.0 (0.6; 0.1)  0.3 (0.2; 0.8)  0.027  Daily corticosteroids, EOS, mg/kg  0.1 (0.08; 0.16)  0.1 (0.06; 0.2)  0.842  Median daily corticosteroids change from BL, %  85 (60; 88)  68 (33; 90)  0.436  Improvement in SLEDAI from BL        SLEDAI30  16 (100)  14 (74)  0.027  SLEDAI50  16 (100)  13 (68)  0.014  SLEDAI70  15 (94)  9 (47)  0.004  SLEDAI 90  7 (44)  7 (37)  0.678  SLEDAI100  5 (31)  6 (32)  0.984  Parameter.  Early start of rituximab (n = 16).  Late start of rituximab (n = 19).  P -value.  Time before rituximab, months  3 (2; 6)  22 (14; 36)  0.00001  SLEDAI, BL, points  22 (15; 26)  10 (6; 16)  0.003  SLEDAI, EOS, points  2 (0; 4)  2 (0; 6)  1.0  SLEDAI changes from BL, points  -18 (-13; -24)  -6 (-14 -14)  0.0006  Patients, improved SLEDAI, %  16 (100)  15 (79)  0.05  SLEDAI changes from BL, %  85 (81; 100)  64 (14; 100)  0.099  Daily corticosteroids, BL, mg/kg  1.0 (0.6; 0.1)  0.3 (0.2; 0.8)  0.027  Daily corticosteroids, EOS, mg/kg  0.1 (0.08; 0.16)  0.1 (0.06; 0.2)  0.842  Median daily corticosteroids change from BL, %  85 (60; 88)  68 (33; 90)  0.436  Improvement in SLEDAI from BL        SLEDAI30  16 (100)  14 (74)  0.027  SLEDAI50  16 (100)  13 (68)  0.014  SLEDAI70  15 (94)  9 (47)  0.004  SLEDAI 90  7 (44)  7 (37)  0.678  SLEDAI100  5 (31)  6 (32)  0.984  Open in new tab OA03 Table 1. Parameter.  Early start of rituximab (n = 16).  Late start of rituximab (n = 19).  P -value.  Time before rituximab, months  3 (2; 6)  22 (14; 36)  0.00001  SLEDAI, BL, points  22 (15; 26)  10 (6; 16)  0.003  SLEDAI, EOS, points  2 (0; 4)  2 (0; 6)  1.0  SLEDAI changes from BL, points  -18 (-13; -24)  -6 (-14 -14)  0.0006  Patients, improved SLEDAI, %  16 (100)  15 (79)  0.05  SLEDAI changes from BL, %  85 (81; 100)  64 (14; 100)  0.099  Daily corticosteroids, BL, mg/kg  1.0 (0.6; 0.1)  0.3 (0.2; 0.8)  0.027  Daily corticosteroids, EOS, mg/kg  0.1 (0.08; 0.16)  0.1 (0.06; 0.2)  0.842  Median daily corticosteroids change from BL, %  85 (60; 88)  68 (33; 90)  0.436  Improvement in SLEDAI from BL        SLEDAI30  16 (100)  14 (74)  0.027  SLEDAI50  16 (100)  13 (68)  0.014  SLEDAI70  15 (94)  9 (47)  0.004  SLEDAI 90  7 (44)  7 (37)  0.678  SLEDAI100  5 (31)  6 (32)  0.984  Parameter.  Early start of rituximab (n = 16).  Late start of rituximab (n = 19).  P -value.  Time before rituximab, months  3 (2; 6)  22 (14; 36)  0.00001  SLEDAI, BL, points  22 (15; 26)  10 (6; 16)  0.003  SLEDAI, EOS, points  2 (0; 4)  2 (0; 6)  1.0  SLEDAI changes from BL, points  -18 (-13; -24)  -6 (-14 -14)  0.0006  Patients, improved SLEDAI, %  16 (100)  15 (79)  0.05  SLEDAI changes from BL, %  85 (81; 100)  64 (14; 100)  0.099  Daily corticosteroids, BL, mg/kg  1.0 (0.6; 0.1)  0.3 (0.2; 0.8)  0.027  Daily corticosteroids, EOS, mg/kg  0.1 (0.08; 0.16)  0.1 (0.06; 0.2)  0.842  Median daily corticosteroids change from BL, %  85 (60; 88)  68 (33; 90)  0.436  Improvement in SLEDAI from BL        SLEDAI30  16 (100)  14 (74)  0.027  SLEDAI50  16 (100)  13 (68)  0.014  SLEDAI70  15 (94)  9 (47)  0.004  SLEDAI 90  7 (44)  7 (37)  0.678  SLEDAI100  5 (31)  6 (32)  0.984  Open in new tab [ABSTRACT FROM AUTHOR]