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Objective: To evaluate the safety, mechanism of action and preliminary efficacy of rituximab combined with belimumab in the treatment of refractory lupus nephritis (LN)
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Method
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In a multicenter, randomized, open-label clinical trial, 43 patients with relapsed or refractory LN received rituximab, cyclophosphamide (CYC) and glucocorticoid treatment, followed by weekly infusion of Bailey Lumumab until the 48th week (RCB group), or use rituximab and CYC but not belimumab (RC group)
Results: Belimumab treatment did not increase the incidence of adverse events in patients with refractory LN
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At week 48, 11 of 21 patients (52%) who received belimumab had a complete or partial renal response, compared with 22 patients in the RC group who did not receive belimumab.
Figure 1 The total number of B cells in peripheral blood mononuclear cells (PBMC) of patients with lupus nephritis and the relative number of B cell subpopulations after RC and RCB treatment
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Before treatment, 12 weeks after treatment (left) and 24-60 weeks after RC or RCB treatment during reconstruction, the A and B cell counts in peripheral blood (left) and 24-60 weeks after RCB treatment (right) in peripheral blood A, B cell count
Figure 1 The total number of B cells in peripheral blood mononuclear cells (PBMC) of patients with lupus nephritis and the relative number of B cell subpopulations after RC and RCB treatment
Figure 2 Reconstruction of autoreactive antinuclear antibody positive (ANA+) B cell subpopulations after RC and RCB treatments in the population that meets the protocol at 48 weeks
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A, the average number of B cell subpopulations in ANA+B cells in each group before treatment and 48 weeks after treatment
Figure 2 Reconstruction of autoreactive antinuclear antibody positive (ANA+) B cell subpopulations after RC and RCB treatments in the population that meets the protocol at 48 weeks
In patients with refractory LN, it is safe to add belimumab to rituximab and CYC treatment regimens
Atisha-Fregoso Y, Malkiel S, Harris KM, et al, Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis .
Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis in this message
