AB0284 COMBINATION THERAPY WITH RITUXIMAB AND BELIMUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Abstract

Objectives:To assess the efficacy of combined therapy with rituximab (RTM) and belimumab (BLM) in patients with active systemic lupus erythematosus (SLE).Methods:The study included 12 SLE pts (1М/11F) with severe (SLEDAI2K≥10 – 8pts.) and moderate (SLEDAI2K<10- 4pts.) disease activity; out of them 5 patients had lupus nephritis, vasculitis and 7 had predominantly mucocutaneous and articular manifestations of SLE. The dose of oral GC was: 60 mg in one patient with vasculitis, LN, cerebrovasculitis; in 9 patients from 10 to 5 mg; in 2 patients without oral glucocorticoids. All patients with SLE with kidney damage, CNS, and vasculitis received cytostatics. All patients with vasculitis, LN, etc. received mycophenolate mofetil or cyclophosphamide. Rituximab (RTM) was administered at 500-2000 mg, with subsequent adding of Belimumab (BLM) 1-6 months later at a standard dosing regimen 10 mg/kg once a month a total of 7 infusions. The following parameters were evaluated: the effectiveness of therapy, the concentration of autoantibodies, the dose of oral corticosteroids initially at the time of RTM administration and then every 3 months after the initiation of BLM therapy.Results:8 pts demonstrated the decrease in clinical and laboratory SLE activity, starting from 3mo of follow-up. After the start of BLM infusions, a decrease in SLE activity was observed in all patients. Among them, 9 had SLEDAI-2K activity of less than 4 points (SLEDAI-2k Me 12 [9,5;17], after treatment of RTM and BLM 4[2;4]). Only one patient (№4) had a relapse of SLE, due to the omission of the BLM infusion. He was receiving standard GC doses. In dynamics, a decrease anti-double DNA titres (Me 101 [39;250]U/ml vs 19 [9;70] U/ml), С3 (0,44 [0,39;0,59]g/l vs 0,81 [0,72;0,87] g/l), С4 (0,06 [0,031;0,1] g/l vs 0,14 [0,13;0,14] g/l) was registered. The GC dose was reduced in most patients (tab. 1), but the previously prescribed immunosuppressive therapy continued. There were no cases of severe infection.Conclusion:Combination therapy allows to gain control over disease activity in short time, due to the effect of RTM, while added BLM provides further prolongation of the effect achieved, minimizing the risk of flare. The use of such therapy contributes to a rapid and effective reduction in the activity of the disease, normalization of laboratory markers of SLE (at to ds-DNA, C3, C4), the use of lower doses of oral GCs. This combination may be used as a method of choice in pts with severe SLE involving vital organs, and in persistent cutaneous-articular disease and high immunological activity.Table 1.Dose of oral glucocorticoids (prednisone), mg№ patientBefore the introduction of RTM, mg1st 7th injection of of BLM, mg7th injection of BLM, mg1202015↓27,555↓3555=4101010↓5555=6607,52,5↓↓↓7102,50↓↓↓810105↓92,52,52,5=1010105↓11000=12000=Disclosure of Interests:None declared