#4844 belimumab and multitarget therapy as induction therapy of severe active lupus nephritis: case series from china

Abstract Background and Aims Belimumab (BLM) has been approved for the treatment of active systemic lupus erythematosus (SLE) and active lupus nephritis (LN). Multitarget therapy (MT) consisting of tacrolimus (FK506), mycophenolate mofetil (MMF), and steroid has been proved that can provide good curative effect as induction therapy for LN. Because of the limitations of BLM's phase III clinical trails, the exact curative effect in severe active LN of BLM is not clear yet. To assess the safety and generate preliminary efficacy data on MT followed by BLM for severe active Chinese LN patients, a case series were investigated. Method Six patients with severe active LN were reported. Among the 6 patients, 2 were treated with MT followed by BLM infusions, 2 were treated with MMF / (FK506) followed by BLM infusions, and 2 were treated with MT. BLM was given 10 mg/kg every 2 weeks for 3 times, then every 4 weeks till Week 24. Primary renal response index, SLEDAI, and safety data were analyzed. Results The patients affected by LN ISN/RNP Class III/IV±V with high disease activity are 3 de no LN and 3 refractory LN (each regimen included 1 de no LN and 1 refractory LN). At baseline, the SLEDAI score were 15,20,17,16,15,15 respectively. 4 of the 6 patients (case 1,case 2,case 3, and case 5) accepted intravenous (IV) methylprednisolone, followed by MT/MMF/FK506 after admission. The initial oral prednisone was 30-45 mg/day. Within 2 weeks of starting treatment, IV BLM was introduced. At Week 24, the SLEDAI score decreased to 2,8,8,10,8,10 respectively. 2 patients accepted BLM and MT achieved complete renal remission, and the other 4 patients achieved partial renal remission (Fig. 1). MT and BLM therapy reduced SLEDAI more rapidly than MMF/FK 506 +BLM or MT (Fig. 2). Prednisone was reduced to 10-15 mg/d. No adverse events occurred. Conclusion The addition of BLM to basic immunosuppressants was effective and safe for severe active LN. The BLM and MT regimen seems to lead a faster and more pronounced remission. Further prospective clinical studies with larger samples are needed to evaluate the benefits of belimumab combined with MT in severe active LN.