Abstract: Objective: To evaluate whether adding belimumab (BLM) to a multi-target therapy regimen (corticosteroids, mycophenolate mofetil and tacrolimus combination therapy, CT) improves complete remission rate in active lupus nephritis with acceptable safety.

Methods: A 24-week, open-label, single-center prospective study comparing CT plus BLM (10 mg/kg intravenous at baseline, Week 2, Week 4, and every 4 weeks thereafter) versus combination therapy alone in biopsy-proven active LN patients. The primary endpoint was complete remission at 24 weeks.

Results: CT+BLM group had a significantly higher complete remission rate (71.4% vs 44.0%, aOR=5.53, P=0.016), but similar overall response (96.4% vs 88.0%, P=0.523) and adverse event rates (17.9% vs 12.0%, P=0.833).

Conclusion: Adding belimumab to multi-target induction therapy regimen significantly increases complete remission rate for active lupus nephritis without increasing adverse events.

CLC Number: 

• R593.24

• R692.3

• R979.5