2082: A Prospective Study on Long-Term Clinical Outcomes of Patients with Lupus Nephritis Treated with an Intensified B-Cell Depletion Protocol Without Maintenance Therapy

Dario Roccatello¹, Savino Sciascia², Carla Naretto¹, Mirella Alpa¹, Roberta Fenoglio¹, Michela Ferro¹, Giacomo Quattrocchio¹, Elena Rubini¹, Elnaz Rahbani¹, Vittorio Modena¹ and Daniela Rossi¹, ¹University of Turin, Turin, Italy, ²University of Turin, Torino, Italy

Background/Purpose: We aimed to investigate the safety and efficacy of an intensified B-cell depletion induction therapy (IBCDT) without immunosuppressive maintenance regimen compared with standard of care in biopsy-proven Lupus Nephritis (LN).

Methods: Thirty patients were administered an IBCDT (4 weekly rituximab [RTX] 375 mg/m² and 2 more doses after 1 and 2 months; 2 infusions of 10 mg/kg cyclophosphamide [CYC], 3 methylprednisolone pulses), followed by oral prednisone (tapered to 5 mg/d by the third month). No immunosuppressive maintenance therapy was given. Thirty patients matched for LN class and age were selected as controls: 20 received 3 methylprednisolone pulses days followed by oral prednisone and mycophenolate mofetil (MMF) 2 to 3 g/d, whereas 10 were given the Euro Lupus CYC. MMF (1-2 g/daily) or azathioprine (AZA, 1-2 mg/kg/day) were given for > 3 years as a maintenance therapy.

Results: At 12 months, complete renal remission was observed in 93% of patients on IBCDT, in 62.7% on MMF, and in 75% on CYC (P = 0.03); the dose of oral prednisone was lower in the IBCDT group (mean ± SD 2.9 ± 5.0 mg/dl) than MMF (10.5 ± 8.0 mg/d, P < 0.01) or CYC group (7.5 ± 9.0 mg/d, P < 0.01). Mean follow-up after treatment was 44.5 months (interquartile range [IQR] 36-120 months), 48.6 months (IQR 36-120 months), and 45.3 (IQR 36-120 months) for IBCDT, MMF, and CYC, respectively. At their last follow-up visit, we observed no significant differences in proteinuria and serum creatinine, nor in the frequency of new flares among the 3 groups.

Conclusion: In biopsy-proven LN, the IBCDT without further immunosuppressive maintenance therapy was shown to be as effective as conventional regimen of MMF or CYC followed by >3-year maintenance either MMF or AZA regimen. Moreover, the use of IBCDT was associated with a marked reduction of glucocorticoid cumulative dose.

Disclosures: D. Roccatello, None; S. Sciascia, None; C. Naretto, None; M. Alpa, None; R. Fenoglio, None; M. Ferro, None; G. Quattrocchio, None; E. Rubini, None; E. Rahbani, None; V. Modena, None; D. Rossi, None.