Cso Tang

Clinical course of lamivudine-resistant HBV infection in renal allograft recipients

1206 12 MONTH RESULTS OF A PHASE III PROSPECTIVE, RANDOMISED STUDY TO EVALUATE CONCENTRATION CONTROLLED RAPAMUNE WITH CYCLOSPORIN DOSE MINIMIZATION OR ELIMINATION IN DE NOVO RENAL ALLOGRAFT RECIPIENTS. Alan G. Jardine. 1Department of Medicine, Western Infirmary, Glasgow, United Kingdom. Objective: To assess the safety and efficacy of sirolimus (SRL) plus low dose steroids as maintenance regimen with or without low dose cyclosporin (CsA) in kidney transplant recipients. Methods: We present a twelve-month interim analysis of data for this international study . 280 recipients of kidney allografts from cadaveric or living donors have been enrolled; 172 patients are presented in this analysis. All patients received CsA (125-250 ng/mL) + SRL (4-12 ng/mL) + low dose steroids daily after transplantation. At three months, eligible patients were randomized 1:1 to CsA elimination (eCsA) or minimization (mCsA). In the mCsA group, drug levels were maintained between 50-100 ng/mL. In both arms, SRL trough levels were increased to achieve maintenance levels of 8-16 ng/mL. Antibody induction was prohibited while steroids were generally tapered to reach 5 mg at six months. Results: Patient and graft survival at 12 months were 98.3% and 95.9% respectively (n = 172). The overall first biopsy proven acute rejection rate at 12 months was 25.0% (43 episodes in 172 patients). This comprised 34 episodes (19.8%) during the first 3 months of the study and 9 episodes (5.2%) following randomization. 117 patients were randomized to receive eCsA (n=59) and mCsA (n= 58) of which 102 completed 12 months study participation. Pretransplant demographic and donor variables were similar between groups. Following randomization, 4 patients experienced acute rejection in the mCsA group and 8 in the eCsA group. 3 of the 8 eCsA patients had already experienced acute rejection whilst on combination treatment. All acute rejections in the post-randomisation period were mild or moderate. At twelve months, creatinine clearance was significantly higher in the eCsA group vs mCsA group; 70.9 mL/min vs 54.6 mL/min (p= 0.0001). Mean serum creatinine at 12 months was significantly lower in the eCsA group vs mCsA group 124.6 v 153.4 umol/l (p= 0.0032). There was no significant difference in serum cholesterol, triglycerides, LDL, or HDL between the groups. No malignancies have been reported to date. Conclusions: Sirolimus permits the elimination of cyclosporin from maintenance immunotherapy and this is associated with improved renal function.

427 Relapse of lupus nephritis – risk factors and impact of mycophenolate treatment

Background and aims The management of lupus nephritis (LN) has evolved over time. There is limited data on renal flares in the recent era. Methods We investigated the renal relapse rate in 139 patients with a history of Class III/IV±V diagnosed during the period of Jan 1983 to Dec 2013, and the factors associated with renal flares. Results 135 episodes of renal relapse occurred over 112.5±88.4 months, giving a flare rate of 0.108 episode per patient-year. Reduced risk of renal flare was associated with maintenance treatment using mycophenolate (MPA) (OR 0.314, 95% CI 0.099–0.994, p=0.049), complete remission after the prior episode of active LN (OR 0.329, 95% CI 0.133–0.810, p=0.016), and diagnosis of LN after 1998 (OR 0.305, 95% CI 0.133–0.700, p=0.005) when maintenance therapy with MPA was instituted. Low-dose prednisolone and MPA maintenance immunosuppression was associated with better relapse-free survival (5 year 91% and 10 year 83%) than prednisolone and azathioprine (AZA) (70% and 52% respectively, p=0.044) (Figure 1). LN diagnosed in 1998–2013 was associated with 5 year and 10 year relapse-free survival rates of 93% and 86% respectively, compared with 81% and 66% respectively (p=0.017) for patients who presented in 1983–1997 (Figure 2). Abstract 427 Figure 1 Abstract 427 Figure 2 Conclusions The risk of renal relapse has decreased in the current era, probably attributed to replacement of AZA with MPA as maintenance treatment.