SaO041PROSPECTIVE LONG TERM FOLLOW UP OF THE RITUXILUP STEROID SPARING REGIMEN IN LUPUS NEPHRITIS

Abstract

Introduction and Aims: Lupus nephritis (LN) is a relapsing/remitting condition & much of the long‐term damage relates to oral steroid use. In a single centre prospective cohort study, the Rituxilup regimen (2 doses Methylprednisolone 500mg & Rituximab 1g, 2 weeks apart, followed by maintenance Mycophenolate Mofetil alone) was a safe, effective treatment for ISN/RPS class II/IV/V lupus nephritis (Ann Rheum Dis 2013) over 1 year follow‐up. We now report outcomes over ≥ 5 years. Methods: By May 2014 of the initial cohort of 50 patients; 4 lost to follow‐up & 4 had < 5 years follow‐up. We report outcomes for the remaining 42. Definitions: Complete Remission (CR):urine PCR<50mg protein/mmol creatinine + creatinine no > than 15% above baseline; Partial Remission (PR):uPCR <300mg/mmol + >50% fall from baseline + creatinine no > than 15% above baseline. Renal flare: uPCR>100mg/mmol on 2 consecutive visits + >50% above remission value +/ or creatinine rise >30% above baseline OR biopsy proven relapse. Non‐Response (NR):failure to achieve CR or PR. Results: 42 patients followed for median of 77 months (24‐96). CR/PR achieved in 37 (88%) & median time to remission 9 months (1‐36). There were 5 (12%) NR. Importantly in the 39 where data available, 77% (30) never required oral steroids, 10% (4) had 120umol/l at baseline predicted poor outcomes whereas flares did not. Median creatinine umol/l(range) at baseline & latest f/up respectively: no flare 89(54‐268) & 75(57‐199); flare 113(56‐383) & 70 (57‐314)+2 in ESRF; NR 96 (71‐125) & 131(86‐169)+2 ESRF. Conclusions: The Rituxilup regimen led to remission, preservation of renal function & minimal oral steroid use in the majority of patients over a prolonged period. Flares were not uncommon, mostly responded to retreatment with no oral steroids & did not predict poor outcomes. Baseline creatinine >120mmol/l or failure to achieve PR at 6 mths predicted poor outcomes. The minimal use of oral steroids should reduce long‐term side effects especially CV risk. The Rituxilup trial (NCT01773616) starting Q1 2015 will address efficacy & safety in an international multicentre randomised controlled trial.