A PROSPECTIVE RANDOMIZED STUDY ON PRE-EMPTIVE IMMUNOSUPPRESSIVE TREATMENT IN LUPUS NEPHRITIS PATIENTS WITH ASYMPTOMATIC SEROLOGICAL REACTIVATION

Abstract Background and Aims The optimal management for asymptomatic serological reactivation (ASR) in lupus nephritis (LN) patients remains undefined. Our previous retrospective study suggested that pre-emptive treatment with moderate increase of immunosuppression may reduce subsequent clinical flares. Method This prospective study randomized LN patients with ASR (defined as >2-fold increase of anti-dsDNA to >100 IU/mL, with or without change in complement level, and absence of clinical lupus exacerbation) to receive pre-emptive treatment (‘Pre-emptive’ group) or unchanged management (‘Control’ group). Pre-emptive treatment included increasing prednisolone dose to 0.5 mg/kg/D, and the dose of mycophenolate to 1g/D or azathioprine to 75 mg/D, then tapered over 12-16 weeks back to the original dosages. Results Thirty-four patients were randomized (17 in each group). Pre-emptive group showed lower anti-dsDNA and higher C3 levels after 12 weeks compared with Controls (90.3±58.3 IU/mL vs. 153.8±92.9 IU/mL, and 98.7±33.4 mg/dL vs. 81.8±26.2 mg/dL, respectively; p<0.001 for both) (Figure 1). Pre-emptive group showed significantly lower incidence rates of all clinical flares and renal flares during subsequent 9 months of follow-up compared with Controls (11.7% vs 47.1%, p=0.01; and 0% vs 17.7%, p=0.03; respectively). Mean time-to-flare was 6.4±4.2 months and 5.2±3.4 months in Pre-emptive and Control groups respectively (p=0.77). There was no clinically significant adverse event. Conclusion Our results suggest that pre-emptive moderate increase of immunosuppressive treatment reduces the risk of disease flare in LN patients with ASR and is well tolerated.