Article Text
Abstract
Objective The recent EULAR SLE guidelines recommend the use of reduced GC regimens (0.3–0.5 mg/kg) in the treatment of LN. However, as they acknowledged, this is not evidence-based. Our objective was to evaluate the effect of different GC regimens with the standard of care therapy on renal response, infections, and mortality among patients with LN.
Methods We performed a systematic review and meta-analysis of the standard-of-care (SoC) arms of randomized clinical trials (RCTs) that used structured GC regimens. We searched in multiple databases from inception up to September 22, 2023. We included RCTs of biopsy-proven LN that used a protocolized scheme of GC in combination with mycophenolic acid analogs (MPAA) or cyclophosphamide and reported the outcomes of complete response (CR), serious infections, or death. We abstracted demographics and characteristics of the GC strategy: start dose of GC, taper scheme, and use of GC pulses. CR was defined as proteinuria <0.5 g/24hrs (or equivalent test) and stabilization of creatinine. We synthesized the estimates using proportional meta-analysis. We performed meta-regression to determine whether a linear relationship exists between the GC start dose and the rate of CR, serious infections, and death.
Results Out of 5,851 studies screened, 37 were included (3,231 patients; mean age 31.2 years; 88% female). A total of 50 individual RCT arms were suitable for meta-analysis. The rate of CR at six months in patients with LN treated with the SoC was 29.8% (95% CI 24.9–35.2%), and at twelve months was 33.9% (95% CI 27.8–40.7%). The meta-regression analysis showed a dose-response gradient between the starting GC dose and the rate of CR, serious infections, and death at six months (figure 1). The rates of CR and death increased with the use of pulses. The meta-regression at twelve months did not show an association with the starting GC dose and CR, infections, and death.
Conclusions Based on the findings of the present meta-analysis in patients with LN treated with the SoC and a structured GC regimen, there is an association between the starting GC dose and the rate of CR, serious infections, and death at six months.
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