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Gospel of patients with lupus nephritis: Voclosporin

  The AURA study published by the American College of Rheumatology Association (ACR / ARHP) in 2016 shows that most patients with lupus nephritis receiving low-dose voclosporin therapy receive complete remission.

  A total of 265 patients with active lupus nephritis were randomized to placebo (n = 88), low-dose voclosporin (23.7 mg, bid, n = 89) and high-dose voclosporin (39.5 mg, bid, n = 88). In addition, the subjects also received mycophenolate mofetil 2 g / day and glucocorticoid therapy.

  Primary endpoint: Complete remission - defined as urinary protein / creatinine ratio ≤ 0.5 mg / mg, estimated glomerular filtration rate ≥ 60 mL / min and reduced eGFR ≤ 20%. Secondary endpoints were complete response time, partial remission (defined as 50% reduction in proteinuria), and partial remission.

  The results showed that the complete response rate was 32.6% in the low-dose group and 27.3% in the high-dose group (P = 0.045). The complete remission rate in the low-dose group was higher than that in the high-dose group (OR = 2.03; P = 0.045). The complete remission rate was 19.3% in the control group.

  Low-dose histone reduction was significantly better than placebo (P = 0.047). The partial response rate was 70% in the low-dose group, 49% in the high-dose group and 66% in the placebo group. (P = 0.002) and placebo (P = 0.003) in the low-dose group compared with the high-dose group (P = 0.002).

  In the low-dose group, complete remission lasted for 7 weeks, and the high-dose group and placebo group continued for more than 10 weeks. Adverse events were frequent. Overall, renal function in patients treated with voclosporin decreased, but not significantly. At the end of the study, 13 deaths were reported and the overall mortality rate was 4.9%.

  "The pharmacokinetics and pharmacodynamics of voclosporin are stable, and mortality is the most feared side effect of voclosporin therapy," said researcher Mary Anne Dooley.

  Source: AURA: Voclosporin gives hope to patients with lupus nephritis. Healio. November 15, 2016


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