Safety and Efficacy of Long-term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial
Arthritis Rheumatol. 2023 DOI: 10.1002/art.42657 Epub ahead of print
AURORA 2 demonstrated the safety and tolerability of continued administration of voclosporin over 3 years of treatment in patients with LN.
Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis
Arthritis Care Res (Hoboken). 2023 Jul;75(7):1399–1408 DOI: 10.1002/acr.25007
Pooled analysis of data from the AURA-LV phase 2 and AURORA 1 phase 3 trials of voclosporin in patients with active LN demonstrated that significantly more patients achieved a complete renal response at 1 year in the voclosporin than the control group (p<0.0001), with no observation of new safety signals.
Clin J Am Soc Nephrol. 2022;17:1620–1630 doi: 10.2215/CJN.02520322
This 28-week, open-label extension of BLISS-LN found no new safety signals and maintained efficacy with belimumab, in patients with lupus nephritis.
A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis
Kidney Int. 2022;101(2):403-413 doi: 10.1016/j.kint.2021.08.027
Post-hoc analysis data suggests that the addition of belimumab to standard therapy may be effective in preserving long-term kidney function in patients with lupus nephritis (LN).
N Engl J Med. 2020;383(12):1117–28.
LN occurs in 25–60% of patients with SLE. However, patients with LN are often excluded from clinical trials of SLE therapies.