Lupus & antiphospholipid syndrome
Safety and Efficacy of Long‐Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial
Authors' conclusion
Data demonstrate the safety and efficacy of long-term voclosporin treatment over three years of follow-up in patients with LN.
Study context
- Population
- Patients with lupus nephritis (LN) who completed the one-year AURORA 1 study86.1% completed
- Participants
- 216 patients
- Comparison
- Voclosporin vs placebo, with MMF and low-dose GC, for an additional two years after AURORA 1
- Primary endpoint
- Safety: AEs and biochemical and hematological assessments
Methodological detailscontinuation study of AURORA 1, double-blinded, placebo-controlled, phase 3
- Continuation study of AURORA 1
- Double-blinded
- Placebo-controlled
- Phase 3
Primary result
As reported in the abstract
AEs
Further findings
| Outcome | Voclosporin | Placebo | OR (95% CI) | |
|---|---|---|---|---|
| Complete renal response · three years | 50.9% | 39.0% | 1.74 (1.00–3.03) | |
| 0.20.5125Odds ratio (log scale) |
mL/min/1.73 m²
| Outcome | Voclosporin | Placebo |
|---|---|---|
| eGFR slope over the two-year period · two years | −0.2 (95% CI −3.0–2.7) | −5.4 (95% CI −8.4–-2.3) |
Estimated GFR (eGFR) slope over the two-year period · two years
- Mean corrected eGFR within the normal range and stable in both groups
Safety
Investigator-reported GFR decrease
Investigator-reported hypertension
Original publication
Safety and Efficacy of Long‐Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial. Arthritis Rheumatol. Published 15 September 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →