Lupus & antiphospholipid syndrome
Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis
Primary result · CRRResult — go to the resultOdds ratio 2.76 95% CI 1.88–4.05Authors' conclusion
This integrated analysis demonstrates the efficacy and safety of voclosporin in the treatment of LN across the diverse racial and ethnic groups studied.
Study context
- Population
- Patients with lupus nephritis (LN) in the AURA-LV and AURORA 1 trials2 trials pooled
- Participants
- 534 patients
- Comparison
- Voclosporin 23.7 mg twice daily vs control, both with mycophenolate mofetil (MMF) and oral GC
- Voclosporinn = 268
- Controln = 266reference
- Primary endpoint
- Complete renal response (CRR)
- Follow-up
- Approximately one year (Week 48 AURA-LV; Week 52 AURORA 1)
Methodological detailspooled data from phase II (AURA-LV) and phase III (AURORA 1) trials, randomized, placebo-controlled, double-blind
- Pooled data from phase II (AURA-LV) and phase III (AURORA 1) trials
- Randomized
- Placebo-controlled
- Double-blind
Primary result
CRR · one year
Odds ratio
2.76
95% CI 1.88–4.05
P < 0.0001
By group
Voclosporinvs Control
OR 2.76 (95% CI 1.88–4.05); P < 0.0001
As reported in the abstract
Safety
Adverse events
Infections and infestations
Gastrointestinal disorders
Adverse events
- Most adverse events (AEs) mild to moderate; no new or unexpected safety signals
Original publication
Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis. Arthritis Care Res (Hoboken). Published 12 February 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →