Long-Term Use of Voclosporin in Patients With Class V Lupus Nephritis: Results From the AURORA 2 Continuation Study
Bibliographic record
Abstract
Background: Persistent proteinuria increases risk of comorbidities in lupus nephritis (LN) and rapid reductions in protein are predictive of improved long-term renal health. Patients (pts) with Class V LN may take longer to respond to therapy and treatments that efficiently reduce proteinuria in this population are needed. We report on a post-hoc analysis of voclosporin in Class V LN using three years of data from the Phase 3 AURORA 1 and AURORA 2 studies. Methods: AURORA 1 enrolled pts with biopsy-proven active LN, UPCR ≥1.5 mg/mg (≥2.0 mg/mg for pure Class V), and eGFR >45 mL/min/1.73 m2. Pts completing AURORA 1 were eligible to enter AURORA 2 on the same blinded therapy (voclosporin or placebo) in combination with MMF and low-dose steroids. Hazard ratios (HR) for the time to UPCR ≤0.5 mg/mg and mean eGFR levels were assessed in pts with mixed and pure Class V LN. Results: A total of 80 Class V pts continued treatment into AURORA 2. Baseline UPCR was 3.7 and 3.4 mg/mg in control and voclosporin arms, respectively. Differences between treatment arms in UPCR reductions were apparent within the first month and sustained at three years; the median time to UPCR ≤0.5 mg/mg was 3.7 and 16.3 months in the voclosporin and control arms, respectively (HR 2.54; p=0.0004). Results were similar in pure and mixed Class V voclosporin arms; control arms took longer to reach the endpoint (Figure 1). Mean corrected eGFR levels were similar in all treatment arms and stable throughout the study (Figure 1). Conclusions: Voclosporin-treated pts with Class V LN saw substantial reductions in UPCR that occurred faster than in pts treated with MMF and low-dose steroids alone. Voclosporin may be beneficial in limiting the negative long-term impact of proteinuria in this population. Funding: Commercial Support - Aurinia Pharmaceuticals Inc.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".