Efficacy and Safety of Voclosporin Over 3 Years in Patients With Severe Lupus Nephritis
Bibliographic record
Abstract
Background: The AURORA 1 study demonstrated that addition of voclosporin, a novel calcineurin inhibitor, to mycophenolate mofetil (MMF) and low-dose steroids significantly increased rates of complete renal response (CRR) at 52 weeks in patients with lupus nephritis, with efficacy maintained for an additional 24 months in those who continued treatment in the AURORA 2 study. Here we report on a post hoc analysis evaluating voclosporin use in patients with severe lupus nephritis using pooled data from the AURORA 1 and AURORA 2 studies. Methods: Patients who completed AURORA 1 were eligible to enter AURORA 2 to continue the same blinded therapy of voclosporin or placebo; all patients received MMF and low-dose steroids. In this post hoc analysis, the definition of severe lupus nephritis included patients with Class III or IV (± Class V) disease with active lesions and urine protein creatinine ratio (UPCR) ≥3 mg/mg at AURORA 1 baseline. CRR was defined as UPCR ≤0.5 mg/mg with stable renal function, use of low-dose steroids, and no use of rescue medication and was assessed over the three-year treatment period of AURORA 1 and AURORA 2. Results: Of the 116 patients in the voclosporin arm and 100 patients in the control arm who continued treatment in AURORA 2, 47 and 37 patients in each arm, respectively, had severe disease. Mean (SD) UPCR at pre-treatment AURORA 1 baseline was 6.02 (2.29) mg/mg in the voclosporin arm and 6.08 (2.46) mg/mg in the control arm. Rates of CRR in the voclosporin and control arms were 46.8% and 21.6%, respectively, at one year (OR 4.41, 95% CI 1.47, 13.26; p=0.008), 57.4% and 35.1% at two years (OR 3.08, 95% CI 1.17, 8.10; p=0.022), and 53.2% and 35.1% at three years (OR 2.92, 95% CI 1.07, 7.94; p=0.036). The rates of serious adverse events were similar in the voclosporin (21.3%) and control (27.0%) arms, with one death occurring in a control-treated patient. Conclusions: In patients with severe lupus nephritis, adding voclosporin to MMF and low-dose steroids results in significantly higher CRR rates and a similar safety profile to that of control. This is clinically meaningful given that patients with severe disease are at higher risk of worse long-term outcomes and development of end stage kidney disease. 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 | 0.002 |
| 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 | 0.000 | 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".