Long-Term Safety and Efficacy of Voclosporin in Black Patients with Lupus Nephritis
Bibliographic record
Abstract
Background: Black patients with lupus nephritis (LN) are reported to have more severe disease, are often refractory to treatment, and have worse long-term outcomes. Voclosporin in conjunction with low-dose glucocorticoids and mycophenolate mofetil (MMF) has shown significant benefit across ancestries and classes of LN. Here we report outcomes on up to three years of follow-up in patients identifying as Black and treated with voclosporin during the global Phase 3 AURORA studies. Methods: Key inclusion criteria for the parent AURORA 1 study included biopsy-proven LN, urine protein creatinine ratio (UPCR) ≥1.5 g/g (≥2 g/g for Class V) and estimated glomerular filtration rate (eGFR) >45 mL/min/1.73 m2. Patients completing AURORA 1 were eligible to enter the AURORA 2 continuation study on the same blinded therapy of voclosporin or placebo in combination with MMF and glucocorticoids for an additional two years. Programmed complete renal response (CRR; UPCR ≤0.5 g/g, stable eGFR, low-dose steroids, and no rescue medication), partial renal response (PRR; reduction in UPCR of ≥50% from baseline) and safety were assessed in patients self-identifying as Black or mixed Black. Results: Twenty-six of 179 (14.5%) and 19 of 178 (10.6%) patients identified as Black or mixed Black in the voclosporin and control arms of AURORA 1. Baseline characteristics were similar between arms. CRR rates at one year numerically favored voclosporin (46.2% vs 15.8%, OR 3.92 [CI 0.95, >9.99] p=0.0597) as did PRR rates (69.2% vs 47.4%, OR 2.62 [CI 0.72, 9.45] p=0.1422). Eighteen voclosporin-treated patients and seven control-treated patients in the Black subgroup continued into AURORA 2. Response rates at three years continued to numerically favor voclosporin (CRR, 44.4% vs. 14.3%, OR 4.17 [CI 0.41, >9.99] p=0.2276; PRR, 66.7% vs. 42.9%; OR 1.67 [CI 0.23, >9.99] p=0.6094). Greater reductions in mean UPCR were observed over the three-year period in the voclosporin arm (change from baseline -3.4 vs -1.5 g/g, p=0.0349). Mean eGFR levels remained stable and in the normal range over three years of treatment. Conclusions: Black patients treated with a voclosporin-based regimen achieved higher rates of renal response than patients treated with MMF and glucocorticoids alone. For patients entering the continuation study, the response was largely durable for up to 3 years. 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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| 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 | 0.000 |
| 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".