Repeat Kidney Biopsies from the AURORA 2 Study of Voclosporin in Active Lupus Nephritis
Bibliographic record
Abstract
Background: Voclosporin is approved for the treatment of adults with active lupus nephritis (LN). Addition of voclosporin to MMF and low-dose glucocorticoids in the Phase 3 global AURORA studies led to significantly earlier and greater reductions in proteinuria while maintaining stable renal function. To characterize the long-term renal impact of voclosporin at the histologic level, we analyzed repeat kidney biopsies from a subset of patients in these studies. Methods: Patients in AURORA 1 had biopsy-proven LN, UPCR ≥1.5 g/g (≥2 g/g for Class V), and eGFR >45 mL/min/m2. Patients were randomized to voclosporin or control for 1 year in AURORA 1 and continued the same blinded therapy for 2 additional years in AURORA 2; all patients received MMF and low-dose glucocorticoids. A subset of patients had a kidney biopsy prior to screening and a repeat biopsy after approximately 18 months of therapy. Histopathologic grading according to NIH indices for LN activity and chronicity was conducted by Arkana Laboratories. Efficacy outcomes and mean eGFR over time were assessed. Results: Repeat biopsy samples were collected from 16 patients in the voclosporin arm and 10 patients in the control arm. Baseline mean activity scores were similar between arms, with scores improving with treatment in both arms. Mean chronicity scores were also similar between arms at baseline and remained stable over time in most patients. Measures of renal function remained stable in both arms over the 3-year follow-up. Voclosporin-treated patients had numerically greater mean reductions from baseline in UPCR year-on-year compared to patients in the control arm. Conclusions: As expected, mean activity scores improved in both treatment arms. Importantly, exposure to voclosporin was not associated with chronic injury, with the mean index remaining stable at follow-up. Similar to the overall population, patients treated with voclosporin saw greater reductions in UPCR over 3 years of treatment; safety outcomes from this small subgroup were also consistent with outcomes in AURORA 1. 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 | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 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) | 0.002 | 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".