Management of Lupus Nephritis (LN) with Voclosporin: An Update from a Pooled Analysis of 534 Patients
Bibliographic record
Abstract
Background: Voclosporin (VCS) is a novel calcineurin inhibitor (CNI) with a favorable metabolic profile and a consistent, predictable dose response potentially eliminating the need for therapeutic drug monitoring. VCS significantly improved renal response (RR) in patients with LN in two pivotal trials. Compared to MMF (target dose 2g/day) and prednisone (rapid taper), the addition of VCS 23.7 mg BID increased renal response by 25% in the Phase 2 AURA-LV (OR: 3.21; 95% CI: 1.68, 6.13; p < 0.001) and 18% in the Phase 3 AURORA (OR: 2.65; 95% CI: 1.64, 4.27; p < 0.001) studies at one year. To provide more information on VCS treatment effect we analyzed an integrated data set from AURA-LV and AURORA. Methods: The two pivotal trials were of similar design, conducted in comparable patient populations and defined similar key outcome measures. The integrated data set included an intent to treat (ITT) population of 266 control and 268 VCS 23.7 mg/BID patients. Here we report key integrated data of interest including renal response, defined as: • UPCR ≤ 0.5 mg/mg • eGFR ≥ 60 mL/min or no decline > 20% from baseline • ≤10 mg prednisone 8 weeks prior to endpoint measurement • No rescue medications Results: RR at one year was 43.7% for VCS vs 23.3% for control (OR 2.76, 95% CI: 1.88, 4.05; p < 0.0001), and at 6 months (VCS 31.7%; control 20.3%), [OR: 2.01; 95% CI: 1.34, 3.01; p = 0.0008]. In addition, 1-year RR for Hispanic patients was 37.9% in VCS arm vs 19.4% control. As expected, the largest estimated eGFR change from baseline for VCS vs control-treated patients occurred early, at week 4, (-5.6 mL/ min, p < 0.0001) which decreased to -3.7 mL/min by week 52 (p = 0.0012). Mean change from baseline of eGFR in the VCS arm at week 52 was -1.0 mL/min (p=ns). Finally, serious adverse events were similar between groups (22.8% VCS vs 18.8% control). Conclusions: This integrated analysis provides further support to the efficacy of VCS seen in both AURA-LV and AURORA including in Hispanic patients, a high-risk LN patient population. Furthermore, VCS’ expected impact on mean eGFR as a CNI was mild over the course of one year. 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 | 0.015 | 0.017 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.009 |
| Bibliometrics | 0.003 | 0.005 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 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".