Voclosporin Is Effective in Achieving Complete Renal Response in Severe Lupus Nephritis
Bibliographic record
Abstract
Background: Voclosporin is a novel calcineurin inhibitor with a favorable metabolic profile and a consistent dose-concentration relationship. The Phase 3 AURORA 1 trial demonstrated that compared to mycophenolate mofetil (MMF) and low-dose steroids, adding voclosporin significantly increased complete renal response (CRR) rates in patients with lupus nephritis (LN). We report the results of a post-hoc analysis evaluating if the efficacy of voclosporin in patients with severe LN is similar to the overall population of AURORA 1. Methods: Patients with systemic lupus erythematosus, biopsy-proven active LN (Class III, IV or V ± III/IV), and proteinuria of ≥1.5 mg/mg (≥2 mg/mg for Class V) were eligible to enroll in AURORA 1. Overall, 179 and 178 patients were randomized to the voclosporin (23.7 mg BID) and control arms, respectively. All patients received MMF (1 g BID) and low-dose oral steroids. Severe LN was defined as baseline UPCR ≥3 mg/mg with Class III or IV biopsy (± Class V) with active lesions. Renal function and serology were evaluated to ensure the population was representative of severe disease in clinical practice. CRR was defined as UPCR ≤0.5 mg/mg with stable renal function, use of low-dose steroids and no use of rescue medication. Results: There were 76 and 72 patients in the voclosporin and control arms, respectively, with severe disease. Mean (SD) UPCR at baseline was 5.9 (2.4) mg/mg (Table 1). CRR at one year was 34.2% and 11.1% in the voclosporin and control arms, respectively (odds ratio 4.43, p=0.001; Figure 1).Table 1.: Key Clinical Characteristics at Baseline and Week 52Figure 1.: Complete Renal Response Rates at One YearConclusions: In patients with severe LN, adding voclosporin to MMF and steroids results in statistically significantly higher CRR rates. This is clinically meaningful given that patients with severe disease are at higher risk of worse long-term outcomes and development of ESKD. 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 | 0.001 |
| 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 | 0.001 |
| 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".