Long-Term Safety and Efficacy of Voclosporin in Patients With Lupus Nephritis and Low eGFR
Bibliographic record
Abstract
Background: Voclosporin (VCS) is a novel calcineurin inhibitor approved for the treatment of adults with lupus nephritis. In the Phase 3 AURORA 1 study, addition of VCS to mycophenolate mofetil (MMF) and steroids increased rates of complete renal response at 1 year. Efficacy was maintained for an additional 2 years in the AURORA 2 continuation study. Here we report on a post-hoc analysis of the long-term safety and efficacy of VCS in patients with low estimated glomerular filtration rate (eGFR) at baseline using 3 years of pooled data from these studies. Methods: Patients from AURORA 1 with a baseline eGFR >45 and <60 mL/min/1.73 m2 who also participated in AURORA 2 were included in this analysis. Patients completing AURORA 1 were eligible to enter AURORA 2 on the same blinded therapy (VCS or placebo) in combination with MMF and steroids. Urine protein creatinine ratio (UPCR) and eGFR changes from baseline were measured. Results: The analysis included 27 patients with low eGFR (13 in the VCS arm and 14 in the control arm) of whom 23 completed 3 years of treatment (12 and 11 patients, respectively). Mean corrected eGFR at baseline for the VCS and control arms was 52.6 and 50.9 mL/min/1.73 m2, respectively. At 6 months, mean eGFR was 62.0 and 63.4 mL/min/1.73 m2 in each arm, respectively, and remained stable in both arms throughout the 3 years of treatment (Figure 1). Safety outcomes were comparable between arms and consistent with the overall study population. Mean UPCR at AURORA 1 baseline was 4.8 mg/mg in the VCS arm and 4.0 mg/mg for the control arm. At 3 months, mean UPCR decreased to 1.7 mg/mg and 2.5 mg/mg in each arm, respectively. Mean UPCR continued to improve throughout AURORA 1, and the reductions were maintained in AURORA 2 for both treatment arms. Conclusions: In this post-hoc analysis of patients with lupus nephritis and low eGFR at baseline, patients treated with VCS achieved rapid and sustained reductions in proteinuria with no decrease in mean eGFR or unexpected adverse events during 3 years of treatment. Funding: Commercial Support - Aurinia Pharmaceuticals Inc.
Stored with the screening record, where it is evidence for the labels above.
How this classification was reachedexpand
The three-model screen
all 5,600 screened works →All three models called this out of scope.
Post-hoc analysis of voclosporin safety and efficacy in lupus nephritis with low eGFR; a clinical trial analysis.
The analysis evaluates the safety and efficacy of a lupus nephritis treatment, not research itself.
Clinical efficacy and safety of voclosporin in lupus nephritis; therapeutic domain study.
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 | 0.004 | 0.004 |
| 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 | 0.001 | 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".