Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States
Bibliographic record
Abstract
Background: Voclosporin is approved for adults with active lupus nephritis (LN). In the AURORA 1 and AURORA 2 studies, adding voclosporin to MMF and low-dose glucocorticoids led to significantly earlier and greater reductions in proteinuria while maintaining stable eGFR for up to 3 years. The Enlight-LN registry is designed to characterize the real-world effectiveness and usage patterns of voclosporin in the United States (US). We describe baseline demographics and clinical characteristics of patients currently enrolled in this ongoing, prospective, observational registry. Methods: The registry is enrolling patients ≥18 years with biopsy-confirmed LN who are initiating or have already initiated treatment with commercial voclosporin within 12 months prior to study consent. Patients receive standard of care according to usual clinical practice. Data are extracted from patient records ~every 3 months up to 36 months and include demographics, disease characteristics, response to therapy and treatment patterns. Results: Data are available on 123 patients enrolled prior to or on December 31, 2023. Patients ranged in age from 18 to 72 years (median, 33 years); 82.9% were female. Most patients self-identified as White (43.1%) or Black/African American (35.8%); 7.3% were Asian. A total of 35.8% were Hispanic/Latino. Median (range) time since first LN diagnosis was 1.1 (0-26.2) years. The majority of patients (62.6%) had Class III or IV +/- V disease; 32.5% had Class V disease. Median (range) eGFR and SCr were 90 (20-143) mL/min/1.73 m2 and 0.9 (0-66) mg/dL, respectively. Median (range) UPCR was 2.0 (0-16.8) g/g. A total of 107 patients were on concomitant immunosuppression at voclosporin initiation (most commonly, antimalarials, 72.4%; MMF/mycophenolate sodium, 70.7%; belimumab, 13%). In addition, 58.5% of patients were on steroids and 40.7% on RAAS agents. Three patients were on SGLT-2 inhibitors. Conclusion: Baseline data on this initial cohort of patients are reflective of the larger LN population in the US, including high percentages of Black and Hispanic and/or Latino patients. Enrollment of additional patients and ongoing data collection will provide valuable insight into the real-world utilization of voclosporin. 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 | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".