PO.7.160 Enlight-LN: a prospective observational registry of patients treated with voclosporin for lupus nephritis in the united states
Bibliographic record
Abstract
Purpose Voclosporin, a novel calcineurin inhibitor, was approved in January 2021 in the United States for the treatment of adult patients with active lupus nephritis in combination with background immunosuppressive therapy. Voclosporin has a favorable metabolic profile and a consistent dose-concentration relationship, eliminating the need for therapeutic drug monitoring associated with other calcineurin inhibitors. Pivotal Phase 2 and Phase 3 studies showed that the addition of voclosporin to mycophenolate mofetil (MMF) and low-dose steroids significantly increased complete renal response (CRR) rates in patients with lupus nephritis at approximately one year of treatment (48 weeks in AURA-LV, 52 weeks in AURORA 1). Here we describe an actively enrolling prospective observational registry, designed to characterize the real world effectiveness profile and utilization patterns of voclosporin in the United States. Methods Patients enrolled in Enlight-LN will receive standard care in accordance with usual clinical practice at each site, with no mandatory visits or assessments required by the protocol. Data will be extracted from patient medical records approximately every 3 months for up to 36 months; collected data will include demographics, disease characteristics, response to therapy, safety, and treatment patterns and utilization. The registry will enroll patients who are initiating or who have already initiated treatment with commercial voclosporin within 3 months prior to consent. Patients ≥18 years of age with biopsy-confirmed lupus nephritis are eligible (Table 1). Secondary objectives include describing at baseline and during the study period the clinical characteristics, treatment and response patterns of patients treated with voclosporin. To date, 36 sites in 16 states have been selected to participate in the registry; Enlight-LN is currently enrolling patients.
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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) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 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) | 0.005 | 0.002 |
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".