Evaluation of Long-Term Disease Modification with Belimumab (BEL) in Routine Care of Patients (Pts) with Lupus Nephritis (LN): The OBSErve-LN Study
Bibliographic record
Abstract
Background: In LN, the treatment goal of disease modification is indicated by preserved kidney function and end-stage kidney disease prevention >5 years after treatment. BEL was approved for active LN following the 2-year BLISS-LN trial (NCT01639339), which demonstrated significant kidney outcome improvements. OBSErve-LN will assess real-world BEL outcomes in active LN, providing the first long-term evaluation of kidney function preservation with BEL. Methods: OBSErve-LN (NCT06527872) is an ongoing Phase 4, non-interventional, global, observational study collecting routine care data retrospectively from enrolment to 12 months pre-index (BEL initiation) and prospectively up to 60 months post-index (Fig) from pts ≥18 years with active LN [Class III–V] initiating BEL 6–24 months before enrolment in China, Japan, Europe, US. Primary endpoint: maintenance of kidney function at Month 24 (≤30% decline in estimated glomerular filtration rate [eGFR] without kidney replacement therapy). Key secondary endpoints: modified partial renal response (≤20% eGFR decline and urine protein/creatinine ratio [uPCR] ≤0.7) and modified complete renal response (≤10% eGFR decline and uPCR ≤0.5) at Months 24 and 60. Other endpoints: changes in glucocorticoid dose and eGFR slope up to Month 60. Pts will complete FACIT-Fatigue and LupusQoL measures at enrolment and specified time points (Fig). Endpoints are evaluated descriptively; target sample size is 300. OBSErve-LN began in October 2024, with last pt last visit anticipated in March 2029. Results: OBSErve-LN is progressing as planned, with recruitment and data collection underway. Planned annual interim analyses will track cohort characteristics. Conclusion: OBSErve-LN demonstrates the feasibility of identifying diverse LN populations across countries. The study will inform on clinical and quality of life real-world outcomes with BEL to support its confirmation as a disease-modifying LN treatment. Funding: Commercial Support - GSK
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 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 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| 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".