BELIMUMAB FOR THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL WORLD: A SINGLE-CENTER STUDY
Bibliographic record
Abstract
PV258b / #492 Poster Topic: AS24 - SLE-Treatment Background/Purpose Objectives To analyze the effectiveness and safety of Belimumab in SLE patients with data from a Real- World cohort. Methods A single-center observational study was performed including SLE patients who had initiated treatment with Belimumab from September 2017 to January 2023. Demographic, clinical, laboratory, effectiveness and safety variables were collected. Effectiveness was evaluated according to changes from the baseline in SLEDAI-2K and disease activity markers (proteinuria, complement consumption and/or Anti DNAds). Safety data was collected including any adverse event (AE) due to any cause. AE was considered serious (SAE) if it was life-threatening or result in hospitalization, disability or in death. Results 15 patients were included in the study. Nine patients were still receiving the drug with a mean drug survival of 15.6 months. Belimumab allowed steroid tapering in all cases, but treatment was discontinued just in 1 patient. Treatment also improved disease activity markers in all patients. Belimumab was well tolerated, and the AE reported were infection (14 events) and malaise in 1 patient. In 11 cases, infection was mild (9 upper respiratory tract infection, 1 urinary tract infection and 1 gastroenteritis). 3 severe infections were registered (1 pneumonia, 1 pyelonephritis and 1 meningitis). Regarding LN patients, treatment exposure achieved was 10.85 patients/year. Renal Biopsy demonstrated class III in a patient (20%) and class IV in 4 patients (80%). Mean proteinuria at baseline was 6.66 g/24h. In 3 cases, Belimumab was started in the first 6 months after LN diagnosis was established. In 4 cases (80%), Belimumab addition allowed significant reduction of proteinuria and corticosteroids. In 2 out 5 (40%) treatment was discontinued, 1 case due to an insufficient response and in the other, to a SAE (Cryptococcus neoformans meningitis). Table 1. Baseline characteristics Conclusions Belimumab maintained an acceptable safety profile and an adequate effectiveness. Intravenous and subcutaneous formulations showed similar performance. Belimumab addition resulted in reduction in proteinuria and corticosteroid use.
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 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".