RESPONSE TO PLACEBO IN PATIENTS WITH ACTIVE LUPUS NEPHRITIS: A SYSTEMATIC REVIEW AND POOLED ANALYSIS
Bibliographic record
Abstract
PV129 / #332 Poster Topic: AS15 - Lupus Nephritis-Clinical Background/Purpose Lupus Nephritis (LN) may result in end-stage kidney disease (ESKD) in up to one-third of the patients 10 years after diagnosis. Most randomized controlled trials (RCTs) have failed to demonstrate the superiority of biologic drugs over standard of care (SoC). The aim of this systematic review was to quantify the response to placebo (and SoC) in patients with active LN. Methods Systematic review (2020 PRISMA statement). PubMed database was searched (01/2000-09/2024) for phase II/III RCTs of biologics in LN. The primary endpoint was complete renal response (CRR, proteinuria <0.5 g/day and serum creatinine <120% from baseline at 48-52 weeks. Secondary endpoints were partial (PRR, 50% improvement in proteinuria and serum creatinine <120% from baseline at 48-52 weeks) and overall renal response (CRR + PRR). The expected and actual differential responses were also recorded. Descriptive statistics were used. Results A total of 10 RCTs (n=2318 in total) were included with 1006 patients treated with placebo and SoC. Baseline characteristics are shown in Table 1. CRR was achieved by 176/660 patients (26.7%), and PRR was achieved by 146/527 patients (27.7%) (Figure 1A). The expected differential response rate was 20%; the actual differential response rate was 7.5% (Figure 1B). Safety: infections 46.4%, serious infections 12%, malignancies 0.2%, deaths 2.88%. Table 1. Baseline characteristics of the placebo (+ SoC) treated patients Figure 1. A. Complete (CRR), partial (PRR), overall (ORR) renal response and percentage of patients achieving the primary endpoint of each study at 48-52 weeks. B. Expected and actual differential treatment effect. Conclusions Approximately 27% of the placebo (+SoC)-treated patients achieved complete renal response while more than half of them achieved an overall (CRR+PRR) renal response at 48 to 52 weeks in RCTs with biologics in LN. There was a significant discrepancy between the expected and actual differential treatment effect that raises significant points to consider for the design of future studies.
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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 | 0.015 | 0.033 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.020 | 0.027 |
| Bibliometrics | 0.006 | 0.007 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".