Efficacy and safety of guselkumab in patients with active lupus nephritis: results from a phase 2, randomized, placebo-controlled study
Bibliographic record
Abstract
OBJECTIVE: Evaluate the efficacy and safety of guselkumab, an IL-23p19-subunit inhibitor, in a phase 2, multicentre, randomized, double-blind, placebo-controlled study of patients with active LN. METHODS: Adults (18-75 years) with active LN [Class III-IV proliferative nephritis (kidney biopsy) and urine protein-to-creatinine ratio (UPCR) of ≥1 mg/mg despite standard-of-care therapy] were randomized (1:1; planned sample = 60) to receive i.v. infusions of guselkumab 400 mg or placebo at weeks 0, 4 and 8, then s.c. injections (guselkumab 200 mg or placebo) at week 12 and every 4 weeks through week 48 in addition to their background therapy. The primary endpoint was achievement of ≥50% decrease in proteinuria from baseline at week 24. Major secondary endpoints (week 24) were achievement of complete renal response (CRR), sustained reduction in steroid dose (≤10 mg/day prednisone/equivalent) from weeks 16-24, UPCR <0.5 mg/mg; <0.75 mg/mg, time to achieving CRR, and time to treatment failure. Safety was assessed through the end of the study. RESULTS: Following enrolment challenges (COVID-19 pandemic; Ukraine/Russia crisis), the sponsor terminated the study early; 33 participants were randomized (placebo, n = 16; guselkumab, n = 17). At week 24, 56.3% (9/16) in the placebo group and 35.3% (6/17) in the guselkumab group achieved the primary endpoint. No apparent differences were observed in the secondary endpoints. Through end-of-study, 75% of placebo patients and 71% of guselkumab patients reported ≥1 adverse event; most were of mild-to-moderate severity. CONCLUSION: Guselkumab+background therapy did not demonstrate superior reduction in proteinuria vs placebo+background therapy in this small cohort of patients with active LN. Safety results were consistent with the known safety profile of guselkumab. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04376827.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".