361. THE EFFECT OF REDUCED-DOSE ORAL GLUCOCORTICOIDS DURING INDUCTION OF REMISSION INDUCTION IN SEVERE ANCA-ASSOCIATED VASCULITIS
Bibliographic record
Abstract
Background: High-dose oral glucocorticoids are used in the treatment of anti-neutrophil cytoplasm antibodies (ANCA)-associated vasculitis (AAV) but cause frequent adverse effects. We hypothesized that a rapidly tapering regimen of oral glucocorticoids would not increase the risk of end-stage renal disease or death and would decrease the risk of serious infections. Methods: We performed an open- label, 2-by-2 factorial randomized controlled trial to separately evaluate two regimens of oral glucocorticoids and plasma exchange in patients with severe AAV, defined by a glomerular filtration rate <50ml/min or lung hemorrhage or both. Participants were randomly assigned to one of two regimens of prednisone or prednisolone in addition to cyclophosphamide or rituximab. The reduced-dose regimen provided approximately 58% of the cumulative dose compared to the standard regimen by 6 months. Participants were followed for the primary composite outcome of death from any cause or end-stage renal disease with a non-inferiority margin of an absolute risk difference of 11%. Results: The primary outcome occurred in 92 of 330 participants (27.9%) in the reduced-dose group and 83 of 325 participants (25.5%) in the standard-dose group (absolute risk difference 2.3%, 95% confidence interval [CI] -3.4% to 8.0%). 142 serious infections occurred in 96 (27.2%) participants within one year of randomization in the reduced glucocorticoid group compared to 180 infections in 116 (33.0%) in the standard group (incidence rate ratio 0.69, 95% CI 0.52 to 0.93; p = 0.016). Conclusion: In the treatment of AAV, a reduced-dose regimen of glucocorticoids was non-inferior to a standard-dose regimen for death or end-stage renal disease but resulted in fewer serious infections. Disclosures: Supported through grants from the National Institute for Health Research (UK): HTA 08/56/04; Food and Drug Administration/National Institutes of Health (USA): FDA R01 FD003516 and the National Institutes of Health (USA) - National Institute of Arthritis and Musculoskeletal and Skin Diseases: U54 AR0573319; National Health and Medical Research Council (Australia): 626939; National Health and Medical Research Council (Australia): APP1086192; National Health and Medical Research Council (Australia): 631731; National Health and Medical Research Council (Australia): APP1092957; Canadian Institutes of Health Research (Canada): 211079; Canadian Institutes of Health Research (Canada): 159662, French Ministry of Health Programme Hospitalier de Recherche Clinique (France): AOM11142, Research Committee on Intractable Vasculitides, the Ministry of Health, Labour and Welfare of Japan; and The Japan Agency for Medical Research and Development (AMED): The Strategic Study Group to Establish the Evidence for Intractable Vasculitis Guideline (Japan); TermuoBCT, TerumoBCT Mexico, Fresenius Medical Care Australia, Baxter Healthcare Pty Ltd (Australia), and Asahi Kasei Medical Co., Ltd. provided in-kind plasma exchange disposables.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".