General, Nervous System, Eye, and Skin Involvement in the Phase 3 Trial of Avacopan for the Treatment of ANCA-Associated Vasculitis
Bibliographic record
Abstract
Background: The most common types of ANCA-associated vasculitis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), can affect many organs. The phase 3 ADVOCATE trial compared avacopan vs a prednisone taper to treat patients with GPA or MPA. Patients receiving avacopan had improvements in sustained remission and kidney outcomes, with less glucocorticoid (GC) exposure and GC-related toxicity than those receiving a prednisone taper. Methods: This post hoc analysis of the ADVOCATE trial reports rates of active general, nervous system, mucous membranes/eyes, and skin involvement based on the Birmingham Vasculitis Activity Score (BVAS) at weeks 4, 26, and 52, and changes from baseline to week 52. Results: In the 330-patient ADVOCATE trial, active involvement of the general, nervous system, mucous membranes/eyes, and skin domains affected 68.2% (n=225), 20.9% (n=69), 20.0% (n=66), and 14.2% (n=47) of patients, respectively; most patients had at least one of these manifestations (Table). Similar and substantial improvements in the control of active disease in these domains were achieved in both groups: reductions from baseline to week 52 in the proportion of patients with active manifestations in the avacopan vs prednisone taper group, respectively, were 97.3% vs 96.5% (general), 100% vs 93.5% (nervous system), 100% vs 95.0% (mucous membranes/eyes), and 83.3% vs 100% (skin). Conclusion: In the ADVOCATE trial, treatment with either avacopan or a prednisone taper was associated with the reversal of nearly all active general, nervous system, mucous membranes/eyes, and skin manifestations of GPA or MPA. Funding: Commercial Support - Amgen
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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 | 0.003 | 0.002 |
| 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 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".