Safety and Efficacy of Avacopan in Patients 65 Years and Older with ANCA-Associated Vasculitis
Bibliographic record
Abstract
Background: Older adults are at increased risk of glucocorticoid (GC)-related toxicity; minimization of GCs is a major focus for treatment of patients with ANCA-associated vasculitis (AAV). Although AAV especially affects older adults, many studies have excluded patients >75 years (y). In the Phase 3 ADVOCATE trial of avacopan, there was no exclusion criterion for maximum participant age. Methods: This post hoc analysis reports safety and efficacy of avacopan compared to a prednisone taper in the subgroups of patients 65-74y (N=109) and ≥75y (N=51). Results: In both studied age and treatment groups, a similar proportion of patients (69.4-73.1%) achieved remission at week 26 (Table 1). In the 65-74y age group, sustained remission rates at week 52 were 55.1% in the prednisone arm and 65.0% in the avacopan arm. Relapse rates were 18.8% in the prednisone arm and 12.3% in the avacopan arm. The total all-source median GC dose was 5.3x higher in the prednisone vs avacopan arm. Serious adverse events (SAEs) occurred in 22/49 patients (45%) in the prednisone arm (2 deaths) and 25/60 patients (42%) in the avacopan arm (2 deaths). In the ≥75y age group, sustained remission rates at week 52 were 56.0% in the prednisone arm and 65.4% in the avacopan arm. Relapse rates were 20.8% in the prednisone arm and 3.8% in the avacopan arm. Median GC dose was 4.8x higher in the prednisone vs avacopan arm. SAEs occurred in 14/25 patients (56%) in the prednisone arm and 17/26 patients (65%) in the avacopan arm. Other results including renal and quality of life outcomes are in Table 1.Table 1:: Safety and Efficacy Outcomes in Patients with ANCA-Associated Vasculitis Aged 65 to 74 Years and 75 Years and Older in the ADVOCATE Trial of AvacopanConclusions: A subgroup analysis of patients ≥65y demonstrated similar trends of efficacy and safety of avacopan as in the overall ADVOCATE trial, including reductions in GC-related toxicities, supporting a role for avacopan in the treatment of older patients with AAV. 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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".