Vasculitis & polymyalgia rheumatica
The Glucocorticoid Toxicity Index-Metabolic Domains, an abridged version of the Glucocorticoid Toxicity Index: post-hoc analysis of data from the ADVOCATE trial
Authors' conclusion
The GTI-MD correlates well with the full GTI and could be incorporated readily into routine clinic workflows without additional input from the clinician.
Study context
- Population
- Patients with AAV in the ADVOCATE trial; validation cohort of patients with GC-dependent asthma and autoimmune blistering disease321 analysed at week 13
- Participants
- 330 patients
- Comparison
- GTI-Metabolic Domains (GTI-MD) vs full Glucocorticoid Toxicity Index (GTI); avacopan vs prednisone taper
- Avacopann = 166
- Prednisonen = 164reference
- Primary endpoint
- Correlation of GTI-MD CWS and AIS with GTI CWS and AIS, and ability of GTI-MD to differentiate avacopan and prednisone groups by GC toxicity
Methodological detailspost-hoc analysis, double-blind, double-dummy, phase 3, validation set
- Post-hoc analysis
- Double-blind
- Double-dummy
- Phase 3
- Validation set
Primary result
As reported in the abstract
Spearman's rank correlation, GTI-MD vs GTI, treatment groups combined (ADVOCATE)
Cumulative worsening score (CWS): Spearman's rank correlation coefficient
0.78
95% CI 0.75–0.81p<0.0001
Aggregate improvement score (AIS): Spearman's rank correlation coefficient
0.73
95% CI 0.69–0.77p<0.0001
Further findings
| Outcome | Avacopan | Prednisone | P value |
|---|---|---|---|
| Mean GTI-MD CWS · 13 weeks | 15.9 | 23.0 | P = 0.0010 |
| Mean GTI-MD CWS · 26 weeks | 26.7 | 31.7 | P = 0.0092 |
| GTI-MD AIS · 13 weeks | 2.5 | 13.0 | P = 0.0003 |
| GTI-MD AIS · 26 weeks | 4.4 | 10.1 | P = 0.027 |
Spearman's rank correlation, GTI-MD vs GTI, validation set (n=159)
- CWS: Spearman's rank correlation coefficient
- 0.61 (95% CI 0.50-0.70; p<0.0001)
- AIS: Spearman's rank correlation coefficient
- 0.58 (95% CI 0.47-0.68; p<0.0001)
GTI-MD score of 0
- Corresponded to a low likelihood of toxicity in the other GTI domains
Original publication
The Glucocorticoid Toxicity Index-Metabolic Domains, an abridged version of the Glucocorticoid Toxicity Index: post-hoc analysis of data from the ADVOCATE trial. Lancet Rheumatol. Published July 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →