Vasculitis & polymyalgia rheumatica
Glucocorticoid Toxicity Index scores by domain in patients with antineutrophil cytoplasmic antibody-associated vasculitis treated with avacopan versus standard prednisone taper: post-hoc analysis of data from the ADVOCATE trial
An erratum to this article was published (Lancet Rheumatol, Aug 2024 ↗)
Authors' conclusion
Replacing a standard prednisone taper with avacopan in patients with ANCA-associated vasculitis reduced glucocorticoid toxicity in multiple GTI domains.
Study context
- Population
- Patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis in the ADVOCATE trialITT
- Participants
- 330 patients
- Comparison
- Avacopan 30 mg orally twice daily for 52 weeks vs prednisone tapered over 20 weeks
- Avacopann = 166
- Prednisonen = 164reference
- Primary endpoint
- Changes in individual GTI domains (CWS and AIS) and their ability to differentiate treatment groups
- Follow-up
- 13 and 26 weeks
Methodological detailsphase 3, double-blind, double-dummy
- Phase 3
- Double-blind
- Double-dummy
Primary result
As reported in the abstract
GTI domain toxicity (CWS and AIS) · week 13
- Significantly less glucocorticoid toxicity with avacopan than prednisone by week 13 in four Glucocorticoid Toxicity Index (GTI) domains (BMI, glucose tolerance, lipid metabolism, skin toxicity), based on both cumulative worsening score (CWS) and aggregate improvement score (AIS)
- CWS in BMI, lipid metabolism and skin toxicity domains significantly lower with avacopan than prednisone at 26 weeks
- No domain favoured prednisone for glucocorticoid toxicity reduction
- Post-hoc analysis
- Mantel-Haenszel χ2 tests
Further findings
Mean glucocorticoid use over 26 weeks
Domains contributing most weight toward CWS · 26 weeks
Blood pressure
Infection
Lipid metabolism
Patients with glucocorticoid toxicity · 26 weeks
- 280 (91%) of 307 patients
Combinations of improvement and worsening in different domains · 26 weeks
- 128 (42%) of 307 patients
Original publication
Glucocorticoid Toxicity Index scores by domain in patients with antineutrophil cytoplasmic antibody-associated vasculitis treated with avacopan versus standard prednisone taper: post-hoc analysis of data from the ADVOCATE trial. Lancet Rheumatol. Published 20 February 2023. doi:10.
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