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Abstract: SA-PO696

Integrated Safety of Avacopan in ANCA-Associated Vasculitis

Session Information

Category: Glomerular Diseases

  • 1303 Glomerular Diseases: Clinical‚ Outcomes‚ and Trials


  • Jayne, David R.W., University of Cambridge, Cambridge, Cambridgeshire, United Kingdom
  • Bekker, Pirow, ChemoCentryx Inc, San Carlos, California, United States

Avacopan (TAVNEOS®) is approved as adjunctive treatment for adults with ANCA-associated vasculitis (AAV). Integrated safety data from 2 Phase 2 and 1 Phase 3 studies in 439 AAV patients is reported.


In the 3 trials, all groups received background cyclophosphamide followed by azathioprine, or rituximab; control groups received full prednisone regimen (60mg tapered to 0 over 20 weeks) plus placebo. The Phase 2 CLEAR trial (Jayne et al. 2017) had 3 groups: control (N=23), avacopan 30mg twice daily (BID)+low dose prednisone (N=22), and avacopan+no prednisone (N=22). The Phase 2 CLASSIC trial (Merkel et al. 2020) had 3 groups: control (N=13), avacopan 10mg BID (N=13), and 30mg BID (N=16). The Phase 3 trial (ADVOCATE; Jayne et al. 2021) had a control group (N=164) and a 30mg avacopan group with no oral glucocorticoid taper (N=166). The treatment period was 12 weeks in Phase 2 and 52 weeks in Phase 3. Integrated exposure-adjusted adverse event (AE) rates were calculated.


439 patients were treated, 200 controls and 239 avacopan. The AE patient first incidence rate and AE rate, serious AE rate, infection event rate, and WBC count decrease AE rate were statistically lower in the avacopan compared to the prednisone group (see table).


In the context of avacopan’s demonstrated efficacy profile, these integrated safety results provide support for avacopan’s use in the treatment of patients with AAV.
Refs: Jayne et al. J Am Soc Nephrol 2017;28:2756; Jayne et al. NEJM 2021;384:599; Merkel et al. ACR Open Rheumatol 2020;2:662.

Exposure-Adjusted Adverse Event Rates by Treatment Group
Exposure-adjusted rate/ 100 patient-yearsPrednisone Control Groups
Avacopan Groups
Difference (95% CI)
Total exposure (patient-years)*195.7212.3 
Adverse event patient first incidence rate**16261328-298 (-583.0, -13.0)
Adverse event rate***1251.71099.8-151.9 (-218.6, -85.3)
SAE patient first incidence rate60.161.61.5 (-16.5, 19.6)
SAE rate91.570.7-20.8 (-38.3, -3.3)
Discontinuation of blinded study medication due to AEs: Patient first incidence rate18.018.20.2 (-8.4, 8.9)
Discontinuation of blinded study medication event rate21.521.70.2 (-8.8, 9.2)
Infections# patient first incidence rate148.5139.1-9.4 (-42.6, 23.7)
Infections event rate166.6142.2-24.3 (-48.5, -0.1)
Liver function AEs#: Patient first incidence rate12.314.72.3 (-5.2, 9.8)
Liver function AE rate17.418.41.0 (-7.2, 9.2)
WBC decrease AEs#: Patient first incidence rate25.018.9-6.1 (-16.0, 3.8)
WBC decrease event rate34.222.6-11.6 (-22.2, -1.2)
Hypersensitivity AEs#: Patient first incidence rate58.057.7-0.3 (-18.1, 17.5)
Hypersensitivity AE rate61.868.86.9 (-8.7, 22.6)
AE=adverse event; SAE=serious adverse event; WBC=white blood cell
*Exposure calculated as follow-up time for all patients in the treatment group (irrespective of whether an event occurred).
**Patient first incidence calculated as number of patients with at least 1 event divided by total follow-up time per 100 patient-years
Follow-up time = total time at risk (in years), defined as the sum of:
(1) follow-up time in patients who did not have a treatment-emergent adverse event, and
(2) time to first occurrence of the event in patients who had a treatment-emergent adverse event.
***Rate calculated as total number of events divided by total follow-up time per 100 patient-years.
# Pre-specified AEs of interest; AE preferred terms identified before unblinding.
Refer to Warnings in full prescribing information for TAVNEOS® that lists hepatotoxicity, hypersensitivity reactions, hepatitis B reactivation, and serious infections.


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