Abstract: FR-PO645
Safety and Tolerability of Avacopan During the Early Access Program for ANCA-Associated Vasculitis
Session Information
- Glomerular Diseases: Clinical, Outcomes, Trials - II
November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1303 Glomerular Diseases: Clinical‚ Outcomes‚ and Trials
Authors
- van Leeuwen, Jolijn R., Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands
- Teng, Yoe Kie Onno, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands
Background
ANCA-associated vasculitis (AAV), a rare and severe disease, is associated with a high risk of complications from AAV and the treatment’s toxic effects. Avacopan, a selective C5aR inhibitor, was recently approved for the adjunctive treatment of AAV. As part of the Early Access Program (EAP), the safety and tolerability of thirty patients treated with avacopan were analyzed.
Methods
Safety data was recorded in a global safety database between February 2019 and November 2021. All participating physicians were ADVOCATE investigators with previous avacopan experience and safety training, including recognizing adverse events (AEs). The safety and tolerability of avacopan during the EAP are described below.
Results
Thirty AAV patients had avacopan exposure during three years of EAP. Twenty-four AEs were reported in eight individual case safety reports (ICSRs) from eight patients (27%). Seventy-three percent (22 patients) of patients did not report any AEs. No deaths were reported. Fifteen events in five patients (16.7%) were considered serious AEs (SAEs) and are listed by System Organ Class in Table 1. Four SAEs were categorized as infection-related events occurring in two patients (6.7%), resulting in three hospitalizations. Six SAEs in 2 patients were assessed as related to avacopan by the reporter, leading to the discontinuation of Avacopan.
Conclusion
Serious Adverse Events occured in five patients (16.7%). The most frequently reported SAEs were observed in the Infections and infestations and Renal and Urinary disorders SOCs. Seventy-three percent (22 patients) of patients did not report any AEs.
Serious Adverse Events reported in 30 AAV patients enrolled in the EAP
| System Organ Class (Preferred Term) | SAE n (%); # | SAEs related to Avacopan* n (%); # |
| Infections and infestations (Klebsiella infection, Staphylococcal bacteraemia, Urosepsis, COVID 19) | 2 (6.7%); 4 | 1 (3.3%); 3 |
| Renal and urinary disorders (Acute kidney injury, End-stage renal disease, Renal failure, Renal impairment) | 3 (10%); 4 | 1 (3.3%); 1 |
| Eye disorders (Age-related macular degeneration, Visual acuity reduced, Metamorphopsia, Retinal oedema) | 1 (3.3%); 4 | 1 (3.3%); 1 |
| Blood and lymphatic system disorders (Lymphopenia) | 1 (3.3%); 1 | - |
| Reproductive system and breast disorders (Prostatitis) | 1 (3.3%); 1 | 1 (3.3%); 1 |
| Vascular disorders (Haemorrhage) | 1 (3.3%); 1 | - |
| Total | 15 | 6 |
N: number of patients. %: percentage of patients. #: number of events. *Causality as assessed by reporter.