Abstract: SA-PO402
Patients with Relapsing ANCA-Associated Vasculitis (AAV) Experience Unmet Needs around Remission Induction and Therapy Related Adverse Events
Session Information
- Glomerular Diseases: Clinical, Outcomes, Trials - III
October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1203 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Rutherford, Peter A., Vifor Pharma, Glattbrugg, Switzerland
- Goette, Dieter Karl, Vifor Pharma, Glattbrugg, Switzerland
- Stamm, Melinda, Elma Research, London, United Kingdom
- Liu, Xierong, Elma Research, London, United Kingdom
Background
Relapse in AAV remains a clinical challenge, with 5-10% of patients experiencing relapses of varying severity each year. Such patients are at risk from both acute vasculitis damage but also drug toxicity and cumulative organ damage related to AAV and glucocorticoid (GC) adverse events. This study aimed to measure outcomes and adverse events in relapsing AAV patients in real clinical practice.
Methods
268 relapsing AAV patients from 4 European countries received remission induction therapy between 2014-17 and data collected at baseline, 1, 3, 6 and 12 months following commencement of induction therapy was reviewed retrospectively.
Results
Patient mean age was 58.3 years with 60% male; 54% of patients had granulomatosis with polyangiitis, and 46% had microscopic polyangiitis. At the time of relapse, 7.1% of patients had experienced a past GC adverse event and only 16.0% were free from comorbidity. Birmingham vasculitis activity score (BVAS) was used in 17% at relapse diagnosis and 21% at time of relapse. Vasculitis was reported as mild/localized in 9.7 % of patients 64.6% as moderate systemic, and 25.7% as severe, life threatening. 44.0% of patients received rituximab and 35.1% received cyclophosphamide, whilst 76.5% received GCs. As BVAS was not used routinely, clinical response was assessed as full (no vasculitis activity and GC taper on track), partial (reduction in vasculitis activity), or no response (no improvement in vasculitis). Response to therapy varied, and adverse events and infections were common.Full response at 1 month was associated with good 12-month outcomes (81% full response), whereas a partial response at 1 month (53%) was associated with less favourable 12-month outcomes (49% full response).
Conclusion
Relapsing AAV patients frequently have comorbidities and their response to remission induction therapy is variable. An early positive response associates with a good response rate at 12 months. Many patients experience adverse events, and infections are common especially early in treatment. Relapsing patients still face unmet medical needs.
| 1 month | 3 months | 6 months | 12 months | |
| Full Response % | 14 | 40 | 57 | 54 |
| At least one AE % | 40.7 | 52.2 | 42.9 | 34.7 |
| At least one infection % | 28.4 | 30.2 | 26.5 | 23.1 |
Funding
- Commercial Support –