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Abstract: TH-OR28

Remission, Glucocorticoid Toxicity, Health-Related Quality of Life, and Safety Outcomes in Patients with Renal Involvement in the ADVOCATE Trial

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Geetha, Duvuru, Johns Hopkins University, Baltimore, Maryland, United States
  • Cortazar, Frank B., St Peter's Hospital, Albany, New York, United States
  • Bruchfeld, Annette, Karolinska Institutet, Stockholm, Stockholm, Sweden
  • Karras, Alexandre, Universite Paris Cite, Paris, Île-de-France, France
  • Merkel, Peter A., University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Jayne, David R.W., University of Cambridge, Cambridge, United Kingdom

Group or Team Name

  • ADVOCATE Study Group.
Background

In the Phase 3 ADVOCATE trial comparing avacopan to a prednisone taper, 81% of patients with ANCA-associated vasculitis (AAV) had renal involvement based on the Birmingham Vasculitis Activity Score. This renal subgroup had a baseline mean estimated glomerular filtration rate of 45.1 mL/min/1.73 m2.

Methods

This post hoc analysis evaluated remission, glucocorticoid (GC) use, GC toxicity index (GTI), health-related quality of life (HRQoL by SF-36), and safety in patients with baseline renal involvement for those treated with avacopan (N=134) versus a prednisone taper (N=134).

Results

Compared to the overall study population, for this subgroup the mean age was similar (62 vs 61 years), but there was a slightly higher proportion of patients with newly diagnosed AAV (74% vs 69%), myeloperoxidase+ ANCA (63% vs 57%), microscopic polyangiitis (52% vs 45%), and use of cyclophosphamide (39% vs 35%). The avacopan group achieved a higher sustained remission rate at week 52 (67.9% vs 56.7%) while receiving a (mean/median) 2.4-/5.3-fold less total GC dose than the prednisone taper group (Table 1). The GTI cumulative worsening and aggregate improvement scores were lower at weeks 13 and 26 in the avacopan group compared to the prednisone group. At weeks 26 and 52 the avacopan group reported a greater improvement in SF-36 physical and mental component summary scores. Serious adverse events occurred in 46% (2 deaths) and 49% (3 deaths) of patients in the avacopan and prednisone groups, respectively.

Conclusion

In the ADVOCATE trial, patients with AAV with baseline renal involvement treated with avacopan achieved higher sustained remission rates while receiving less GCs, experiencing less GC-related toxicity, and reporting greater improvements in HRQoL versus those treated with a prednisone taper.

Funding

  • Commercial Support – Amgen