Conference Update

Phase 3 study of avacopan revealed higher remission rates for anti-neutrophil cytoplasmic antibody-associated vasculitis

Rheumatology
2 months ago, OP Editor


Primary Endpoints:

  • At week 26, 72.3% of patients in the avacopan group achieved remission compared to 70.1% of patients in the prednisone group (p<0.0001 for non-inferiority)
  • At week 52, 65.7% of the avacopan arm’s cohort group achieved sustained remission compared to 54.9% in the prednisone arm group (p=0.0066 for the superiority of avacopan)

Secondary Endpoints:

  • There was a significant decrease in glucocorticoid-related toxicity for patients treated with avacopan in contrast to the control group, as indicated by the Glucocorticoid Toxicity Index of Cumulative Worsening Score (p=0.0002) and Aggregate Improvement Score (p=0.0082) results
  • At week 26, the average glucocorticoid toxicity index worsening score was 39.7% in the avacopan arm versus 56.6% in the control group
  • Patients treated with avacopan experienced a steroid-sparing effect
  • At 52 weeks, for the subgroup of patients with renal disease at baseline treated with avacopan, there was a mean increase in estimated glomerular filtration rate (eGFR) of 7.3mL/min/1.73m2 as compared to 4.0mL/min/1.73m2 increase in the prednisone group (p=0.0259)
  • Patients in both the avacopan and prednisone group experienced severe adverse events, 42.2% and 45.1% respectively, that were consistent with previous AAV trials
  1. Merkel P et al. OP0011 A randomized, double-blind, active-controlled study of Avacopan in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Annals of the Rheumatic Diseases 2020; 79:8.
  2. Merkel P et al. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients with Antineutrophil Cytoplasmic Antibody–Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial. JMIR Res Protoc 2020;9(4): e16664

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