(HealthDay News) — Avacopan is noninferior, but not superior, to prednisone with respect to remission at week 26 for patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, according to a study published in the Feb. 18 issue of the New England Journal of Medicine.
David R.W. Jayne, MD, from Addenbrooke’s Hospital in Cambridge, United Kingdom, and colleagues randomly assigned 331 patients with ANCA-associated vasculitis to receive either oral avacopan or oral prednisone on a tapering schedule (166 and 165 patients, respectively). All patients received standard therapy for remission induction with either cyclophosphamide (followed by azathioprine) or rituximab.
The researchers found that in both groups, the mean Birmingham Vasculitis Activity Score (BVAS) at baseline was 16; the first primary end point (remission, defined as a BVAS of 0) was observed in 72.3% and 70.1% receiving avacopan and prednisone, respectively (estimated common difference, 3.4 percentage points; 95% confidence interval [CI], −6.0, 12.8; P < .001 for noninferiority; P = .24 for superiority).
The second primary end point of sustained remission at week 52 occurred in 65.7% and 54.9% of those receiving avacopan and prednisone, respectively (estimated common difference, 12.5 percentage points; 95% CI, 2.6-22.3; P < .001 for noninferiority; P = .007 for superiority). In 37.3% and 39.0% of patients receiving avacopan and prednisone, respectively, serious adverse events occurred.
“Longer trials are required to determine the durability and safety of avacopan in patients with ANCA-associated vasculitis,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including ChemoCentryx, which developed avacopan and funded the study.