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  • Pivotal Phase III ADVOCATE study of CCX 168 in vas...

Pivotal Phase III ADVOCATE study of CCX 168 in vasculitis published in NEJM.- ChemoCentryx

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Published:19th Feb 2021
ChemoCentryx announced that The New England Journal of Medicine (NEJM) has published results from ADVOCATE, the pivotal Phase III study evaluating CCX 168 (avacopan), an orally-administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis). The publication also featured an editorial titled, “Avacopan — Time to Replace Glucocorticoids?” written by Kenneth J. Warrington, M.D., Chair in the Division of Rheumatology, Department of Internal Medicine at Mayo Clinic in Rochester, Minn.The study met both of its primary endpoints, demonstrating disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score (BVAS). Specifically, BVAS remission at week 26 was achieved in 72.3% of the avacopan treated patients vs. 70.1% of subjects in the prednisone group (p<0.0001 for non-inferiority). sustained remission at 52 weeks was observed in 65.7% of the avacopan treated subjects vs. 54.9% in the prednisone group, achieving both non-inferiority and superiority to the prednisone group (p="0.007" for superiority of avacopan). additionally, results published in the nejm also show that, compared to the prednisone group, avacopan treatment: reduced the risk of vasculitis relapse by 54%; there was a 10.1% relapse rate in the avacopan group compared to 21.0% in the prednisone group. demonstrated greater improvement in kidney function, with a mean increase from baseline to week 52 in estimated glomerular filtration rate (egfr) of 7.3 ml min 1.73 m2 with avacopan therapy vs. an increase in egfr of 4.1 ml min 1.73 m2 in the prednisone group, and the difference between groups was 3.2 ml min 1.73 m2 (95% ci, 0.3 to 6.1). significantly lowered glucocorticoid toxicity, with avacopan therapy 39.7 vs. 56.6 in the prednisone group in the glucocorticoid toxicity index (gti) cumulative worsening score with a difference between groups of -16.8 points (95% ci, -25.6 to -8.0), and 11.2 with avacopan therapy vs. 23.4 for the prednisone group in the gti aggregate improvement score, with a difference between groups of -12.1 points (95% ci, -21.1 to -3.2). led to greater improvement in health-related quality of life, measured by the short form 36 (sf-36) version 2 and the euroqol-5d-5l instrument (both visual analogue scale and eq index), compared to the prednisone group.avacopan demonstrated favorable safety results in this serious and life-threatening disease, with fewer subjects having serious adverse events in the avacopan group than in the prednisone group.see: "avacopan for the treatment of anca-associated vasculitis" david r.w. jayne et al. n engl j med 2021; february 18, 2021 384:599-609 doi: 10.1056 nejmoa2023386>
Condition: Vasculitis
Type: drug

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