TY - JOUR
T1 - Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis
AU - Zonozi, Reza
AU - Aqeel, Faten
AU - Le, Dustin
AU - Cortazar, Frank B.
AU - Thaker, Jugal
AU - Zabala Ramirez, Maria Jose
AU - Sattui Cortes, Sebastian Eduardo
AU - Attieh, Rose Mary
AU - Chung, Madeline
AU - Bulbin, David H.
AU - Shaikh, Aisha
AU - Guaman, Karina
AU - Ford, Julia
AU - Diffie, Colin
AU - Gewurz-Singer, Ora
AU - Sauvage, Gabriel
AU - Jeyabalan, Anushya
AU - Geara, Abdallah
AU - Ayoub, Isabelle
AU - Bomback, Andrew
AU - Khoury, Lara L.
AU - George, Jason C.
AU - Jhaveri, Kenar D.
AU - Derebail, Vimal Kumar
AU - Niles, John L.
AU - Geetha, Duvuru
N1 - Publisher Copyright:
© 2024 International Society of Nephrology
PY - 2024/6
Y1 - 2024/6
N2 - Introduction: Postmarketing data on outcomes of avacopan use in antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) are lacking. Methods: We performed a multicenter retrospective analysis of 92 patients with newly diagnosed or relapsing AAV who received therapy with avacopan. The coprimary outcome measures were clinical remission at 26 and 52 weeks. We use descriptive statistics and univariate logistic regression to assess outcomes and predictors of remission, respectively. Results: Of the 92 patients, 23% (n = 21) had a baseline estimated glomerular filtration rate (eGFR) < 15 ml/min per 1.73 m2 and 10% on kidney replacement therapy at baseline. Among those with kidney involvement, mean (SD) enrollment eGFR was 33 (27) ml/min per 1.73 m2 with a mean (SD) change of +12 (25) and +20 (23) ml/min per 1.73 m2 at weeks 26 and 52, respectively. In addition to avacopan, 47% of patients received combination therapy of rituximab and low-dose cyclophosphamide, and 14% of patients received plasma exchange (PLEX). After induction, the median (interquartile range [IQR]) time to start avacopan was 3.6 (2.1–7.7) weeks, and the median time to discontinue prednisone after starting avacopan was 5.6 (3.3–9.5) weeks. Clinical remission was achieved in 90% of patients at week 26 and 84% of patients at week 52. Of the patients, 20% stopped avacopan due to adverse events, with the most common being elevated serum aminotransferases (4.3%). Conclusion: A high rate of remission and an acceptable safety profile were observed with the use of avacopan in the treatment of AAV in this postmarketing analysis, including the populations excluded from the ADVOCATE trial.
AB - Introduction: Postmarketing data on outcomes of avacopan use in antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) are lacking. Methods: We performed a multicenter retrospective analysis of 92 patients with newly diagnosed or relapsing AAV who received therapy with avacopan. The coprimary outcome measures were clinical remission at 26 and 52 weeks. We use descriptive statistics and univariate logistic regression to assess outcomes and predictors of remission, respectively. Results: Of the 92 patients, 23% (n = 21) had a baseline estimated glomerular filtration rate (eGFR) < 15 ml/min per 1.73 m2 and 10% on kidney replacement therapy at baseline. Among those with kidney involvement, mean (SD) enrollment eGFR was 33 (27) ml/min per 1.73 m2 with a mean (SD) change of +12 (25) and +20 (23) ml/min per 1.73 m2 at weeks 26 and 52, respectively. In addition to avacopan, 47% of patients received combination therapy of rituximab and low-dose cyclophosphamide, and 14% of patients received plasma exchange (PLEX). After induction, the median (interquartile range [IQR]) time to start avacopan was 3.6 (2.1–7.7) weeks, and the median time to discontinue prednisone after starting avacopan was 5.6 (3.3–9.5) weeks. Clinical remission was achieved in 90% of patients at week 26 and 84% of patients at week 52. Of the patients, 20% stopped avacopan due to adverse events, with the most common being elevated serum aminotransferases (4.3%). Conclusion: A high rate of remission and an acceptable safety profile were observed with the use of avacopan in the treatment of AAV in this postmarketing analysis, including the populations excluded from the ADVOCATE trial.
KW - ANCA-associated vasculitis
KW - avacopan
KW - complement
KW - kidney recovery
KW - remission
UR - http://www.scopus.com/inward/record.url?scp=85190481440&partnerID=8YFLogxK
U2 - 10.1016/j.ekir.2024.03.022
DO - 10.1016/j.ekir.2024.03.022
M3 - Article
C2 - 38899183
AN - SCOPUS:85190481440
SN - 2468-0249
VL - 9
SP - 1783
EP - 1791
JO - Kidney International Reports
JF - Kidney International Reports
IS - 6
ER -