Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis
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....
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-06-01
|
| Series: | Kidney International Reports |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S246802492401605X |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850127924280164352 |
|---|---|
| author | Reza Zonozi Faten Aqeel Dustin Le Frank B. Cortazar Jugal Thaker Maria Jose Zabala Ramirez Sebastian Eduardo Sattui Cortes Rose Mary Attieh Madeline Chung David H. Bulbin Aisha Shaikh Karina Guaman Julia Ford Colin Diffie Ora Gewurz-Singer Gabriel Sauvage Anushya Jeyabalan Abdallah Geara Isabelle Ayoub Andrew Bomback Lara L. Khoury Jason C. George Kenar D. Jhaveri Vimal Kumar Derebail John L. Niles Duvuru Geetha |
| author_facet | Reza Zonozi Faten Aqeel Dustin Le Frank B. Cortazar Jugal Thaker Maria Jose Zabala Ramirez Sebastian Eduardo Sattui Cortes Rose Mary Attieh Madeline Chung David H. Bulbin Aisha Shaikh Karina Guaman Julia Ford Colin Diffie Ora Gewurz-Singer Gabriel Sauvage Anushya Jeyabalan Abdallah Geara Isabelle Ayoub Andrew Bomback Lara L. Khoury Jason C. George Kenar D. Jhaveri Vimal Kumar Derebail John L. Niles Duvuru Geetha |
| author_sort | Reza Zonozi |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e281f4ce4fcd4c92b2fdee3485620be4 |
| institution | OA Journals |
| issn | 2468-0249 |
| language | English |
| publishDate | 2024-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Kidney International Reports |
| spelling | doaj-art-e281f4ce4fcd4c92b2fdee3485620be42025-08-20T02:33:31ZengElsevierKidney International Reports2468-02492024-06-01961783179110.1016/j.ekir.2024.03.022Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated VasculitisReza Zonozi0Faten Aqeel1Dustin Le2Frank B. Cortazar3Jugal Thaker4Maria Jose Zabala Ramirez5Sebastian Eduardo Sattui Cortes6Rose Mary Attieh7Madeline Chung8David H. Bulbin9Aisha Shaikh10Karina Guaman11Julia Ford12Colin Diffie13Ora Gewurz-Singer14Gabriel Sauvage15Anushya Jeyabalan16Abdallah Geara17Isabelle Ayoub18Andrew Bomback19Lara L. Khoury20Jason C. George21Kenar D. Jhaveri22Vimal Kumar Derebail23John L. Niles24Duvuru Geetha25Nephrology Associates of Northern Virginia, Fairfax, Virginia, USA; Inova Fairfax Hospital, Falls Church, Virginia, USAJohns Hopkins Hospital, Baltimore, Maryland, USAJohns Hopkins Hospital, Baltimore, Maryland, USANew York Nephrology Vasculitis and Glomerular Center, Albany, New York, USAUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USAUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USAUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USANorthwell Health, New Hyde Park, NY Division of Kidney Diseases and Hypertension, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USAOhio State University, Wexner Medical Center, Columbus, Ohio, USAGeisinger Health Medicine, Danville, Pennsylvania, USAWashington University in St. Louis, St. Louis, Missouri, USAColumbia University Medical Center, New York, New York, USAUniversity of Michigan, Ann Arbor, Michigan, USAWashington University in St. Louis, St. Louis, Missouri, USAUniversity of Michigan, Ann Arbor, Michigan, USAVasculitis and Glomerulonephritis Center, Massachusetts General Hospital, Boston, Massachusetts, USAVasculitis and Glomerulonephritis Center, Massachusetts General Hospital, Boston, Massachusetts, USAUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USAOhio State University, Wexner Medical Center, Columbus, Ohio, USAColumbia University Medical Center, New York, New York, USANorthwell Health, New Hyde Park, NY Division of Kidney Diseases and Hypertension, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USAGeisinger Health Medicine, Danville, Pennsylvania, USANorthwell Health, New Hyde Park, NY Division of Kidney Diseases and Hypertension, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USAUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USAVasculitis and Glomerulonephritis Center, Massachusetts General Hospital, Boston, Massachusetts, USAJohns Hopkins Hospital, Baltimore, Maryland, USA; Correspondence: Duvuru Geetha, Department of Medicine, Johns Hopkins University School of Hygiene, 301 Mason Lord Drive, Baltimore, Maryland 212424, USA.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.http://www.sciencedirect.com/science/article/pii/S246802492401605XavacopanANCA-associated vasculitiscomplementremissionkidney recovery |
| spellingShingle | Reza Zonozi Faten Aqeel Dustin Le Frank B. Cortazar Jugal Thaker Maria Jose Zabala Ramirez Sebastian Eduardo Sattui Cortes Rose Mary Attieh Madeline Chung David H. Bulbin Aisha Shaikh Karina Guaman Julia Ford Colin Diffie Ora Gewurz-Singer Gabriel Sauvage Anushya Jeyabalan Abdallah Geara Isabelle Ayoub Andrew Bomback Lara L. Khoury Jason C. George Kenar D. Jhaveri Vimal Kumar Derebail John L. Niles Duvuru Geetha Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis Kidney International Reports avacopan ANCA-associated vasculitis complement remission kidney recovery |
| title | Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis |
| title_full | Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis |
| title_fullStr | Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis |
| title_full_unstemmed | Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis |
| title_short | Real-World Experience With Avacopan in Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis |
| title_sort | real world experience with avacopan in antineutrophil cytoplasmic autoantibody associated vasculitis |
| topic | avacopan ANCA-associated vasculitis complement remission kidney recovery |
| url | http://www.sciencedirect.com/science/article/pii/S246802492401605X |
| work_keys_str_mv | AT rezazonozi realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT fatenaqeel realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT dustinle realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT frankbcortazar realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT jugalthaker realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT mariajosezabalaramirez realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT sebastianeduardosattuicortes realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT rosemaryattieh realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT madelinechung realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT davidhbulbin realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT aishashaikh realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT karinaguaman realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT juliaford realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT colindiffie realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT oragewurzsinger realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT gabrielsauvage realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT anushyajeyabalan realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT abdallahgeara realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT isabelleayoub realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT andrewbomback realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT laralkhoury realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT jasoncgeorge realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT kenardjhaveri realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT vimalkumarderebail realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT johnlniles realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis AT duvurugeetha realworldexperiencewithavacopaninantineutrophilcytoplasmicautoantibodyassociatedvasculitis |