Efficacy and safety of avacopan in patients aged 65 years and older with ANCA-associated vasculitis: a post hoc analysis of data from the ADVOCATE trial

ADVOCATE Study Group

doi:10.1093/rheumatology/keaf122

Efficacy and safety of avacopan in patients aged 65 years and older with ANCA-associated vasculitis: a post hoc analysis of data from the ADVOCATE trial

ADVOCATE Study Group

Abstract

Objectives: To evaluate the efficacy and safety of avacopan in patients aged ≥65 years with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in the phase 3 ADVOCATE trial of avacopan vs a prednisone taper, plus either rituximab or cyclophosphamide. Methods: In this descriptive, post hoc analysis, patients receiving avacopan or a prednisone taper were stratified by age. Key efficacy outcomes included the rate of remission at week 26 and sustained remission at week 52. Results: Of 160 patients aged ≥65, 109 were aged 65-74 and 51 were ≥75. Remission at week 26 was achieved in 71.7% vs 69.4% of patients aged 65-74 and 73.1% vs 72.0% aged ≥75 in the avacopan vs prednisone taper groups, respectively. Sustained remission at week 52 was observed in 65.0% vs 55.1% of patients aged 65-74 and 65.4% vs 56.0% aged ≥75. Relapse rates in the avacopan vs prednisone taper groups were 12.3% vs 18.8% and 3.8% vs 20.8% in the 65-74 and ≥75 subgroups, respectively. Improvements in estimated glomerular filtration rate and health-related quality of life were observed in both treatment groups. Use of avacopan compared with a prednisone taper was associated with a 61% and 49% reduction in mean glucocorticoid dose in the 65-74 and ≥75 subgroups, respectively, and lower glucocorticoid toxicity. The proportions of patients with adverse events were similar between treatment groups within each age subgroup. Conclusion: These data support the efficacy and safety of an avacopan-based regimen to treat patients with GPA or MPA aged ≥65.

Originalsprache	Englisch
Zeitschrift	Rheumatology
Jahrgang	64
Ausgabenummer	6
Seiten (von - bis)	3863-3871
Seitenumfang	9
ISSN	1462-0324
DOIs	https://doi.org/10.1093/rheumatology/keaf122
Publikationsstatus	Veröffentlicht - 01.06.2025

Fördermittel

Disclosure statement: D.G. reports consultant fees from Amgen, ChemoCentryx (a wholly owned subsidiary of Amgen), Aurinia, Otsuka, Calliditas, Vera Therapeutics and GlaxoSmithKline (GSK). C.P. reports consultant fees from Otsuka and AstraZeneca and speaker fees from Otsuka and GSK. S.E.S. reports grants from the Rheumatology Research Foundation and Bristol Myers Squibb Foundation, research support from AstraZeneca and GSK, consultant fees from Sanofi (all funds toward research support), speaker fees from Fresenius Kabi (all funds toward research support), travel support from the National Center for Advancing Transitional Sciences and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and advisory board participation for Amgen and Sanofi (all funds toward research support). P.A.M. reports royalties from UpToDate; consultant fees from AbbVie, Alpine, Amgen, Argenx, AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, CSL Behring, GSK, HiBio, iCell, InflaRx, Janssen, Kinevant, Kyverna, Metagenomia, Novartis, NS Pharma, Q32 Bio, Regeneron, Sanofi, Sparrow, Takeda and Visterra; stock options for Kyverna, Q32 Bio and Sparrow; and grants to his institution from AbbVie, Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Eicos, Electra, Forbius, Genentech/Roche, GSK, InflaRx, Neutrolis and Takeda. M.W. reports consultant fees from CSL Vifor, speaker fees from CSL Vifor and AstraZeneca, and grants to her institution from the Swedish Kidney Foundation and the Swedish Medical Society. J.D. reports grants from CSL Vifor, speaker fees from Alexion and CSL Vifor, funding for educational programmes or training activities from Alexion, travel support from CSL Vifor, and advisory board participation for CSL Vifor. S.F. reports consultant fees from Novartis SA, Abionyx Pharma and CSL Vifor; speaker fees from CSL Vifor and Baxter, travel support from Alexion and CSL Vifor, and advisory board participation for Sanofi-Genzyme and CSL Vifor. S.B. is an employee of Amgen and owns Amgen shares. R.E.G. is an employee of Amgen. M.B. is an employee of CSL Vifor and owns Amgen and CSL Vifor shares. A.B. reports consultant and speaker fees from Alexion, AstraZeneca, Bayer, Boehringer-Ingelheim, CSL Vifor and GSK; payment for expert testimony from the Swedish National Board of Health and Welfare; and advisory board participation for Alexion. D.R.J. reports consultant fees from AstraZeneca, Amgen, CSL Vifor, Novartis, Roche and Visterra; speaker fees from Amgen and CSL Vifor; advisory board participation for Chinook, GSK and Takeda; stock options for Aurinia and Alentis; and grants to his institution from GSK, CSL Vifor and Roche. Acknowledgements The authors are grateful to all the study coordinators, investigators and patients who participated in the ADVOCATE study. Amgen and Vifor Fresenius Medical Care Renal Pharma Ltd supported part of the data analysis for this manuscript. Medical writing support was provided by Scarlett Dell-Cronin and Bryony Brockhurst of Obsidian Healthcare Group Ltd, UK, and funded by Vifor Fresenius Medical Care Renal Pharma Ltd. A portion of the results included in this manuscript were previously presented as an abstract and poster at the American Society of Nephrology Kidney Week 2023 in Philadelphia, PA, USA, 2-5 November 2023 and at the American College of Rheumatology Convergence 2023 meeting in San Diego, CA, USA, 10-15 November 2023. Funding for the ADVOCATE study was provided by ChemoCentryx (a wholly owned subsidiary of Amgen).

Träger	Trägernummer
AstraZeneca
Vifor Fresenius Medical Care Renal Pharma Ltd
Fresenius Kabi
Swedish Medical Society
CSL Vifor
National Center for Advancing Transitional Sciences
ChemoCentryx, Inc.
Rheumatology Research Foundation
Bristol Myers Squibb Foundation
Alexion Pharmaceuticals, Inc.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
GlaxoSmithKline
Swedish Kidney Foundation

UN SDGs

Dieser Output leistet einen Beitrag zu folgendem(n) Ziel(en) für nachhaltige Entwicklung

SDG 3 – Gesundheit und Wohlergehen

Strategische Forschungsbereiche und Zentren

Forschungsschwerpunkt: Infektion und Entzündung - Zentrum für Infektions- und Entzündungsforschung Lübeck (ZIEL)

DFG-Fachsystematik

2.21-05 Immunologie
2.22-18 Rheumatologie

Dokumente

10.1093/rheumatology/keaf122

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@article{b472d5b50fd145369cce11b5997b5d85,

title = "Efficacy and safety of avacopan in patients aged 65 years and older with ANCA-associated vasculitis: a post hoc analysis of data from the ADVOCATE trial",

abstract = "Objectives: To evaluate the efficacy and safety of avacopan in patients aged ≥65 years with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in the phase 3 ADVOCATE trial of avacopan vs a prednisone taper, plus either rituximab or cyclophosphamide. Methods: In this descriptive, post hoc analysis, patients receiving avacopan or a prednisone taper were stratified by age. Key efficacy outcomes included the rate of remission at week 26 and sustained remission at week 52. Results: Of 160 patients aged ≥65, 109 were aged 65-74 and 51 were ≥75. Remission at week 26 was achieved in 71.7\% vs 69.4\% of patients aged 65-74 and 73.1\% vs 72.0\% aged ≥75 in the avacopan vs prednisone taper groups, respectively. Sustained remission at week 52 was observed in 65.0\% vs 55.1\% of patients aged 65-74 and 65.4\% vs 56.0\% aged ≥75. Relapse rates in the avacopan vs prednisone taper groups were 12.3\% vs 18.8\% and 3.8\% vs 20.8\% in the 65-74 and ≥75 subgroups, respectively. Improvements in estimated glomerular filtration rate and health-related quality of life were observed in both treatment groups. Use of avacopan compared with a prednisone taper was associated with a 61\% and 49\% reduction in mean glucocorticoid dose in the 65-74 and ≥75 subgroups, respectively, and lower glucocorticoid toxicity. The proportions of patients with adverse events were similar between treatment groups within each age subgroup. Conclusion: These data support the efficacy and safety of an avacopan-based regimen to treat patients with GPA or MPA aged ≥65.",

author = "\{ADVOCATE Study Group\} and Duvuru Geetha and C. Pagnoux and Sattui, \{Sebastian E.\} and Merkel, \{Peter A.\} and Maria Weiner and Juliana Draibe and Stanislas Faguer and Sarah Bray and Gurlin, \{Rachel E.\} and Monica Balcells-Oliver and A. Bruchfeld and Jayne, \{David R.\} and \{Au Peh\}, C. and A. Chakera and B. Cooper and J. Kurtkoti and D. Langguth and V. Levidiotis and G. Luxton and P. Mount and D. Mudge and E. Noble and R. Phoon and D. Ranganathan and A. Ritchie and J. Ryan and M. Suranyi and A. Rosenkranz and K. Lhotta and A. Kronbichler and N. Demoulin and C. Bovy and R. Hellemans and J. Hougardy and B. Sprangers and K. Wissing and C. Pagnoux and S. Barbour and S. Brachemi and S. Cournoyer and L. Girard and L. Laurin and P. Liang and D. Philibert and M. Walsh and V. Tesar and R. Becvar and M. Busch and F. Arndt and P. Lamprecht",

note = "Publisher Copyright: {\textcopyright} 2025 The Author(s). Published by Oxford University Press on behalf of the British Society for Rheumatology.",

year = "2025",

month = jun,

day = "1",

doi = "10.1093/rheumatology/keaf122",

language = "English",

volume = "64",

pages = "3863--3871",

journal = "Rheumatology",

issn = "1462-0324",

publisher = "Oxford University Press",

number = "6",

}

TY - JOUR

T1 - Efficacy and safety of avacopan in patients aged 65 years and older with ANCA-associated vasculitis

T2 - a post hoc analysis of data from the ADVOCATE trial

AU - ADVOCATE Study Group

AU - Geetha, Duvuru

AU - Pagnoux, C.

AU - Sattui, Sebastian E.

AU - Merkel, Peter A.

AU - Weiner, Maria

AU - Draibe, Juliana

AU - Faguer, Stanislas

AU - Bray, Sarah

AU - Gurlin, Rachel E.

AU - Balcells-Oliver, Monica

AU - Bruchfeld, A.

AU - Jayne, David R.

AU - Au Peh, C.

AU - Chakera, A.

AU - Cooper, B.

AU - Kurtkoti, J.

AU - Langguth, D.

AU - Levidiotis, V.

AU - Luxton, G.

AU - Mount, P.

AU - Mudge, D.

AU - Noble, E.

AU - Phoon, R.

AU - Ranganathan, D.

AU - Ritchie, A.

AU - Ryan, J.

AU - Suranyi, M.

AU - Rosenkranz, A.

AU - Lhotta, K.

AU - Kronbichler, A.

AU - Demoulin, N.

AU - Bovy, C.

AU - Hellemans, R.

AU - Hougardy, J.

AU - Sprangers, B.

AU - Wissing, K.

AU - Pagnoux, C.

AU - Barbour, S.

AU - Brachemi, S.

AU - Cournoyer, S.

AU - Girard, L.

AU - Laurin, L.

AU - Liang, P.

AU - Philibert, D.

AU - Walsh, M.

AU - Tesar, V.

AU - Becvar, R.

AU - Busch, M.

AU - Arndt, F.

AU - Lamprecht, P.

PY - 2025/6/1

Y1 - 2025/6/1

N2 - Objectives: To evaluate the efficacy and safety of avacopan in patients aged ≥65 years with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in the phase 3 ADVOCATE trial of avacopan vs a prednisone taper, plus either rituximab or cyclophosphamide. Methods: In this descriptive, post hoc analysis, patients receiving avacopan or a prednisone taper were stratified by age. Key efficacy outcomes included the rate of remission at week 26 and sustained remission at week 52. Results: Of 160 patients aged ≥65, 109 were aged 65-74 and 51 were ≥75. Remission at week 26 was achieved in 71.7% vs 69.4% of patients aged 65-74 and 73.1% vs 72.0% aged ≥75 in the avacopan vs prednisone taper groups, respectively. Sustained remission at week 52 was observed in 65.0% vs 55.1% of patients aged 65-74 and 65.4% vs 56.0% aged ≥75. Relapse rates in the avacopan vs prednisone taper groups were 12.3% vs 18.8% and 3.8% vs 20.8% in the 65-74 and ≥75 subgroups, respectively. Improvements in estimated glomerular filtration rate and health-related quality of life were observed in both treatment groups. Use of avacopan compared with a prednisone taper was associated with a 61% and 49% reduction in mean glucocorticoid dose in the 65-74 and ≥75 subgroups, respectively, and lower glucocorticoid toxicity. The proportions of patients with adverse events were similar between treatment groups within each age subgroup. Conclusion: These data support the efficacy and safety of an avacopan-based regimen to treat patients with GPA or MPA aged ≥65.

AB - Objectives: To evaluate the efficacy and safety of avacopan in patients aged ≥65 years with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in the phase 3 ADVOCATE trial of avacopan vs a prednisone taper, plus either rituximab or cyclophosphamide. Methods: In this descriptive, post hoc analysis, patients receiving avacopan or a prednisone taper were stratified by age. Key efficacy outcomes included the rate of remission at week 26 and sustained remission at week 52. Results: Of 160 patients aged ≥65, 109 were aged 65-74 and 51 were ≥75. Remission at week 26 was achieved in 71.7% vs 69.4% of patients aged 65-74 and 73.1% vs 72.0% aged ≥75 in the avacopan vs prednisone taper groups, respectively. Sustained remission at week 52 was observed in 65.0% vs 55.1% of patients aged 65-74 and 65.4% vs 56.0% aged ≥75. Relapse rates in the avacopan vs prednisone taper groups were 12.3% vs 18.8% and 3.8% vs 20.8% in the 65-74 and ≥75 subgroups, respectively. Improvements in estimated glomerular filtration rate and health-related quality of life were observed in both treatment groups. Use of avacopan compared with a prednisone taper was associated with a 61% and 49% reduction in mean glucocorticoid dose in the 65-74 and ≥75 subgroups, respectively, and lower glucocorticoid toxicity. The proportions of patients with adverse events were similar between treatment groups within each age subgroup. Conclusion: These data support the efficacy and safety of an avacopan-based regimen to treat patients with GPA or MPA aged ≥65.

UR - https://www.scopus.com/pages/publications/105006780923

U2 - 10.1093/rheumatology/keaf122

DO - 10.1093/rheumatology/keaf122

M3 - Journal articles

C2 - 40037556

AN - SCOPUS:105006780923

SN - 1462-0324

VL - 64

SP - 3863

EP - 3871

JO - Rheumatology

JF - Rheumatology

IS - 6

ER -

Efficacy and safety of avacopan in patients aged 65 years and older with ANCA-associated vasculitis: a post hoc analysis of data from the ADVOCATE trial

Abstract

Fördermittel

UN SDGs

Strategische Forschungsbereiche und Zentren

DFG-Fachsystematik

Dokumente

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