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Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial

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Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial. / Geetha, Duvuru; Dua, Anisha; Yue, Huibin; Springer, Jason; Salvarani, Carlo; Jayne, David; Merkel, Peter; ADVOCATE Study Group.

In: ANN RHEUM DIS, Vol. 83, No. 2, 11.01.2024, p. 223-232.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Geetha, D, Dua, A, Yue, H, Springer, J, Salvarani, C, Jayne, D, Merkel, P & ADVOCATE Study Group 2024, 'Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial', ANN RHEUM DIS, vol. 83, no. 2, pp. 223-232. https://doi.org/10.1136/ard-2023-224816

APA

Geetha, D., Dua, A., Yue, H., Springer, J., Salvarani, C., Jayne, D., Merkel, P., & ADVOCATE Study Group (2024). Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial. ANN RHEUM DIS, 83(2), 223-232. https://doi.org/10.1136/ard-2023-224816

Vancouver

Geetha D, Dua A, Yue H, Springer J, Salvarani C, Jayne D et al. Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial. ANN RHEUM DIS. 2024 Jan 11;83(2):223-232. https://doi.org/10.1136/ard-2023-224816

Bibtex

@article{21d46b9aeca345548a02d5eec4bbdda7,
title = "Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial",
abstract = "OBJECTIVES: To evaluate the efficacy and safety of avacopan in the subgroup of patients with antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis receiving background induction therapy with rituximab in the phase 3 ADVOCATE trial.METHODS: Key efficacy outcomes were remission at week 26 and sustained remission at week 52. Additional outcomes included the Glucocorticoid Toxicity Index, estimated glomerular filtration rate, urinary albumin to creatinine ratio, health-related quality of life and safety.RESULTS: Of the 330 patients who received study medication, 214 (64.8%) received rituximab (once weekly for 4 weeks), with a mean age of 59.8 years; 163 (76.2%) had renal vasculitis and 125 (58.4%) were newly diagnosed. Remission at week 26 and sustained remission at week 52 were achieved by 83/107 (77.6%) and 76/107 (71.0%) patients in the avacopan group and 81/107 (75.7%) and 60/107 (56.1%) in the prednisone taper group, respectively. The relapse rate, recovery of renal function, speed of reduction in albuminuria and glucocorticoid toxicity favoured the avacopan group. Serious adverse events occurred in 34.6% and 39.3% of patients in the avacopan and prednisone taper groups, respectively.CONCLUSIONS: These data suggest that in patients with ANCA-associated vasculitis receiving rituximab, efficacy of treatment with avacopan compared with a prednisone taper was similar at week 26 and greater at week 52, with a favourable safety profile. In addition, avacopan was associated with improved renal outcomes and lower glucocorticoid toxicity. These results demonstrate the efficacy and safety of avacopan in patients receiving background induction therapy with rituximab.TRIAL REGISTRATION NUMBER: NCT02994927.",
keywords = "Humans, Middle Aged, Rituximab/adverse effects, Immunosuppressive Agents/therapeutic use, Prednisone, Glucocorticoids/adverse effects, Quality of Life, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy, Remission Induction, Antibodies, Antineutrophil Cytoplasmic, Aniline Compounds, Nipecotic Acids",
author = "Duvuru Geetha and Anisha Dua and Huibin Yue and Jason Springer and Carlo Salvarani and David Jayne and Peter Merkel and {ADVOCATE Study Group} and Ina K{\"o}tter",
note = "{\textcopyright} Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2024",
month = jan,
day = "11",
doi = "10.1136/ard-2023-224816",
language = "English",
volume = "83",
pages = "223--232",
journal = "ANN RHEUM DIS",
issn = "0003-4967",
publisher = "BMJ PUBLISHING GROUP",
number = "2",

}

RIS

TY - JOUR

T1 - Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial

AU - Geetha, Duvuru

AU - Dua, Anisha

AU - Yue, Huibin

AU - Springer, Jason

AU - Salvarani, Carlo

AU - Jayne, David

AU - Merkel, Peter

AU - ADVOCATE Study Group

AU - Kötter, Ina

N1 - © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2024/1/11

Y1 - 2024/1/11

N2 - OBJECTIVES: To evaluate the efficacy and safety of avacopan in the subgroup of patients with antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis receiving background induction therapy with rituximab in the phase 3 ADVOCATE trial.METHODS: Key efficacy outcomes were remission at week 26 and sustained remission at week 52. Additional outcomes included the Glucocorticoid Toxicity Index, estimated glomerular filtration rate, urinary albumin to creatinine ratio, health-related quality of life and safety.RESULTS: Of the 330 patients who received study medication, 214 (64.8%) received rituximab (once weekly for 4 weeks), with a mean age of 59.8 years; 163 (76.2%) had renal vasculitis and 125 (58.4%) were newly diagnosed. Remission at week 26 and sustained remission at week 52 were achieved by 83/107 (77.6%) and 76/107 (71.0%) patients in the avacopan group and 81/107 (75.7%) and 60/107 (56.1%) in the prednisone taper group, respectively. The relapse rate, recovery of renal function, speed of reduction in albuminuria and glucocorticoid toxicity favoured the avacopan group. Serious adverse events occurred in 34.6% and 39.3% of patients in the avacopan and prednisone taper groups, respectively.CONCLUSIONS: These data suggest that in patients with ANCA-associated vasculitis receiving rituximab, efficacy of treatment with avacopan compared with a prednisone taper was similar at week 26 and greater at week 52, with a favourable safety profile. In addition, avacopan was associated with improved renal outcomes and lower glucocorticoid toxicity. These results demonstrate the efficacy and safety of avacopan in patients receiving background induction therapy with rituximab.TRIAL REGISTRATION NUMBER: NCT02994927.

AB - OBJECTIVES: To evaluate the efficacy and safety of avacopan in the subgroup of patients with antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis receiving background induction therapy with rituximab in the phase 3 ADVOCATE trial.METHODS: Key efficacy outcomes were remission at week 26 and sustained remission at week 52. Additional outcomes included the Glucocorticoid Toxicity Index, estimated glomerular filtration rate, urinary albumin to creatinine ratio, health-related quality of life and safety.RESULTS: Of the 330 patients who received study medication, 214 (64.8%) received rituximab (once weekly for 4 weeks), with a mean age of 59.8 years; 163 (76.2%) had renal vasculitis and 125 (58.4%) were newly diagnosed. Remission at week 26 and sustained remission at week 52 were achieved by 83/107 (77.6%) and 76/107 (71.0%) patients in the avacopan group and 81/107 (75.7%) and 60/107 (56.1%) in the prednisone taper group, respectively. The relapse rate, recovery of renal function, speed of reduction in albuminuria and glucocorticoid toxicity favoured the avacopan group. Serious adverse events occurred in 34.6% and 39.3% of patients in the avacopan and prednisone taper groups, respectively.CONCLUSIONS: These data suggest that in patients with ANCA-associated vasculitis receiving rituximab, efficacy of treatment with avacopan compared with a prednisone taper was similar at week 26 and greater at week 52, with a favourable safety profile. In addition, avacopan was associated with improved renal outcomes and lower glucocorticoid toxicity. These results demonstrate the efficacy and safety of avacopan in patients receiving background induction therapy with rituximab.TRIAL REGISTRATION NUMBER: NCT02994927.

KW - Humans

KW - Middle Aged

KW - Rituximab/adverse effects

KW - Immunosuppressive Agents/therapeutic use

KW - Prednisone

KW - Glucocorticoids/adverse effects

KW - Quality of Life

KW - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy

KW - Remission Induction

KW - Antibodies, Antineutrophil Cytoplasmic

KW - Aniline Compounds

KW - Nipecotic Acids

U2 - 10.1136/ard-2023-224816

DO - 10.1136/ard-2023-224816

M3 - SCORING: Journal article

C2 - 37979959

VL - 83

SP - 223

EP - 232

JO - ANN RHEUM DIS

JF - ANN RHEUM DIS

SN - 0003-4967

IS - 2

ER -