Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial
Standard
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, Jahrgang 83, Nr. 2, 11.01.2024, S. 223-232.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
Harvard
APA
Vancouver
Bibtex
}
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 -