Rheumatology (Oxford, England) · 2025
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.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Geetha Duvuru, Pagnoux Christian, Sattui Sebastian E, Merkel Peter A, Weiner Maria, Draibe Juliana, Faguer Stanislas, Bray Sarah, Gurlin Rachel E, Balcells-Oliver Monica, Bruchfeld Annette, Jayne David R, ADVOCATE Study Group
Аннотация
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.
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.