Rheumatology (Oxford, England) · 2025
The real-world use and effectiveness of avacopan in routine practice for the treatment of ANCA vasculitis. First experiences in Spain.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Draibe Juliana, Espigol-Frigolé Georgina, Cid Maria Cinta, Prados M C, Guillén E, Villacorta J, Vega C, Martins J, daSilva I, Martin-Gomez Mª Adoración, Huerta A, Martinez-Valenzuela L, Morales Enrique
Аннотация
OBJECTIVES: ANCA-associated vasculitis (AAV) is a group of chronic diseases with relapses that associate organic damage because of the disease and its treatment. Avacopan is a new treatment indicated for AAV. We present the first experiences with avacopan in Spain as part of an Early Access program.
METHODS: Patients with AAV who started avacopan between June 2022 and September 2023 were included. For comparison, a historical cohort of patients diagnosed with AAV around the same time and treated without avacopan was also included.
RESULTS: Twenty-nine patients treated with avacopan were analysed. Twelve patients (41.4%) were male, and median age was 56 years. Most patients were ANCA MPO positive (21/29, 72.4%). The most frequently affected organ was the kidney (23/29, 79.31%), with a mean estimated glomerular filtration rate (eGFR) of 23.2 ml/min. Mean follow-up was 456.8 (±181.7) days with a remission rate of 86.2%. eGFR increased from 23.2 (11.2) to 38.38 (18.55) ml/min after 12 months of diagnosis. Two patients had adverse events related to avacopan (severe neutropenia and a gastrointestinal affectation), 13 infections were reported and one death. Patients treated with avacopan received a significantly lower cumulative dose of prednisone at 6 and 12 months (P-values of 0.02 and <0.01, respectively) compared with historical controls. The evolution of GFR at 1 year of follow-up and the incidence of relapse were similar in both groups.
CONCLUSION: The combination of avacopan with standard immunosuppressive therapy presents a good safety profile and provides added value by contributing to the control of AAV activity, increase GFR and removal of steroids.
METHODS: Patients with AAV who started avacopan between June 2022 and September 2023 were included. For comparison, a historical cohort of patients diagnosed with AAV around the same time and treated without avacopan was also included.
RESULTS: Twenty-nine patients treated with avacopan were analysed. Twelve patients (41.4%) were male, and median age was 56 years. Most patients were ANCA MPO positive (21/29, 72.4%). The most frequently affected organ was the kidney (23/29, 79.31%), with a mean estimated glomerular filtration rate (eGFR) of 23.2 ml/min. Mean follow-up was 456.8 (±181.7) days with a remission rate of 86.2%. eGFR increased from 23.2 (11.2) to 38.38 (18.55) ml/min after 12 months of diagnosis. Two patients had adverse events related to avacopan (severe neutropenia and a gastrointestinal affectation), 13 infections were reported and one death. Patients treated with avacopan received a significantly lower cumulative dose of prednisone at 6 and 12 months (P-values of 0.02 and <0.01, respectively) compared with historical controls. The evolution of GFR at 1 year of follow-up and the incidence of relapse were similar in both groups.
CONCLUSION: The combination of avacopan with standard immunosuppressive therapy presents a good safety profile and provides added value by contributing to the control of AAV activity, increase GFR and removal of steroids.