{"title":"anakinra和canakinumab在VEXAS综合征患者中的比较疗效和安全性-一项国际多中心研究","authors":"Tali Eviatar,Dafne Capelusnik,Corrado Campochiaro,Valentin Lacombe,Vincent Jachiet,Michael Zisapel,Iftach Sagy,Oshrat E Tayer-Shifman,David Ozeri,Shaye Kivity,Alessandro Tomelleri,Benjamin Terrier,Hagit Peleg,Thibault Comont,Karim Sacre,Pascal Woaye-Hune,Laurent Arnaud,Estibaliz Lazaro,Vincent Grobost,Francois Lifermann,Maxime Samson,Samuel Ardois,Alice Garnier,Alexandre Maria,Alain Cantagrel,Aurore Meyer,Jean-David Bouaziz,Mael Heiblig,Lorenzo Dagna,Elisa Diral,Olivier Kosmider,Ori Elkayam,Jérôme Hadjadj,Sophie Georgin-Lavialle,Olivier Fain,Arsene Mekinian","doi":"10.1002/art.43384","DOIUrl":null,"url":null,"abstract":"OBJECTIVES\r\nThe aim of this study was to compare differences in clinical response, drug survival, and adverse event rates between anakinra and canakinumab in VEXAS syndrome.\r\n\r\nMETHODS\r\nThis multicenter international study includes VEXAS patients from France, Israel, and Italy treated with IL1 inhibition (IL1i). Global response (GR) was defined as the absence of inflammatory symptoms, 50% or greater decrease in steroid dose and C-reactive protein. Multiple regression analysis was performed to identify associated variables. Drug survival was analyzed using Kaplan-Meier plots and log-rank test, with Cox-regression models for associated factors.\r\n\r\nRESULTS\r\nWe included 47 male VEXAS patients; 44 received anakinra, and 9 received canakinumab, with 6 patients using both at different time points. GR at 1 month was 34% for anakinra and 100% for canakinumab (p<0.001), 22% and 78% at 3 months, respectively (p=0.001). Treatment with canakinumab was associated with higher odds ratio (OR) of achieving GR at 3 months (OR 28.8, 95%CI 3·0-273·9, p=0.004) in a multivariable analysis. Median drug survival was 54 (30-56) months for canakinumab at 300 mg/month, compared to 7 (4-8) months for canakinumab 150 mg/month and 1 (1-2.5) months for anakinra (p=0.01). Injection site reactions were only recorded for the anakinra group (47 vs 0%; p=0.006), whereas infections were more frequent in the anakinra group (31% and 11%; p=0·3).\r\n\r\nCONCLUSIONS\r\nCanakinumab demonstrated superior clinical response and drug survival with fewer adverse events compared to anakinra. Monthly Canakinumab 300 mg may be considered as an effective steroid-sparing therapeutic option for VEXAS patients.","PeriodicalId":129,"journal":{"name":"Arthritis & Rheumatology","volume":"196 1","pages":""},"PeriodicalIF":10.9000,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative efficacy and safety of anakinra and canakinumab in patients with VEXAS syndrome - an international multicenter study.\",\"authors\":\"Tali Eviatar,Dafne Capelusnik,Corrado Campochiaro,Valentin Lacombe,Vincent Jachiet,Michael Zisapel,Iftach Sagy,Oshrat E Tayer-Shifman,David Ozeri,Shaye Kivity,Alessandro Tomelleri,Benjamin Terrier,Hagit Peleg,Thibault Comont,Karim Sacre,Pascal Woaye-Hune,Laurent Arnaud,Estibaliz Lazaro,Vincent Grobost,Francois Lifermann,Maxime Samson,Samuel Ardois,Alice Garnier,Alexandre Maria,Alain Cantagrel,Aurore Meyer,Jean-David Bouaziz,Mael Heiblig,Lorenzo Dagna,Elisa Diral,Olivier Kosmider,Ori Elkayam,Jérôme Hadjadj,Sophie Georgin-Lavialle,Olivier Fain,Arsene Mekinian\",\"doi\":\"10.1002/art.43384\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"OBJECTIVES\\r\\nThe aim of this study was to compare differences in clinical response, drug survival, and adverse event rates between anakinra and canakinumab in VEXAS syndrome.\\r\\n\\r\\nMETHODS\\r\\nThis multicenter international study includes VEXAS patients from France, Israel, and Italy treated with IL1 inhibition (IL1i). Global response (GR) was defined as the absence of inflammatory symptoms, 50% or greater decrease in steroid dose and C-reactive protein. Multiple regression analysis was performed to identify associated variables. Drug survival was analyzed using Kaplan-Meier plots and log-rank test, with Cox-regression models for associated factors.\\r\\n\\r\\nRESULTS\\r\\nWe included 47 male VEXAS patients; 44 received anakinra, and 9 received canakinumab, with 6 patients using both at different time points. GR at 1 month was 34% for anakinra and 100% for canakinumab (p<0.001), 22% and 78% at 3 months, respectively (p=0.001). Treatment with canakinumab was associated with higher odds ratio (OR) of achieving GR at 3 months (OR 28.8, 95%CI 3·0-273·9, p=0.004) in a multivariable analysis. Median drug survival was 54 (30-56) months for canakinumab at 300 mg/month, compared to 7 (4-8) months for canakinumab 150 mg/month and 1 (1-2.5) months for anakinra (p=0.01). Injection site reactions were only recorded for the anakinra group (47 vs 0%; p=0.006), whereas infections were more frequent in the anakinra group (31% and 11%; p=0·3).\\r\\n\\r\\nCONCLUSIONS\\r\\nCanakinumab demonstrated superior clinical response and drug survival with fewer adverse events compared to anakinra. Monthly Canakinumab 300 mg may be considered as an effective steroid-sparing therapeutic option for VEXAS patients.\",\"PeriodicalId\":129,\"journal\":{\"name\":\"Arthritis & Rheumatology\",\"volume\":\"196 1\",\"pages\":\"\"},\"PeriodicalIF\":10.9000,\"publicationDate\":\"2025-09-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Arthritis & Rheumatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/art.43384\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Arthritis & Rheumatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/art.43384","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
Comparative efficacy and safety of anakinra and canakinumab in patients with VEXAS syndrome - an international multicenter study.
OBJECTIVES
The aim of this study was to compare differences in clinical response, drug survival, and adverse event rates between anakinra and canakinumab in VEXAS syndrome.
METHODS
This multicenter international study includes VEXAS patients from France, Israel, and Italy treated with IL1 inhibition (IL1i). Global response (GR) was defined as the absence of inflammatory symptoms, 50% or greater decrease in steroid dose and C-reactive protein. Multiple regression analysis was performed to identify associated variables. Drug survival was analyzed using Kaplan-Meier plots and log-rank test, with Cox-regression models for associated factors.
RESULTS
We included 47 male VEXAS patients; 44 received anakinra, and 9 received canakinumab, with 6 patients using both at different time points. GR at 1 month was 34% for anakinra and 100% for canakinumab (p<0.001), 22% and 78% at 3 months, respectively (p=0.001). Treatment with canakinumab was associated with higher odds ratio (OR) of achieving GR at 3 months (OR 28.8, 95%CI 3·0-273·9, p=0.004) in a multivariable analysis. Median drug survival was 54 (30-56) months for canakinumab at 300 mg/month, compared to 7 (4-8) months for canakinumab 150 mg/month and 1 (1-2.5) months for anakinra (p=0.01). Injection site reactions were only recorded for the anakinra group (47 vs 0%; p=0.006), whereas infections were more frequent in the anakinra group (31% and 11%; p=0·3).
CONCLUSIONS
Canakinumab demonstrated superior clinical response and drug survival with fewer adverse events compared to anakinra. Monthly Canakinumab 300 mg may be considered as an effective steroid-sparing therapeutic option for VEXAS patients.
期刊介绍:
Arthritis & Rheumatology is the official journal of the American College of Rheumatology and focuses on the natural history, pathophysiology, treatment, and outcome of rheumatic diseases. It is a peer-reviewed publication that aims to provide the highest quality basic and clinical research in this field. The journal covers a wide range of investigative areas and also includes review articles, editorials, and educational material for researchers and clinicians. Being recognized as a leading research journal in rheumatology, Arthritis & Rheumatology serves the global community of rheumatology investigators and clinicians.