Comparative efficacy and safety of anakinra and canakinumab in patients with VEXAS syndrome - an international multicenter study

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

Comparative efficacy and safety of anakinra and canakinumab in patients with VEXAS syndrome - an international multicenter study

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 LifermannMaxime 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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Journal	Arthritis & Rheumatology
DOIs	https://doi.org/10.1002/art.43384
Publication status	E-pub ahead of print - 22 Sept 2025

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10.1002/art.43384Licence: CC BY-NC-ND

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Eviatar, T., Capelusnik, D., Campochiaro, C., Lacombe, V., Jachiet, V., Zisapel, M., Sagy, I., Tayer-Shifman, O. E., Ozeri, D., Kivity, S., Tomelleri, A., Terrier, B., Peleg, H., Comont, T., Sacre, K., Woaye-Hune, P., Arnaud, L., Lazaro, E., Grobost, V., ... Mekinian, A. (2025). Comparative efficacy and safety of anakinra and canakinumab in patients with VEXAS syndrome - an international multicenter study. Arthritis & Rheumatology. Advance online publication. https://doi.org/10.1002/art.43384

@article{95b277dc8f924d739a48fe46a1737adb,

title = "Comparative efficacy and safety of anakinra and canakinumab in patients with VEXAS syndrome - an international multicenter study",

abstract = "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.",

author = "Tali Eviatar and Dafne Capelusnik and Corrado Campochiaro and Valentin Lacombe and Vincent Jachiet and Michael Zisapel and Iftach Sagy and Tayer-Shifman, \{Oshrat E\} and David Ozeri and Shaye Kivity and Alessandro Tomelleri and Benjamin Terrier and Hagit Peleg and Thibault Comont and Karim Sacre and Pascal Woaye-Hune and Laurent Arnaud and Estibaliz Lazaro and Vincent Grobost and Francois Lifermann and Maxime Samson and Samuel Ardois and Alice Garnier and Alexandre Maria and Alain Cantagrel and Aurore Meyer and Jean-David Bouaziz and Mael Heiblig and Lorenzo Dagna and Elisa Diral and Olivier Kosmider and Ori Elkayam and J{\'e}r{\^o}me Hadjadj and Sophie Georgin-Lavialle and Olivier Fain and Arsene Mekinian",

year = "2025",

month = sep,

day = "22",

doi = "10.1002/art.43384",

language = "English",

journal = "Arthritis \& Rheumatology",

issn = "2326-5191",

publisher = "John Wiley \& Sons Inc.",

}

Eviatar, T, Capelusnik, D, Campochiaro, C, Lacombe, V, Jachiet, V, Zisapel, M, Sagy, I, Tayer-Shifman, OE, Ozeri, D, Kivity, S, Tomelleri, A, Terrier, B, Peleg, H, Comont, T, Sacre, K, Woaye-Hune, P, Arnaud, L, Lazaro, E, Grobost, V, Lifermann, F, Samson, M, Ardois, S, Garnier, A, Maria, A, Cantagrel, A, Meyer, A, Bouaziz, J-D, Heiblig, M, Dagna, L, Diral, E, Kosmider, O, Elkayam, O, Hadjadj, J, Georgin-Lavialle, S, Fain, O & Mekinian, A 2025, 'Comparative efficacy and safety of anakinra and canakinumab in patients with VEXAS syndrome - an international multicenter study', Arthritis & Rheumatology. https://doi.org/10.1002/art.43384

TY - JOUR

T1 - Comparative efficacy and safety of anakinra and canakinumab in patients with VEXAS syndrome - an international multicenter study

AU - Eviatar, Tali

AU - Capelusnik, Dafne

AU - Campochiaro, Corrado

AU - Lacombe, Valentin

AU - Jachiet, Vincent

AU - Zisapel, Michael

AU - Sagy, Iftach

AU - Tayer-Shifman, Oshrat E

AU - Ozeri, David

AU - Kivity, Shaye

AU - Tomelleri, Alessandro

AU - Terrier, Benjamin

AU - Peleg, Hagit

AU - Comont, Thibault

AU - Sacre, Karim

AU - Woaye-Hune, Pascal

AU - Arnaud, Laurent

AU - Lazaro, Estibaliz

AU - Grobost, Vincent

AU - Lifermann, Francois

AU - Samson, Maxime

AU - Ardois, Samuel

AU - Garnier, Alice

AU - Maria, Alexandre

AU - Cantagrel, Alain

AU - Meyer, Aurore

AU - Bouaziz, Jean-David

AU - Heiblig, Mael

AU - Dagna, Lorenzo

AU - Diral, Elisa

AU - Kosmider, Olivier

AU - Elkayam, Ori

AU - Hadjadj, Jérôme

AU - Georgin-Lavialle, Sophie

AU - Fain, Olivier

AU - Mekinian, Arsene

PY - 2025/9/22

Y1 - 2025/9/22

N2 - 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.

AB - 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.

U2 - 10.1002/art.43384

DO - 10.1002/art.43384

M3 - Article

SN - 2326-5191

JO - Arthritis & Rheumatology

JF - Arthritis & Rheumatology

ER -

Comparative efficacy and safety of anakinra and canakinumab in patients with VEXAS syndrome - an international multicenter study

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