Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial
Abstract Background Efficacy and tolerance of anakinra (ANK) in the treatment of giant cell arteritis (GCA) need to be assessed. Methods This phase 3 study (NCT02902731) was a prospective multicenter, randomized, double-blind, placebo-controlled trial conducted over a 52-week period. GCA patients we...
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BMC
2025-06-01
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| Online Access: | https://doi.org/10.1186/s13075-025-03493-z |
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| author | Hubert de Boysson Kim Heang Ly Loïk Geffray Thomas Quemeneur Eric Liozon Holy Bezanahary Noémie Le Gouellec Alexandra Audemard Anael Dumont Samuel Deshayes Jonathan Boutemy Gwénola Maigné Nicolas Martin Silva Audrey Sultan Brigitte Le Mauff Gauthier Petit Jean-Jacques Parienti Achille Aouba |
| author_facet | Hubert de Boysson Kim Heang Ly Loïk Geffray Thomas Quemeneur Eric Liozon Holy Bezanahary Noémie Le Gouellec Alexandra Audemard Anael Dumont Samuel Deshayes Jonathan Boutemy Gwénola Maigné Nicolas Martin Silva Audrey Sultan Brigitte Le Mauff Gauthier Petit Jean-Jacques Parienti Achille Aouba |
| author_sort | Hubert de Boysson |
| collection | DOAJ |
| description | Abstract Background Efficacy and tolerance of anakinra (ANK) in the treatment of giant cell arteritis (GCA) need to be assessed. Methods This phase 3 study (NCT02902731) was a prospective multicenter, randomized, double-blind, placebo-controlled trial conducted over a 52-week period. GCA patients were randomized 1:1. From inclusion to week 16 (W16), patients in the anakinra (ANK) group received a daily subcutaneous injection of 100 mg of anakinra, whereas patients in the other group received placebo (PBO). In both arms, glucocorticoid (GC) discontinuation was planned at week 52 (W52). The endpoints were the relapse rates at W16, W26, and W52 and the completion of GC tapering. Given the emergence of the SARS-CoV-2 pandemic, the study was stopped prematurely. Results Thirty patients with new GCA diagnoses from 5 centers were randomized as follows: 17 in the ANK group and 13 in the PBO group. During the first 16 weeks, the relapse rates were 12% (n = 2) and 23% (n = 3) in the ANK and PBO groups, respectively (p = 0.63). At week 26, 12 (40%) patients had relapsed: 8 (47%) in the ANK group and 4 (31%) in the PBO group (p = 0.47). At W52, the relapse rate (overall, 50%) did not differ between the ANK group (53%; 9/17 patients) and the PBO group (46%; 6/13 patients) (p = 1). Two patients in each group discontinued GCs (p = 0.87). Seven serious AEs were reported in five patients, including 4 in patients receiving ANK. Conclusions Although prematurely discontinued, this study does not support the use of 4 months of treatment with anakinra combined with GCs to reduce the risk of relapse or GC exposure. Trial registration ClinicalTrials.gov NCT02902731. |
| format | Article |
| id | doaj-art-796bd240ed6a491c8d5f1ac58909eadf |
| institution | OA Journals |
| issn | 1478-6362 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMC |
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| series | Arthritis Research & Therapy |
| spelling | doaj-art-796bd240ed6a491c8d5f1ac58909eadf2025-08-20T02:05:39ZengBMCArthritis Research & Therapy1478-63622025-06-012711810.1186/s13075-025-03493-zFour months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trialHubert de Boysson0Kim Heang Ly1Loïk Geffray2Thomas Quemeneur3Eric Liozon4Holy Bezanahary5Noémie Le Gouellec6Alexandra Audemard7Anael Dumont8Samuel Deshayes9Jonathan Boutemy10Gwénola Maigné11Nicolas Martin Silva12Audrey Sultan13Brigitte Le Mauff14Gauthier Petit15Jean-Jacques Parienti16Achille Aouba17Department of Internal Medicine, Caen University HospitalDepartment of Internal Medicine, Limoges University HospitalDepartment of Internal Medicine, Lisieux HospitalDepartment of Internal Medicine, Valenciennes HospitalDepartment of Internal Medicine, Limoges University HospitalDepartment of Internal Medicine, Limoges University HospitalDepartment of Internal Medicine, Valenciennes HospitalDepartment of Internal Medicine, Caen University HospitalDepartment of Internal Medicine, Caen University HospitalDepartment of Internal Medicine, Caen University HospitalDepartment of Internal Medicine, Caen University HospitalDepartment of Internal Medicine, Caen University HospitalDepartment of Internal Medicine, Caen University HospitalDepartment of Internal Medicine, Caen University HospitalUniversity of Caen NormandieDepartment of Immunology and Histocompatibility (HLA), Caen University HospitalUniversity of Caen NormandieDepartment of Internal Medicine, Caen University HospitalAbstract Background Efficacy and tolerance of anakinra (ANK) in the treatment of giant cell arteritis (GCA) need to be assessed. Methods This phase 3 study (NCT02902731) was a prospective multicenter, randomized, double-blind, placebo-controlled trial conducted over a 52-week period. GCA patients were randomized 1:1. From inclusion to week 16 (W16), patients in the anakinra (ANK) group received a daily subcutaneous injection of 100 mg of anakinra, whereas patients in the other group received placebo (PBO). In both arms, glucocorticoid (GC) discontinuation was planned at week 52 (W52). The endpoints were the relapse rates at W16, W26, and W52 and the completion of GC tapering. Given the emergence of the SARS-CoV-2 pandemic, the study was stopped prematurely. Results Thirty patients with new GCA diagnoses from 5 centers were randomized as follows: 17 in the ANK group and 13 in the PBO group. During the first 16 weeks, the relapse rates were 12% (n = 2) and 23% (n = 3) in the ANK and PBO groups, respectively (p = 0.63). At week 26, 12 (40%) patients had relapsed: 8 (47%) in the ANK group and 4 (31%) in the PBO group (p = 0.47). At W52, the relapse rate (overall, 50%) did not differ between the ANK group (53%; 9/17 patients) and the PBO group (46%; 6/13 patients) (p = 1). Two patients in each group discontinued GCs (p = 0.87). Seven serious AEs were reported in five patients, including 4 in patients receiving ANK. Conclusions Although prematurely discontinued, this study does not support the use of 4 months of treatment with anakinra combined with GCs to reduce the risk of relapse or GC exposure. Trial registration ClinicalTrials.gov NCT02902731.https://doi.org/10.1186/s13075-025-03493-zGiant cell arteritisAnakinraGlucocorticoidsInterleukin-1Quality of life |
| spellingShingle | Hubert de Boysson Kim Heang Ly Loïk Geffray Thomas Quemeneur Eric Liozon Holy Bezanahary Noémie Le Gouellec Alexandra Audemard Anael Dumont Samuel Deshayes Jonathan Boutemy Gwénola Maigné Nicolas Martin Silva Audrey Sultan Brigitte Le Mauff Gauthier Petit Jean-Jacques Parienti Achille Aouba Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial Arthritis Research & Therapy Giant cell arteritis Anakinra Glucocorticoids Interleukin-1 Quality of life |
| title | Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_full | Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_fullStr | Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_full_unstemmed | Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_short | Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_sort | four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis a multicenter randomized double blind placebo controlled trial |
| topic | Giant cell arteritis Anakinra Glucocorticoids Interleukin-1 Quality of life |
| url | https://doi.org/10.1186/s13075-025-03493-z |
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