de Boysson Hubert, Ly Kim Heang, Geffray Loïk, Quemeneur Thomas, Liozon Eric, Bezanahary Holy, Gouellec Noémie Le, Audemard Alexandra, Dumont Anael, Deshayes Samuel, Boutemy Jonathan, Maigné Gwénola, Martin Silva Nicolas, Sultan Audrey, Le Mauff Brigitte, Petit Gauthier, Parienti Jean-Jacques, Aouba Achille
Department of Internal Medicine, Caen University Hospital, Avenue de la Côte de Nacre, Caen, 14000, France.
University of Caen Normandie, Caen, 14000, France.
Arthritis Res Ther. 2025 Jun 7;27(1):122. doi: 10.1186/s13075-025-03493-z.
Efficacy and tolerance of anakinra (ANK) in the treatment of giant cell arteritis (GCA) need to be assessed.
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.
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.
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.
ClinicalTrials.gov NCT02902731.
需要评估阿那白滞素（ANK）治疗巨细胞动脉炎（GCA）的疗效和耐受性。
这项3期研究（NCT02902731）是一项前瞻性多中心、随机、双盲、安慰剂对照试验，为期52周。GCA患者按1:1随机分组。从纳入研究至第16周（W16），阿那白滞素（ANK）组患者每日皮下注射100mg阿那白滞素，而另一组患者接受安慰剂（PBO）。两组均计划在第52周（W52）停用糖皮质激素（GC）。终点指标为W16、W26和W52时的复发率以及GC减量的完成情况。鉴于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）大流行的出现，该研究提前终止。
来自5个中心的30例新诊断为GCA的患者随机分组如下：ANK组17例，PBO组13例。在最初的16周内，ANK组和PBO组的复发率分别为12%（n = 2）和23%（n = 3）（p = 0.63）。在第26周时，12例（40%）患者复发：ANK组8例（47%），PBO组4例（31%）（p = 0.47）。在W52时，ANK组（53%；9/17例患者）和PBO组（46%；6/13例患者）的复发率（总体为50%）无差异（p = 1）。每组有2例患者停用GC（p = 0.87）。5例患者报告了7例严重不良事件，其中接受ANK治疗的患者有4例。
尽管该研究提前终止，但并不支持使用4个月的阿那白滞素联合GC治疗以降低复发风险或减少GC暴露。
ClinicalTrials.gov NCT02902731。
