阿那白滞素

阿那白滞素（Anakinra），以Kineret名称出售。是一种治疗类风湿性关节炎, 隐热蛋白相关周期性综合症、家族性地中海热、成人史迪尔氏病的生物制药。是人类白细胞介素1受体拮抗剂蛋白质的重组及修改版本 It is marketed by Swedish Orphan Biovitrum.。可由皮下注射。

**医疗用途**
在疾病缓解抗风湿药治疗失败后，阿那白滞素被用作二线治疗控制类风湿性关节炎。可与某些DMARD结合使用。
用于患有隐热蛋白相关周期性综合症的人，包括新生儿多系统炎症性疾病。
用于治疗Schnitzler综合症（在美国不符合标签）。 Its response rate is such that it has been suggested that "Treatment failures should lead to reconsider the diagnosis."
仿单标示外使用, it is used to treat 幼年特发性关节炎 (SJIA), 痛风, 二水合焦磷酸钙晶体沉积病 (CPPD), 贝赛特氏症, 强直性脊柱炎, 葡萄膜炎, and other 自身炎症性疾病.
In December 2021, the 欧洲药品管理局 authorized the use of anakinra "to treat 2019冠状病毒病 in adults with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml." In November 2022, the United States 美国食品药品监督管理局 approved its use under an 紧急使用授权 "for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR)."

**Safety**
It was not tested in pregnant women, but appeared to be safe in animal studies.
It should not be used in people who have active infections or latent tuberculosis, who have low 白血球 counts, or who are taking TNF inhibitors.

**Adverse effects**
More than ten percent of people taking Anakinra have injection site reactions, headaches, and have increased cholesterol levels. Between one and ten percent of recipients have severe infections, decreased white blood cells, or decreased 血小板. It is unclear if taking Anakinra increases cancer risk; studies are complicated by the fact that people with rheumatoid arthritis already face higher cancer risk.

**Chemistry**
Anakinra differs from the sequence of Interleukin 1 receptor antagonist by one 甲硫氨酸 氨基酸 added to its N端; it also differs from the human protein in that it is not 糖基化, as it is 工业发酵 in 大肠杆菌.

**History**
It was approved for medical use in the US in 2001, and in the European Union in 2002.
In 2018, NHS England published a Clinical Commissioning Policy: Anakinra to treat periodic fevers and autoinflammatory disorders (all ages) allowing Anakinra to be commissioned as a first-line treatment for Schnitzler's syndrome and in cases where the first-line treatment is not effective for Familial Mediterranean fever, Hyper-IgD syndrome also known as Mevalonate kinase deficiency, and TNF receptor associated periodic syndrome (TRAPS), and a Clinical Commissioning Policy: Anakinra/tocilizumab for the treatment of Adult-Onset Still's Disease refractory to second-line therapy (adults), allowing Anakinra to be commissioned for adult-onset Still's disease "as a third line treatment where patients are refractory to steroid-sparing effect DMARDs".
In December 2020, Anakinra was approved by the US Food and Drug Administration for the treatment of deficiency of the interleukin-1–receptor antagonist (DIRA), a rare autoinflammatory disease of infancy. In 2021, it was announced that the 俄罗斯联邦卫生部 had approved the use of Anakinra for the treatment of CAPS.
In October 2021, NHS England published Clinical Commissioning Policy: Anakinra for Haemophagocytic Lymphohistiocytosis (HLH) for adults and children in all ages, allowing Anakinra to be used in the treatment of HLH.

**Society and culture**

**Legal status**

**Research**
Anakinra effectively treated meningitis caused by a rare genetic mutation in the gene NALP3 in a 67-year-old man enrolled in the Undiagnosed Diseases Network. Researchers at 约翰斯·霍普金斯大学 announced in 2019 that anakinra given to pregnant mice with 兹卡病毒 had reduced fetal deaths and birth defects. In November 2019, researchers at the 曼彻斯特大学 reported that Anakinra might have a use in preventing breast cancer from spreading to the bones.
In 2021, it was reported that Anakinra appeared to reduce the 神经性疼痛 experienced by patients undergoing 化学疗法 with 长春新碱, saying that "repurposing anakinra may be an effective co-treatment strategy to prevent vincristine-induced peripheral neuropathy".
A review published in 2022 found that "Anakinra appears to show efficacy for numerous 皮肤病学 conditions, with the strongest evidence for hidradenitis suppurativa, 贝赛特氏症, Muckle–Wells syndrome, and SAPHO syndrome." and concluded that "Overall, anakinra appears to be a promising option in the treatment of numerous dermatologic inflammatory conditions refractory to first line therapies, but further and higher-quality data is needed to clarify its therapeutic role."
In 2023, researchers at 哥伦比亚大学 explored the effect of Anakinra on the ageing of  造血干细胞s in mice. They concluded "that targeting IL-1 as a key mediator of niche inflammation is a tractable strategy to improve blood production during ageing" and were reported to have said "that their findings could pave the way for science to delay aging and even lengthen the lifespan of humans".

**COVID-19**
Anakinra is undergoing multiple clinical trials to treat 2019冠状病毒病 patients, by targeting mechanisms in patients with hyperinflammation. In 2021 a review and 元分析 of 9 studies involving 1,119 cases concluded that "Available evidence shows that treatment with anakinra reduces both the need for invasive mechanical ventilation and mortality risk of hospitalized non-intubated patients with COVID-19 without increasing the risk of adverse events."
, the 欧洲药品管理局 (EMA) is evaluating an application to extend the use of anakinra to include treatment of 2019冠状病毒病 in adults with pneumonia who are at risk of developing severe respiratory failure (inability of the lungs to work properly). According to study results published in September 2021 in 自然-医学, hospitalized COVID-19 patients at increased risk for 呼吸衰竭 showed significant improvement after treatment with Anakinra.

**参考**

**外部链接**
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