Kansas City Multiple Sclerosis and Headache Center, 10600 Mastin Entrance C, Overland Park, KS, 66212, USA.
Columbia University Medical Center, New York, NY, USA.
Clin Drug Investig. 2023 Oct;43(10):739-761. doi: 10.1007/s40261-023-01303-5. Epub 2023 Oct 4.
Acthar Gel (repository corticotropin injection) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides that is believed to have both steroidogenic and nonsteroidogenic immunomodulatory effects via activation of melanocortin receptors in various cells throughout the body. Since 1952, Acthar has been approved by the US Food and Drug Administration to treat a variety of autoimmune and inflammatory diseases. Since 2014, Mallinckrodt Pharmaceuticals has conducted a large number of preclinical, clinical, and real-world-evidence studies of Acthar for the treatment of rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis and polymyositis, multiple sclerosis relapse, ophthalmic disorders, sarcoidosis, and nephrotic syndrome. To date, Acthar has been the subject of more than 500 publications, many of which demonstrate the safety and efficacy of Acthar in patients with inflammatory diseases for whom standard treatments were ineffective or intolerable. Here, we review the history of Acthar and the findings of studies that have investigated the mechanism of action, safety, efficacy, and real-world effectiveness of Acthar for the treatment of inflammatory diseases.
Acthar Gel（促肾上腺皮质激素凝胶）是一种天然来源的复杂混合物，包含促肾上腺皮质激素类似物和其他垂体肽，据信通过激活体内各种细胞中的黑素细胞刺激素受体，具有甾体生成和非甾体生成的免疫调节作用。自 1952 年以来，Acthar 已获得美国食品和药物管理局批准，用于治疗多种自身免疫性和炎症性疾病。自 2014 年以来，Mallinckrodt 制药公司已经进行了大量的 Acthar 治疗类风湿关节炎、系统性红斑狼疮、皮肌炎和多发性肌炎、多发性硬化症复发、眼病、结节病和肾病综合征的临床前、临床和真实世界证据研究。迄今为止，Acthar 已成为 500 多项研究的主题，其中许多研究表明，对于标准治疗无效或不耐受的炎症性疾病患者，Acthar 具有安全性和疗效。在这里，我们回顾了 Acthar 的历史以及研究其作用机制、安全性、疗效和治疗炎症性疾病的实际效果的研究结果。
