Church Leigh D, McDermott Michael F
Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, Wellcome Trust Brenner Building, St James's University Hospital, Leeds, LS9 7TF, UK.
Curr Opin Mol Ther. 2009 Feb;11(1):81-9.
Novartis AG is developing canakinumab, an intravenously or subcutaneously infused, fully human mAb that neutralizes the bioactivity of human IL-1beta, which is involved in several inflammatory disorders. Canakinumab has promising clinical safety and pharmacokinetic properties, and demonstrated potential for the treatment of cryopyrin-associated periodic syndromes (CAPS) and possibly for other complex inflammatory diseases, such as rheumatoid arthritis, systemic-onset juvenile idiopathic arthritis (SoJIA), COPD disease and ocular diseases. Currently in phase III clinical development, canakinumab was recently granted EU and US Orphan Drug status for SoJIA and CAPS. Early clinical trials have established the administration of canakinumab every 2 weeks to be safe and effective, offering a considerable advantage over the existing treatment with the human IL-1 receptor antagonist anakinra, which must be injected daily and which is often poorly tolerated by patients. The availability of more than one IL-1 targeting biological agent is undoubtedly advantageous, not only for patients and clinicians, but also for the elucidation of disease mechanisms.
诺华公司正在研发卡那单抗，这是一种可静脉注射或皮下注射的全人源单克隆抗体，能中和人白细胞介素-1β的生物活性，白细胞介素-1β参与多种炎症性疾病。卡那单抗具有良好的临床安全性和药代动力学特性，在治疗冷吡啉相关周期性综合征（CAPS）以及可能治疗其他复杂炎症性疾病（如类风湿关节炎、全身型幼年特发性关节炎（SoJIA）、慢性阻塞性肺疾病（COPD）和眼部疾病）方面显示出潜力。卡那单抗目前正处于III期临床开发阶段，最近已被授予欧盟和美国针对SoJIA和CAPS的孤儿药地位。早期临床试验已证实每2周注射一次卡那单抗是安全有效的，这比现有的人白细胞介素-1受体拮抗剂阿那白滞素治疗具有显著优势，阿那白滞素必须每日注射，且患者通常耐受性较差。多种靶向白细胞介素-1的生物制剂的出现无疑是有利的，这不仅对患者和临床医生有益，也有助于阐明疾病机制。
