Cazzola Mario, Matera Maria Gabriella, Levi-Schaffer Francesca, Rogliani Paola
a Unit of Respiratory Medicine, Department of Experimental Medicine and Surgery , University of Rome 'Tor Vergata' , Rome , Italy.
b Unit of Pharmacology, Department of Experimental Medicine , University of Campania 'Luigi Vanvitelli' , Naples , Italy.
Expert Opin Drug Saf. 2018 Apr;17(4):429-435. doi: 10.1080/14740338.2018.1446940. Epub 2018 Mar 8.
Reslizumab, a humanized mAb against IL-5, reduces the number of eosinophils in the blood and lungs. Based on efficacy and safety data from pivotal RCTs, reslizumab had been approved for use as an add-on maintenance treatment of severe asthma with an eosinophilic phenotype in adults who have a history of exacerbations despite receiving their current asthma medicines. Areas covered: Current literature on reslizumab has been reviewed with a specific focus on its safety profile in the treatment of severe asthma. Expert opinion: Large pivotal and supportive trials reinforce the view that reslizumab is well tolerated, with an acceptable safety profile in patients exposed for longer than 2 years. However, no or few data concerning safety in special populations such as smokers, those with immune- and cellular senescence, patients with comorbidities and those receiving multi-drug treatments are available as yet. Furthermore, we need to fully elucidate some fundamental issues such as the risk of anaphylaxis and the long-term risk-benefit ratio of the impact of depletion of eosinophils and the potential risk of malignancies induced by a treatment with this anti-IL-5 agent.
瑞利珠单抗是一种抗白细胞介素-5的人源化单克隆抗体,可减少血液和肺部的嗜酸性粒细胞数量。基于关键随机对照试验的疗效和安全性数据,瑞利珠单抗已被批准用于对尽管接受了当前哮喘药物治疗仍有急性加重病史的成人嗜酸性粒细胞型重度哮喘进行附加维持治疗。涵盖领域:对瑞利珠单抗的现有文献进行了综述,特别关注其在重度哮喘治疗中的安全性。专家意见:大型关键试验和支持性试验强化了这样一种观点,即瑞利珠单抗耐受性良好,在暴露超过2年的患者中具有可接受的安全性。然而,关于特殊人群(如吸烟者、免疫和细胞衰老者、合并症患者以及接受多药治疗者)安全性的数据目前尚无或很少。此外,我们需要充分阐明一些基本问题,如过敏反应风险、嗜酸性粒细胞耗竭影响的长期风险效益比以及使用这种抗白细胞介素-5药物治疗引发恶性肿瘤的潜在风险。