Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, 200443, China.
Department of Dermatology, Longgang Central Hospital of Shenzhen, Shenzhen, Guangdong, China.
Drug Saf. 2024 Jul;47(7):711-719. doi: 10.1007/s40264-024-01427-3. Epub 2024 Apr 30.
Ixekizumab, a monoclonal antibody against interleukin-17A, is efficacious and well tolerated for the treatment of moderate-to-severe plaque psoriasis. However, there are limited data on the real-world safety of ixekizumab in Chinese patient populations. We performed an observational study of ixekizumab for the treatment of moderate-to-severe plaque psoriasis in routine clinical practice in China. Here we present a further safety analysis of this study.
In this prospective, observational, single-arm, multicenter, post-marketing safety study, adults (≥18 years) with moderate-to-severe plaque psoriasis receiving ixekizumab were enroled at dermatology departments in hospitals across China and prospectively followed for 12 weeks or until their last dose of ixekizumab. In this analysis, we evaluated adverse events (AEs) of special interest (AESIs) identified using MedDRA search strategies. We also analyzed AEs and AESIs occurring in greater than ten patients in subgroups by age (< 65/≥ 65 years), sex, body weight (< 60/60 kg to < 80/≥ 80 kg), renal impairment, hepatic impairment, history of tuberculosis, history of HBV infection, recent or active infection, history of allergic reaction/hypersensitivity, and number (0-1/2-4/5-7) of ixekizumab 80 mg injections after baseline until day 105.
This analysis included 663/666 patients enrolled in the primary study. At least one AESI was reported in 224 (33.8%) patients and considered related to ixekizumab in 181 (27.3%); the most common were injection site reactions (n = 131, 19.8%), infections (n = 80, 12.1%), and allergic reactions/hypersensitivity events (n = 59, 8.9%). The proportion of patients with ≥ 1 AE was higher for females versus males (99/186, 53.2% versus 184/477, 38.6%, p = 0.0006). The proportion of patients with ≥ 1 AE increased with the number of ixekizumab injections after baseline [61/188 (32.4%) for zero to one injection, 151/338 (44.7%) for two to four injections, and 61/106 (57.5%) for five to seven injections; p = 0.0001].
In this real-world study, ixekizumab was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis, with no difference in safety across most patient subgroups.
依奇珠单抗是一种针对白细胞介素-17A 的单克隆抗体，对于治疗中度至重度斑块型银屑病是有效且耐受良好的。然而，在中国患者人群中，依奇珠单抗的真实世界安全性数据有限。我们在中国的常规临床实践中进行了一项关于依奇珠单抗治疗中度至重度斑块型银屑病的观察性研究。在此，我们进一步分析了该研究的安全性。
在这项前瞻性、观察性、单臂、多中心、上市后安全性研究中，接受依奇珠单抗治疗的中度至重度斑块型银屑病成年患者（≥18 岁）在中国各地医院的皮肤科接受登记，并前瞻性随访 12 周或直至最后一次依奇珠单抗给药。在这项分析中，我们使用 MedDRA 搜索策略评估了特定关注的不良事件（AESI）。我们还分析了按年龄（＜65/≥65 岁）、性别、体重（＜60/60 千克至＜80/≥80 千克）、肾功能不全、肝功能不全、结核病史、HBV 感染史、近期或活动性感染、过敏反应/超敏反应史以及基线后至第 105 天依奇珠单抗 80mg 注射次数（0-1/2-4/5-7 次）的亚组中发生的不良事件（AE）和 AESI，出现大于 10 例的 AE。
本分析包括主要研究中登记的 663/666 例患者。224 例（33.8%）患者报告了至少一次 AESI，其中 181 例（27.3%）认为与依奇珠单抗相关；最常见的是注射部位反应（n=131，19.8%）、感染（n=80，12.1%）和过敏反应/超敏反应事件（n=59，8.9%）。女性中≥1 例 AE 的患者比例高于男性（99/186，53.2%与 184/477，38.6%，p=0.0006）。随着基线后依奇珠单抗注射次数的增加，发生≥1 例 AE 的患者比例增加[0-1 次注射为 61/188（32.4%），2-4 次注射为 151/338（44.7%），5-7 次注射为 61/106（57.5%）；p=0.0001]。
在这项真实世界研究中，依奇珠单抗在中国中度至重度斑块型银屑病患者中耐受良好，大多数患者亚组之间的安全性无差异。
