Department of Dermatology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Skin Health Institute, Carlton, Victoria, Australia.
Australas J Dermatol. 2021 Feb;62(1):e47-e54. doi: 10.1111/ajd.13450. Epub 2020 Sep 4.
Psoriasis is a chronic inflammatory disease affecting ~2-3% of the Australasian population. Therapeutic options include topical agents, phototherapy, systemic immunomodulators and biologic agents. Biologics present an acceptable short- and medium-term safety profile, derived mainly from randomised controlled trials (RCTs) and, however, may not represent real-world rates of adverse events (AEs).
A retrospective, observational study of patients enrolled in The Australasian Psoriasis Registry from April 2008 to October 2018 was conducted. Data were collected from 104 sites in Australia and New Zealand. Patient characteristics, treatments and AE data were collected. AEs were classified by MedDRA System events.
2094 patients were included (3765 patient-treatments), comprising; 1110 phototherapy, 1280 systemic and 1375 biologic therapy patient-treatments. Treatment arms were not mutually exclusive. The mean ± SD from date of diagnosis of psoriasis to commencement of biologic therapy was 8.9 ± 12.3 years. Methotrexate had the longest exposure time (3740.3 patient-years), and ustekinumab had the longest median (95% CI) time on treatment, 4.3 years (2.2, 6.6). AE differences on biologic treatment were present between patients who would have been eligible or ineligible for RCTs. Approximately 29% of registry patients would have been excluded from clinical trials enrolment. Patients ineligible for RCTs had increased adjusted hazard ratios (95% CI) of: infections and infestations (2.3, 1.7-3.1; P < 0.001), cardiac (8.2, 3.5-25.6; P < 0.001), gastrointestinal (3.5, 1.52-8.0; P < 0.001), hepatobiliary (5.6 1.7-19.1; P < 0.001), psychiatric (4.7, 1.5-14.1; P = 0.006) and eye disorders (4.8 1.5-15.6; P = 0.008), compared to those eligible for RCTs. Incidence rates in the trial eligible patients were similar to those reported from RCT rates.
This study establishes treatment modalities in use for severe psoriasis and the clinical rates of AEs associated with biologic therapy.
银屑病是一种影响~2-3%澳大拉西亚人群的慢性炎症性疾病。治疗选择包括局部制剂、光疗、系统免疫调节剂和生物制剂。生物制剂具有可接受的短期和中期安全性，主要来源于随机对照试验（RCT），然而，它们可能无法代表真实世界的不良事件（AE）发生率。
对 2008 年 4 月至 2018 年 10 月期间参加澳大利亚银屑病登记处的患者进行了一项回顾性、观察性研究。数据来自澳大利亚和新西兰的 104 个地点。收集患者特征、治疗和 AE 数据。AE 按 MedDRA 系统事件分类。
共纳入 2094 例患者（3765 例患者治疗），包括 1110 例光疗、1280 例系统治疗和 1375 例生物治疗患者治疗。治疗组之间没有相互排斥。从银屑病诊断到开始生物治疗的平均（±）SD 为 8.9（±）12.3 年。甲氨蝶呤的暴露时间最长（3740.3 患者年），乌司奴单抗的中位（95%CI）治疗时间最长，4.3 年（2.2，6.6）。生物治疗的 AE 差异存在于有资格或无资格参加 RCT 的患者之间。大约 29%的登记患者将被排除在临床试验招募之外。无资格参加 RCT 的患者调整后的危险比（95%CI）为：感染和寄生虫病（2.3，1.7-3.1；P<0.001）、心脏（8.2，3.5-25.6；P<0.001）、胃肠道（3.5，1.52-8.0；P<0.001）、肝胆（5.6，1.7-19.1；P<0.001）、精神（4.7，1.5-14.1；P=0.006）和眼部疾病（4.8，1.5-15.6；P=0.008），与有资格参加 RCT 的患者相比。有资格参加 RCT 的患者的发病率与 RCT 报告的发病率相似。
本研究确立了严重银屑病的治疗方式和与生物治疗相关的 AE 临床发生率。
