Sobi, Stockholm, Sweden.
Apellis Pharmaceuticals, Waltham, Massachusetts, USA.
Eur J Haematol. 2024 Apr;112(4):516-529. doi: 10.1111/ejh.14139. Epub 2023 Nov 23.
To describe real-world use/effectiveness of pegcetacoplan (PEG) in paroxysmal nocturnal haemoglobinuria (PNH).
Data were drawn from the Adelphi PNH Disease Specific Programme™, a cross-sectional survey conducted in France, Italy, Germany, Spain and the United States from January to November 2022. Patients had a confirmed PNH diagnosis and received PEG for ≥1 month. Physicians reported patient characteristics, treatment use/satisfaction and their perception of patients' fatigue and health-related quality of life (HRQoL). Patients reported treatment satisfaction and completed questionnaires assessing fatigue, HRQoL and productivity. Descriptive statistics were reported.
Overall, 14 physicians provided data for 61 patients who had received 1080 mg/dose PEG for 1.3-14.8 months. At data collection compared to PEG initiation: haemoglobin was 2.5 g/dL higher on average; proportion of patients with lactate dehydrogenase (LDH) ≥1.5 × upper limit of normal was reduced by 27.4%; physician-perceived fatigue was lower and HRQoL better. Physician- and patient-reported treatment satisfaction was high for >90% of patients. Physicians and patients were more satisfied with PEG than previously prescribed C5 complement inhibitors. Mean work impairment and activity impairment in the 7 days prior to data collection were 32.9% and 22.4%, respectively.
These real-world data support the effectiveness of PEG through positive effects on haemoglobin, LDH, fatigue and HRQoL.
描述阵发性睡眠性血红蛋白尿症(PNH)中培西加群(PEG)的实际应用/疗效。
数据来自 Adelphi PNH 疾病专项计划™,这是一项于 2022 年 1 月至 11 月在法国、意大利、德国、西班牙和美国进行的横断面调查。患者确诊为 PNH,且接受 PEG 治疗 ≥1 个月。医生报告患者特征、治疗使用/满意度,以及他们对患者疲劳和健康相关生活质量(HRQoL)的看法。患者报告治疗满意度,并完成了评估疲劳、HRQoL 和生产力的问卷。报告了描述性统计数据。
总体而言,14 名医生提供了 61 名患者的数据,这些患者接受了 1080mg/剂量的 PEG 治疗,治疗时间为 1.3-14.8 个月。与 PEG 起始时相比,在数据收集时:血红蛋白平均升高了 2.5g/dL;乳酸脱氢酶(LDH)≥1.5×正常值上限的患者比例降低了 27.4%;医生感知的疲劳程度较低,HRQoL 更好。超过 90%的患者对治疗的满意度很高。医生和患者对 PEG 的满意度均高于之前开具的 C5 补体抑制剂。在数据收集前 7 天,平均工作障碍和活动障碍分别为 32.9%和 22.4%。
这些真实世界的数据通过对血红蛋白、LDH、疲劳和 HRQoL 的积极影响,支持了 PEG 的疗效。