Real-world implementation of continuous subcutaneous foslevodopa/foscarbidopa in advanced Parkinson's disease: first clinical experience from the Middle East.
Shivam Om Mittal, Kiran Waqar, Emma De Freitas, Yasmin Abdelmajid, Arshiya Anjum, Leanne Brown, Moncy Thomas
{"title":"Real-world implementation of continuous subcutaneous foslevodopa/foscarbidopa in advanced Parkinson's disease: first clinical experience from the Middle East.","authors":"Shivam Om Mittal, Kiran Waqar, Emma De Freitas, Yasmin Abdelmajid, Arshiya Anjum, Leanne Brown, Moncy Thomas","doi":"10.1177/17562864261464300","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Continuous subcutaneous foslevodopa/foscarbidopa (FLD/FCD) is the first 24-h levodopa-based subcutaneous infusion therapy for advanced Parkinson's disease (PD). Real-world data from the Middle East region are absent.</p><p><strong>Objectives: </strong>To report the first Middle Eastern clinical experience with foslevodopa/foscarbidopa, evaluating motor and non-motor outcomes, safety profile, and treatment continuation rates in routine clinical practice.</p><p><strong>Design: </strong>Retrospective, single-center, observational cohort study.</p><p><strong>Methods: </strong>Twenty-eight consecutive patients with advanced PD underwent inpatient foslevodopa/foscarbidopa initiation between January 2025 and January 2026 at a quaternary academic medical center in Abu Dhabi, United Arab Emirates. Primary outcomes were Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, daily OFF/ON hours, and Hoehn and Yahr stage; secondary outcomes included Non-Motor Symptoms Scale (NMSS) total and domain scores and MDS-UPDRS Parts I and II. Motor assessments were conducted in the practically defined OFF state at baseline and in the ON state at follow-up on stable foslevodopa/foscarbidopa therapy. Safety was assessed by systematic recording of adverse events. Paired comparisons used Wilcoxon signed-rank tests.</p><p><strong>Results: </strong>Mean age was 61.3 ± 13.5 years; disease duration 10.1 ± 7.4 years; baseline levodopa equivalent daily dose 1018 ± 574 mg. MDS-UPDRS Part III improved from 50.7 ± 14.5 (OFF-state baseline) to 27.1 ± 13.6 (ON-state follow-up; change -23.6 ± 8.3, <i>p</i> < 0.0001), representing elimination of wearing-off disability. Daily OFF time fell from 2.8 ± 1.4 to 0.9 ± 0.6 h (-1.9 ± 1.4 h; <i>p</i> < 0.0001), and good ON time increased by 2.0 ± 1.3 h (<i>p</i> < 0.0001). Hoehn and Yahr stage improved from median 3 (interquartile range (IQR) 3-4) to 2 (IQR 2-3; <i>p</i> < 0.0001). Non-motor symptom burden decreased substantially: MDS-UPDRS Parts I and II fell by 22.7 ± 9.3 points (<i>p</i> = 0.001) and NMSS total score by 29.7 ± 18.7 points (~49% reduction; <i>p</i> = 0.0007). Infusion site reactions occurred in 22 patients (79%) but were generally manageable. Six patients (21%) discontinued therapy (median 4.8 months), primarily because of skin reactions or compliance difficulties.</p><p><strong>Conclusion: </strong>Foslevodopa/foscarbidopa produced clinically meaningful improvements in motor fluctuations and non-motor symptom burden in this first Middle Eastern real-world cohort, supporting its role as an effective and feasible non-surgical device-aided therapy for advanced PD.</p>","PeriodicalId":22980,"journal":{"name":"Therapeutic Advances in Neurological Disorders","volume":"19 ","pages":"17562864261464300"},"PeriodicalIF":4.0000,"publicationDate":"2026-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13373433/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Neurological Disorders","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562864261464300","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Continuous subcutaneous foslevodopa/foscarbidopa (FLD/FCD) is the first 24-h levodopa-based subcutaneous infusion therapy for advanced Parkinson's disease (PD). Real-world data from the Middle East region are absent.
Objectives: To report the first Middle Eastern clinical experience with foslevodopa/foscarbidopa, evaluating motor and non-motor outcomes, safety profile, and treatment continuation rates in routine clinical practice.
Methods: Twenty-eight consecutive patients with advanced PD underwent inpatient foslevodopa/foscarbidopa initiation between January 2025 and January 2026 at a quaternary academic medical center in Abu Dhabi, United Arab Emirates. Primary outcomes were Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, daily OFF/ON hours, and Hoehn and Yahr stage; secondary outcomes included Non-Motor Symptoms Scale (NMSS) total and domain scores and MDS-UPDRS Parts I and II. Motor assessments were conducted in the practically defined OFF state at baseline and in the ON state at follow-up on stable foslevodopa/foscarbidopa therapy. Safety was assessed by systematic recording of adverse events. Paired comparisons used Wilcoxon signed-rank tests.
Results: Mean age was 61.3 ± 13.5 years; disease duration 10.1 ± 7.4 years; baseline levodopa equivalent daily dose 1018 ± 574 mg. MDS-UPDRS Part III improved from 50.7 ± 14.5 (OFF-state baseline) to 27.1 ± 13.6 (ON-state follow-up; change -23.6 ± 8.3, p < 0.0001), representing elimination of wearing-off disability. Daily OFF time fell from 2.8 ± 1.4 to 0.9 ± 0.6 h (-1.9 ± 1.4 h; p < 0.0001), and good ON time increased by 2.0 ± 1.3 h (p < 0.0001). Hoehn and Yahr stage improved from median 3 (interquartile range (IQR) 3-4) to 2 (IQR 2-3; p < 0.0001). Non-motor symptom burden decreased substantially: MDS-UPDRS Parts I and II fell by 22.7 ± 9.3 points (p = 0.001) and NMSS total score by 29.7 ± 18.7 points (~49% reduction; p = 0.0007). Infusion site reactions occurred in 22 patients (79%) but were generally manageable. Six patients (21%) discontinued therapy (median 4.8 months), primarily because of skin reactions or compliance difficulties.
Conclusion: Foslevodopa/foscarbidopa produced clinically meaningful improvements in motor fluctuations and non-motor symptom burden in this first Middle Eastern real-world cohort, supporting its role as an effective and feasible non-surgical device-aided therapy for advanced PD.
背景:连续皮下左旋多巴/foscarbidopa (FLD/FCD)是首个以左旋多巴为基础的24小时皮下输注治疗晚期帕金森病(PD)的方法。没有来自中东地区的真实数据。目的:报告首个中东地区使用foslevodopa/foscarbidopa的临床经验,评估常规临床实践中的运动和非运动结果、安全性和治疗延续率。设计:回顾性、单中心、观察性队列研究。方法:2025年1月至2026年1月,在阿拉伯联合酋长国阿布扎比的一家第四学术医疗中心,连续28例晚期PD患者接受了foslevodopa/foscarbidopa的住院治疗。主要结局是运动障碍学会统一帕金森病评定量表(MDS-UPDRS)第三部分,每日OFF/ON小时数,Hoehn和Yahr分期;次要结局包括非运动症状量表(NMSS)总分和领域评分以及MDS-UPDRS第一部分和第二部分。在稳定的foslevodopa/foscarbidopa治疗后,基线时在实际定义的OFF状态下进行运动评估,随访时在ON状态下进行。通过系统记录不良事件来评估安全性。配对比较采用Wilcoxon符号秩检验。结果:平均年龄61.3±13.5岁;病程10.1±7.4年;基线左旋多巴当量日剂量1018±574 mg。MDS-UPDRS第三部分从50.7±14.5分(OFF-state baseline)改善到27.1±13.6分(ON-state随访;变化-23.6±8.3分,p p p p p = 0.001), NMSS总分提高29.7±18.7分(~49%降低,p = 0.0007)。22名患者(79%)发生了输液部位反应,但通常是可控的。6名患者(21%)停止治疗(中位4.8个月),主要是因为皮肤反应或依从性困难。结论:Foslevodopa/foscarbidopa在第一个中东现实世界队列中对运动波动和非运动症状负担有临床意义的改善,支持其作为有效和可行的非手术器械辅助治疗晚期PD的作用。
期刊介绍:
Therapeutic Advances in Neurological Disorders is a peer-reviewed, open access journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of neurology. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in neurology, providing a forum in print and online for publishing the highest quality articles in this area.