视网膜疾病生物类似药：美国-欧洲认知度调查（Bio-USER调查）
Biosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER - survey).
作者信息
Sharma Ashish, Holz Frank G, Regillo Carl D, Freund K Bailey, Sarraf David, Khanani Arshad M, Baumal Caroline, Holekamp Nancy, Tadayoni Ramin, Kumar Nilesh, Parachuri Nikulaa, Kuppermann Baruch D, Bandello Francesco, Querques Giuseppe, Loewenstein Anat, Özdek Şengül, Rezai Kourous, Laurent Kodjikian, Bilgic Alper, Lanzetta Paolo, Zur Dinah, Yannuzzi Nicolas, Corradetti Giulia, Kaiser Peter, Hilely Assaf, Boyer David, Rachitskaya Aleksandra, Chakravarthy Usha, Wintergerst Maximilian, Sarao Valentina, Parolini Barbara, Mruthyunjaya Prithvi, Nguyen Quan Dong, Do Diana, Keane Pearse A, Hassan Tarek, Sridhar Jayanth, Eichenbaum David, Grewal Dilraj, Splitzer Martin
机构信息
Lotus Eye Hospital and Institute, Coimbatore, India.
Department of Ophthalmology, University of Bonn, Bonn, Germany.
出版信息
Expert Opin Biol Ther. 2023 Jul-Dec;23(8):851-859. doi: 10.1080/14712598.2023.2176218. Epub 2023 Feb 19.
PURPOSE
To assess the awareness of biosimilar intravitreal anti-VEGF agents among retina specialists practicing in the United States (US) and Europe.
METHODS
A 16-question online survey was created in English and distributed between Dec 01, 2021 and Jan 31, 2022. A total of 112 respondents (retinal physicians) from the US and Europe participated.
RESULTS
The majority of the physicians (56.3%) were familiar with anti-VEGF biosimilars. A significant number of physicians needed more information (18.75%) and real world data (25%) before switching to a biosimilar. About one half of the physicians were concerned about biosimilar safety (50%), efficacy (58.9 %), immunogenicity (50%), and their efficacy with extrapolated indications (67.8 %). Retinal physicians from the US were less inclined to shift from off-label bevacizumab to biosimilar ranibizumab or on-label bevacizumab (if approved) compared to physicians from Europe (p=0.0001). Furthermore, physicians from the US were more concerned about biosimilar safety (p=0.0371) and efficacy compared to Europe (p= 0.0078).
CONCLUSIONS
The Bio-USER survey revealed that while the majority of retinal physicians need additional information regarding the safety, efficacy and immunogenicity when making clinical decisions regarding their use. Retinal physicians from US are more comfortable in continuing to use off-label bevacizumab compared to physicians from Europe.
目的
评估在美国和欧洲执业的视网膜专科医生对生物类似物玻璃体内抗血管内皮生长因子（VEGF）药物的认知情况。
方法
创建了一份包含16个问题的在线调查问卷，问卷为英文，于2021年12月1日至2022年1月31日期间分发。共有来自美国和欧洲的112名受访者（视网膜医生）参与。
结果
大多数医生（56.3%）熟悉抗VEGF生物类似物。相当数量的医生在转而使用生物类似物之前需要更多信息（18.75%）和真实世界数据（25%）。约一半的医生担心生物类似物的安全性（50%）、疗效（58.9%）、免疫原性（50%）及其在扩展适应症方面的疗效（67.8%）。与欧洲医生相比，美国的视网膜医生不太倾向于从非标签使用的贝伐单抗转而使用生物类似物雷珠单抗或标签内使用的贝伐单抗（如果获批）（p = 0.0001）。此外，与欧洲相比，美国医生更担心生物类似物的安全性（p = 0.0371）和疗效（p = 0.0078）。
结论
Bio-USER调查显示，虽然大多数视网膜医生在就生物类似物的使用做出临床决策时需要有关其安全性、疗效和免疫原性的更多信息。与欧洲医生相比，美国的视网膜医生更愿意继续使用非标签的贝伐单抗。
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