دورية أكاديمية
أعرض في EDS

Evaluating the Efficacy and Safety of Aflibercept Biosimilar (P041) Compared with Originator Product in Patients with Neovascular Age-Related Macular Degeneration.

التفاصيل البيبلوغرافية
العنوان: Evaluating the Efficacy and Safety of Aflibercept Biosimilar (P041) Compared with Originator Product in Patients with Neovascular Age-Related Macular Degeneration.
المؤلفون: Karkhaneh R; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Faghihi H; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Riazi-Esfahani H; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Abrishami M; Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Bazvand F; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Ebrahimiadib N; Department of Ophthalmology, Eye Research Center, Tehran University of Medical Sciences, Tehran, Iran., Johari M; Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran., Akhlaghi M; Isfahan Eye Research Center, Department of Ophthalmology, Isfahan University of Medical Sciences, Isfahan, Iran., Shoeibi N; Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Norouzzadeh MH; Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran., Ansari Astaneh MR; Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Khojasteh H; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Imani Fooladi M; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Khodabande A; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Ghassemi F; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Khalili Pour E; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Zarei M; Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Mirshahi A; Eye Research Centre, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran., Fazel F; Isfahan Eye Research Center, Department of Ophthalmology, Isfahan University of Medical Sciences, Isfahan, Iran., Ashraf H; Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran., Hosseini SM; Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Dourandeesh M; Eye Research Center, Department of Eye, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran., Feghhi M; Department of Ophthalmology, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran., Alizadeh Y; Department of Ophthalmology, Eye Research Center, Guilan University of Medical Sciences, Rasht, Iran., Behboudi H; Eye Research Center, Department of Eye, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran., Azadi P; Eye Research Center, Emam khomeini Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran., Sabzvari A; CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran., Kafi H; Medical Department, Orchid Pharmed Company, Tehran, Iran., Ghasemi Falavarjani K; Eye Research Center, The Five Senses Health Institute, Rassoul Akram Hospital, School of Medicine, Iran University of Medical Sciences, Tehran, Iran; Stem Cell and Regenerative Medicine Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: drghasemi@yahoo.com.
المصدر: Ophthalmology. Retina [Ophthalmol Retina] 2024 Aug; Vol. 8 (8), pp. 744-753. Date of Electronic Publication: 2024 Feb 28.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial; Clinical Trial, Phase III
اللغة: English
بيانات الدورية: Publisher: Published by Elsevier Inc. on behalf of American Academy of Ophthalmology Country of Publication: United States NLM ID: 101695048 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2468-6530 (Electronic) Linking ISSN: 24686530 NLM ISO Abbreviation: Ophthalmol Retina Subsets: MEDLINE
أسماء مطبوعة: Original Publication: New York, NY : Published by Elsevier Inc. on behalf of American Academy of Ophthalmology, [2017]-
مواضيع طبية MeSH: Receptors, Vascular Endothelial Growth Factor*/administration & dosage , Receptors, Vascular Endothelial Growth Factor*/antagonists & inhibitors , Recombinant Fusion Proteins*/administration & dosage , Recombinant Fusion Proteins*/adverse effects , Visual Acuity* , Intravitreal Injections* , Angiogenesis Inhibitors*/administration & dosage , Wet Macular Degeneration*/drug therapy , Wet Macular Degeneration*/diagnosis , Biosimilar Pharmaceuticals*/administration & dosage , Biosimilar Pharmaceuticals*/adverse effects , Biosimilar Pharmaceuticals*/therapeutic use, Humans ; Male ; Female ; Double-Blind Method ; Aged ; Treatment Outcome ; Tomography, Optical Coherence/methods ; Follow-Up Studies ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Dose-Response Relationship, Drug ; Aged, 80 and over ; Fluorescein Angiography/methods
مستخلص: Objective: To assess the noninferiority of biosimilar aflibercept (P041, CinnaGen) to the originator aflibercept (AFL, Regeneron) in terms of efficacy, safety, and immunogenicity.
Design: This was a phase Ш, 52-week, multicenter, randomized, double-masked, and active control trial involving eyes in a 1:1 ratio.
Subjects: Patients with active subfoveal choroidal neovascularization secondary to age-related macular degeneration randomized into the 2 groups of P041 and AFL.
Methods: Patients received an injection of aflibercept every 4 weeks for 3 doses, followed by administration every 8 weeks up to week 48.
Main Outcome Measures: The primary outcome was the noninferiority analysis of eyes maintaining vision at week 52. Secondary outcomes included the changes in visual acuity and retinal thickness, safety evaluation, and immunogenicity during the study.
Results: In total, 168 eyes of 168 patients were included. At week 52, the proportion of patients maintaining vision was 94.44% in the P041 group compared with 94.52% in the AFL group. The 95% confidence interval (CI) for the difference of maintaining vision from baseline did not exceed the predefined noninferiority margin of 10% (difference, -0.0008; 95% CI, -0.074 to 0.074; P = 0.98). Secondary outcomes indicated similar results in both arms (all P > 0.05). Safety measured outcomes and immunogenicity were similar between the 2 study groups.
Conclusions: Biosimilar aflibercept was noninferior to AFL in eyes with neovascular age-related macular degeneration. Other efficacy and safety findings also indicated the similarity of 2 products.
Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
(Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
فهرسة مساهمة: Keywords: Aflibercept; Age-related macular degeneration; Biosimilar; Choroidal neovascularization; VEGF-Trap
المشرفين على المادة: EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor)
0 (Recombinant Fusion Proteins)
15C2VL427D (aflibercept)
0 (Angiogenesis Inhibitors)
0 (Biosimilar Pharmaceuticals)
0 (Vascular Endothelial Growth Factor A)
تواريخ الأحداث: Date Created: 20240301 Date Completed: 20240803 Latest Revision: 20240803
رمز التحديث: 20240804
DOI: 10.1016/j.oret.2024.02.012
PMID: 38428459
قاعدة البيانات: MEDLINE
الوصف
تدمد:2468-6530
DOI:10.1016/j.oret.2024.02.012