Cargando…

Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab

PURPOSE: The aim of this study was to evaluate the efficacy and safety of Razumab (the biosimilar Ranibizumab by Intas Pharmaceuticals Ltd.) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), choroidal neovascular membrane (CNVM), and macular edema secondary t...

Descripción completa

Detalles Bibliográficos
Autores principales: Verma, Lalit, Thulasidas, Mithun, Purohit, Ajay, Gupta, Avnindra, Narula, Ritesh, Talwar, Dinesh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7933889/
https://www.ncbi.nlm.nih.gov/pubmed/33463589
http://dx.doi.org/10.4103/ijo.IJO_2516_20
_version_ 1783660711778451456
author Verma, Lalit
Thulasidas, Mithun
Purohit, Ajay
Gupta, Avnindra
Narula, Ritesh
Talwar, Dinesh
author_facet Verma, Lalit
Thulasidas, Mithun
Purohit, Ajay
Gupta, Avnindra
Narula, Ritesh
Talwar, Dinesh
author_sort Verma, Lalit
collection PubMed
description PURPOSE: The aim of this study was to evaluate the efficacy and safety of Razumab (the biosimilar Ranibizumab by Intas Pharmaceuticals Ltd.) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), choroidal neovascular membrane (CNVM), and macular edema secondary to retinal vein occlusion (RVO). METHODS: We conducted a single-center, retrospective study, including patients with DME, CNVM, and RVO, who had received treatment with Razumab® between October 2018 and September 2019. Primary outcome measures were the changes in corrected distance visual acuity (CDVA) and central foveal thickness (CFT) from baseline to 1 month and 3 months. Secondary outcome measures included intraocular pressure (IOP) at day 1, any signs of ocular inflammation or systemic adverse events during the follow-up. RESULTS: One hundred and fifty-three eyes of 141 patients were analyzed. The indications included DME in 70 (45.8%) eyes, CNVM in 70 (45.8%) eyes, and RVO in 13 (8.4%) eyes. Mean CDVA improved from baseline (0.62 ± 0.44) to month 1 (0.45 ± 0.42) and maintained till 3 months (0.42 ± 0.44; P < 0.001). Mean CFT showed significant reduction from baseline (405.68 ± 192.422 μm) to month 1 (286.08 ± 118.36 μm) and month 3 (271 ± 104.24 μm; P < 0.001). None of the eyes recorded IOP >20 mmHg on day 1. No evidence of ocular toxicity or systemic adverse event was noted. CONCLUSION: Razumab® showed a rapid improvement in CDVA and CFT in most of the eyes with efficacy observed as early as 1 month and maintained till 3 months. The biosimilar Ranibizumab can be a safe and effective low-cost drug for treating macular diseases.
format Online
Article
Text
id pubmed-7933889
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Wolters Kluwer - Medknow
record_format MEDLINE/PubMed
spelling pubmed-79338892021-03-08 Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab Verma, Lalit Thulasidas, Mithun Purohit, Ajay Gupta, Avnindra Narula, Ritesh Talwar, Dinesh Indian J Ophthalmol Special Focus on Anti-VEGF, Original Article PURPOSE: The aim of this study was to evaluate the efficacy and safety of Razumab (the biosimilar Ranibizumab by Intas Pharmaceuticals Ltd.) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), choroidal neovascular membrane (CNVM), and macular edema secondary to retinal vein occlusion (RVO). METHODS: We conducted a single-center, retrospective study, including patients with DME, CNVM, and RVO, who had received treatment with Razumab® between October 2018 and September 2019. Primary outcome measures were the changes in corrected distance visual acuity (CDVA) and central foveal thickness (CFT) from baseline to 1 month and 3 months. Secondary outcome measures included intraocular pressure (IOP) at day 1, any signs of ocular inflammation or systemic adverse events during the follow-up. RESULTS: One hundred and fifty-three eyes of 141 patients were analyzed. The indications included DME in 70 (45.8%) eyes, CNVM in 70 (45.8%) eyes, and RVO in 13 (8.4%) eyes. Mean CDVA improved from baseline (0.62 ± 0.44) to month 1 (0.45 ± 0.42) and maintained till 3 months (0.42 ± 0.44; P < 0.001). Mean CFT showed significant reduction from baseline (405.68 ± 192.422 μm) to month 1 (286.08 ± 118.36 μm) and month 3 (271 ± 104.24 μm; P < 0.001). None of the eyes recorded IOP >20 mmHg on day 1. No evidence of ocular toxicity or systemic adverse event was noted. CONCLUSION: Razumab® showed a rapid improvement in CDVA and CFT in most of the eyes with efficacy observed as early as 1 month and maintained till 3 months. The biosimilar Ranibizumab can be a safe and effective low-cost drug for treating macular diseases. Wolters Kluwer - Medknow 2021-02 2021-01-18 /pmc/articles/PMC7933889/ /pubmed/33463589 http://dx.doi.org/10.4103/ijo.IJO_2516_20 Text en Copyright: © 2021 Indian Journal of Ophthalmology http://creativecommons.org/licenses/by-nc-sa/4.0 This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Special Focus on Anti-VEGF, Original Article
Verma, Lalit
Thulasidas, Mithun
Purohit, Ajay
Gupta, Avnindra
Narula, Ritesh
Talwar, Dinesh
Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab
title Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab
title_full Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab
title_fullStr Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab
title_full_unstemmed Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab
title_short Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab
title_sort clinical efficacy and safety of razumab® (cesar) study: our experience with the world's first biosimilar ranibizumab
topic Special Focus on Anti-VEGF, Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7933889/
https://www.ncbi.nlm.nih.gov/pubmed/33463589
http://dx.doi.org/10.4103/ijo.IJO_2516_20
work_keys_str_mv AT vermalalit clinicalefficacyandsafetyofrazumabcesarstudyourexperiencewiththeworldsfirstbiosimilarranibizumab
AT thulasidasmithun clinicalefficacyandsafetyofrazumabcesarstudyourexperiencewiththeworldsfirstbiosimilarranibizumab
AT purohitajay clinicalefficacyandsafetyofrazumabcesarstudyourexperiencewiththeworldsfirstbiosimilarranibizumab
AT guptaavnindra clinicalefficacyandsafetyofrazumabcesarstudyourexperiencewiththeworldsfirstbiosimilarranibizumab
AT narularitesh clinicalefficacyandsafetyofrazumabcesarstudyourexperiencewiththeworldsfirstbiosimilarranibizumab
AT talwardinesh clinicalefficacyandsafetyofrazumabcesarstudyourexperiencewiththeworldsfirstbiosimilarranibizumab