A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion
Abstract Purpose The REal life assessmENt of safety And effeCTiveness of Razumab 2 (RE-ENACT 2) study evaluated the long-term effectiveness of biosimilar ranibizumab. We present the subgroup analysis of patients with retinal vein occlusion (RVO). Methods Data of patients who received pro re nata (PR...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2020-07-01
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| Series: | Ophthalmology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40123-020-00277-3 |
| _version_ | 1818574686992203776 |
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| author | Shashikant Sharma RE-ENACT 2 Study Investigators Group Mujtaba Khan Alok Chaturvedi |
| author_facet | Shashikant Sharma RE-ENACT 2 Study Investigators Group Mujtaba Khan Alok Chaturvedi |
| author_sort | Shashikant Sharma |
| collection | DOAJ |
| description | Abstract Purpose The REal life assessmENt of safety And effeCTiveness of Razumab 2 (RE-ENACT 2) study evaluated the long-term effectiveness of biosimilar ranibizumab. We present the subgroup analysis of patients with retinal vein occlusion (RVO). Methods Data of patients who received pro re nata (PRN) biosimilar ranibizumab (November 2015 to December 2018, 17 centers) were analyzed. Endpoints were change from baseline in best corrected visual acuity (BCVA, Snellen’s/logMAR), central subfield thickness (CSFT), intraocular pressure (IOP), and proportions of patients having intraretinal fluid (IRF) and subretinal fluid (SRF) at weeks 4, 8, 12, 16, 20, 24, 30, 36, and 48. Results Of 101 patients, 48.51% were men, and the majority (79.21%) were treatment naïve and had received 3 (range 1–5) injections (53.5%). Significant improvements (P < 0.05) were observed from baseline to all timepoints for BCVA [baseline, 0.89 ± 0.06 (n = 94); week 48, 0.41 ± 0.08 (n = 14)] and CSFT [baseline, 527.58 ± 19.9 (n = 85); week 48, 307.47 ± 16.4 (n = 15)]. Changes in IOP (mmHg) were non-significant [baseline, 15.38 ± 0.4 (n = 94); week 48, 13.94 ± 0.6 (n = 16); P = 0.5575). Proportions of patients having IRF [baseline, 71.3% (n = 84) vs week 48, 0% (n = 15)] and SRF [baseline, 52.5% (n = 83) vs week 48, 0% (n = 15)] were decreased. Similar results for BCVA, CSFT, IOP, IRF, and SRF were observed for BRVO and CRVO subgroups. There were no new safety concerns. Conclusions Biosimilar ranibizumab demonstrated improvements in visual acuity and disease outcomes up to 48 weeks in patients with RVO without any new safety concerns. |
| first_indexed | 2024-12-15T00:29:51Z |
| format | Article |
| id | doaj.art-b1682f44c5e64863837e5a1858953581 |
| institution | Directory Open Access Journal |
| issn | 2193-8245 2193-6528 |
| language | English |
| last_indexed | 2024-12-15T00:29:51Z |
| publishDate | 2020-07-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Ophthalmology and Therapy |
| spelling | doaj.art-b1682f44c5e64863837e5a18589535812022-12-21T22:42:03ZengAdis, Springer HealthcareOphthalmology and Therapy2193-82452193-65282020-07-019362563910.1007/s40123-020-00277-3A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein OcclusionShashikant Sharma0RE-ENACT 2 Study Investigators GroupMujtaba Khan1Alok Chaturvedi2Medical Services, Intas Pharmaceuticals Ltd.Medical Services, Intas Pharmaceuticals Ltd.Medical Services, Intas Pharmaceuticals Ltd.Abstract Purpose The REal life assessmENt of safety And effeCTiveness of Razumab 2 (RE-ENACT 2) study evaluated the long-term effectiveness of biosimilar ranibizumab. We present the subgroup analysis of patients with retinal vein occlusion (RVO). Methods Data of patients who received pro re nata (PRN) biosimilar ranibizumab (November 2015 to December 2018, 17 centers) were analyzed. Endpoints were change from baseline in best corrected visual acuity (BCVA, Snellen’s/logMAR), central subfield thickness (CSFT), intraocular pressure (IOP), and proportions of patients having intraretinal fluid (IRF) and subretinal fluid (SRF) at weeks 4, 8, 12, 16, 20, 24, 30, 36, and 48. Results Of 101 patients, 48.51% were men, and the majority (79.21%) were treatment naïve and had received 3 (range 1–5) injections (53.5%). Significant improvements (P < 0.05) were observed from baseline to all timepoints for BCVA [baseline, 0.89 ± 0.06 (n = 94); week 48, 0.41 ± 0.08 (n = 14)] and CSFT [baseline, 527.58 ± 19.9 (n = 85); week 48, 307.47 ± 16.4 (n = 15)]. Changes in IOP (mmHg) were non-significant [baseline, 15.38 ± 0.4 (n = 94); week 48, 13.94 ± 0.6 (n = 16); P = 0.5575). Proportions of patients having IRF [baseline, 71.3% (n = 84) vs week 48, 0% (n = 15)] and SRF [baseline, 52.5% (n = 83) vs week 48, 0% (n = 15)] were decreased. Similar results for BCVA, CSFT, IOP, IRF, and SRF were observed for BRVO and CRVO subgroups. There were no new safety concerns. Conclusions Biosimilar ranibizumab demonstrated improvements in visual acuity and disease outcomes up to 48 weeks in patients with RVO without any new safety concerns.https://doi.org/10.1007/s40123-020-00277-3Anti-VEGFBiosimilar ranibizumabRazumabRetinal vein occlusionRVO |
| spellingShingle | Shashikant Sharma RE-ENACT 2 Study Investigators Group Mujtaba Khan Alok Chaturvedi A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion Ophthalmology and Therapy Anti-VEGF Biosimilar ranibizumab Razumab Retinal vein occlusion RVO |
| title | A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion |
| title_full | A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion |
| title_fullStr | A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion |
| title_full_unstemmed | A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion |
| title_short | A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion |
| title_sort | multicenter retrospective study re enact 2 on razumab™ world s first biosimilar ranibizumab in retinal vein occlusion |
| topic | Anti-VEGF Biosimilar ranibizumab Razumab Retinal vein occlusion RVO |
| url | https://doi.org/10.1007/s40123-020-00277-3 |
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