Research Article
Shashikant Sharma, RE-ENACT
Abstract
Objective: The effectiveness of RazumabTM (world’s first biosimilar ranibizumab) in macular disorders wasestablished in the RE-ENACT study. The current RE-ENACT 2 study was conducted to evaluate the effectiveness ofbiosimilar ranibizumab in macular disorders for a longer-term.Methods: RE-ENACT 2 was a multicenter, retrospective data collection study. Data were collected from themedical records of adult patients who received biosimilar ranibizumab injections between July 2015 and February2019 at multiple centers (17 centers) across India. The study comprised both the previously treated and treatmentnaive patients. Data were analyzed for improvements in: best corrected visual acuity (BCVA), central subfieldthickness (CSFT), intraocular pressure (IOP), and proportions of patients having intraretinal fluid (IRF), subretinalfluid (SRF) from baseline at Weeks 4, 8, 12, 16, 20, 24, 30, 36 and 48.Results: A total of 341 patients were included in this study. Majority of the patients were also suffering fromhypertension (58.1%) and diabetes (15.8%). The disease indications comprised wet age-related maculardegeneration (wet AMD, 30.2%, n=103), retinal vein occlusion (RVO, 29.6%, n=101), diabetic macular edema(DME, 30.2%, n=103) and myopic choroidal neovascularization (mCNV, 10%, n=34). Majority of the patients weremen (60.1%) and were treatment naïve (73.6%); majority (59.2%) of the patients had received 3 (range 1-5)biosimilar ranibizumab injections. From baseline to all timepoints, significant improvements (P<0.001) wereobserved for BCVA (baseline: 0.89 ± 0.6; Week 48: 0.43 ± 0.3) and CSFT (baseline: 467.09 ± 159.6; Week 48:296.56 ± 49.7). Minimal changes in IOP, though not significant, were observed (baseline: 14.92 ± 3.4; Week 48:13.89 ± 2.2; P=0.4307). A decrease in proportions of patients having IRF and SRF was also observed. There wereno new safety concerns reported.Conclusion: The RE-ENACT 2 study further strengthens the data of biosimilar ranibizumab with improvements invisual acuity and disease outcomes observed for a longer follow-up duration up to 48 weeks in patients with wetage-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidalneovascularization without any new safety issues.