Real-Life Clinical Effectiveness of Razumab (R) (the World's First Biosimilar of Ranibizumab) in Retinal Vein Occlusion: A Subgroup Analysis of the Pooled Retrospective RE-ENACT Study

摘要

Background: This subgroup analysis of the RE-ENACT study evaluates the effectiveness of Razumab (R) (the world's first biosimilar of ranibizumab by Intas Pharmaceuticals Ltd.) in Indian patients with retinal vein occlusion (RVO). Methods: The data on patients with RVO who had received = 3 injections of Razumab (R) between January and August 2016 were analyzed. Endpoints were: improvement in best corrected visual acuity (BCVA), and a decrease in central macular thickness (CMT), intraretinal fluid (IRF), and subretinal fluid (SRF) from baseline at weeks 4, 8, and 12. Results: Of 160 patients, the majority (61.87%) were men. The mean (+/- SE) BCVA improved from baseline (0.76 +/- 0.04) to week 4 (0.73 +/- 0.03; p = 0.0656), which attained significance at week 8 (0.55 +/- 0.02; p 0.0001) and week 12 (0.47 +/- 0.02; p 0.0001). The mean (+/- SE) CMT significantly decreased from baseline (447.60 +/- 10.91 mu m) to week 4 (431.84 +/- 10.92 mu m; p = 0.0028), week 8 (339.28 +/- 8.12 mu m; p 0.0001), and week 12 (298.23 +/- 6.68 mu m; p 0.0001). The proportion of patients with IRF and SRF significantly (p 0.0001) decreased from baseline to weeks 4, 8, and 12 (IRF: from 70.63 to 45.63, 39.38, and 30.00%, respectively; SRF: from 65.63 to 37.50, 28.13, and 24.38%, respectively). A subgroup analysis of branch RVO and central RVO showed similar results. No new safety concerns were observed. Conclusion: Razumab (R) (biosimilar of ranibizumab) effectively improved visual acuity and disease outcomes in patients with RVO in a real-world setting with no new safety concerns. (C) 2018 The Author(s) Published by S. Karger AG, Basel.