Real-life clinical effectiveness of Razumab in retinal vein occlusion

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Real-life clinical effectiveness of Razumab in retinal vein occlusion

Biosimilars/Research | Posted 02/11/2018 0 Post your comment

Authors from Intas Pharmaceuticals presented data from a subgroup analysis of the RE-ENACT study (retrospective, multicentre, observational pooled study on wet age-related macular degeneration [wet AMD], diabetic macular oedema, and retinal vein occlusion) [1]. The RE-ENACT study evaluated the effectiveness of the ranibizumab similar biologic Razumab in Indian patients with retinal vein occlusion (RVO).

Data of patients with RVO, who were treated with three or more injections of Razumab between January and August 2016, were included and analysed. Study endpoints were improvement in best corrected visual acuity (BCVA, measured by LogMAR/Snellen’s chart), decrease in central macular thickness (CMT, measured by Spectral Domain Optical Coherence Tomography), intra-retinal fluid (IRF) and sub-retinal fluid (SRF) from baseline at Weeks 4, 8 and 12.

Medical charts of 160 RVO patients were analysed; 99 (61.87%) were men, 61 (38.13%) were women. Mean ±SE BCVA improved from baseline (0.76±0.04) at Week 4 (0.73±0.03; p = 0.0656) and attained significance at Week 8 (0.55±0.02; p < 0.0001) and 12 (0.47±0.02; p < 0.0001) for both time points); mean ±SE CMT significantly decreased from baseline (447.60±10.91 μm) to Week 4 (431.84±10.92 μm; p = 0.0028), 8 (339.28±8.12 μm; p < 0.0001) and 12 (298.23±6.68 μm; p < 0.0001). Proportion of patients with IRF and SRF significantly (p < 0.0001) decreased from baseline to Week 4, 8 and 12 (70.63% vs 45.63%, 39.38% and 30.00%, respectively for IRF; and 65.63% vs 37.50%, 28.13%, 24.38%, respectively for SRF). In addition, the subgroup analysis of patients with branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) also demonstrated the same results. No new safety concerns with biosimilar ranibizumab were observed.

The authors therefore concluded that Razumab showed effective improvement in the visual acuity and disease outcomes with no new safety concerns in patients with RVO in the real-world setting.

Conflict of interest
The authors of the research paper [1] S Sharma, MA Khan, A Chaturvedi are employees of Intas Pharmaceuticals.

Abstracted by Shashikant Sharma, Intas Pharmaceuticals Ltd, Ahmedabad, India.

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Reference
1. Sharma S, Khan MA, Chaturvedi A; RE-ENACT Study Investigators Group. Real-life clinical effectiveness of Razumab® (the World's first biosimilar of Ranibizumab) in retinal vein occlusion: a subgroup analysis of the pooled retrospective RE-ENACT Study. Ophthalmologica 2018:1-8. doi:10.1159/000488602. [Epub ahead of print]

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