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

Abstract

Background: This subgroup analysis of the RE-ENACT study evaluates the effectiveness of Razumab® (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® 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 μm) to week 4 (431.84 ± 10.92 μm; p = 0.0028), week 8 (339.28 ± 8.12 μm; p < 0.0001), and week 12 (298.23 ± 6.68 μm; 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® (biosimilar of ranibizumab) effectively improved visual acuity and disease outcomes in patients with RVO in a real-world setting with no new safety concerns.

A Multicenter, Retrospective Study (RE-ENACT 2) on the Use of Razumab™ (World’s First Biosimilar Ranibizumab) in Wet Age-Related Macular Degeneration

“…Razumab, the world's first biosimilar ranibizumab, has shown effectiveness for various vitreoretinal disorders in both prospective [18] and retrospective real-world studies [19]. The RE-ENACT (n = 561) study, a multicenter, retrospective study, strengthened the effectiveness of biosimilar ranibizumab in vitreoretinal disorders in Indian patients in routine clinical settings.…”

“…A previous retrospective, multicenter, observational study, REal life assessmENt of safety And effeCTiveness of Razumab (RE-ENACT), established the use of biosimilar ranibizumab for the treatment of retinal disorders in a realworld clinical setting [19][20][21]. The RE-ENACT 2 study generated long-term data on the use of biosimilar ranibizumab.…”

Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study

“…Further, with over 5.5 million patient-treatment years of exposure [13] the efficacy and safety of ranibziumab is well-established across all approved indications [14][15][16][17]. However, real-world studies with ranibizumab in BRVO patients are mostly limited to either specific regions, countries or small patient populations [18][19][20][21][22]. Further, real-world evidence data coming from a more heterogenous patient population will help gain better insights on treatment patterns, outcomes, access to treatment, and management of BRVO patients with ranibizumab.…”

Therapeutic effect of Ranibizumab combined with Triamcinolone Acetonide on wet age-related macular degeneration and its effect on interleukin

“…It can inactivate VEGF by inhibiting the mitosis of endothelial cells, and it is a commonly-used anti-VEGF drug in the aspect of ophthalmology. [11] Triamcinolone acetonide is a clinical anti-inflammatory drug which is commonly used to reduce vascular permeability and inhibit angiogenesis. The intravitreal injection of triamcinolone acetonide can make the effect last 2-3 weeks.…”