Biosimilar Ranibizumab Effective in Treating RVO in a Real-World Setting

Retinal vein occlusion (RVO) is a common cause of vision loss, and it can be treated with anti—vascular endothelial growth factor therapies such as ranibizumab (Lucentis).

While no biosimilars of ranibizumab are yet approved in the highly regulated territories of the United States or the European Union, in India, Razumab, manufactured by Intas Pharmaceuticals, was approved as a similar biologic in 2015; the retrospective study RE-ENACT collected data and analyzed the effectiveness of this biosimilar product in the real-world setting in patients with age-related macular degeneration, diabetic macular edema, and RVO. In a newly published subset analysis of the 160 patients with RVO who were enrolled in RE-ENACT, researchers found that the biosimilar effectively improved visual acuity and disease outcomes in the real-world setting.

The patients, all 18 years or older, received at least 3 ranibizumab injections between January 2016 and August 2016 as part of their routine care for RVO. The primary endpoints of the study were mean change in best corrected visual acuity (BCVA), mean change in central macular thickness (CMT), and the proportion of patients showing intraretinal or subretinal fluid.

The researchers found the following:

• BCVA, measured by the logMAR chart, improved from a baseline of 0.76 (±0.04) to 0.73 (±0.03) at week 4 after ranibizumab injection (P = .0656), and further improved to 0.55 (±0.02) at week 8 (P <.0001).
• CMT improved from a mean pretreatment measurement of 447.60 μm (±10.91 μm) to 431.84 μm (±10.92 μm) at week 4 (P = .0028). Similar improvements were observed at week 8 (339.28 μm, ±8.12 μm) and week 12 (298.23 μm, ±6.68 μm).
• The percentage of patients who had intraretinal fluid decreased from 70.63% at baseline to 45.63% at week 4, 39.38% at week 8, and 30.00% at week 12. Similarly, the percentage of patients with subretinal fluid decreased from 64.63% at baseline to 37.50% at week 4, 28.13% at week 8, and 24.38% at week 12.
• Improvements across all 3 study endpoints were present in the entire study population, and these improvements were similar in patients with branch RVO and central RVO.
• While the RE-ENACT study did not capture complete information on adverse events in patients’ medical records, overall, say the study’s authors, no new safety concerns were observed relative to the originator ranibizumab. (The patient data included in the study are from the period after Intas revised its manufacturing process for the biosimilar; early in the production of Razumb, manufacturing issues related to the drug reportedly caused ocular inflammation in approximately 10% of patients treated with the injected product.)

“The current subgroup analysis of patients with RVO showed that intravitreal injection of Razumab…is effective in reducing macular thickness and improving visual acuity in the real-world setting,” conclude the authors.

Reference

Sharma S, Khan MA, Chaturvedi A. 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;26:1-8. doi: 10.1159/000488602.