Long-term efficacy and safety of RazumabTM (biosimilar ranibizumab) in Indian patients with retinal diseases: results from retrospective REAR RD-2 study

Shashikant Sharma, Alok Chaturvedi, Nilanj Dave, Ankita Shah

Abstract

Background: To evaluate risk factors associated with retinal diseases and efficacy and safety of RazumabTM (biosimilar ranibizumab) in the management of retinal diseases in Indian patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).

Methods: In the retrospective, observational REAR RD-2 study, all patients with retinal diseases who were treated with biosimilar ranibizumab were included from multiple Indian sites. The demographic parameters, disease characteristics and treatment details were recorded. Efficacy assessments included improvement in best corrected visual acuity (BCVA), and decrease in central subfield thickness (CSFT), intra-retinal fluid (IRF) and sub-retinal fluid (SRF) from baseline to week 48.

Results: Data of 1422 patients (wet AMD-27.57%; DME-30.7%, RVO-33.47%; mCNV-5.48%), who were treated with biosimilar ranibizumab, was analyzed. The most common age group of patients was 61-70 years (36.6%). The most common ocular risk factor identified was glaucoma (24.90%). A total of 85.72% patients were treatment naïve and 14.28% were previously treated patients. Biosimilar ranibizumab treatment resulted in significant (p<0.05) improvements in the mean BCVA and CSFT, and the proportion of patients with IRF and SRF was significantly reduced throughout the treatment. No new safety concerns with biosimilar ranibizumab were observed.

Conclusions: Retinal diseases are more common in the age group of 61-70 years. Glaucoma was the most common ocular risk factor identified for retinal diseases. Long-term treatment with biosimilar ranibizumab was effective and well-tolerated in retinal diseases including wAMD, DME, RVO and mCNV in real-world Indian scenario. 

 

Keywords

Wet AMD, DME, RVO, mCNV

Full Text:

PDF

References

Danyliv A, Glanville J, McCool R, Ferreira A, Skelly A, Jacob RP. The Clinical Effectiveness of Ranibizumab Treat and Extend Regimen in nAMD: Systematic Review and Network Meta-Analysis. Adv Ther. 2017;34:611-9.

Daien V, Eldem BM, Talks JS, Korobelnik J-F, Mitchell P, Finger RP, et al. Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy–a systematic approach to identify and characterize data sources. BMC Ophthalmol. 2019;19:1-12.

Keane PA, Sadda SR. Development of Anti-VEGF Therapies for Intraocular Use: A Guide for Clinicians. J Ophthalmol. 2012;2012:483034.

García-Layana A, Figueroa MS, Arias L, Araiz J, Ruiz-Moreno JM, García-Arumí J, et al. Individualized therapy with ranibizumab in wet age-related macular degeneration. J Ophthalmol. 2015;2015.

Kim R. Introduction, mechanism of action and rationale for anti-vascular endothelial growth factor drugs in age-related macular degeneration. Indian J Ophthalmol. 2007;55:413-5.

Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. N Eng J Medic. 2006;355:1419-31.

Dervenis N, Mikropoulou AM, Tranos P, Dervenis P. Ranibizumab in the Treatment of Diabetic Macular Edema: A Review of the Current Status, Unmet Needs, and Emerging Challenges. Adv Ther. 2017;34:1270-82.

Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, et al. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010;117:1124-33.

Hu Q, Li H, Du Y, He J. Comparison of intravitreal bevacizumab and ranibizumab used for myopic choroidal neovascularization: A PRISMA-compliant systematic review and meta-analysis of randomized controlled trials. Medicine. 2019;98:e14905.

Sameera VV, Ayachit A, Joshi S, Guruprasad AS. Safety and efficacy of Razumab – The new biosimilar in India: Our experience. Kerala J Ophthalmol. 2016;28:180.

Raina SK, Razdan S, Nanda R. Prevalence of neurological disorders in children less than 10 years of age in RS Pura town of Jammu and Kashmir. J Pediatr Neurosci. 2011;6:103.

CADTH, Treating Retinal Diseases in the Era of Anti-VEGF Therapies. A Position Paper Regarding the CADTH Therapeutic Review. Anti-Vascular Endothelial Growth Factor Drugs for the Treatment of Retinal Conditions. Recommendations Rep. 2016;2016.

Siddiqui PA, Warkhede P. Role of Ranibizumab in various retinal disorders. 2017;16:142-7.

Bolz M, Simader C, Ritter M, Ahlers C, Benesch T, Prünte C, et al. Morphological and functional analysis of the loading regimen with intravitreal ranibizumab in neovascular age-related macular degeneration. Br J Ophthalmol. 2010;94:185-9.

Ercalik NY, Imamoglu S, Kumral ET, Yenerel NM, Bardak H, Bardak Y. Influence of the epiretinal membrane on ranibizumab therapy outcomes in patients with diabetic macular edema. Arq Bras Oftalmol. 2016;79:373-5.

LUCENTIS® (ranibizumab injection) for intravitreal injection. Prescribing Information. Genentech, Inc. Revised 03, 2018.

Alexandru MR, Alexandra NM. Wet age related macular degeneration management and follow-up. Romanian J Ophthalmol. 2016;60:9.

Topal T, Kar T, Yıldırım Y, Sercan KS, Büyükavşar C, Kaya A, et al. Evaluation of aflibercept treatment responses in eyes with bevacizumab/ranibizumab-resistant wet age-related macular degeneration.Turk Oftalmoloji Dergisi. 2017;47:133.

Friedman DS, O’Colmain BJ, Munoz B, Tomany SC, McCarty C, De Jong P, et al. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004;122:564-72.

Thapa R, Bajimaya S, Paudyal G, Khanal S, Tan S, Thapa SS, et al. Prevalence of and risk factors for age-related macular degeneration in Nepal: the Bhaktapur retina study. Clin Ophthalmol (Auckland, NZ). 2017;11:963.

Azad R, Vivek K, Sharma Y, Chandra P, Sain S, Venkataraman A. Ranibizumab as an adjunct to laser for macular edema secondary to branch retinal vein occlusion. Indian J Ophthalmol. 2012;60:263.

Rehak J, Rehak M. Branch retinal vein occlusion: pathogenesis, visual prognosis, and treatment modalities. Curr Eye Res. 2008;33:111-31.

Ciulla TA, Amador AG, Zinman B. Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies. Diabetes Care. 2003;26:2653-64.

Willis JR, Vitale S, Morse L, Parke II DW, Rich WL, Lum F, et al. The prevalence of myopic choroidal neovascularization in the United States: analysis of the IRIS® data registry and NHANES. Ophthalmology. 2016;123:1771-82.

Ohno-Matsui K, Ikuno Y, Lai TY, Cheung CMG. Diagnosis and treatment guideline for myopic choroidal neovascularization due to pathologic myopia. Prog Retin Eye Res. 2018;63:92-106.

Thapa R, Khanal S, Tan HS, Thapa SS, van Rens G. Prevalence, Pattern and Risk Factors of Retinal Diseases Among an Elderly Population in Nepal: The Bhaktapur Retina Study. Clin Ophthalmol. 2020;14:2109-18.

Abdelfattah NS, Zhang H, Boyer DS, Rosenfeld PJ, Feuer WJ, Gregori G, et al. Drusen Volume as a Predictor of Disease Progression in Patients With Late Age-Related Macular Degeneration in the Fellow Eye. Invest Ophthalmol Vis Sci. 2016;57:1839-46.

Boyer DS, Hopkins JJ, Sorof J, Ehrlich JS. Anti-vascular endothelial growth factor therapy for diabetic macular edema. Ther Adv Endocrinol Metab. 2013;4:151-69.

Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006;355:1432-1444.

Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for Neovascular Age-Related Macular Degeneration. N Engl J Med. 2006;355:1419-31.

Cha DM, Kim TW, Heo JW, Woo SJ, Park KH, Yu HG, et al. Comparison of 1-year therapeutic effect of ranibizumab and bevacizumab for myopic choroidal neovascularization: a retrospective, multicenter, comparative study. BMC Ophthalmol. 2014;14:69.

Intas Pharmaceuticals Limited. Intas Launches RAZUMAB, Globally the First Biosimilar to Lucentis® (Ranibizumab). 2015. Available at: https://www.prnewswire.com/in/news-releases/intas-launches-razumab-globally-the-first-biosimilar-to-lucentis-ranibizumab-508383021.html. Accessed on 25th June 2022.

Sharma S, Sharma T, Prasad S, Gopalakrishnan M, Chaturvedi A. Treatment Landscape of Macular Disorders in Indian Patients with the Advent of Razumab™ (World's First Biosimilar Ranibizumab): A Comprehensive Review. Ophthalmol Ther. 2021;10:431-43.

Sharma S, Khan M, Chaturvedi A. A multicenter, retrospective study (RE-ENACT 2) on the use of Razumab™ (world’s first biosimilar ranibizumab) in wet age-related macular degeneration. Ophthalmol Therapy. 2020;9:103-14.

Verma L, Thulasidas M, Purohit A, Gupta A, Narula R, Talwar D. Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab. Indian J Ophthalmol. 2021;69:347.

Chakraborty D, Stewart MW, Sheth JU, Sinha TK, Boral S, Das A, et al. Real-World Safety Outcomes of Intravitreal Ranibizumab Biosimilar (Razumab) Therapy for Chorioretinal Diseases. Ophthalmol Ther. 2021;10:337-48.