Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial
- Abstract
- Importance: Neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older. The availability of a ranibizumab biosimilar product (SB11) may facilitate access to an effective alternative to this treatment.
Objective: To demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11 compared with the reference ranibizumab.
Design, setting, and participants: This randomized, double-masked, parallel-group phase 3 equivalence study was conducted in 75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. Analysis was performed on an intent-to-treat basis.
Interventions: Intravitreous injection of SB11 or ranibizumab, 0.5 mg, every 4 weeks through week 48.
Main outcomes and measures: Preplanned interim analysis after all participants completed the week 24 assessment of primary efficacy end points at week 8 for change from baseline in best-corrected visual acuity (BCVA) and week 4 for central subfield thickness (CST), with predefined equivalence margins for adjusted treatment differences of -3 letters to 3 letters for BCVA and -36 μm to 36 μm for CST.
Results: Baseline and disease characteristics among 705 randomized participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years) were comparable between treatment groups (SB11, 351; ranibizumab, 354). Least-squares mean (SE) changes in BCVA from baseline at week 8 were 6.2 (0.5) letters in the SB11 group vs 7.0 (0.5) letters in the ranibizumab group, with an adjusted treatment difference of -0.8 letter (90% CI, -1.8 to 0.2 letters). Least-squares mean (SE) changes in CST from baseline at week 4 were -108 (5) μm in the SB11 group vs -100 (5) μm in the ranibizumab group, with an adjusted treatment difference of -8 μm (95% CI, -19 to 3 μm). Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups. Immunogenicity was low, with a cumulative incidence of antidrug antibodies up to week 24 of 3.0% (10 of 330) in the SB11 group and 3.1% (10 of 327) in the ranibizumab group.
Conclusions and relevance: These findings of equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab support the use of SB11 for patients with neovascular age-related macular degeneration.
- Author(s)
- 우세준; 윤영희; Andras Papp; Attila Vajas; Dominik Zalewski; Donghoon Shin; James Luu; Jan Ernest; Jan Hamouz; Jan Studni?ka; Miroslav Veith; Neil M. Bressler; Taehyung Kim; Tamas Pregun; Veronika Matuskova; Vogt Gabor
- Issued Date
- 2021
- Type
- Article
- Keyword
- Aged; Aged; 80 and over; Angiogenesis Inhibitors / adverse effects; Angiogenesis Inhibitors / pharmacokinetics; Angiogenesis Inhibitors / therapeutic use*; Biosimilar Pharmaceuticals / adverse effects; Biosimilar Pharmaceuticals / pharmacokinetics; Biosimilar Pharmaceuticals / therapeutic use*; Choroidal Neovascularization / diagnosis; Choroidal Neovascularization / drug therapy*; Choroidal Neovascularization / physiopathology; Double-Blind Method; Female; HumansIntravitreal Injections; Macular Degeneration / diagnosis; Macular Degeneration / drug therapy*; Macular Degeneration / physiopathology; Male
Middle Aged; Ranibizumab / adverse effects; Ranibizumab / pharmacokinetics; Ranibizumab / therapeutic use*; Recovery of Function; Therapeutic Equivalency; Time Factors; Treatment Outcome; Vascular Endothelial Growth Factor A / antagonists & inhibitors*; Vision; Ocular / drug effects*
- DOI
- 10.1001/jamaophthalmol.2020.5053
- URI
- https://oak.ulsan.ac.kr/handle/2021.oak/7665
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_pubmed_primary_33211076&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Efficacy%20and%20Safety%20of%20a%20Proposed%20Ranibizumab%20Biosimilar%20Product%20vs%20a%20Reference%20Ranibizumab%20Product%20for%20Patients%20With%20Neovascular%20Age-Related%20Macular%20Degeneration:%20A%20Randomized%20Clinical%20Trial&offset=0&pcAvailability=true
- Publisher
- JAMA Ophthalmology
- Location
- 미국
- Language
- 한국어
- ISSN
- 2168-6165
- Citation Volume
- 139
- Citation Number
- 1
- Citation Start Page
- 68
- Citation End Page
- 76
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