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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
SJ. Woo, M. Veith, J. Hamouz, J. Ernest, D. Zalewski, J. Studnicka, A. Vajas, A. Papp, V. Gabor, J. Luu, V. Matuskova, YH. Yoon, T. Pregun, T. Kim, D. Shin, NM. Bressler
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, hodnocení ekvivalence, časopisecké články, multicentrická studie, práce podpořená grantem
- MeSH
- biosimilární léčivé přípravky škodlivé účinky farmakokinetika terapeutické užití MeSH
- časové faktory MeSH
- dvojitá slepá metoda MeSH
- inhibitory angiogeneze škodlivé účinky farmakokinetika terapeutické užití MeSH
- injekce intravitreální MeSH
- lidé středního věku MeSH
- lidé MeSH
- makulární degenerace diagnóza farmakoterapie patofyziologie MeSH
- neovaskularizace choroidey diagnóza farmakoterapie patofyziologie MeSH
- obnova funkce MeSH
- ranibizumab škodlivé účinky farmakokinetika terapeutické užití MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- terapeutická ekvivalence MeSH
- vaskulární endoteliální růstový faktor A antagonisté a inhibitory MeSH
- výsledek terapie MeSH
- zrak účinky léků MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- hodnocení ekvivalence MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- srovnávací studie MeSH
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. Trial Registration: ClinicalTrials.gov Identifier: NCT03150589.
Department of Ophthalmology 3rd Faculty of Medicine Charles University Prague Prague Czech Republic
Department of Ophthalmology Asan Medical Center University of Ulsan College of Medicine Seoul Korea
Department of Ophthalmology Bajcsy Zsilinszky Hospital Budapest Hungary
Department of Ophthalmology Central Military Hospital Prague Czech Republic
Department of Ophthalmology Medical Centre Hungarian Defence Forces Budapest Hungary
Department of Ophthalmology Semmelweis University Budapest Hungary
Department of Ophthalmology University Hospital Brno Brno Czech Republic
Department of Ophthalmology University Hospital Hradec Kralove Hradec Kralove Czech Republic
Department of Ophthalmology University Hospital Kralovske Vinohrady Prague Czech Republic
Department of Ophthalmology University of Debrecen Debrecen Hungary
Diagnostic and Microsurgery Center of the Eye LENS Olsztyn Poland
Faculty of Medicine Masaryk University Brno Czech Republic
Medical Team Samsung Bioepis Incheon Korea
Retina Consultants of Southern Colorado Colorado Springs
Wilmer Eye Institute Johns Hopkins University School of Medicine Baltimore Maryland
Citace poskytuje Crossref.org
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- $a 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. Trial Registration: ClinicalTrials.gov Identifier: NCT03150589.
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