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Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes
NM. Bressler, M. Veith, J. Hamouz, J. Ernest, D. Zalewski, J. Studnička, A. Vajas, A. Papp, G. Vogt, J. Luu, V. Matuskova, YH. Yoon, T. Pregun, T. Kim, D. Shin, I. Oh, H. Jeong, MY. Kim, SJ. Woo
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu klinické zkoušky, fáze III, randomizované kontrolované studie, časopisecké články, práce podpořená grantem
NLK
ProQuest Central
od 1922-01-01 do Před 6 měsíci
Health & Medicine (ProQuest)
od 1922-01-01 do Před 6 měsíci
- MeSH
- biosimilární léčivé přípravky * terapeutické užití MeSH
- inhibitory angiogeneze terapeutické užití MeSH
- injekce intravitreální MeSH
- lidé středního věku MeSH
- lidé MeSH
- makulární degenerace * farmakoterapie MeSH
- ranibizumab terapeutické užití MeSH
- vaskulární endoteliální růstový faktor A MeSH
- vlhká makulární degenerace * diagnóza farmakoterapie MeSH
- výsledek terapie MeSH
- zraková ostrost MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND/AIMS: To provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD). METHODS: Setting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥50 years old participants with nAMD (n=705), one 'study eye'. INTERVENTION: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ. Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks. RESULTS: Baseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was -0.6 letters (90% CI -2.1 to 0.9) and of change from baseline in central subfield thickness was -14.9 μm (95% CI -25.3 to -4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively. CONCLUSIONS: Longer-term results of this study further support the biosimilarity established between SB11 and RBZ.
Department of Ophthalmology 3rd Faculty of Medicine Charles University Prague Czech Republic
Department of Ophthalmology Asan Medical Center Songpa gu Seoul South Korea
Department of Ophthalmology Bajcsy Zsilinszky Hospital and Clinic Budapest Hungary
Department of Ophthalmology Central Military Hospital Praha Czech Republic
Department of Ophthalmology Faculty of Medicine Masaryk University Brno Czech Republic
Department of Ophthalmology Hungarian Defence Forces Medical Centre Budapest Hungary
Department of Ophthalmology Semmelweis University Budapest Hungary
Department of Ophthalmology Seoul National University Bundang Hospital Seongnam South Korea
Department of Ophthalmology Seoul National University College of Medicine Seoul South Korea
Department of Ophthalmology University Hospital Kralovske Vinohrady Prague Czech Republic
Department of Ophthalmology University of Debrecen Debrecen Hajdú Bihar Hungary
Diagnostic and Microsurgery Center of the Eye LENS Olsztyn Poland
Johns Hopkins Medicine Wilmer Eye Institute Baltimore Maryland USA
Retina Consultants of Southern Colorado PC Colorado Springs Colorado USA
Samsung Bioepis Co Ltd Incheon South Korea
University Hospital Brno Brno Czech Republic
University Hospital Hradec Kralove Hradec Kralove Královéhradecký Czech Republic
University Hospital Kralovske Vinohrady Praha Czech Republic
University of Ulsan College of Medicine Songpa gu Seoul South Korea
Citace poskytuje Crossref.org
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