Biosimilar SB11 versus reference ranibizumab in neovascular
age-related macular degeneration: 1-year phase III randomised
clinical trial outcomes

J 2023

Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes

BRESSLER, N. M., M. VEITH, Jan HAMOUZ, Jan ERNEST, D. ZALEWSKI et. al.

Základní údaje

Originální název

Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes

Autoři

BRESSLER, N. M., M. VEITH, Jan HAMOUZ (203 Česká republika), Jan ERNEST (203 Česká republika), D. ZALEWSKI, Jan STUDNICKA (203 Česká republika), A. VAJAS, A. PAPP, G. VOGT, J. LUU, Veronika MATUŠKOVÁ (203 Česká republika, domácí), Y. H. YOON, T. PREGUN, T. KIM, D. SHIN, I. OH, H. JEONG, M. Y. KIM a S. J. WOO (garant)

Vydání

The British journal of ophthalmology : incorporating the Royal London ophthalmic hospital reports, the Ophthalmic review and the Ophthalmoscope, London, British Journal of Ophthalmology, 2023, 0007-1161

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30207 Ophthalmology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 4.100 v roce 2022

Kód RIV

RIV/00216224:14110/23:00129940

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1136/bjophthalmol-2021-319637

UT WoS

000723337800001

Klíčová slova anglicky

retina; neovascularisation; macula; degeneration

Štítky

14110219, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 26. 1. 2024 09:44, Mgr. Tereza Miškechová

Anotace

V originále

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 mu m (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.

Citovat

BRESSLER, N. M., M. VEITH, Jan HAMOUZ, Jan ERNEST, D. ZALEWSKI, Jan STUDNICKA, A. VAJAS, A. PAPP, G. VOGT, J. LUU, Veronika MATUŠKOVÁ, Y. H. YOON, T. PREGUN, T. KIM, D. SHIN, I. OH, H. JEONG, M. Y. KIM a S. J. WOO. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes. The British journal of ophthalmology : incorporating the Royal London ophthalmic hospital reports, the Ophthalmic review and the Ophthalmoscope. London: British Journal of Ophthalmology, 2023, roč. 107, č. 3, s. 384-391. ISSN 0007-1161. Dostupné z: https://dx.doi.org/10.1136/bjophthalmol-2021-319637.

@article{1818479,
   author = {Bressler, N. M. and Veith, M. and Hamouz, Jan and Ernest, Jan and Zalewski, D. and Studnicka, Jan and Vajas, A. and Papp, A. and Vogt, G. and Luu, J. and Matušková, Veronika and Yoon, Y. H. and Pregun, T. and Kim, T. and Shin, D. and Oh, I. and Jeong, H. and Kim, M. Y. and Woo, S. J.},
   article_location = {London},
   article_number = {3},
   doi = {http://dx.doi.org/10.1136/bjophthalmol-2021-319637},
   keywords = {retina; neovascularisation; macula; degeneration},
   language = {eng},
   issn = {0007-1161},
   journal = {The British journal of ophthalmology : incorporating the Royal London ophthalmic hospital reports, the Ophthalmic review and the Ophthalmoscope},
   title = {Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes},
   url = {https://bjo.bmj.com/content/early/2021/10/16/bjophthalmol-2021-319637},
   volume = {107},
   year = {2023}
}

TY  - JOUR
ID  - 1818479
AU  - Bressler, N. M. - Veith, M. - Hamouz, Jan - Ernest, Jan - Zalewski, D. - Studnicka, Jan - Vajas, A. - Papp, A. - Vogt, G. - Luu, J. - Matušková, Veronika - Yoon, Y. H. - Pregun, T. - Kim, T. - Shin, D. - Oh, I. - Jeong, H. - Kim, M. Y. - Woo, S. J.
PY  - 2023
TI  - Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes
JF  - The British journal of ophthalmology : incorporating the Royal London ophthalmic hospital reports, the Ophthalmic review and the Ophthalmoscope
VL  - 107
IS  - 3
SP  - 384-391
EP  - 384-391
PB  - British Journal of Ophthalmology
SN  - 00071161
KW  - retina
KW  - neovascularisation
KW  - macula
KW  - degeneration
UR  - https://bjo.bmj.com/content/early/2021/10/16/bjophthalmol-2021-319637
N2  - 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 mu m (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.
ER  -

BRESSLER, N. M., M. VEITH, Jan HAMOUZ, Jan ERNEST, D. ZALEWSKI, Jan STUDNICKA, A. VAJAS, A. PAPP, G. VOGT, J. LUU, Veronika MATUŠKOVÁ, Y. H. YOON, T. PREGUN, T. KIM, D. SHIN, I. OH, H. JEONG, M. Y. KIM a S. J. WOO. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes. \textit{The British journal of ophthalmology : incorporating the Royal London ophthalmic hospital reports, the Ophthalmic review and the Ophthalmoscope}. London: British Journal of Ophthalmology, 2023, roč.~107, č.~3, s.~384-391. ISSN~0007-1161. Dostupné z: https://dx.doi.org/10.1136/bjophthalmol-2021-319637.

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