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.

Basic information

Original name

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

Authors

BRESSLER, N. M., M. VEITH, Jan HAMOUZ (203 Czech Republic), Jan ERNEST (203 Czech Republic), D. ZALEWSKI, Jan STUDNICKA (203 Czech Republic), A. VAJAS, A. PAPP, G. VOGT, J. LUU, Veronika MATUŠKOVÁ (203 Czech Republic, belonging to the institution), Y. H. YOON, T. PREGUN, T. KIM, D. SHIN, I. OH, H. JEONG, M. Y. KIM and S. J. WOO (guarantor)

Edition

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

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30207 Ophthalmology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 4.100 in 2022

RIV identification code

RIV/00216224:14110/23:00129940

Organization unit

Faculty of Medicine

DOI

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

UT WoS

000723337800001

Keywords in English

retina; neovascularisation; macula; degeneration

Abstract

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 and 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, vol. 107, No 3, p. 384-391. ISSN 0007-1161. Available from: 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 and 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, vol.~107, No~3, p.~384-391. ISSN~0007-1161. Available from: https://dx.doi.org/10.1136/bjophthalmol-2021-319637.

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