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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F23%3A00076543" target="_blank" >RIV/65269705:_____/23:00076543 - isvavai.cz</a>

Alternative codes found

RIV/00216224:14110/23:00129940 RIV/00216208:11120/23:43922418 RIV/00216208:11150/23:10432780 RIV/00179906:_____/23:10432780 RIV/00064173:_____/23:43922418

Result on the web

<a href="https://bjo.bmj.com/content/bjophthalmol/early/2022/07/01/bjophthalmol-2021-319637.full.pdf" target="_blank" >https://bjo.bmj.com/content/bjophthalmol/early/2022/07/01/bjophthalmol-2021-319637.full.pdf</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/bjophthalmol-2021-319637" target="_blank" >10.1136/bjophthalmol-2021-319637</a>

Result language

angličtina

Original language name

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

Original language description

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: &gt;= 50 years old participants with nAMD (n=705), one &apos;study eye&apos;. 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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30207 - Ophthalmology

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2023

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

British Journal of Ophthalmology

ISSN

0007-1161

e-ISSN

1468-2079

Volume of the periodical

107

Issue of the periodical within the volume

3

Country of publishing house

GB - UNITED KINGDOM

Number of pages

8

Pages from-to

384-391

UT code for WoS article

000723337800001

EID of the result in the Scopus database

2-s2.0-85148479419