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

Kód výsledku v 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>

Nalezeny alternativní kódy

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

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30207 - Ophthalmology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2023

Kód důvěrnosti údajů

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

Název periodika

British Journal of Ophthalmology

ISSN

0007-1161

e-ISSN

1468-2079

Svazek periodika

107

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

384-391

Kód UT WoS článku

000723337800001

EID výsledku v databázi Scopus

2-s2.0-85148479419