Similar efficacy, safety and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F21%3AN0000218" target="_blank" >RIV/00064173:_____/21:N0000218 - isvavai.cz</a>

Výsledek na webu

<a href="https://doi.org/10.1080/14712598.2021.1851362" target="_blank" >https://doi.org/10.1080/14712598.2021.1851362</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/14712598.2021.1851362" target="_blank" >10.1080/14712598.2021.1851362</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Similar efficacy, safety and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study

Popis výsledku v původním jazyce

BACKGROUND: : BI 695501 is an approved biosimilar to Humira(R) reference product (RP). RESEARCH DESIGN AND METHODS: : In this randomized Phase III trial (VOLTAIRE-PSO), patients with moderate-to-severe chronic plaque psoriasis received BI 695501 or adalimumab RP (24-week treatment). Primary efficacy endpoint: proportion of patients with GREATER-THAN OR EQUAL TO75% reduction in Psoriasis Area and Severity Index (PASI 75) response at week 16 (+-18% equivalence limits for two-sided 95% confidence interval between treatment groups). Safety, pharmacokinetics and immunogenicity were also assessed. RESULTS: : Baseline characteristics were balanced between treated groups (BI 695501, n = 159; adalimumab RP, n = 158). PASI 75 response rates (full analysis set, n = 158; n = 157) were 68.2% (BI 695501) and 70.4% (adalimumab RP) at week 16 (95% CI: -14.4%, 8.7%), and 75.3% and 72.4%, at week 24, respectively. At week 24, 41.5% (BI 695501) and 44.9% (adalimumab RP) of treated patients had treatment-emergent adverse events (AEs), 3.1% and 4.4% had serious AEs, and 0.0% and 1.9% had AEs of special interest. Of treated patients, 75.3% (BI 695501) and 77.9% (adalimumab RP) were anti-drug antibody-positive. CONCLUSION: : These data demonstrate equivalent efficacy and highly similar safety and immunogenicity between BI 695501 and adalimumab RP in patients with chronic plaque psoriasis. STUDY IDENTIFIER: NCT02850965.

Název v anglickém jazyce

Similar efficacy, safety and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study

Popis výsledku anglicky

BACKGROUND: : BI 695501 is an approved biosimilar to Humira(R) reference product (RP). RESEARCH DESIGN AND METHODS: : In this randomized Phase III trial (VOLTAIRE-PSO), patients with moderate-to-severe chronic plaque psoriasis received BI 695501 or adalimumab RP (24-week treatment). Primary efficacy endpoint: proportion of patients with GREATER-THAN OR EQUAL TO75% reduction in Psoriasis Area and Severity Index (PASI 75) response at week 16 (+-18% equivalence limits for two-sided 95% confidence interval between treatment groups). Safety, pharmacokinetics and immunogenicity were also assessed. RESULTS: : Baseline characteristics were balanced between treated groups (BI 695501, n = 159; adalimumab RP, n = 158). PASI 75 response rates (full analysis set, n = 158; n = 157) were 68.2% (BI 695501) and 70.4% (adalimumab RP) at week 16 (95% CI: -14.4%, 8.7%), and 75.3% and 72.4%, at week 24, respectively. At week 24, 41.5% (BI 695501) and 44.9% (adalimumab RP) of treated patients had treatment-emergent adverse events (AEs), 3.1% and 4.4% had serious AEs, and 0.0% and 1.9% had AEs of special interest. Of treated patients, 75.3% (BI 695501) and 77.9% (adalimumab RP) were anti-drug antibody-positive. CONCLUSION: : These data demonstrate equivalent efficacy and highly similar safety and immunogenicity between BI 695501 and adalimumab RP in patients with chronic plaque psoriasis. STUDY IDENTIFIER: NCT02850965.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30216 - Dermatology and venereal diseases

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2021

Kód důvěrnosti údajů

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

Název periodika

Expert Opinion on Biological Therapy

ISSN

1471-2598

e-ISSN

1744-7682

Svazek periodika

21

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

10

Strana od-do

87-96

Kód UT WoS článku

000603930400001

EID výsledku v databázi Scopus

2-s2.0-85098637826