The EGALITY study: A confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F17%3A43912296" target="_blank" >RIV/00216208:11120/17:43912296 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064173:_____/17:N0000065

Výsledek na webu

<a href="http://dx.doi.org/10.1111/bjd.15152" target="_blank" >http://dx.doi.org/10.1111/bjd.15152</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/bjd.15152" target="_blank" >10.1111/bjd.15152</a>

Jazyk výsledku

angličtina

Název v původním jazyce

The EGALITY study: A confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis

Popis výsledku v původním jazyce

BACKGROUND: GP2015 is a proposed etanercept biosimilar. OBJECTIVE: To demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and etanercept originator (ETN, Enbrel((R)) ) in patients with moderate to severe chronic plaque-type psoriasis. METHODS: 531 eligible patients were randomised 1:1 to self-administer GP2015 or ETN twice-weekly subcutaneously. Patients with a 50% improvement in psoriasis area and severity index (PASI 50) at week 12 were re-randomised to continue the same treatment on a once-weekly dosing schedule or to undergo a sequence of 3 treatment switches between GP2015 and ETN until week 30. Thereafter, patients continued treatment with the product they had been assigned to last, up to week 52. RESULTS: The difference in PASI 75 (75% improvement from baseline PASI score) response rates at week 12 between GP2015 and ETN (primary endpoint) was -2.3%. The 95% confidence interval (-9.85, 5.30) was well contained within the pre-specified margin range of (-18, 18). Incidence of treatment-emergent adverse events up to week 52 was comparable between continued GP2015 (59.8%) and ETN (57.3%); switching treatments revealed comparable safety profiles. Anti-drug antibodies, all non-neutralising, were limited to 5 patients on ETN during treatment period 1, and 1 patient in the switched ETN group, who had been treated with GP2015 for 12 weeks at time of the finding. CONCLUSION: The EGALITY study demonstrated equivalent efficacy and comparable safety and immunogenicity of GP2015 and ETN. The study results provided the final clinical confirmation of biosimilarity and contributed to the totality-of-the-evidence proposing that GP2015 is an etanercept biosimilar.

Název v anglickém jazyce

The EGALITY study: A confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis

Popis výsledku anglicky

BACKGROUND: GP2015 is a proposed etanercept biosimilar. OBJECTIVE: To demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and etanercept originator (ETN, Enbrel((R)) ) in patients with moderate to severe chronic plaque-type psoriasis. METHODS: 531 eligible patients were randomised 1:1 to self-administer GP2015 or ETN twice-weekly subcutaneously. Patients with a 50% improvement in psoriasis area and severity index (PASI 50) at week 12 were re-randomised to continue the same treatment on a once-weekly dosing schedule or to undergo a sequence of 3 treatment switches between GP2015 and ETN until week 30. Thereafter, patients continued treatment with the product they had been assigned to last, up to week 52. RESULTS: The difference in PASI 75 (75% improvement from baseline PASI score) response rates at week 12 between GP2015 and ETN (primary endpoint) was -2.3%. The 95% confidence interval (-9.85, 5.30) was well contained within the pre-specified margin range of (-18, 18). Incidence of treatment-emergent adverse events up to week 52 was comparable between continued GP2015 (59.8%) and ETN (57.3%); switching treatments revealed comparable safety profiles. Anti-drug antibodies, all non-neutralising, were limited to 5 patients on ETN during treatment period 1, and 1 patient in the switched ETN group, who had been treated with GP2015 for 12 weeks at time of the finding. CONCLUSION: The EGALITY study demonstrated equivalent efficacy and comparable safety and immunogenicity of GP2015 and ETN. The study results provided the final clinical confirmation of biosimilarity and contributed to the totality-of-the-evidence proposing that GP2015 is an etanercept biosimilar.

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

2017

Kód důvěrnosti údajů

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

Název periodika

British Journal of Dermatology

ISSN

0007-0963

e-ISSN

—

Svazek periodika

176

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

928-938

Kód UT WoS článku

000399363100037

EID výsledku v databázi Scopus

2-s2.0-85014009195