A switch from originator-adalimumab to the biosimilar SB5 in patients with Crohn’s disease: an analysis of two propensity score-matched cohorts

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F67985807%3A_____%2F22%3A00556729" target="_blank" >RIV/67985807:_____/22:00556729 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/22:10442614

Výsledek na webu

<a href="http://dx.doi.org/10.1080/00365521.2022.2041082" target="_blank" >http://dx.doi.org/10.1080/00365521.2022.2041082</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/00365521.2022.2041082" target="_blank" >10.1080/00365521.2022.2041082</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A switch from originator-adalimumab to the biosimilar SB5 in patients with Crohn’s disease: an analysis of two propensity score-matched cohorts

Popis výsledku v původním jazyce

BACKGROUND/AIMS: Originator-adalimumab, an established treatment for patients with Crohn’s disease (CD), showed no difference in efficacy or adverse events versus adalimumab biosimilar SB5 (SB5-adalimumab) over 10 weeks (W) of treatment. To understand the long-term effectiveness of SB5-adalimumab in CD, patients switched from originator-adalimumab to SB5-adalimumab were compared with patients remaining on originator-adalimumab over 104 W. METHODS: Data on patients aged ≥18 years, diagnosed with CD and treated at ISCARE, were collected prospectively from July 2018 to January 2021. Primary outcome: clinical disease activity at W52, measured by Harvey-Bradshaw index (HBI). Secondary outcomes: C-reactive protein (CRP), faecal calprotectin (FC) and adalimumab concentrations at W10, 26, 52 and 104, and treatment persistence. To ensure comparable cohorts, patients were propensity score (PS)-matched for age, gender and disease activity. RESULTS: After matching, 54 patients remained per cohort. At W52, mean (SD) HBI score was 3.2 (2.5) for originator-adalimumab and 4.0 [3.6] for SB5-adalimumab (difference [95% CI] −0.78 [−2.8, 1.3], n = 18/cohort). No clinically meaningful differences in CRP, FC or drug concentrations were noted. Kaplan–Meier’s estimates (95% CI) of remaining on treatment were originator-adalimumab: 0.870 (0.785–0.965) versus SB5-adalimumab: 0.648 (0.533–0.789) at W52 and significantly lower for SB5-adalimumab versus originator-adalimumab (p < .001) over 104 W. Local skin reaction events/pain was the main reason for treatment discontinuation in the SB5-adalimumab cohort (n = 20/54 [37%]). CONCLUSIONS: These long-term results of CD patients receiving originator-adalimumab or following nonmedical switch to SB5-adalimumab show similar therapeutic effects on clinical disease activity, biological parameters and pharmacokinetic profile in both cohorts from 52 to 104 W. A separation in persistence was observed beyond W26, mainly due to differences in local reactions at the injection site.

Název v anglickém jazyce

A switch from originator-adalimumab to the biosimilar SB5 in patients with Crohn’s disease: an analysis of two propensity score-matched cohorts

Popis výsledku anglicky

BACKGROUND/AIMS: Originator-adalimumab, an established treatment for patients with Crohn’s disease (CD), showed no difference in efficacy or adverse events versus adalimumab biosimilar SB5 (SB5-adalimumab) over 10 weeks (W) of treatment. To understand the long-term effectiveness of SB5-adalimumab in CD, patients switched from originator-adalimumab to SB5-adalimumab were compared with patients remaining on originator-adalimumab over 104 W. METHODS: Data on patients aged ≥18 years, diagnosed with CD and treated at ISCARE, were collected prospectively from July 2018 to January 2021. Primary outcome: clinical disease activity at W52, measured by Harvey-Bradshaw index (HBI). Secondary outcomes: C-reactive protein (CRP), faecal calprotectin (FC) and adalimumab concentrations at W10, 26, 52 and 104, and treatment persistence. To ensure comparable cohorts, patients were propensity score (PS)-matched for age, gender and disease activity. RESULTS: After matching, 54 patients remained per cohort. At W52, mean (SD) HBI score was 3.2 (2.5) for originator-adalimumab and 4.0 [3.6] for SB5-adalimumab (difference [95% CI] −0.78 [−2.8, 1.3], n = 18/cohort). No clinically meaningful differences in CRP, FC or drug concentrations were noted. Kaplan–Meier’s estimates (95% CI) of remaining on treatment were originator-adalimumab: 0.870 (0.785–0.965) versus SB5-adalimumab: 0.648 (0.533–0.789) at W52 and significantly lower for SB5-adalimumab versus originator-adalimumab (p < .001) over 104 W. Local skin reaction events/pain was the main reason for treatment discontinuation in the SB5-adalimumab cohort (n = 20/54 [37%]). CONCLUSIONS: These long-term results of CD patients receiving originator-adalimumab or following nonmedical switch to SB5-adalimumab show similar therapeutic effects on clinical disease activity, biological parameters and pharmacokinetic profile in both cohorts from 52 to 104 W. A separation in persistence was observed beyond W26, mainly due to differences in local reactions at the injection site.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

10103 - Statistics and probability

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2022

Kód důvěrnosti údajů

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

Název periodika

Scandinavian Journal of Gastroenterology

ISSN

0036-5521

e-ISSN

1502-7708

Svazek periodika

57

Číslo periodika v rámci svazku

7

Stát vydavatele periodika

NO - Norské království

Počet stran výsledku

11

Strana od-do

814-824

Kód UT WoS článku

000763356000001

EID výsledku v databázi Scopus

2-s2.0-85126012656