Adalimumab versus infliximab in pediatric patients with Crohn's disease: A propensity-score analysis and predictors of treatment escalation

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F22%3A10442607" target="_blank" >RIV/00064203:_____/22:10442607 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11130/22:10442607

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=QmL_eWUqaj" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=QmL_eWUqaj</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.14309/ctg.0000000000000490" target="_blank" >10.14309/ctg.0000000000000490</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Adalimumab versus infliximab in pediatric patients with Crohn's disease: A propensity-score analysis and predictors of treatment escalation

Popis výsledku v původním jazyce

BACKGROUND: Two anti-tumor necrosis factor therapies (infliximab [IFX], adalimumab [ADA]) have been approved for the treatment of pediatric Crohn&apos;s disease (CD), but have not been compared in head-to-head trials. The aim of this study was to compare the efficacy and safety of ADA and IFX by propensity score matching in a prospective cohort of pediatric patients with luminal CD and at least 24-month follow-up. METHODS: Among 100 patients, 75 met the inclusion criteria and 62 were matched by propensity score. We evaluated time to treatment escalation as the primary outcome and primary non-response, predictors of treatment escalation and relapse, serious adverse events (SAE), pharmacokinetics, and effect of concomitant immunomodulators (IMM) as secondary outcomes. RESULTS: There was no difference between ADA and IFX in time to treatment escalation (HR=0.63 [95% CI 0.31-1.28] P=0.20), primary non-response (P=0.95), or SAEs. Median (IQR) trough levels at the primary outcome were 14.05 (10.88-15.40) and 6.15 (2.08-6.58) µg/mL in the ADA and IFX groups, respectively. Upon multivariate analysis, the combination of ASCA negativity and pANCA positivity was a strong independent predictor of treatment escalation (HR 5.19, [95% CI 2.41-11.18], p&lt;0.0001). The SES-CD score, L3 disease phenotype, and use of concomitant IMM for at least the first 6 months revealed a trend towards significance upon univariate analysis. DISCUSSION: Propensity score matching did not reveal substantial differences in efficacy or safety between ADA and IFX. The ASCA-/pANCA+ combination is a strong predictor of treatment escalation.

Název v anglickém jazyce

Adalimumab versus infliximab in pediatric patients with Crohn's disease: A propensity-score analysis and predictors of treatment escalation

Popis výsledku anglicky

BACKGROUND: Two anti-tumor necrosis factor therapies (infliximab [IFX], adalimumab [ADA]) have been approved for the treatment of pediatric Crohn&apos;s disease (CD), but have not been compared in head-to-head trials. The aim of this study was to compare the efficacy and safety of ADA and IFX by propensity score matching in a prospective cohort of pediatric patients with luminal CD and at least 24-month follow-up. METHODS: Among 100 patients, 75 met the inclusion criteria and 62 were matched by propensity score. We evaluated time to treatment escalation as the primary outcome and primary non-response, predictors of treatment escalation and relapse, serious adverse events (SAE), pharmacokinetics, and effect of concomitant immunomodulators (IMM) as secondary outcomes. RESULTS: There was no difference between ADA and IFX in time to treatment escalation (HR=0.63 [95% CI 0.31-1.28] P=0.20), primary non-response (P=0.95), or SAEs. Median (IQR) trough levels at the primary outcome were 14.05 (10.88-15.40) and 6.15 (2.08-6.58) µg/mL in the ADA and IFX groups, respectively. Upon multivariate analysis, the combination of ASCA negativity and pANCA positivity was a strong independent predictor of treatment escalation (HR 5.19, [95% CI 2.41-11.18], p&lt;0.0001). The SES-CD score, L3 disease phenotype, and use of concomitant IMM for at least the first 6 months revealed a trend towards significance upon univariate analysis. DISCUSSION: Propensity score matching did not reveal substantial differences in efficacy or safety between ADA and IFX. The ASCA-/pANCA+ combination is a strong predictor of treatment escalation.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30219 - Gastroenterology and hepatology

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

Clinical and Translational Gastroenterology

ISSN

2155-384X

e-ISSN

2155-384X

Svazek periodika

13

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

e00490

Kód UT WoS článku

000799468800001

EID výsledku v databázi Scopus

2-s2.0-85131017424