Subcutaneous Infliximab in Refractory Crohn's Disease Patients: A Possible Biobetter?

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F67985904%3A_____%2F23%3A00580326" target="_blank" >RIV/67985904:_____/23:00580326 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11130/23:10471708 RIV/00216208:11110/23:10471708 RIV/00216208:11120/23:43926209 RIV/00064173:_____/23:43926209 RIV/00064203:_____/23:10471708

Výsledek na webu

<a href="https://academic.oup.com/crohnscolitis360/article/5/4/otad040/7231024?login=true" target="_blank" >https://academic.oup.com/crohnscolitis360/article/5/4/otad040/7231024?login=true</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/crocol/otad040" target="_blank" >10.1093/crocol/otad040</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Subcutaneous Infliximab in Refractory Crohn's Disease Patients: A Possible Biobetter?

Popis výsledku v původním jazyce

Background A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab.Methods Patients with refractory Crohn's disease (CD, n = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment.Results Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 mu g/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (n = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (P = .0341), fecal calprotectin (P = .0002), and Harvey-Bradshaw index (P = .0029) since W0.Conclusions Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.nInfliximab is currently administered intravenously to treat Crohn's disease patients. In this study, subcutaneous administration of infliximab was found to have advantages for refractory CD patients, including stable, consistently higher levels of the drug and significantly lower immunogenicity.

Název v anglickém jazyce

Subcutaneous Infliximab in Refractory Crohn's Disease Patients: A Possible Biobetter?

Popis výsledku anglicky

Background A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab.Methods Patients with refractory Crohn's disease (CD, n = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment.Results Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 mu g/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (n = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (P = .0341), fecal calprotectin (P = .0002), and Harvey-Bradshaw index (P = .0029) since W0.Conclusions Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.nInfliximab is currently administered intravenously to treat Crohn's disease patients. In this study, subcutaneous administration of infliximab was found to have advantages for refractory CD patients, including stable, consistently higher levels of the drug and significantly lower immunogenicity.

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

2023

Kód důvěrnosti údajů

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

Název periodika

Crohns & Colitis 360

ISSN

2631-827X

e-ISSN

2631-827X

Svazek periodika

5

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

7

Strana od-do

otad040

Kód UT WoS článku

001100924200001

EID výsledku v databázi Scopus

2-s2.0-85178005189