Abstract:Purpose
A large number of people with Crohn's disease (CD) fail to recover from conventional therapy or biological therapy. Some studies showed that adalimumab (ADA) may be an effective alternative therapy for these patients. The aim of this study was to evaluate the efficacy and safety of ADA in inducing CD remission.
Methods
We performed search of Pubmed/MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Register, and several other data… Show more
“…our subgroup analysis demonstrated that previous exposure to IFX have less effect on the e cacy of ADA compared with patients with IFX-naïve. This is consistent with the results of Song et al [11] However, Yin et al [12] assessed the e cacy and safety of ADA in inducing and maintaining remission of participants with CD, which included four RCTs and concluded that e cacy rates were similar between the TNF-α-naïve and TNF-α exposed subgroups. We think the possibility might be that patients with previous IFX treatment probably had more severe disease for a longer period of time, which led them to receive anti-TNF therapy.…”
Section: Discussionsupporting
confidence: 85%
“…Adalimumab(ADA), as a fully humanized TNF-α monoclonal antibody has been approved by the United States Food and Drug Administration for the treatment of moderate and severe CD in children, and recommended by the European consensus guidelines for the treatment of long-term active intestinal diseases in children [9]. Several systematic review and meta-analysis have demonstrated that ADA is safe and effective in the treatment of CD in adults [10][11][12]. However, it is unclear whether adalimumab has similar e cacy in children with CD.This systematic review aimed to examine the e cacy and safety of ADA for inducing and maintaining remission in pediatric patients with CD.…”
Background:
There is no curative treatment for childhood Crohn’s disease (CD). We conducted this meta-analysis to validate the efficacy and safety of adalimumab (ADA) in pediatric patients with CD.
Methods:
We searched and investigated all relevant studies in the PubMed, Web of Science, Embase, and Cochrane Library databases. Primary outcomes were induction (≤12 week) and maintenance (up to 48 week) of remission and response. Secondary outcomes were severe adverse events, opportunistic infections to adalimumab (ADA). The Cochrane bias assessment tool was used to assess the risk of bias in randomized controlled trials (RCTs). The methodological quality of single-arm studies was assessed using the methodological index for non-randomized studies (MINORS) tool.
Results:
A total of 10 clinical trials involving 885 patients were identified. Results indicate that 59% (95% confidence interval [CI]: 39%–80%) of the subjects treated with ADA achieved induction of remission and response 60% (95% CI: 35%–86%), 57% (95% CI: 44%–70%) achieved maintenance of remission, 63% (95% CI: 26%–69%) achieved maintenance of response.
Conclusion:
Current evidence indicates that ADA is effective in children and adolescents with CD and adverse events are varied but usually not sever.
Systematic Review Registration:
https://www.crd.york.ac.uk/prospero/, identifier
CRD42023402199.
“…our subgroup analysis demonstrated that previous exposure to IFX have less effect on the e cacy of ADA compared with patients with IFX-naïve. This is consistent with the results of Song et al [11] However, Yin et al [12] assessed the e cacy and safety of ADA in inducing and maintaining remission of participants with CD, which included four RCTs and concluded that e cacy rates were similar between the TNF-α-naïve and TNF-α exposed subgroups. We think the possibility might be that patients with previous IFX treatment probably had more severe disease for a longer period of time, which led them to receive anti-TNF therapy.…”
Section: Discussionsupporting
confidence: 85%
“…Adalimumab(ADA), as a fully humanized TNF-α monoclonal antibody has been approved by the United States Food and Drug Administration for the treatment of moderate and severe CD in children, and recommended by the European consensus guidelines for the treatment of long-term active intestinal diseases in children [9]. Several systematic review and meta-analysis have demonstrated that ADA is safe and effective in the treatment of CD in adults [10][11][12]. However, it is unclear whether adalimumab has similar e cacy in children with CD.This systematic review aimed to examine the e cacy and safety of ADA for inducing and maintaining remission in pediatric patients with CD.…”
Background:
There is no curative treatment for childhood Crohn’s disease (CD). We conducted this meta-analysis to validate the efficacy and safety of adalimumab (ADA) in pediatric patients with CD.
Methods:
We searched and investigated all relevant studies in the PubMed, Web of Science, Embase, and Cochrane Library databases. Primary outcomes were induction (≤12 week) and maintenance (up to 48 week) of remission and response. Secondary outcomes were severe adverse events, opportunistic infections to adalimumab (ADA). The Cochrane bias assessment tool was used to assess the risk of bias in randomized controlled trials (RCTs). The methodological quality of single-arm studies was assessed using the methodological index for non-randomized studies (MINORS) tool.
Results:
A total of 10 clinical trials involving 885 patients were identified. Results indicate that 59% (95% confidence interval [CI]: 39%–80%) of the subjects treated with ADA achieved induction of remission and response 60% (95% CI: 35%–86%), 57% (95% CI: 44%–70%) achieved maintenance of remission, 63% (95% CI: 26%–69%) achieved maintenance of response.
Conclusion:
Current evidence indicates that ADA is effective in children and adolescents with CD and adverse events are varied but usually not sever.
Systematic Review Registration:
https://www.crd.york.ac.uk/prospero/, identifier
CRD42023402199.
“…There are five further systematic review and meta-analysis studies that evaluated the effectiveness and security of ADA in CD patients. All of these reviews reached the same conclusion as revealed by us and showed that ADA was effective and significantly improved the life quality of CD participants [34][35][36][37][38].…”
Background: Numerous patients with inflammatory bowel disease (IBD) do not respond to conventional or biological therapy. Adalimumab (ADA) and vedolizumab (VDZ), according to certain research, may be a useful alternative treatment for these people. The purpose of this study was to assess the effectiveness and safety of using ADA and VDZ to treat moderate to severe IBD: Crohn's disease (CD) and ulcerative colitis (UC).
Methods:We searched PubMed, Medline, Web of Science, Scopus, the Cochrane Library, Embase, Google Scholar, CINAHL, Clinicaltrials.gov, and WHO trials registry (ICTRP). Randomized controlled trials (RCTs) comparing ADA or VDZ with placebo in participants with active CD or UC were included. The primary outcomes were the clinical response and remission at induction and maintenance phases and mucosal healing. The secondary outcome was the incidence of profound negative events. The research used Comprehensive Meta-Analysis version 3 (Biostat Inc., USA).Results: Eighteen RCTs were incorporated, in which 11 studies described the usefulness and safeness of ADA or VDZ in CD patients, and seven studies investigated the efficacy and safety of ADA or VDZ in UC patients. The meta-analysis revealed that both ADA and VDZ treatments were superior to placebo for producing clinical remission and eliciting clinical response at induction and maintenance phases in individuals with moderately to severely active CD or UC. Interestingly, we found that ADA was superior to VDZ as first-line treatment for patients with CD, but not UC.
Conclusion:ADA and VDZ are effective and safe in CD and UC patients. However, RCTs of a larger number of patients are still required for better assessing the safety profile of ADA and VDZ.
“…Finamente, otro agente biológico significativo es el Adalimumab, debido a que ha demostrado ser más eficaz al momento de tratar la enfermedad de Crohn, poniendo a consideración que presenta un menor desarrollo de efectos secundarios, así como también una mejor respuesta frente al placebo aplicado, con tasas de remisión de entre el 16.5 al 18 (Kucharzik et al, 2020;Yin et al, 2022;Zaltman et al, 2019).…”
La enfermedad inflamatoria intestinal engloba dos enfermedades importantes como la colitis ulcerosa y la enfermedad de Crohn, las cuales son trastornos de patología multifactorial que afectan el tracto intestinal causando un grave deterioro de la calidad de vida de los pacientes que la padecen e incluso pueden llegar a provocar cáncer colorrectal. Para su tratamiento existen distintos fármacos como los 5-aminosalicilatos, esteroides tópicos, esteroides sistémicos, inmuno modulares e inmunosupresores, cuando esta terapia convencional no refleja resultados favorecedores para los pacientes se aplica la terapia biológica, que permite modificar la historia natural de la enfermedad. En esta revisión se tiene como objetivo el describir la terapia biológica más eficaz aplicada al paciente con enfermedad inflamatoria intestinal. La base de datos empleada para la búsqueda de la información presentada fue PubMed, buscando artículos en el periodo de 2018 a 2023, con los descriptores bibliográficos DeCS y MeSH como: enfermedad inflamatoria intestinal, terapia biológica, enfermedad de Crohn y colitis ulcerosa, potencializando la búsqueda con el operador booleano AND. En los 20 artículos obtenidos se puede describir la tasa de remisión alcanza en los distintos pacientes que consumieron medicamentos biológicos como: Infliximab, Adalimumab, Golimumab, Vedolizumab, Ustekinumab y Tofacitinib, describiéndose remisiones en periodos de 8 a 10 semanas y de 6 a 12 meses. Se concluyó que estos fármacos son más eficaces que el placebo además de ser una excelente opción para pacientes refractarios al tratamiento convencional, llegando a mejorar la calidad de vida de estos.
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