Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

Lukin, Dana J.; Faleck, David; Xu, Ronghui; Zhang, Yiran; Weiss, Aaron; Aniwan, Satimai; Kadire, Siri; Tran, Gloria; Rahal, Mahmoud; Winters, Adam C.; Chablaney, Shreya; Koliani-Pace, Jenna L.; Meserve, Joseph; Campbell, James P.; Kochhar, Gursimran; Bohm, Matthew; Varma, Sashidhar; Fischer, Monika; Boland, Brigid S.; Singh, Siddharth; Hirten, Robert; Ungaro, Ryan C.; Lasch, Karen; Shmidt, Eugenia; Jairath, Vipul; Hudesman, David; Chang, Shannon; Swaminath, Arun; Shen, Bo; Kane, Sunanda V.; Loftus, Edward V.; Sands, Bruce E.; Colombel, Jean Fréd́eric; Siegel, Corey A.; Sandborn, William J.; Dulai, Parambir S.

doi:10.1016/j.cgh.2020.10.003

Cited by 35 publications

(17 citation statements)

References 45 publications

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“…Por otro lado, la curación de la mucosa es un objetivo importante en el tratamiento de la EII asociado con una remisión clínica sostenida [31][32][33] . Las recientes directrices clínicas de tratamiento establecen que solo los pacientes con cicatrización de la mucosa, es decir, ausencia de signos macroscópicos de inflamación activa, sin signos o síntomas muy leves o sin signos y síntomas deben considerarse remitidos 33 .…”

Section: Discussionunclassified

Vedolizumab como terapia primaria en colitis ulcerosa y en la enfermedad de Crohn de moderada a grave: revisión y metaanálisis

Vaca¹,

Cortés-Espinoza²,

Maldonado-Arriaga³

et al. 2023

IMIDS

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La colitis ulcerosa (CU) y la enfermedad de Crohn (EC) tienen diferentes opciones de tratamiento, que incluyen aminosalicilatos, corticosteroides, tiopurinas, inhibidores de calcineurina y biológicos como anticitocinas y antiintegrinas. Y recientemente el uso de vedolizumab (VDZ), el cual es un anticuerpo monoclonal humanizado selectivo para el intestino que se une a las integrinas α4β7, bloqueando selectivamente el tráfico de linfocitos en el intestino. El objetivo de este metaanálisis fue estimar la eficacia y seguridad del fármaco VDZ en ensayos clínicos aleatorizados en pacientes adultos no tratados previamente con terapia biológica y corticosteroides con CU y EC. Metodología: Se realizó una revisión sistemática de la literatura y un metaanálisis para evaluar la efectividad y seguridad del VDZ en pacientes con CU y EC. Se realizó una búsqueda en las bases de datos PubMed/Medline sobre pacientes adultos con CU sin previo uso de terapia biológica y corticosteroides bajo tratamiento de VDZ en ensayos clínicos aleatorizados. Resultados: Se seleccionaron cinco estudios que cumplieron los criterios de selección. Y se determinó que en la semana 14 de tratamiento, el 32% de los pacientes con CU estaban en remisión; y a los 12 meses, el 46% estaba en remisión clínica. Las tasas de remisión sin corticosteroides fueron del 26% en la semana 14 y del 42% en el mes 12. En el mes 12, del 33 al 77% de los pacientes con CU presentaron curación de la mucosa. El 9% de los pacientes informaron eventos adversos graves. Conclusiones: El VDZ demostró eficacia en pacientes con CU y EC activa de moderada a grave, logrando la remisión en el mes 12 de tratamiento. Estos hallazgos concuerdan con los datos y el apoyo de los ensayos clínicos aleatorizados muestran el perfil de riesgo-beneficio a largo plazo del VDZ.

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Section: Discussionunclassified

Vedolizumab como terapia primaria en colitis ulcerosa y en la enfermedad de Crohn de moderada a grave: revisión y metaanálisis

Vaca¹,

Cortés-Espinoza²,

Maldonado-Arriaga³

et al. 2023

IMIDS

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“…T-cell trafficking blockade with an anti-α4β7 integrin antibody or FTY720 strongly reduced the median number of tumors in the AOM/DSS model of CAC. These drugs are effective against colonic inflammation,[38, 39] and they could thus indirectly reduce colitis-associated tumorigenesis. However, the loss of differences in tumor number and the reduced intra-tumor CD3+/CD8+ T-cell densities between the appendectomy and control groups after trafficking blockade suggested that the effect of appendectomy could be mediated by lymphocyte recirculation towards the colonic lamina propria and tumors.…”

Section: Discussionmentioning

confidence: 99%

The appendix orchestrates T-cell mediated immunosurveillance in colitis-associated cancer

Tourneur-Marsille

Uzzan

et al. 2021

Preprint

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Objective. While appendectomy may reduce colorectal inflammation in patients with ulcerative colitis (UC), appendectomy has been suggested to be associated with an increased risk of colitis-associated cancer (CAC). The aim of this study was to explore the mechanism underlying the appendectomy-associated increased risk of CAC. Design. Five-week-old male BALB/c mice underwent appendectomy, appendicitis induction or sham laparotomy. They were then exposed to azoxymethane/dextran sodium sulfate (AOM/DSS) to induce CAC. Mice were sacrificed 12 weeks later, and colons were taken for pathological analysis and immunohistochemistry (CD3 and CD8 staining). Human colonic tumors from 21 UC patients who underwent surgical resection for CAC were immunophenotyped and stratified according to the appendectomy status. Results. While appendectomy significantly reduced colitis severity and increased CAC number, appendicitis induction without appendectomy led to opposite results. Intra-tumor CD3+ and CD8+ T-cell densities were lower after appendectomy and higher after appendicitis induction compared to the sham laparotomy group. Blocking lymphocyte trafficking to the colon with the anti-alpha4-beta7 integrin antibody or a sphingosine-1-phosphate receptor agonist suppressed the inducing effect of the appendectomy on tumors′ number and on CD3+/CD8+ intra-tumoral density. CD8+ or CD3+ T cells isolated from inflammatory neo-appendix and intravenously injected into AOM/DSS-treated recipient mice increased CD3+/CD8+ T-cell tumor infiltration and decreased tumor number. In UC patients with a history of appendectomy, intra-tumor CD3+ and CD8+ T-cell densities were decreased compared to UC patients without history of appendectomy. Conclusions. In UC, appendectomy could suppress a major site of T-cell priming resulting in a less efficient CAC immunosurveillance.

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“…These findings have been confirmed by the recently published study of the VICTORY Consortium, which analyzed the effect of VDZ and TNF-α inhibitors in UC using propensity score weighted comparisons. 29 VDZ-treated patients were more likely to achieve clinical remission, steroid-free clinical remission, and steroid-free deep remission than those treated with TNF-α inhibitors. Results were consistent across subgroup analyses in TNF-antagonist naive and exposed patients, and for VDZ versus IFX and versus subcutaneous TNF-α inhibitors separately.…”

Section: Head-to-head Comparisons Of Biologicals In Ibd Arising From Rwementioning

confidence: 91%

Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

Macaluso

Maida²,

Grova

et al. 2021

Therap Adv Gastroenterol

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During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.

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Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

Cited by 35 publications

References 45 publications

Vedolizumab como terapia primaria en colitis ulcerosa y en la enfermedad de Crohn de moderada a grave: revisión y metaanálisis

Vedolizumab como terapia primaria en colitis ulcerosa y en la enfermedad de Crohn de moderada a grave: revisión y metaanálisis

The appendix orchestrates T-cell mediated immunosurveillance in colitis-associated cancer

Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

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