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Inicio Gastroenterología y Hepatología (English Edition) Vedolizumab, an option in patients with inflammatory bowel disease intolerant to...
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Vol. 41. Issue 9.
Pages 535-543 (November 2018)
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Vol. 41. Issue 9.
Pages 535-543 (November 2018)
Original article
DOI: 10.1016/j.gastre.2018.11.007
Vedolizumab, an option in patients with inflammatory bowel disease intolerant to thiopurines and refractory to biological agents
Vedolizumab, una opción en pacientes con enfermedad inflamatoria intestinal intolerantes a tiopurinas y refractarios a biológicos
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Marisa Iborraa, Belén Beltrána,
Corresponding author
belenbeltranniclos@gmail.com

Corresponding author.
, Nuria Marotob, Pablo Navarro-Cortésc, Maia Boscá-Wattsc, Isabel Ferrer-Bradleyb, Natalia García-Moralesa, Esteban Sáez-Gonzáleza, Joaquín Hinojosab, Miguel Mínguezc, Pilar Nosa
a Departamento de Gastroenterología, Hospital Universitari i Politecnic La Fe, CiberEHD, Valencia, Spain
b Departamento de Gastroenterología, Hospital de Manises, Valencia, Spain
c Departamento de Gastroenterología, Hospital Clinic Universitari de Valencia, Valencia, Spain
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Table 1. Patient demographic and clinical characteristics.
Table 2. History of previous treatments.
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Abstract

Vedolizumab (VDZ), a human monoclonal antibody that binds specifically to α4β7-integrin, and is approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC), has demonstrated its efficacy in controlled clinical trials.

Objective

To describe a population treated with VDZ and to evaluate its long-term efficacy and safety in clinical practice.

Methods

An observational and multicentre study was carried out on patients with inflammatory bowel disease treated with VDZ for at least one year. An evaluation was performed on the activity indices, faecal calprotectin and C-reactive protein levels, hospital admissions, surgeries, and adverse events.

Results

A total of 73 patients were analysed (43 UC and 30 CD). More than one anti-TNF and more than one immunosuppressive was previously used by 74 and 23%, respectively, of UC patients, and 90 and 37%, respectively of CD patients. VDZ was stopped in 17 (23%) patients, 10 UC and 7 CD, due to a lack or loss of response before the first year, or due to adverse events. An intensification of the dose was required in 26 (63%) UC, and 16 (53%) CD patients. At 6 months, 70 and 42% of UC patients, and 80 and 43% of CD patients achieved a clinical response and remission, respectively. At one year, 58 and 35% of UC patients and 47 and 43% of CD patients, maintained the clinical response and remission, respectively. The C-reactive protein decreased significantly in both CD and UC patients. However, the decrease in faecal calprotectin was only achieved during follow-up in UC, but not in CD patients. Eight patients with CD that had been treated previously with ustekinumab avoided surgery at one year. A colectomy was performed on 8 (18.6%) UC patients, and 4 (13.3%) CD patients needed surgery. Six patients (8%) (5 UC and 1 CD) had adverse events. The concomitant use of corticosteroids or immunomodulators did not increase the efficacy. Those with a higher number of previous anti-TNF treatments showed less remissions in UC and responses in CD.

Conclusions

After one year of VDZ, a clinical response and remission was induced in a considerable percentage of patients refractory to different biological or immunosuppressive therapies. VDZ can be considered as an alternative in those intolerant to immunosuppressives, with few adverse events.

Keywords:
Ulcerative colitis
Crohn's disease
Biological treatment
Vedolizumab
Resumen

Vedolizumab (VDZ), un anticuerpo monoclonal humanizado que se une específicamente a -α4β7-integrina, aprobado para el tratamiento de la enfermedad de Crohn (EC) y la colitis ulcerosa (CU), ha demostrado su eficacia en ensayos clínicos controlados.

Objetivo

Describir una población tratada con VDZ y evaluar su efectividad y seguridad a largo plazo en práctica clínica.

Métodos

Estudio observacional y multicéntrico en pacientes con enfermedad inflamatoria intestinal tratados con VDZ durante al menos un año. Se evaluaron los índices de actividad, niveles de calprotectina fecal y proteína C reactiva, hospitalizaciones, cirugías y eventos adversos.

Resultados

Se analizaron un total de 73 pacientes (43 CU y 30 EC). El 74 y 23% de CU y el 90 y 37% de EC habían llevado previamente más de un anti-TNF y más de un inmunosupresor respectivamente. VDZ se suspendió en 17 pacientes (23%), 10 CU y 7 EC, debido a la falta o pérdida de respuesta antes del primer año o a eventos adversos. Veintisiete (63%) CU y 16 (53%) pacientes con EC requirieron intensificación de la dosis. A los 6 meses, el 70 y 42% de CU y el 80 y 43% de EC lograron respuesta clínica y remisión respectivamente. Al año, el 58 y 35% de CU y el 47 y 43% de EC mantuvieron la respuesta clínica y la remisión, respectivamente. La proteína C reactiva disminuyó significativamente tanto en la EC como en la CU. Sin embargo, la disminución de la calprotectina fecal se logró durante el seguimiento solo en CU pero no en EC. Ocho pacientes con EC que habían sido tratados previamente con ustekinumab evitaron la cirugía al año. En 8 CU (18,6%) se realizó colectomía y 4 EC (13,3%) necesitaron cirugía. Seis pacientes (8%) (5 UC y una enfermedad de Crohn) tuvieron eventos adversos. El uso concomitante de corticoides o inmunomoduladores no aumentó la efectividad. A mayor número de anti-TNF previos, menos remisión en la CU y respuesta en la EC.

Conclusiones

Tras un año de VDZ se induce respuesta y remisión clínica en una no desdeñable proporción de pacientes refractarios a diferentes biológicos o inmunosupresores. VDZ puede considerarse una alternativa en intolerantes a inmunosupresores con pocos eventos adversos.

Palabras clave:
Colitis ulcerosa
Enfermedad de Crohn
Tratamiento biológico
Vedolizumab

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