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Vol. 43. Issue 9.
Pages 497-505 (November 2020)
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Vol. 43. Issue 9.
Pages 497-505 (November 2020)
Original article
Ustekinumab in Crohn's disease: Effectiveness and safety in clinical practice
Ustekinumab en enfermedad de Crohn: efectividad y seguridad en práctica clínica
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Cristina Saldaña Dueñasa,
Corresponding author
crisaldu@hotmail.com

Corresponding author.
, María Rullán Iriartea, Alfonso Elosua Gonzálezb, Cristina Rodríguez Gutiérreza, Saioa Rubio Iturriaa, Óscar Nantes Castillejoa
a Servicio de Aparato Digestivo, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
b Servicio de Aparato Digestivo, Hospital García Orcoyen, Estella, Navarra, Spain
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Tables (5)
Table 1. Demographic baseline characteristics of the patients.
Table 2. Clinical baseline characteristics of activity and biochemical parameters.
Table 3. Response rates depending on whether ustekinumab was the second, third, fourth or fifth biological.
Table 4. Response rates according to the reason for indication of ustekinumab (no primary response, loss of secondary response or allergy/intolerance of previous biological).
Table 5. Summary of the baseline characteristics of the different clinical practice studies.
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Abstract
Introduction

Ustekinumab (UST) is a monoclonal antibody against IL-12/23 approved in Spain (2017) to treat moderate/severe Crohn's disease.

Objective

To evaluate the effectiveness and safety in real clinical practice in patients treated with UST in our centre.

Methods

This is a prospective observational study including patients who started UST from 08/01/2017 to 02/28/2019 with follow-up up to that date. We analyse response and remission in weeks 16, 24 and 52, using “Crohn's Disease Activity Index” (response if 100 point decrease and remission if <150) and Physician's Global Assessment.

Results

We included 61 patients with a median duration of Crohn's disease of 14.6 years (0–36). The 83.6% of patients without steroids and 73.8% without associated immunosuppressors. Previously all patients had received anti-TNF and 14.8%, in addition, vedolizumab.

We observed a good correlation between Crohn's Disease Activity Index and Physician's Global Assessment (r=0.89, p<.001). In week 16 (n=45) 75.6% response (57.8% remission), in week 24 (n=35) 69.9% response (45.7% remission) and in week 52 (n=12) 75% response (58.3% remission). There were no statistically significant differences in the response/remission rates at week 16 or 24 depending on the reason for the onset of UST or the number of previous biologics. In 2 patients it was withdrawn due to toxicity (arthralgia/myalgia).

Conclusion

UST is an effective and safe treatment in real clinical practice with high rates of clinical remission at week 16, 24 and 52 regardless of the order of biological used and the reason for starting UST.

Keywords:
Ustekinumab
Crohn's disease
Inflamatory bowel disease
Resumen
Introducción

Ustekinumab (UST) es un anticuerpo monoclonal frente a IL-12/23 aprobado en España (2017) para tratar el brote moderado/grave de enfermedad de Crohn.

Objetivo

Evaluar la efectividad y seguridad en práctica clínica real en los pacientes tratados con UST en nuestro centro.

Métodos

Estudio prospectivo observacional unicéntrico incluyendo los pacientes que iniciaron UST desde el 1/08/2017 hasta el 28/02/2019 con seguimiento hasta esa fecha. Analizamos respuesta y remisión en semanas 16, 24 y 52, utilizando «Crohn's Disease Activity Index» (respuesta si descenso de 100 puntos y remisión si <150) y la «Valoración Global del especialista» traducción del «Physician's Global Assessment».

Resultados

Incluimos 61 pacientes con una mediana de duración de enfermedad de Crohn de 14,6 años (0-36). El 83,6% sin esteroides y el 73,8% sin inmunosupresores asociados. Previamente todos habían recibido anti-TNF y el 14,8%, además, vedolizumab.

Observamos buena correlación entre Crohn's Disease Activity Index y Valoración Global del especialista (r=0,89, p<0,001). En la semana 16 (n=45) un 75,6% de respuesta (57,8% remisión), en semana 24 (n=35) 69,9% respuesta (45,7% remisión) y en semana 52 (n=12) 75% respuesta (58,3% remisión). No se obtuvieron diferencias estadísticamente significativas en la tasa de respuesta/remisión en semana 16 ni 24 en función del motivo de inicio de UST o el número de biológicos previos. En 2 pacientes se retiró por toxicidad (artralgias/mialgias).

Conclusión

UST es un fármaco eficaz y seguro en práctica clínica real con altas tasas de remisión clínica en semana 16, 24 y 52 independientemente del orden de biológico utilizado y del motivo de inicio de UST.

Palabras clave:
Ustekinumab
Enfermedad de Crohn
Enfermedad inflamatoria intestinal

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