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Inicio Gastroenterología y Hepatología (English Edition) Rapidity of clinical response to adalimumab and improvement of quality of life i...
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Vol. 45. Issue 3.
Pages 165-176 (March 2022)
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Vol. 45. Issue 3.
Pages 165-176 (March 2022)
Original article
Rapidity of clinical response to adalimumab and improvement of quality of life in luminal Crohn's disease: RAPIDA study
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Ignacio Marín-Jiméneza,
Corresponding author
ignacio.marin@salud.madrid.org

Corresponding author.
, Manuel Barreiro-de Acostab, María Estevec,d, Luisa Castro-Lariae, Santiago García-Lópezf, Daniel Ceballosg, Ana Echarrih, María Dolores Martín-Arranzi, David Busquetsj, Jordina Llaók, Mercè Navarro-Llavatl, José María Huguetm, Federico Argüelles-Ariase,n, Raquel Vicentef, José Miguel Boudetf, Gema Díazo, Ana M. Sánchez-Migallónp, Francesc Casellasq, for RAPIDA trial investigators 1
a Hospital Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
b Department of Gastroenterology, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain
c Department of Gastroenterology, Hospital Universitari Mutua Terrassa, Terrassa, Spain
d Centro de investigación biomédica en Red (CIBERehd), Spain
e Department of Gastroenterology, Hospital Virgen Macarena, Sevilla, Spain
f Department of Gastroenterology, Hospital Universitario Miguel Servet, Zaragoza, Spain
g Department of Gastroenterology, Hospital Universitario Doctor Negrin, Las Palmas, Spain
h Department of Gastroenterology, Complejo Hospitalario Universitario de Ferrol, Ferrol, Spain
i Department of Gastroenterology, Hospital Universitario la Paz, IdiPaz, Madrid, Spain
j Department of Gastroenterology, Hospital Universitari Doctor Josep Trueta, Girona, Spain
k Althaia, Xarxa Assistencial Universitària de Manresa, Spain
l Department of Gastroenterology, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain
m Department of Gastroenterology, Hospital General Universitario de Valencia, Valencia, Spain
n Facultad de Medicina, Universidad de Sevilla, Sevilla, Spain
o Former AbbVie Spain S.L.U. Employee, Madrid, Spain
p AbbVie Spain S.L.U., Madrid, Spain
q Unidad de atención Crohn-Colitis (UACC), Hospital Universitari Vall d’Hebron, Barcelona, Spain
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Table 1. Baseline clinical and demographic characteristics and QoL scores of patients.
Table 2. Adverse events related to the study drug.
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Abstract
Objective

No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD.

Patients and methods

RAPIDA was an open-label, single-arm, prospective, multicenter clinical trial. Adult patients with moderately-to-severely active luminal CD, anti-TNF-naïve, and unresponsive to conventional therapy were treated with adalimumab. Clinical disease activity, QoL and inflammatory biomarkers were measured at day 4, and weeks 1, 2, 4, and 12 after treatment initiation.

Results

Eighty-six patients were included in the intention-to-treat (ITT) analyses. Clinical disease activity was reduced from a median of 9.0 points to 6.0 points at day 4. Clinical response (≥ 3-point reduction in the Harvey-Bradshaw Index, HBI) was achieved by 61.6% (d4) and 75.6% (w1) of patients in the ITT population (median 2.5 days) and with non-responder imputation (NRI), by 55.8% and 53.4%, respectively. The proportion of patients in clinical remission (HBI<5) at weeks 2 and 4 in the ITT population was 54.7% and 62.8%, respectively (median 7.0 days), and 38.4% and 45.3% in the NRI population. All QoL scores significantly improved and inflammatory biomarkers significantly decreased from day 4 onwards (p<0.0001).

Conclusion

Rapid clinical response and remission, improvement in QoL and fatigue, and a reduction of inflammatory biomarkers were achieved with adalimumab as early as day 4 in adult anti-TNF-naïve patients with moderately-to-severely active CD.

Keywords:
Crohn's disease
Inflammatory bowel disease
Biologic therapies
Inflammation
Resumen
Objetivo

No hay estudios que evalúen la rapidez de la respuesta a las terapias biológicas en la enfermedad de Crohn (EC). El objetivo fue evaluar la rapidez del inicio de la respuesta clínica y el impacto en la calidad de vida (CdV) de la terapia con adalimumab en pacientes adultos con EC moderada-grave.

Pacientes y métodos

RAPIDA fue un ensayo clínico abierto, de un solo brazo, prospectivo y multicéntrico. Se trató con adalimumab a pacientes adultos con EC luminal activa moderada-grave, sin tratamiento previo con anti-TNF y sin respuesta a terapia convencional. Se midieron la actividad clínica de la enfermedad, la CdV y los biomarcadores inflamatorios el día 4 y las semanas 1, 2, 4 y 12 tras el tratamiento.

Resultados

Se incluyeron 86 pacientes en los análisis por intención de tratar (IdT). La actividad clínica de la enfermedad se redujo de una mediana de 9,0 a 6,0 puntos en el día 4. La respuesta clínica (reducción ≥3 puntos en el Índice Harvey-Bradshaw, IHB) se dio en un 61,4% (d4) y un 75,6% (s1) de los pacientes IdT y en un 55,8% y un 53,4% con imputación de no respondedores (INR). La proporción de pacientes IdT en remisión clínica (IHB<5) en las s2 y s4 fue de 54,7% y 62,8%, respectivamente, y 38,4% y 45,3% en la población INR. Todas las puntuaciones de CdV mejoraron significativamente y los biomarcadores inflamatorios disminuyeron significativamente desde el día 4 (p<0,0001).

Conclusiones

Se logró una rápida respuesta clínica y remisión, mejoría en la CdV y fatiga, y una reducción de los biomarcadores inflamatorios en los pacientes tratados con adalimumab ya en el día 4.

Palabras clave:
Enfermedad de Crohn
Enfermedad inflamatoria intestinal
Terapias biológicas
Inflamación

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