1. Inicio
  2. Publicaciones
  3. Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial

Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Lopez-Sanroman, A
  • Vera-Mendoza, I
  • Domènech E
  • Taxonera, C
  • Vega Ruiz V
  • Marin-Jimenez, I
  • Guardiola, J
  • Castro, L
  • Esteve, M
  • Iglesias, E
  • Ceballos, D
  • Martinez-Montiel, P
  • Gisbert, JP
  • Minguez, M
  • Echarri, A
  • Calvet, X
  • Barrio, J
  • Hinojosa, J
  • Martin-Arranz, MD
  • Marquez-Mosquera, L
  • Bermejo, F
  • Rimola, J
  • Spanish GETECCU Grp APPRECIA Study

Grupos

Abstract

Background and Aims: Postoperative recurrence of Crohn's disease [POR-CD] is almost certain if no prophylaxis is administered. Evidence for optimal treatment is lacking. Our aim was to compare the efficacy of adalimumab [ADA] and azathioprine [AZA] in this setting. Methods: We performed a phase 3, 52-week, multicentre, randomised, superiority study [APPRECIA], in which patients with ileocolonic resection were randomised either to ADA 160-80-40 mg subcutaneously [SC] or AZA 2.5 mg/kg/day, both associated with metronidazole. The primary endpoint was endoscopic recurrence at 1 year [Rutgeerts i2b, i3, i4], as evaluated by a blinded central reader. Results: We recruited 91 patients [median age 35.0 years, disease duration 6.0 years, 23.8% smokers, 7.1% previous resections]. The study drugs were administered to 84 patients. Treatment was discontinued owing to adverse events in 11 patients [13.1%]. Discontinuation was significantly less frequent in the ADA [4.4%] than in the AZA group [23.2%] (dif.: 18.6% [95% CI 4.1-33.2], p = 0.011). According to the intention-to-treat analysis, therapy failed in 23/39 patients in the AZA group [59%] and 19/45 patients in the ADA group [42.2%] [p = 0.12]. In the per-protocol analysis [61 patients with centrally evaluable images], recurrence was recorded in 8/24 [33.3%] patients in the AZA and 11/37 [29.7%] in the ADA group [p = 0.76]. No statistically significant differences between the groups were found for recurrence in magnetic resonance images, biological markers of activity, surgical procedures, or hospital admissions. Conclusions: ADA has not demonstrated a better efficacy than AZA [both associated with metronidazole] for prophylaxis of POR-CD in an unselected population, although tolerance to ADA is significantly better.

Datos de la publicación

ISSN/ISSNe:
1873-9946, 1876-4479

Journal of Crohns & Colitis  OXFORD UNIV PRESS

Tipo:
Article
Páginas:
1293-1301
PubMed:
28402454
Factor de Impacto:
2,728 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 71

Documentos

  • No hay documentos

Métricas

Filiaciones mostrar / ocultar

Keywords

  • Crohn's disease; azathioprine; adalimumab

Campos de Estudio

Compartir