Format

Send to

Choose Destination
J Crohns Colitis. 2017 Oct 27;11(11):1293-1301. doi: 10.1093/ecco-jcc/jjx051.

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

Author information

1
Gastroenterology-Hepatology Unit, Hospital Ramón y Cajal, Madrid, Spain.
2
Gastroenterology-Hepatology Unit, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain.
3
Gastroenterology-Hepatology Unit, Hospital Germans Trias i Pujol, Badalona, Spain.
4
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBERehd], Instituto de Salud Carlos III, Madrid, Spain.
5
Digestive Diseases Unit, Hospital Clínico San Carlos, Instituto Investigación Sanitaria San Carlos [IdISSC], Madrid, Spain.
6
General Surgery Unit, Hospital Universitario Puerto Real, Puerto Real, Spain.
7
Digestive Diseases Unit, Hospital Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón [IiSGM], Madrid, Spain.
8
Gastroenterology-Hepatology Unit, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, Spain.
9
Digestive Diseases Unit, Hospital Universitario Virgen de Macarena, Sevilla, Spain.
10
Gastroenterology-Hepatology Unit, Hospital Universitari Mutua Terrassa, Terrassa, Spain.
11
Digestive Diseases Unit, Hospital Reina Sofía, Córdoba, Spain.
12
Gastroenterology-Hepatology Unit, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas, Spain.
13
Digestive Diseases Unit, Hospital 12 de Octubre, Madrid, Spain.
14
Digestive Diseases Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria La Princesa [IIS-IP], Madrid, Spain.
15
Digestive Diseases Unit, Hospital Clínic de Valencia, University of Valencia, Valencia, Spain.
16
Digestive Diseases Unit, Hospital Arquitecto Marcide, Ferrol, Spain.
17
Digestive Diseases Unit, Corporació Sanitària Parc Taulí, Sabadell, Spain.
18
Digestive Diseases Unit, Hospital Universitario Río Hortega, Valladolid, Spain.
19
Digestive Diseases Unit, Hospital de Manises, Valencia, Spain.
20
Digestive Diseases Unit, Hospital Universitario La Paz, Madrid, Spain.
21
Gastroenterology-Hepatology Unit, Hospital Del Mar, Barcelona, Spain.
22
Digestive Diseases Unit, Hospital Universitario de Fuenlabrada, Fuenlabrada, Spain.
23
Radiology Unit, Hospital Clínic, University of Barcelona, Barcelona, Spain.
24
Digestive Diseases Unit, Hospital Universitario y Politécnico de La Fe, Valencia, Spain.

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. ClinicalTrials.gov NCT01564823.

KEYWORDS:

Crohn’s disease; adalimumab; azathioprine

PMID:
28402454
DOI:
10.1093/ecco-jcc/jjx051
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center