%0 Journal Article
%A López-Sanromán, Antonio
%A Vera-Mendoza, Isabel
%A Domènech, Eugeni
%A Taxonera, Carlos
%A Vega Ruiz, Vicente
%A Marín-Jiménez, Ignacio
%A Guardiola, Jordi
%A Castro, Luisa
%A Esteve, María
%A Iglesias, Eva
%A Ceballos, Daniel
%A Martínez-Montiel, Pilar
%A Gisbert, Javier P
%A Mínguez, Miguel
%A Echarri, Ana
%A Calvet, Xavier
%A Barrio, Jesús
%A Hinojosa, Joaquín
%A Martín-Arranz, María Dolores
%A Márquez-Mosquera, Lucía
%A Bermejo, Fernando
%A Rimola, Jordi
%A Pons, Vicente
%A Nos, Pilar
%A Spanish GETECCU group [APPRECIA                    study]
%T Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial.
%D 2017
%U http://hdl.handle.net/10668/11087
%X 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. 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. 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. 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.
%K Crohn’s disease
%K adalimumab
%K azathioprine
%~