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Title: Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial.
Authors: López-Sanromán, Antonio
Vera-Mendoza, Isabel
Domènech, Eugeni
Taxonera, Carlos
Vega Ruiz, Vicente
Marín-Jiménez, Ignacio
Guardiola, Jordi
Castro, Luisa
Esteve, María
Iglesias, Eva
Ceballos, Daniel
Martínez-Montiel, Pilar
Gisbert, Javier P
Mínguez, Miguel
Echarri, Ana
Calvet, Xavier
Barrio, Jesús
Hinojosa, Joaquín
Martín-Arranz, María Dolores
Márquez-Mosquera, Lucía
Bermejo, Fernando
Rimola, Jordi
Pons, Vicente
Nos, Pilar
Spanish GETECCU group [APPRECIA study]
Keywords: Crohn’s disease;adalimumab;azathioprine
metadata.dc.subject.mesh: Adalimumab
Crohn Disease
Immunosuppressive Agents
Postoperative Care
Secondary Prevention
Issue Date: 2017
Abstract: 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. NCT01564823.
metadata.dc.identifier.doi: 10.1093/ecco-jcc/jjx051
Appears in Collections:Producción 2020

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