Adalimumab vs Azathioprine for Preventing CD Recurrence: Which Is Better?

Adalimumab (ADA) is not a more effective prophylaxis than azathioprine (AZA) for the prevention of Crohn disease (CD) recurrence following ileocolonic resection, according to a recent study. However, ADA was much more tolerable in this cohort.

CD will almost certainly recur postoperatively without the use of prophylaxis. However, little evidence for optimal treatment options currently exists.
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For their study, the researchers assessed 91 patients who had received ileocolonic resection. Median patient age was 35 years, and median disease duration was 6 years. Additionally, 23.8% of patients were smokers, and 7.1% had previous resections. Patients were randomly assigned to receive either 160-80-40 mg subcutaneous ADA or 2.5 mg/kg/day AZA, both associated with metronidazole.

The primary outcome, which was evaluated by a blinded central reader, was endoscopic recurrence at 1 year, defined as Rutgeerts i2b, i3, or i4.

A total of 84 patients received the study drugs, while 11 (13.1%) discontinued treatment due to adverse events. Results indicated that treatment discontinuation had been significantly less frequent in patients taking ADA (4.4%) vs patients taking AZA (23.2%).

The intention-to-treat analysis showed that therapy had failed in 23 (59%) patients taking AZA, and in 19 (42.2%) taking ADA. Furthermore, the per-protocol analysis of 61 patients with centrally evaluable images indicated that CD recurrence had occurred in 8 (33%) patients taking AZA and 11 (29.7%) taking ADA.

“ADA has not demonstrated a better efficacy than AZA (both associated with metronidazole) for prophylaxis of [postoperative recurrence of CD] in an unselected population, although tolerance to ADA is significantly better,” the researchers concluded.

—Christina Vogt

Reference:

López-Sanromán A, Vera-Mendoza I, Domènech E, et al; Spanish GETECCU group. Adalimumab vs azathioprine in the prevention of postoperative Crohn’s disease recurrence. A GETECCU randomised trial. J Crohn Colitis.2017;11(11):1293-1301. https://doi.org/10.1093/ecco-jcc/jjx051.