September 17, 2013
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Adalimumab prevented Crohn’s disease recurrence after resection better than standard therapies

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Adalimumab was more effective than azathioprine or mesalamine at preventing endoscopic and clinical Crohn’s disease recurrence after ileocolonic resection in a recent study.

Researchers randomly assigned 51 patients with Crohn’s disease who had undergone ileocolonic resection to subcutaneous injections of 40 mg adalimumab (ADA) every 2 weeks (n=16), 2 mg/kg/day azathioprine (AZA) (n=17) or 3/g/day mesalamine (n=18) for 2 years between May 2008 and October 2010. Treatment began 2 to 4 weeks after resection, with incidence of endoscopic or clinical recurrence after 2 years as the primary outcome. Quality of life was measured via the Inflammatory Bowel Disease Questionnaire (IBD-Q) 1 month before surgery and at 12 and 24 months.

Patients in the ADA group (6.3%) had a significantly lower rate of endoscopic recurrence than either AZA (64.7%; OR=0.036; 95% CI, 0.004-0.347) or mesalamine recipients (83.3%, OR=0.013; 95% CI, 0.001-0.143). ADA patients (12.5%) also had significantly lower incidence of clinical recurrence than either group (64.7% among AZA patients; OR=0.078; 95% CI, 0.013-0.464; 50% among mesalamine patients; OR=0.143; 95% CI, 0.025-0.819). Clinical remission, defined as a CDAI score below 150, was significantly less common in the AZA group (OR=0.021; 95% CI, 0.002-0.207) and mesalamine group (OR=0.033; 95% CI, 0.004-0.316) compared with ADA recipients.

Questionnaire responses indicated a better quality of life in the ADA group than either AZA (OR=0.028; 95% CI, 0.004-0.196) or mesalamine recipients (OR=0.015; 95% CI, 0.002-0.134). Investigators said AZA and mesalamine patients did not differ significantly with regard to endoscopic or clinical recurrence or quality of life.

Adverse events occurred at similar rates across all groups.

“Our study provides strong evidence that ADA is much more effective than the traditional medications (AZA or mesalamine) in preventing endoscopic and clinical postoperative recurrence of CD, and provides a rationale for aggressive postoperative chemoprevention with biologic therapy,” the researchers wrote. “To our knowledge, this is the first randomized controlled trial in which ADA has been successfully used to prevent postoperative CD recurrence, an event considered almost mandatory in the natural history of this disorder.”

Disclosure: The researchers report no relevant financial disclosures.