Adalimumab no better than azathioprine for preventing Crohn's disease recurrence

Last Updated: 2017-04-26

By Will Boggs MD

NEW YORK (Reuters Health) - Adalimumab is no better than azathioprine for preventing recurrence of Crohn's disease after surgery, researchers from Spain report.

"We started the study thinking that adalimumab would be clearly superior, influenced by data on infliximab available at the time,” Dr. Antonio Lopez-SanRoman from Hospital Ramon y Cajal, Madrid, Spain told Reuters Health. “We were surprised to find adalimumab and azathioprine to be equivalent in this setting.”

After surgery, up to 70% of patients with Crohn's disease develop lesions proximal to the ileocolonic anastomosis. Thiopurines help prevent postoperative recurrence, but they carry a high risk of adverse events. Limited data support the use of infliximab and adalimumab in this setting.

Dr. Lopez-SanRoman and colleagues in the APPRECIA study compared early postoperative use of adalimumab or azathioprine for preventing postoperative recurrence in a randomized controlled trial of 85 patients undergoing surgery for Crohn's disease.

Twelve of 40 patients randomized to azathioprine dropped out (nine due to adverse events), as did four of 45 randomized to adalimumab (one due to an adverse event), researchers reported April 11th online in the Journal of Crohn's and Colitis.

Endoscopic recurrence rates did not differ between the azathioprine group (8/24, 33.3%) and the adalimumab group (11/37, 29.7%; P=0.76).

The two groups did not differ significantly in changes of Crohn's Disease Activity Index after 24 or 52 weeks of therapy, and there were no differences in hospitalizations or surgery or in C-reactive protein, fecal calprotectin, or erythrocyte sedimentation rate.

Overall, 72 patients (85.7%) experienced 232 adverse events, with no significant differences between the groups.

“In conclusion, our trial could not demonstrate the superiority of adalimumab over azathioprine (both associated to metronidazole) in the prevention of postoperative recurrence,” the researchers say. “In view of its availability, convenience, and cost, azathioprine should be still the drug of choice in this setting, except in the case of patients with previous or current intolerance, who should receive adalimumab if necessary. The efficacy of both drugs, however, is partial, and an endoscopic examination should be performed at some point to assess the presence of significant endoscopic recurrence, which can then be treated.”

“Prophylaxis of Crohn's disease postoperative recurrence is still an undecided issue,” Dr. Lopez-SanRoman said. “Thinking away from thiopurines is probably not wise.”

Fourteen of the 24 authors had various relationships with AbbVie Inc.

SOURCE: http://bit.ly/2pzQiK5

J Crohns Colitis 2017.