High reoperation rates after resective surgery for Crohn's Disease have lead to an increase in the use of conservative surgery.
This study by Sandro Ardizzone and colleagues looks at the efficacy and safety of azathioprine and mesalamine in the prevention of clinical and surgical relapse in patients who have undergone conservative surgery for Crohn’s disease.
Mesalamine was investigated for the prevention of postoperative relapse, with disappointing results.
The role of azathioprine in the postoperative setting is unknown.
The group performed a prospective, open-label, randomized study, in which a total of 142 patients received azathioprine or mesalamine for 24 months.
|Comparable risk of clinical relapse with azathioprine and mesalamine.|
No difference in surgical relapse.
The researchers' definition of clinical relapse was: "the presence of symptoms with a Crohn’s Disease Activity Index score >200" and surgical relapse as "the presence of symptoms refractory to medical treatment or complications requiring surgery."
The group found that after 24 months, the risk of clinical relapse was comparable in the azathioprine and mesalamine groups, both on intention-to-treat and per-protocol analyses. However, they found no difference with respect to surgical relapse at 24 months between the 2 groups.
Further subgroup analysis revealed that azathioprine was more effective than mesalamine in preventing clinical relapse in patients with previous intestinal resections.
22% of patients receiving azathioprine were forced to withdraw from treatment due to adverse effects compared to only 8% of those on mesalamine.
The group commented, "No difference was observed in the efficacy of azathioprine and mesalamine in preventing clinical and surgical relapses after conservative surgery."
"However, azathioprine is more effective in those patients who have undergone previous intestinal resection."