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Early azathioprine therapy did not lead to Crohn’s disease remission
Patients with Crohn’s disease treated with azathioprine shortly after diagnosis were no more likely to experience corticosteroid-free remission than those who received standard care or placebo in two recent studies.
In a multicenter, open-label trial, researchers randomly assigned patients diagnosed with Crohn’s disease (CD) within the prior 6 months 2.5 mg/kg/day azathioprine (n=65) or standard care (n=67), in which azathioprine is administered only if poor response to or dependency on corticosteroids, chronic active disease or severe perianal disease occurs.
During 3 years of follow-up, remission was observed in a median of 67% of trimesters, compared with 56% of standard care patients (P=.69 for difference). More patients in the azathioprine group did not require perianal surgery (P=.04), but a similar number underwent intestinal surgery (P=.68). Flares, hospitalizations, and corticosteroid and anti-TNF medication use occurred similarly between groups.
“These results do not support systematic early prescription of azathioprine in adult patients with CD at risk for a disabling course,” the researchers concluded.
In a separate, prospective, double blind trial, patients diagnosed with CD within the previous 8 weeks were randomly assigned 2.5 mg/kg/day azathioprine (n=68) or placebo (n=63) for 76 weeks.
Corticosteroid-free remission was observed in 44.1% of treated and 36.5% of placebo recipients during follow-up (P=.48), and the study was stopped early after meeting predetermined futility criteria during interim analysis. Corticosteroids were required with similar frequency between groups. Relapse, defined as a Crohn’s Disease Activity Index (CDAI) score above 175 after 12 weeks, was similar among groups, but less common in treated patients when relapse was defined as CDAI above 220 (11.8% of patients vs. 30.2%; P=.01).
“Azathioprine was not effective for achieving sustained corticosteroid-free remission in an unselected population of adults with newly diagnosed CD,” the researchers wrote, “but the superiority of azathioprine for preventing moderate to severe relapse observed in a post-hoc analysis suggests that the treatment might be of benefit in a selected population of more severe patients, although this remains to be proven in a study focused on this population.”
Disclosure: Researchers for the study by Cosnes reported numerous relevant financial disclosures; those for the Panés trial reported no relevant financial disclosures.