Original ResearchFull Report: Clinical—Alimentary TractEarly Azathioprine Therapy Is No More Effective Than Placebo for Newly Diagnosed Crohn's Disease
Section snippets
Study Design
The AZathioprine for Treatment or Early Crohn's disease in adults (AZTEC) study (EudraCT 2005-001186-34) was an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial conducted in 31 Spanish hospitals under the auspice of the Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) between February 2006 and September 2009. The investigational review board at each center approved the protocol, and all patients provided written informed consent
Patient Characteristics and Disposition
A total of 131 patients were randomized to treatment; 68 were assigned to azathioprine and 63 to placebo. The baseline characteristics of the patients were similar (Table 1); in all cases, the presence of active lesions was shown by endoscopy and/or magnetic resonance imaging within the 8 weeks before randomization. In keeping with the inclusion criteria that mandated inclusion of patients with new-onset disease and no internal penetrating or perianal fistulizing disease, none of the patients
Discussion
In this study performed in adults with new-onset CD, treatment with azathioprine within 8 weeks of diagnosis was not more effective than placebo for achieving long-term sustained corticosteroid-free remission. Although a number of predefined secondary efficacy measures pointed toward a benefit of azathioprine, these differences were not statistically significant. Only a post hoc analysis redefining the criteria for relapse as a CDAI score >220 showed that the proportion of patients experiencing
Acknowledgments
A list of investigators and centers of the AZTEC Study Group is provided in Appendix.
The authors thank Dr Brian G. Feagan for providing his insight and advice in the preparation of the manuscript as well as Dr Carlos Cara and UCB Pharma Iberica for supplying the study medication.
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Author names in bold designate shared co-first authorship.
Conflicts of interest The authors disclose no conflicts.
Funding Sponsored by Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa.