This study aim was to clarify the efficacy of early adalimumab (ADA) and azathioprine (AZA) in Postoperative recurrence of Crohn’s disease (CD).

In a 78-week single-center prospective study, patients with bowel resection were randomly assigned to ADA 160-80-40 mg subcutaneously (SC) or AZA 0.5-1.5 mg/kg/day. The primary endpoint was endoscopic remission at 18 months (Rutgeerts i0, i1 and Simple endoscopic score for CD (SES-CD) ≤ 4).

A total of 47 patients (median age 39.0 years, disease duration 9.5 years, 19.1% smokers, 44.6% previous resections) were recruited, 39 patients were received the study drugs. Endoscopic remission was confirmed in 5/16 patients in the AZA group (31.2%) and 7/12 patients in the ADA group (58.3%) (p=0.24) in the intention-to-treat population. In the per-protocol population (19 patients with evaluable images), remission was recorded in 3/9 (33.3%) patients in the AZA and 7/10 (70.0%) in the ADA group (p=0.17). Re-surgery rate was trend to higher in the AZA group (21.1%) than in the ADA group (0%) (p=0.10). Treatment was discontinued due to adverse events in 6 patients (15.3%), severe adverse events were significantly more frequent in the AZA group than in the ADA group (AZA, 25.0% vs ADA, 0%; p=0.04). Conclusions: Early ADA did not show statistically better efficacy than AZA for postoperative CD recurrence in this study, although safety profile of ADA is better. (UMIN000032485).

Crohn's disease (CD) is known in its various forms as regional enteritis, granulomatous ileitis and colitis. Clinical and endoscopic recurrence are common after CD surgery, and a substantial proportion of patients require multiple surgeries. Despite increasing evidence for CD postoperative outcome and drug therapies, therapy for prevention of postoperative recurrence (POR) remains the subject of debate. Thiopurines and anti-TNF-α agents are more effective than placebo for preventing POR. Direct comparison of efficacy ADA or AZA for POR is not sufficient, and this study was conducted.

The Study was 78-week, single-center, prospective randomized study. The study was approved by the Institutional Review Board of the coordinating center (Sakura medical center, Toho university: and confirmed by the local ethics committees) (UMIN000032485). The study period ranged from January 2015 to December 2018. Patients aged 20-70 years with a confirmed diagnosis of CD based on the criteria determined by the Japanese Ministry of Health, Labor and Welfare, and who were candidates for clinically indicated intestinal resection, were approached to obtain their informed consent before surgery. Patients with stoma creation or perianal surgery were excluded. The usual contraindications to azathioprine and anti-TNFα therapy were also exclusion criteria.

Thanks and Regards,

Alpine

Associate

Journal of Clinical Trials

clinicaltrials@eclinicalsci.com