P557 Improved mucosal healing during scheduled adalimumab maintenance therapy in patients with Crohn's disease initiated following surgical resection of active lesions
A. Yamada*, H. Iwashita, T. Sasaki, M. Katsumata, M. Miyamura, H. Kikuchi, T. Arai, R. Iwasa, R. Furukawa, K. Sono, A. Osamura, K. Nakamura, H. Aoki, Y. Yoshimatsu, Y. Tsuda, K. Takeuchi, N. Takada, Y. Suzuki
Toho University, Sakura Medical Centre, Division of Gastroenterology, Department of Internal Medicine, Sakura, Japan
Crohn's disease (CD) is a chronic relapsing-remitting inflammatory bowel disorder with variable disease expressions, giving rise to multiple complications. CD can affect any part of the digestive track from the mouth to the perianal region. Adalimumab(ADA) is an anti-tumour necrosis factor (TNF) antibody, which has shown efficacy in patients with CD. Further, given its efficacy in active CD, ADA has been reported to be effective as maintenance therapy to post-operative recurrence. However, examinations of endoscopic images indicate that during maintenance ADA, complete mucosal healing is not achieved and that disease activity continues including the formation of intestinal strictures.
With the afore background in mind, we thought that ADA maintenance therapy might produce an improved efficacy if administered immediately following surgical removal of active CD lesions (we called this 'Re-set ADA therapy'). This study was prospective, single center, open-label analysis. A total of 48 patients were included, the conventional therapy group (conventional, n=15), the routine ADA group (Routine ADA, n=6) and the Re-set ADA group (Re-set ADA, n=27). In the conventional group at low-risk for post-operative recurrence (POR), patients received metronidazole, 5-ASA, enteral nutrition or azathiopurine to induce remission of CD relapse following surgery. In the Routine ADA group, patients received ADA to induce remission of CD relapse following surgery to eliminate all colonoscopically detectable active CD lesions and then received scheduled maintenance. Similarly, in the Re-set ADA group at high risk for POR, patients received scheduled maintenance ADA immediately following surgery to eliminate active CD lesions. Several groups were followed for 1 year during which patients disease profiles including mucosal healing were monitored.
During 1 years of follow up, remission maintenance rates were 33.3%, respectively in the conventional group. The corresponding maintenance remission rates in the Routine ADA group were 33.3%, and in the Re-set ADA group 70.3%. Likewise, complete mucosal healing (rutgeerts score i0) rate at 1 year was 0% in the conventional group, 0% in the Routine ADA and 54.5% in the Re-set ADA group, reflecting vastly better maintenance efficacy rates in the Re-set ADA group as compared with the conventional group or Routine ADA group. (p=0.00153, p=0.090)
In the clinical settings described above, scheduled maintenance ADA therapy appeared to produce improved efficacy outcomes when initiated immediately after resections of active CD lesions. More notably, the efficacy of ADA to induce mucosal healing was better in the Re-set treatment setting vs the conventional therapy or routine setting.