P-060 Mid- to Long-Term Outcomes of Adalimumab Maintenance Treatment for Japanese Patients with Crohnʼs Disease and Associated Prognostic Factors

Abstract

Background: Maintenance treatment with adalimumab has enabled the achievement of mid- to long-term remission in patients with Crohn's disease (CD). However, there are few reports on the efficacy of adalimumab in Japanese CD patients. Here, we evaluated the mid- to long-term outcomes of adalimumab maintenance treatment in Japanese patients with CD and associated prognostic factors. Methods: We investigated all patients treated with adalimumab for luminal CD between October 2010 and November 2013 at the IBD Center, Sapporo Kosei General Hospital. The effectiveness of adalimumab maintenance treatment was evaluated using sustained treatment success rates, which were estimated using the Kaplan-Meier method. Sustained treatment success was defined as a lack of treatment failure. Treatment failure was defined as follows: (1) discontinuation of adalimumab because of the loss of response or side effects; (2) dose escalation required because of the loss of response; or (3) need of surgery for CD. Prognostic factors associated to the sustained treatment success rates were evaluated using log-rank tests and multivariate Cox regression analysis. Results: Of the 131 patients included in this study (mean age, 30.3 years), 48 were females. The mean duration of disease was 8.1 years. The mean C-reactive protein level was 2.0 mg/dL. Ninety-two patients had ileocolitis, 23 had ileitis, and 16 had colitis. In addition, 39 patients had stricturing disease, 9 had intra-abdominal fistulas, and 70 had perianal disease. Thirty-three patients were smokers. Concomitant treatment with azathioprine or 6-mercaptopurine, 5-aminosalicylic acid, elemental diet therapy, and prednisolone was administered in 52, 111, 54, and 15 patients, respectively. Before initiating adalimumab therapy, 58 patients had had at least one intestinal resection, 73 patients were naive to infliximab. The 1-, 2-, 3- and 4-year sustained treatment success rates were 66%, 53%, 47%, and 44%, respectively. Previous infliximab use, stricturing disease, intra-abdominal fistulas, and previous bowel resection were significant prognostic factors of treatment failure. Previous infliximab use, stricturing disease, intraabdominal fistulas, and colitis type were identified as independent predictors of treatment failure. The 1-, 2-, 3- and 4-year sustained treatment success rates in patients naive to infliximab were 77%, 72%, 65%, and 60%, respectively. Conclusions: Treatment failure was experienced by about 60% of Japanese patients with CD receiving adalimumab maintenance treatment over a 4-year period. Care should be taken when administering adalimumab maintenance treatment to CD patients with previous use of infliximab, stricturing disease, or intra-abdominal fistulas. In addition, the mid- to long-term outcomes of adalimumab maintenance treatment of CD patients naive to infliximab was comparatively good