P-059 Short-Term Outcomes of Adalimumab for Japanese Patients with Crohn's Disease and Associated Prognostic Factors. (March 2016)

• Record Type: Journal Article
• Authors: Miyakawa, Maki; Tanaka, Hiroki; Nasuno, Masanao; Motoya, Satoshi
• Is Part Of: Inflammatory bowel diseases. Volume 22(2016:Mar.)Supplement 1
• Publication Date: 2016-03
• Subjects: Inflammatory bowel diseases -- Periodicals; Colitis, Ulcerative -- Periodicals; Crohn Disease -- Periodicals; Inflammatory Bowel Diseases -- Periodicals; 616.344
• DOI: 10.1097/01.MIB.0000480163.00922.bd
• Languages: English
• ISSNs: 1078-0998

Abstract

Abstract : Background: In Japan, adalimumab has only been used to treat patients with Crohn's disease (CD) for approximately 4 years. Therefore, the factors that determine the efficacy of adalimumab treatment in Japanese CD patients are unclear. Here, we evaluated the short-term outcomes of adalimumab for patients with CD and its associated prognostic factors. Methods: Retrospective data were collected from patients with luminal CD who received adalimumab treatment at some time between October 2010 to November 2014 at the IBD Center, Sapporo Kosei General Hospital. The initial Harvey–Bradshaw index (HBI) score of these subjects was ≥5; remission was defined as an HBI score of ⩽4 and complete remission (CR) was defined as an HBI score of ⩽4 with a normal C-reactive protein (CRP) level. The HBI score and CRP level were investigated at baseline and at 2, 4, 8, and 12 weeks following adalimumab administration. Missing data were imputed by the last observation carried forward method. The prognostic factors associated with the CR rate at 12 weeks were evaluated via univariate analysis. Further, we investigated the effect of previous treatment with infliximab on the CR rate at 12 weeks. Results: Of the 78 patients included in this study (mean age, 31.2 years), 28 were females. The mean duration of disease was 6.4 years. The mean CRP level and HBI score at baseline were 1.87 mg/dL and 8.1, respectively. Fifty-two patients had ileocolitis, 13 had ileitis, and 13 had colitis. In addition, 23 patients had stricturing disease, 4 had intra-abdominal fistulas, and 43 had perianal disease. Sixteen patients were smokers. Concomitant treatment with azathioprine or 6-mercaptopurine, 5-aminosalicylic acid, elemental diet therapy, and prednisolone was administered in 29, 64, 30, and 14 patients, respectively. Before initiating adalimumab therapy, 23 patients had had at least one intestinal resection, and 51 patients were naïve to infliximab. The respective HBI scores and CRP levels significantly decreased sequentially from baseline to 2, 4, 8, and 12 weeks as follows: from 8.1 and 1.87 mg/dL to 4.0 and 0.76 mg/dL, 3.1 and 0.54 mg/dL, 3.4 and 0.83 mg/dL, and 3.4 and 1.12 mg/dL. The remission and CR rates at 2, 4, 8, and 12 weeks were 64% and 35%, 80% and 59%, 73% and 56%, and 73% and 55%, respectively. Stricturing disease, intra-abdominal fistulas, previous bowel resection, and previous infliximab use significantly decreased the CR rate at 12 weeks. A significant 12-week CR rate was achieved in patients with greater disease duration and a higher baseline HBI score. The CR rate at 12 weeks was significantly higher in patients naïve to infliximab compared with those who had previously undergone infliximab therapy (73% versus 22%, P < 0.001); no significant prognostic factor associated to the CR rate at 12 weeks was identified in both groups. Conclusions: The efficacy of adalimumab treatment for Japanese patients with CD was demonstrated early, with CR rates of approximately 50%. Compared with patients with previous infliximab use, those who were naïve to infliximab achieved higher CR rates, regardless of their clinical characteristics.