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P666 Short-term outcomes of adalimumab for patients with Crohn's disease and associated prognostic factors: a multicentre retrospective cohort study

Nasuno M.*1, Tanaka H.1, Miyakawa M.1, Motoya S.1, Ishii M.2, Shiotani A.2, Yamashita M.3, Itoh F.3, Tanuma T.4, Sakemi R.5, So S.5, Suzuki R.6, Yanagisawa H.7, Onodera K.8, Kaneto H.9, Nojima M.10, Nakase H.8

1Sapporo Kosei General Hospital, IBD Center, Sapporo, Japan 2Kawasaki Medical School, Department of Internal Medicine, Division of Gastroenterology, Kurashiki, Japan 3St. Marianna University School of Medicine, Division of Gastroenterology and Hepatology, Kawasaki, Japan 4Teine Keijinkai Hospital, Center for Gastroenterology, Sapporo, Japan 5Tobata Kyoritsu Hospital, Department of Gastroenterology, Kitakyusyu, Japan 6Hakodate Goryoukaku Hospital, Department of Gastroenterology, Hakodate, Japan 7Obihiro Kosei General Hospital, Department of Gastroenterology and Hepatology, Obihiro, Japan 8Sapporo Medical University, School of Medicine, Department of Gastroenterology and Hepatology, Sapporo, Japan 9Muroran City General Hospital, Department of Gastroenterology, Muroran, Japan 10The University of Tokyo, The Institute of Medical Science, Center for Translational Research, Tokyo, Japan

Background

There are few studies on the short-term efficacy of adalimumab treatment for patients with Crohn's disease (CD). Here, we report the results of the Short-term Outcomes of Adalimumab for Patients with Crohn's disease and Associated Prognostic Factors: A Multicentre Retrospective Cohort Study in Japan (SAPPORO).

Methods

The SAPPORO study was conducted at 9 institutions. Data were retrospectively collected from CD patients who received adalimumab from October 2010 to September 2015. Patients had to have a Harvey–Bradshaw index (HBI) of ≥5 points at the first adalimumab administration. The HBI score and C-reactive protein (CRP) level were investigated at baseline and at 2, 4, 8 and 12 weeks following adalimumab administration. Remission was defined as an HBI score of ≤4. Rate of remission and remission with a normal CRP level were assessed at 2, 4, 8 and 12 weeks. The prognostic factors associated with the rate of remission with a normal CRP level at 4 and 12 weeks were evaluated using univariate and multivariate logistic regression analysis.

Results

Of the 160 patients included in this study (median age, 29.3 years), 56 were female. The HBI scores significantly decreased sequentially from baseline to 2, 4, 8 and 12 weeks as follows: 8.0, 4.0, 3.3, 3.4 and 3.5, respectively. The CRP levels also significantly decreased sequentially as follows: 2.43, 0.71, 0.95, 0.91 and 1.37 mg/dL, respectively. Rates of remission at 2, 4, 8 and 12 weeks were 61%, 73%, 71% and 69%, respectively, while rates of remission with a normal CRP level were 36%, 51%, 49% and 49%, respectively. In the univariate analyses, previous infliximab (IFX) use, penetrating disease, a disease duration of ≥4.3 years, previous bowel resection, being ≥29.3 years old and CRP levels of ≥1.55 mg/dL were significant prognostic factors for a lower rate of remission with a normal CRP level at 4 and 12 weeks. In addition, a body mass index (BMI) of ≥18.5 and HBI of ≥7 were significant prognostic factors for a lower remission rate with a normal CRP level at 12 weeks. In the multivariate logistic regression analysis, previous IFX use and CRP levels of ≥1.55 mg/dL were identified as independent predictors of a lower rate of remission with a normal CRP level at 4 and 12 weeks. Furthermore, a BMI of ≥18.5 was identified as an independent predictor for a lower rate of remission with a normal CRP level at 12 weeks.

Conclusion

The short-term efficacy of adalimumab treatment for CD patients was demonstrated by the second week. Approximately 50% of the patients achieved remission with a normal CRP level at 4 weeks. Previous IFX use, higher CRP levels and a higher BMI appear to be associated with poor short-term outcomes of adalimumab treatment.