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P641 Long-term outcome of adalimumab therapy and predictors of response in 254 patients with Crohn's disease: a hospital-based cohort study from Korea

Seo H.*1, Ye B.D.1,2, Lee S.-H.1, Chang K.1, Song E.M.1, Kim G.-U.1, Seo M.1, Lee H.-S.3, Hwang S.W.1,2, Park S.H.1,2, Yang D.-H.1, Kim K.-J.1,2, Byeon J.-S.1, Myung S.-J.1, Yang S.-K.1,2

1University of Ulsan College of Medicine, Asan Medical Center, Department of Gastroenterology, Seoul, South Korea 2University of Ulsan College of Medicine, Asan Medical Center, Inflammatory Bowel Disease Center, Seoul, South Korea 3University of Ulsan College of Medicine, Asan Medical Center, Health Screening and Promotion Center, Seoul, South Korea

Background

Large scaled-studies regarding long-term outcomes of adalimumab (ADA) treatment in Korean patients with Crohn's disease (CD) are still lacking.

Methods

We retrospectively analyzed long-term outcomes of ADA treatment in Korean CD patients who started to be given scheduled ADA treatments at Asan Medical Center between November 2008 and July 2016. Clinical responses were defined as maintaining ADA therapy without major abdominal surgery (MAS) or dose intensification.

Results

Among 254 patients who received at least two doses of ADA by 2-weeks interval as an induction therapy, 250 (98.4%) patients had a primary response at week 4. Among primary responders, 243 patients were followed up for longer than 4 weeks and were included for further analysis. The median (interquartile range, IQR) duration of ADA maintenance therapy was 19.0 (6.4–32.2) months. At the end of the follow-up, 31 patients (12.8%) experienced MAS after a median (IQR) of 8.9 (2.8–18.7) months and 45 patients (18.5%) required dose intensification after a median (IQR) of 16.8 (7.3–23.4) months. Finally, 161 (66.3%) patients were still receiving ADA without MAS or dose intensification. The cumulative survival for maintenance of ADA without MAS or dose intensification was 81.1% at 1 year, 54.4% at 3 years, and 36.5% at 5 years (Figure 1).

Multivariate analysis using Cox proportional hazard model identified the previous exposure to infliximab (p=0.018, hazard ratio 1.79, 95% confidence interval 1.10–2.89) and an elevated level of C-reactive protein (>5 mg/dL) at the initiation of ADA (p=0.014, hazard ratio 2.34, 95% confidence interval 1.19–4.58) as independent predictors of a poor long-term response to ADA (Table 1).

Figure 1. The cumulative survival for a) maintenance of adalimumab (ADA), b) maintenance of ADA without major abdominal surgery (MAS), c) maintenance of ADA without dose intensification, d) maintenance of ADA without MAS or dose intensification.

Table 1. Predictors of a poor response to adalimumab in Korean patients with Crohn's disease

Conclusion

The long-term outcome of ADA in a large, real-life cohort of Korean patients with CD appears to be comparable to that in previously published Western studies.