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P348. The efficacy and safety of infliximab therapy in Korean patients with Crohn's diseases: a retrospective, multicenter study

C.H. Choi1, K.H. Lee1, S.K. Chang1, W.H. Kim2, Y.H. Kim3, 1Chung-Ang University College of Medicine, Internal Medicine, Seoul, South Korea, 2Yonsei University College of Medicine, Internal Medicine, Seoul, South Korea, 3Sungkyunkwan University College of Medicine, South Korea

Background

The aim of this study was to evaluate the efficacy and safety of infliximab in Korean patients with inflammatory and fistulizing Crohn's disease (CD).

Methods

A total of 317 patients with refractory luminal CD (n = 198) and fistulizing CD (n = 86) or both of them (n = 33) between 2007 and 2011 were reviewed retrospectively in 28 Korean referral centers. Patients received 5 mg/kg of infliximab intravenously on week 0, 2, 6 and then every 8 weeks thereafter. Clinical response was classified as complete response (CR), partial response (PR), and non-response (NR). In luminal CD, CR was defined as a decrease of CDAI score to less than 150 points and PR as a decrease in CDAI score of 70 points or more from the baseline value and at least a 25% reduction in the total score. In fistulizing CD, CR was defined as the absence of draining fistulas and PR as a reduction of at least 50 percent from base line in the number or size of draining fistulas.

Results

The total patients were comprised of 206 (65.0%) men and 111 (35.1%) women with a median age of 27 years (13–79). The patients received a median of 8 infusions (1–31) and had a median follow-up period of 19 months (0–103). At week 2, the response rate (CR + PR) in luminal CD was 163/227 (71.8%); CR 89/227 (39.2%) and PR 74/227 (32.6%). At week 6, the response rate was 177/206 (85.9%); CR 110/206 (53.4%) and PR 67/206 (32.5%). Among week-2 responders, the responses were maintained in 94/103 (91.3%) at week 30 and in 56/75 (74.7%) at week 54, respectively. The response rates at week 30 and 54 were not different according to the time from diagnosis to 1st infliximab infusion (<5 years vs. >5 years) and the co-therapy with azathioprine. In patients with fistulizing diseases, the response rate was 62/73 (84.9%) at week 14; CR 41/73 (56.2%) and PR 21/73 (28.8%). Among week-14 responders, the responses were maintained in 57/67 (85.1%) at week 30 and 26/40 (65.0%) at week 54, respectively. The response rate tended to be better in perianal fistulas than in the others, but statistically not significant. Thirty-two patients (10.1%) experienced adverse events. Serious adverse events were developed in 12 (3.8%) patients and then infliximab infusion was stopped.

Conclusion

Infliximab induction and maintenance therapies were effective and safe in Korean patients with refractory luminal and fistulizing CD. The efficacy of maintenance therapy was not different according to the starting time of infliximab and the co-therpy with azathioprine.