P526. Efficacy, safety, and predictors of response to infliximab therapy for ulcerative colitis: a Korean multicentre study
K.-M. Lee1, Y.T. Jeen2, J.Y. Cho3, C.K. Lee4, D.I. Park3, J.-P. Im5, S.-A. Jung6, H. Choi7, S.J. Park8, Y.S. Kim9, 1The Catholic University of Korea, Suwon, South Korea, 2Korea University, South Korea, 3Sungkyunkwan University, South Korea, 4Kyung Hee University, South Korea, 5Seoul National University, South Korea, 6Ewha Womans University, South Korea, 7The Catholic University of Korea, South Korea, 8Yonsei University, South Korea, 9Inje University, South Korea
Infliximab is currently used for the treatment of moderate to severe ulcerative colitis (UC) with an inadequate response to conventional agents. To date, most of the data about efficacy and safety of infliximab therapy have been reported from Western countries which have different genetic and ethnic backgrounds from Asian countries. Therefore, we assess the efficacy, safety and predictors of response to infliximab in Korean patients with UC.
This was a retrospective multicenter study including all adult patients who received at least one infliximab infusion for UC. Eligible patients should have active disese with a Mayo score of at least 6 and moderate-to-severe inflammation on sigmoidoscopy despite concurrent treatment with corticosteroids and/or immunomodulators.
A total of 134 UC patients were included. Prior to infliximab administration, all patients were treated with corticosteroids, and 95 patients (71%) had a history of IMMs use. The indications for infliximab therapy were acute severe UC in 28%, steroid-dependency in 38%, and steroid-refractoriness in 33%, respectively. Clinical response and remission rates were 80/26% at week 2, 87/45% at week 8, and 71/52% at long-term follow-up (mean 18.5, range 6–112 months). Endoscopy was followed in 81 patients after induction therapy and it revealed mucosal healing in 47 patients (58%). In multivariate analysis, we found significant predictors of clinical remission at week 8: immunomodulator-naïve (OR = 4.89, 95% CI: 1.44–16.66, p = 0.01), Hb ≥11.5 g/dl (OR = 4.47, 95% CI: 1.48–13.45, p = 0.008), CRP ≥3 mg/dl (OR = 4.77, 95% CI: 1.43–15.94, p = 0.01) and response at week 2 (OR = 20.54, 95% CI: 2.40–175.71, p = 0.006). Long-term clinical response and remission rates were 71/52% and mucosal healing was the only factor influencing long-term response. Adverse events related to infliximab occurred in 15% of patients and most of them were mild and transient.
Infliximab is effective and safe in the treatment of active UC in Korea. No history of previous immunomodulator use and high baseline CRP are independent predictors of good response.