Efficacy, Safety, and Predictors of Response to Infliximab Therapy for Ulcerative Colitis

A Korean Multicenter Retrospective Study

Kang-Moon Lee; Yoon Tae Jeen; Ju Yeon Cho; Chang Kyun Lee; Ja-Seol Koo; Dong Il Park; Jong Pil Im; Soo Jung Park; You Sun Kim; Tae Oh Kim; Suck-Ho Lee; Byung Ik Jang; Ji Won Kim; Young Sook Park; Eun-Soo Kim; Chang Hwan Choi; Hyo Jong Kim

Disclosures

J Gastroenterol Hepatol. 2013;28(12):1829-1833. 

In This Article

Abstract and Introduction

Abstract

Background/Aims Infliximab is currently used for the treatment of moderate-to-severe ulcerative colitis (UC) with an inadequate response to conventional agents. The efficacy and safety of infliximab in Korean patients with UC were assessed.

Methods This was a retrospective multicenter study including all adult patients who received at least one infliximab infusion for UC. Short- and long-term clinical outcomes and adverse events of infliximab therapy were evaluated, and predictors of response were identified.

Results A total of 134 UC patients were included. The indications for infliximab therapy were acute severe UC in 28%, steroid-dependency in 38%, and steroid-refractoriness in 33%, respectively. The rates of clinical response and remission were 87% and 45% at week 8. In multivariate analysis, we found significant predictors of clinical remission at week 8: immunomodulator-naïve (odds ratio [OR] = 4.89, 95% confidence interval [CI]: 1.44–16.66, P = 0.01), hemoglobin ≥ 11.5 g/dL (OR = 4.47, 95% CI: 1.48–13.45, P = 0.008), C-reactive protein ≥ 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% and 52%, respectively, 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.

Conclusions Infliximab is effective and safe in the treatment of active UC in Korea. No history of previous immunomodulator use and high baseline C-reactive protein are independent predictors of good response.

Introduction

Ulcerative colitis (UC) is a chronic remitting and relapsing disease characterized by continuous mucosal inflammation of the colon. Despite proven efficacy of conventional medical therapies for UC, such as 5-aminosalicylates, corticosteroids, and immunomodulators (IMMs), some patients still evolves to disabling condition because of insufficient response to or side-effects of drugs.[1,2] The introduction of infliximab, an antitumor necrosis factor a antibody, has greatly improved the treatment options in UC. In the Active Controlled Ulcerative Colitis Trial (ACT) trials, infliximab was significantly more effective than placebo for inducing and maintaining clinical response in patients who had active disease despite treatment with conventional therapy.[3] In addition, infliximab was superior to placebo for inducing mucosal healing, which is a strong predictor of favorable long-term outcome.[4] Data from retrospective observational studies showed that infliximab rescue therapy was effective in avoiding colectomy in acute, severe, steroid-refractory UC patients.[5,6] Despite well-known adverse events, such as infusion reaction and risk of opportunistic infection, it has been reported that infliximab treatment is safe and tolerable in most of UC patients.[3,7] Many studies have investigated predictors of short- and long-term responses to infliximab and suggested several clinical parameters as positive (mucosal healing[4]) and negative (steroid dependency/refractoriness,[8,9] absence of short-term response,[10,11] high baseline C-reactive protein (CRP),[9,11] indication for acute severe colitis[9,11]) predictors, but there is no consistent results.

However, most of the data have been reported from Western countries that have different genetic and ethnic backgrounds from Asian countries.[12] To our best knowledge, there is no published data about the efficacy and safety of infliximab for Asian UC patients. In Korea, the incidence rate of inflammatory bowel disease (IBD) has been increasing,[13] and infliximab treatment for IBD has been covered by health insurance since a few years ago. As a result, infliximab use for steroids/IMMs-refractory UC is rapidly increasing.

We conducted multicenter, retrospective study to confirm the efficacy and safety of infliximab in Korean patients with UC in the real-life clinical setting and to investigate clinical predictors of response.

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