Long-Term Clinical Outcomes of Korean Patient With Crohn's Disease Following Early Use of Infliximab

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Abstract

Background/Aims

Several recent studies have reported that the early use of infliximab (IFX) improves the prognosis of Crohn's disease (CD). However, no data are available from Asian populations, as the forementioned studies have all been conducted in Western countries. The aim of the current study was to evaluate the impact of early use of IFX on the prognosis of Korean patients with CD.

Methods

Patients with a diagnosis of CD established between July 1987 and January 2012 were investigated in 12 university hospitals in Korea. Because insurance coverage for IFX treatment began in August 2005, patients were assigned to either of 2 groups based on diagnosis date. The first group included patients diagnosed from July 1987 to December 2005, and the second from January 2006 to January 2012. We compared the cumulative probabilities of operation and reoperation between the two groups using the Kaplan-Meier method and a log-rank test.

Results

Of the 721 patients investigated, 443 (61.4%) comprized the second group. Although the cumulative probabilities of immunosuppressant ( P<0.001) and IFX use ( P<0.001) after diagnosis were significantly higher in the second group, there were no significant differences in cumulative probabilities of operation ( P=0.905) or reoperation ( P=0.418) between two groups.

Conclusions

The early use of IFX did not reduce CD-related surgery requirements in Korean patients with CD. These study results suggest that the early use of IFX may have little impact on the clinical outcome of CD in Korean patients in the setting of a conventional step-up algorithm.

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Most cited references 12

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Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial.

Jean-Frédéric Colombel, William J Sandborn, Paul Rutgeerts … (2007)

This study evaluated the efficacy and safety of adalimumab, a fully human, anti-tumor necrosis factor monoclonal antibody administered subcutaneously, in the maintenance of response and remission in patients with moderate to severe Crohn's disease (CD). Patients received open-label induction therapy with adalimumab 80 mg (week 0) followed by 40 mg (week 2). At week 4, patients were stratified by response (decrease in Crohn's Disease Activity Index > or =70 points from baseline) and randomized to double-blind treatment with placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg weekly through week 56. Co-primary end points were the percentages of randomized responders who achieved clinical remission (Crohn's Disease Activity Index score <150) at weeks 26 and 56. The percentage of randomized responders in remission was significantly greater in the adalimumab 40-mg eow and 40-mg weekly groups versus placebo at week 26 (40%, 47%, and 17%, respectively; P < .001) and week 56 (36%, 41%, and 12%, respectively; P < .001). No significant differences in efficacy between adalimumab eow and weekly were observed. More patients receiving placebo discontinued treatment because of an adverse event (13.4%) than those receiving adalimumab (6.9% and 4.7% in the 40-mg eow and 40-mg weekly groups, respectively). Among patients who responded to adalimumab, both adalimumab eow and weekly were significantly more effective than placebo in maintaining remission in moderate to severe CD through 56 weeks. Adalimumab was well-tolerated, with a safety profile consistent with previous experience with the drug.

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A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group.

S. Targan, S Hanauer, S J van Deventer … (1997)

Studies in animals and an open-label trial have suggested a role for antibodies to tumor necrosis factor alpha, specifically chimeric monoclonal antibody cA2, in the treatment of Crohn's disease. We conducted a 12-week multicenter, double-blind, placebo-controlled trial of cA2 in 108 patients with moderate-to-severe Crohn's disease that was resistant to treatment. All had scores on the Crohn's Disease Activity Index between 220 and 400 (scores can range from 0 to about 600, with higher scores indicating more severe illness). Patients were randomly assigned to receive a single two-hour intravenous infusion of either placebo or cA2 in a dose of 5 mg per kilogram of body weight, 10 mg per kilogram, or 20 mg per kilogram. Clinical response, the primary end point, was defined as a reduction of 70 or more points in the score on the Crohn's Disease Activity Index at four weeks that was not accompanied by a change in any concomitant medications. At four weeks, 81 percent of the patients given 5 mg of cA2 per kilogram (22 of 27 patients), 50 percent of those given 10 mg of cA2 per kilogram (14 of 28), and 64 percent of those given 20 mg of cA2 per kilogram (18 of 28) had had a clinical response, as compared with 17 percent of patients in the placebo group (4 of 24) (p<0.001 for the comparison of the cA2 group as a whole with placebo). Thirty-three percent of the patients given cA2 went into remission (defined as a score below 150 on the Crohn's Disease Activity Index), as compared with 4 percent of the patients given placebo (P=0.005). At 12 weeks, 41 percent of the cA2-treated patients (34 of 83) had had a clinical response, as compared with 12 percent of the patients in the placebo group (3 of 25) (P=0.008). The rates of adverse effects were similar in the groups. A single infusion of cA2 was an effective short-term treatment in many patients with moderate-to-severe, treatment-resistant Crohn's disease.

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Infliximab for the treatment of fistulas in patients with Crohn's disease.

D Present, P Rutgeerts, S Targan … (1999)

Enterocutaneous fistulas are a serious complication of Crohn's disease and are difficult to treat. Infliximab, a chimeric monoclonal antibody to tumor necrosis factor alpha, has recently been developed as a treatment for Crohn's disease. We conducted a randomized, multicenter, double-blind, placebo-controlled trial of infliximab for the treatment of fistulas in patients with Crohn's disease. The study included 94 adult patients who had draining abdominal or perianal fistulas of at least three months' duration as a complication of Crohn's disease. Patients were randomly assigned to receive one of three treatments: placebo (31 patients), 5 mg of infliximab per kilogram of body weight (31 patients), or 10 mg of infliximab per kilogram (32 patients); all three were to be administered intravenously at weeks 0, 2, and 6. The primary end point was a reduction of 50 percent or more from base line in the number of draining fistulas observed at two or more consecutive study visits. A secondary end point was the closure of all fistulas. Sixty-eight percent of the patients who received 5 mg of infliximab per kilogram and 56 percent of those who received 10 mg per kilogram achieved the primary end point, as compared with 26 percent of the patients in the placebo group (P=0.002 and P=0.02, respectively). In addition, 55 percent of the patients assigned to receive 5 mg of infliximab per kilogram and 38 percent of those assigned to 10 mg per kilogram had closure of all fistulas, as compared with 13 percent of the patients assigned to placebo (P=0.001 and P=0.04, respectively). The median length of time during which the fistulas remained closed was three months. More than 60 percent of patients in all the groups had adverse events. For patients treated with infliximab, the most common were headache, abscess, upper respiratory tract infection, and fatigue. Infliximab is an efficacious treatment for fistulas in patients with Crohn's disease.

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Author and article information

Journal

Journal ID (nlm-ta): Intestinal Res

Journal ID (iso-abbrev): Intestinal Res

Journal ID (publisher-id): IR

Title: Intestinal Research

Publisher: Korean Association for the Study of Intestinal Diseases

ISSN (Print): 1598-9100

ISSN (Electronic): 2288-1956

Publication date (Print): October 2014

Publication date (Electronic): 27 October 2014

Volume: 12

Issue: 4

Pages: 281-286

Affiliations

Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.

[1 ]Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

[2 ]Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.

[3 ]Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.

[4 ]Department of Internal Medicine, Dongguk University College of Medicine, Goyang, Korea.

[5 ]Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea.

[6 ]Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.

[7 ]Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea.

[8 ]Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Seoul, Korea.

[9 ]Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.

[10 ]Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea College of Medicine, Suwon, Korea.

[11 ]Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea.

Author notes

Correspondence to Dong Il Park, Department of Internal Medicine, Kangbuk Samsung Medical Center, 29 Saemunan-ro, Jongno-gu, Seoul 110-746, Korea. Tel: +82-2-2001-2059, Fax: +82-2-2001-2610, diksmc.park@ 123456samsung.com

Article

DOI: 10.5217/ir.2014.12.4.281

PMC ID: 4214954

PubMed ID: 25374493

SO-VID: 874c990c-38d4-4c1f-9950-ab02d27b91e2

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Long-Term Clinical Outcomes of Korean Patient With Crohn's Disease Following Early Use of Infliximab

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Abstract

Background/Aims

Methods

Results

Conclusions

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Karger: Oncology

Most cited references 12

Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial.

A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group.

Infliximab for the treatment of fistulas in patients with Crohn's disease.

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