Clinical Outcome of Treatment with Infliximab in Crohn's Disease: A Single-Center Experience

Yeon-Ju Kim; Jung-Wook Kim; Chang Kyun Lee; Hyun Jin Park; Jae-Jun Shim; Jae Young Jang; Suk Ho Dong; Hyo Jong Kim; Byung-Ho Kim; Young Woon Chang

doi:10.4166/kjg.2013.61.5.270

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Kim, Kim, Lee, Park, Shim, Jang, Dong, Kim, Kim, and Chang: Clinical Outcome of Treatment with Infliximab in Crohn's Disease: A Single-Center Experience

Original Article

Korean J Gastroenterol 2013;61(5):270-278.

Published online: 4 October 2013

DOI: https://doi.org/10.4166/kjg.2013.61.5.270

Clinical Outcome of Treatment with Infliximab in Crohn's Disease: A Single-Center Experience

Yeon-Ju Kim, Jung-Wook Kim, Chang Kyun Lee, Hyun Jin Park, Jae-Jun Shim, Jae Young Jang, Suk Ho Dong, Hyo Jong Kim, Byung-Ho Kim, Young Woon Chang

Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea

Correspondence to: Chang Kyun Lee, Department of Internal Medicine, Kyung Hee University Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul 130-872, Korea. Tel: +82-2-958-8258, Fax: +82-2-968-1648, E-mail: cklee92@paran.com

Received 19 November 201219 February 2013 Accepted 4 March 2012

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.

Abstract

Background/Aims

Our aim was to assess the long-term data regarding efficacy and safety of infliximab (IFX) treatment for refractory Crohn's disease (CD) patients in our tertiary teaching hospital.

Methods

We have retrospectively analyzed the medical records of 89 CD patients who underwent IFX treatment between March 2003 and February 2011 at Kyung Hee University Hospital (Seoul, Korea). The primary outcome measurements were the rates of initial clinical response (CR) at 10 weeks after the 1st IFX infusion and sustained CR at the end of the follow-up. Overall adverse events related to IFX treatment were also evaluated.

Results

The mean (SD) follow-up period of eligible 80 patients was 33.7 (21.9) months. A total of 77 patients (96%) showed initial clinical response, but 8 patients showed loss of response to IFX during the follow-up. Finally, 59 patients (59/77, 76.6%) showed sustained CR at the end of the study. Logistic regression analyses showed that an initial CR at 10 weeks was the independent predictor associated with sustained CR (OR 22.286, 95% CI 2.742–132.717, p=0.001). Overall adverse events reported in 18 patients (18/80, 23.3%), including 3 serious infection (pulmonary tuberculosis and herpes zoster).

Conclusions

Treatment with IFX was efficacious and relatively safe for refractory CD patients in Korea. An initial CR at 10 weeks was significantly associated with sustained CR.

Keywords: Inflammatory bowel disease, Crohn's disease, Infliximab, Safety

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Fig. 1.

Flow chart of the study population. CD, Crohn's disease; IFX, infliximab; TB, tuberculosis.

Fig. 2.

Clinical response at 10 weeks after the initiation of the infliximab treatment. CD, Crohn's disease.

Fig. 3.

The sustained clinical and biologic response in patients with Crohn's disease (CD) at the end of follow-up.

Fig. 4.

The sustained clinical response in patients with Crohn's disease at the end of follow-up stratified by of the disease prior to the infliximab (IFX) treatment (A) and clinical complete response at 10 weeks (B) via Kaplan Meier survival plots. CR, complete response; PR, partial response.

Table 1.

Patients' Baseline Characteristics

Characteristic	Data (n=80)
Male/female	55/25 (68.8/31.2)
Age (yr)
At diagnosis	27.0±8.9
At the first infusion of IFX	28.5±10.3
Smoker	14 (17.5)
BMI (kg/m²)	19.8±3.4
Previous abdominal surgery	17 (21.3)
CDAI	284±79
CRP (mg/dL)	3.37±3.67
Montreal classification
Age at diagnosis (A1/A2/A3) ^a	16/58/6 (20.0/72.5/7.5)
Location (L1/L2/L3/L4) ^b	12/18/49/1 (15.0/22.5/61.3/1.2)
Behavior (B1/B2/B3) ^c	63/13/4 (78.8/16.2/5.0)
Indication for IFX treatment
Luminal CD	35 (43.8)
Fistulising CD	45 (56.2)
Treatment schedule
Episodic treatment	14 (17.5)
Scheduled treatment	66 (82.5)
Duration of disease prior to 1st IFX infusion (mo)	55.6±52.6
Follow up period after 1st IFX infusion (mo)	33.7±21.9
Number of infusion of IFX	13.8±8.4 (3–37)
Concomitant medication at 1st IFX
Aminosalicylates	63 (78.8)
Steroids	15 (18.8)
AZA/6-MP	67 (83.8)
MTX	1 (1.3)
QuantiFERON-TB Gold test	48/7/25 (60.0/8.8/31.2)

(negative/positive/no test)

Values are presented as n (%), mean±SD, or mean±SD (range). CDAI, Crohn's disease activity index; CD, Crohn's disease; IFX, infliximab; AZA, azathioprine; 6-MP, 6-mercaptopurine; MTX, methotrexate.

^a A1, ≤16; A2, 17–40; A3, ≥40.

^b L1, ileitis; L2, colitis; L3, ileocolitis; L4, upper gastrointestinal.

^c B1, inflammatory or nonstricturing; B2, stricturing; B3, penetrating.

Table 2.

Factors Predicting Sustained Clinical Response to Infliximab Therapy by Multiple Regression Analysis

	OR	95% CI	p-value
Presence of fistula	6.275	0.603–65.361	0.124
Smoking	0.644	0.032–12.913	0.774
Age at diagnosis (＞20 yr)	0.525	0.018–14.965	0.707
Age at the 1st infusion (＞25 yr)	1.313	0.144–12.008	0.809
Duration prior to 1st IFX (＜48 mo)	0.646	0.090–4.623	0.646
Concomitant medication
Aminosalicylates	0.544	0.071–4.199	0.559
Steroid	0.501	0.057–4.413	0.534
Clinical CR at 10 weeks	22.286	2.742–132.717	0.001

IFX, infliximab; AZA, azathioprine; 6-MP, 6-mercaptopurine; CR, complete response.

Table 3.

Adverse Events after Infliximab Treatment

Types of adverse events	Data
Minor and transient side effects ^a	13 (16.9)
Acute infusion reaction	2 (2.6)
Serious adverse events	3 (3.9)
Herpes zoster	1 (1.3)
Pulmonary tuberculosis	2 (2.6)
Total	18 (23.3)

Values are presented as n (%).

^a Myalgia, flu-like symptom or arthralgia.

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