Yonsei Med J.  2016 Nov;57(6):1376-1385. 10.3349/ymj.2016.57.6.1376.

Efficacy and Safety of Infliximab Therapy and Predictors of Response in Korean Patients with Crohn's Disease: A Nationwide, Multicenter Study

• Choi CH
• Song ID
• Kim YH
• Koo JS
• Kim YS
• Kim JS
• Kim N
• Kim ES
• Kim JH
• Kim JW
• Kim TO
• Kim HS
• Kim HJ
• Park YS
• Park DI
• Park SJ
• Song HJ
• Shin SJ
• Yang SK
• Ye BD
• Lee KM
• Lee BI
• Lee SY
• Lee CK
• Im JP
• Jang BI
• Jeon TJ
• Cho YK
• Chang SK
• Jeon SR
• Jung SA
• Jeen YT
• Cha JM
• Han DS
• Kim WH
• IBD Study Group of the Korean Association for the Study of the Intestinal Diseases

• KMID: 2427155
• DOI: http://doi.org/10.3349/ymj.2016.57.6.1376

Abstract

PURPOSE
Infliximab is currently used for the treatment of active Crohn's disease (CD). We aimed to assess the efficacy and safety of infliximab therapy and to determine the predictors of response in Korean patients with CD.
MATERIALS AND METHODS
A total of 317 patients who received at least one infliximab infusion for active luminal CD (n=198) and fistulizing CD (n=86) or both (n=33) were reviewed retrospectively in 29 Korean referral centers. Clinical outcomes of induction and maintenance therapy with infliximab, predictors of response, and adverse events were evaluated.
RESULTS
In patients with luminal CD, the rates of clinical response and remission at week 14 were 89.2% and 60.0%, respectively. Male gender and isolated colonic disease were associated with higher remission rates at week 14. In week-14 responders, the probabilities of sustained response and remission were 96.2% and 93.3% at week 30 and 88.0% and 77.0% at week 54, respectively. In patients with fistulizing CD, clinical response and remission were observed in 85.0% and 56.2% of patients, respectively, at week 14. In week-14 responders, the probabilities of sustained response and remission were 94.0% and 97.1%, respectively, at both week 30 and week 54. Thirty-nine patients (12.3%) experienced adverse events related to infliximab. Serious adverse events developed in 19 (6.0%) patients including seven cases of active pulmonary tuberculosis.
CONCLUSION
Infliximab induction and maintenance therapy are effective and well tolerable in Korean patients with luminal and fistulizing CD. However, clinicians must be aware of the risk of rare yet critical adverse events.

Keyword

Crohn's disease; infliximab; tuberculosis

MeSH Terms

Adolescent
Adult
Anti-Inflammatory Agents/administration & dosage
Antibodies, Monoclonal/therapeutic use
Crohn Disease/*drug therapy/ethnology
Drug Administration Schedule
Female
Gastrointestinal Agents/administration & dosage/*therapeutic use
Humans
Infliximab/*therapeutic use
Infusions, Intravenous
Male
Middle Aged
Prednisone/administration & dosage
Regression Analysis
Remission Induction
Retrospective Studies
Treatment Outcome
Anti-Inflammatory Agents
Antibodies, Monoclonal
Gastrointestinal Agents
Infliximab
Prednisone

Figure

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  Fig. 1 Flow chart of study population. CD, Crohn's disease.

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  Fig. 2 Clinical response (complete and partial response) and remission (complete response) at weeks 2, 6, and 14 in patients with active luminal Crohn's disease.

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  Fig. 3 (A) Cumulative probabilities of sustained clinical response for week 14 responders and (B) cumulative probabilities of sustained clinical remission for patients in remission at week 14 among patients with active luminal Crohn's disease.

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  Fig. 4 Clinical response (complete and partial response) and remission (complete response) at week 14 in patients with fistulizing Crohn's disease.

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