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


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.


CONCLUSIONS
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.
Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Chang Hwan
CH
Choi
Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
In Do
ID
Song
Department of Internal Medicine, Sungkyunkwan University School of Medicine, Seoul, Korea.
Young Ho
YH
Kim
Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
Ja Seol
JS
Koo
Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
You Sun
YS
Kim
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Joo Sung
JS
Kim
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Nayoung
N
Kim
Department of Internal Medicine, Kyungpook National University Graduate School of Medicine, Daegu, Korea.
Eun Soo
ES
Kim
Department of Internal Medicine, Dongguk University College of Medicine, Goyang, Korea.
Jae Hak
JH
Kim
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Ji Won
JW
Kim
Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
Tae Oh
TO
Kim
Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
Hyun Soo
HS
Kim
Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.
Hyo Jong
HJ
Kim
Department of Internal Medicine, Eulji University College of Medicine, Seoul, Korea.
Young Sook
YS
Park
Department of Internal Medicine, Sungkyunkwan University School of Medicine, Seoul, Korea.
Dong Il
DI
Park
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Soo Jung
SJ
Park
Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea.
Hyun Joo
HJ
Song
Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.
Sung Jae
SJ
Shin
Department of Gastroenterology, University of Ulsan College of Medicine, Seoul, Korea.
Suk Kyun
SK
Yang
Department of Gastroenterology, University of Ulsan College of Medicine, Seoul, Korea.
Byong Duk
BD
Ye
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Kang Moon
KM
Lee
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Bo In
BI
Lee
Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.
Sun Young
SY
Lee
Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.
Chang Kyun
CK
Lee
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Jong Pil
JP
Im
Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Byung Ik
BI
Jang
Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
Tae Joo
TJ
Jeon
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Yu Kyung
YK
Cho
Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Sae Kyung
SK
Chang
Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
Seong Ran
SR
Jeon
Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
Sung Ae
SA
Jung
Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
Yoon Tae
YT
Jeen
Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.
Jae Myung
JM
Cha
Department of Internal Medicine, Hanyang University College of Medicine, Guri, Korea.
Dong Soo
DS
Han
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. kimwonho@yuhs.ac.
Won Ho
WH
Kim
D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D003424:Crohn Disease / Q000188:drug therapy* / Q000208:ethnology; D004334:Drug Administration Schedule; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D012044:Regression Analysis; D012074:Remission Induction; D012189:Retrospective Studies; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab; D011241:Prednisone
Crohn's disease; infliximab; tuberculosis