Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study.
OBJECTIVE
Only moderate to severe Crohn's Disease (CD) patients without a satisfactory conventional therapy effect are eligible to get reimbursement from the National Health Insurance of Taiwan for using adalimumab. These are more stringent criteria than in many Western countries and Japan and Korea. We aim to explore the efficacy of using adalimumab in CD patients under such stringent criteria.


METHODS
A retrospective analysis was conducted in nine medical centers in Taiwan and we collected the results of CD patients receiving adalimumab from Sep 2009 to Mar 2014. The clinical characteristics, response measured by CDAI (Crohn's Disease Activity Index), adverse events and survival status were recorded and analyzed. CR-70, CR-100, and CR-150 were defined as attaining a CDAI decrease of 70, 100 or 150 points compared with baseline.


RESULTS
A total of 103 CD patient records were used in this study. Sixty percent of these patients received combination therapy of adalimumab together with immunomodulators. CR-70 was 68.7%, 74.5% and 88.4% after week 4, 8 and 12 of treatment, respectively. The steroid-free rate, complications and survival were 47.6%, 9.7% and 99% of patients, respectively. In considering the mucosal healing, only 25% patients achieve mucosal healing after treatment for 6 to 12 months. Surgery was still needed in 16.5% of patients. Combination treatment of adalimumab with immunomodulators further decreased the level of CDAI at week 8 when compared with the monotherapy.


CONCLUSIONS
Even under the stringent criteria for using adalimumab, the response rate was comparable to those without stringent criteria.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei; Mackay Junior College of Medicine, Nursing and Management, Taipei; Mackay Medical College, New Taipei, Taiwan.
Chen-Wang
CW
Chang
Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.
Shu-Chen
SC
Wei
Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Jen-Wei
JW
Chou
Division of Colon and Rectal Surgery, Department of Surgery, Mackay Memorial Hospital, Taipei, Taiwan.
Tzu-Chi
TC
Hsu
Department of Internal Medicine, Medical College and Hospital, National Cheng-Kung University, Tainan, Taiwan.
Chiao-Hsiung
CH
Chuang
Division of Gastroenterology, Chung Shan Medical University, Taichung, Taiwan.
Ching-Pin
CP
Lin
Department of Gastroenterology, Kaohsiung Medical University, Kaohsiung, Taiwan.
Wen-Hung
WH
Hsu
Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan.
Hsu-Heng
HH
Yen
Division of Colon and Rectal Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei; Department of Surgery, School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Jen-Kou
JK
Lin
Division of Gastroenterology, Department of Medicine, Show Chwan Memorial Hospital, Changhuan, Taiwan.
Yi-Jen
YJ
Fang
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei; Mackay Junior College of Medicine, Nursing and Management, Taipei; Mackay Medical College, New Taipei, Taiwan.
Horng-Yuan
HY
Wang
Division of Colon and Rectal Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei; Department of Surgery, School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Hung-Hsin
HH
Lin
Department of Gastroenterology, Kaohsiung Medical University, Kaohsiung, Taiwan.
Deng Cheng
DC
Wu
Department of Pediatrics, National Taiwan University, Taipei, Taiwan.
Yen Hsuan
YH
Ni
Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.
Cheng-Yi
CY
Wang
Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.
Jau-Min
JM
Wong
Adalimumab; Crohn disease; Efficacy; Safety