Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study

被引：22

作者：

Chang, Chen-Wang ^{[1
,2
,3
]}

Wei, Shu-Chen ^{[4
,5
]}

Chou, Jen-Wei ^{[6
]}

Hsu, Tzu-Chi ^{[7
]}

Chuang, Chiao-Hsiung ^{[8
]}

Lin, Ching-Pin ^{[9
]}

Hsu, Wen-Hung ^{[10
]}

Yen, Hsu-Heng ^{[11
]}

Lin, Jen-Kou ^{[12
,13
]}

Fang, Yi-Jen ^{[14
]}

Wang, Horng-Yuan ^{[1
,2
,3
]}

Lin, Hung-Hsin ^{[13
]}

Wu, Deng Cheng ^{[10
]}

Ni, Yen Hsuan ^{[15
]}

Wang, Cheng-Yi ^{[4
,5
]}

Wong, Jau-Min ^{[4
,5
]}

机构：

[1] Mackay Mem Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Taipei, Taiwan

[2] Mackay Jr Coll Med Nursing & Management, Taipei, Taiwan

[3] Mackay Med Coll, New Taipei, Taiwan

[4] Natl Taiwan Univ Hosp, Dept Internal Med, Taipei, Taiwan

[5] Coll Med, Taipei, Taiwan

[6] China Med Univ Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Taichung, Taiwan

[7] Mackay Mem Hosp, Div Colon & Rectal Surg, Dept Surg, Taipei, Taiwan

[8] Natl Cheng Kung Univ, Dept Internal Med, Med Coll & Hosp, Tainan, Taiwan

[9] Chung Shan Med Univ, Div Gastroenterol, Taichung, Taiwan

[10] Kaohsiung Med Univ, Dept Gastroenterol, Kaohsiung, Taiwan

[11] Changhua Christian Hosp, Dept Gastroenterol, Changhua, Taiwan

[12] Taipei Vet Gen Hosp, Div Colon & Rectal Surg, Dept Surg, Taipei, Taiwan

[13] Natl Yang Ming Univ, Dept Surg, Sch Med, Taipei, Taiwan

[14] Show Chwan Mem Hosp, Div Gastroenterol, Dept Med, Changhuan, Taiwan

[15] Natl Taiwan Univ, Dept Pediat, Taipei, Taiwan

来源：

INTESTINAL RESEARCH | 2014年 / 12卷 / 04期

关键词：

Crohn disease; Adalimumab; Efficacy; Safety;

D O I：

10.5217/ir.2014.12.4.287

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background/Aims: 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 to12 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.

引用

页码：287 / 292

页数：6