Intest Res.  2014 Oct;12(4):287-292. 10.5217/ir.2014.12.4.287.

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

• Chang CW
• Wei SC
• Chou JW
• Hsu TC
• Chuang CH
• Lin CP
• Hsu WH
• Yen HH
• Lin JK
• Fang YJ
• Wang HY
• Lin HH
• Wu DC
• Ni YH
• Wang CY
• Wong JM

• KMID: 2174405
• DOI: http://doi.org/10.5217/ir.2014.12.4.287

Abstract

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.

Keyword

Crohn disease; Adalimumab; Efficacy; Safety

MeSH Terms

Adalimumab
Crohn Disease*
Humans
Immunologic Factors
Inflammatory Bowel Diseases*
Japan
Korea
National Health Programs
Retrospective Studies
Taiwan*
Immunologic Factors

Figure

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  Fig. 1 Levels of CDAI at week 0, week 4, week 8 and week 12 of CD patients receiving adalimumab treatment.

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  Fig. 2 The percentages of CR-70, CR-100 and CR-150 at week 4, week 8 and week 12. CR-70, decrease in CDAI of at least 70 points; CR-100, decrease in CDAI of at least 100 points; CR-150, decrease in CDAI of at least 150 points.

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