Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study
Background/AimsOnly 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...
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Korean Association for the Study of Intestinal Diseases
2014-10-01
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Series: | Intestinal Research |
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Online Access: | http://www.irjournal.org/upload/pdf/ir-12-287.pdf |
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language |
English |
format |
Article |
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DOAJ |
author |
Chen-Wang Chang Shu-Chen Wei Jen-Wei Chou Tzu-Chi Hsu Chiao-Hsiung Chuang Ching-Pin Lin Wen-Hung Hsu Hsu-Heng Yen Jen-Kou Lin Yi-Jen Fang Horng-Yuan Wang Hung-Hsin Lin Deng Cheng Wu Yen Hsuan Ni Cheng-Yi Wang Jau-Min Wong |
spellingShingle |
Chen-Wang Chang Shu-Chen Wei Jen-Wei Chou Tzu-Chi Hsu Chiao-Hsiung Chuang Ching-Pin Lin Wen-Hung Hsu Hsu-Heng Yen Jen-Kou Lin Yi-Jen Fang Horng-Yuan Wang Hung-Hsin Lin Deng Cheng Wu Yen Hsuan Ni Cheng-Yi Wang Jau-Min Wong Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study Intestinal Research Crohn disease Adalimumab Efficacy Safety |
author_facet |
Chen-Wang Chang Shu-Chen Wei Jen-Wei Chou Tzu-Chi Hsu Chiao-Hsiung Chuang Ching-Pin Lin Wen-Hung Hsu Hsu-Heng Yen Jen-Kou Lin Yi-Jen Fang Horng-Yuan Wang Hung-Hsin Lin Deng Cheng Wu Yen Hsuan Ni Cheng-Yi Wang Jau-Min Wong |
author_sort |
Chen-Wang Chang |
title |
Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study |
title_short |
Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study |
title_full |
Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study |
title_fullStr |
Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study |
title_full_unstemmed |
Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study |
title_sort |
safety and efficacy of adalimumab for patients with moderate to severe crohn's disease: the taiwan society of inflammatory bowel disease (tsibd) study |
publisher |
Korean Association for the Study of Intestinal Diseases |
series |
Intestinal Research |
issn |
1598-9100 2288-1956 |
publishDate |
2014-10-01 |
description |
Background/AimsOnly 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.MethodsA 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.ResultsA 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.ConclusionsEven under the stringent criteria for using adalimumab, the response rate was comparable to those without stringent criteria. |
topic |
Crohn disease Adalimumab Efficacy Safety |
url |
http://www.irjournal.org/upload/pdf/ir-12-287.pdf |
work_keys_str_mv |
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doaj-9ef81f0e359d4991b18fd1b2967d7c6d2020-11-24T21:48:24ZengKorean Association for the Study of Intestinal DiseasesIntestinal Research1598-91002288-19562014-10-0112428729210.5217/ir.2014.12.4.28736Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) StudyChen-Wang Chang0Shu-Chen Wei1Jen-Wei Chou2Tzu-Chi Hsu3Chiao-Hsiung Chuang4Ching-Pin Lin5Wen-Hung Hsu6Hsu-Heng Yen7Jen-Kou Lin8Yi-Jen Fang9Horng-Yuan Wang10Hung-Hsin Lin11Deng Cheng Wu12Yen Hsuan Ni13Cheng-Yi Wang14Jau-Min Wong15Division 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.Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.Division of Colon and Rectal Surgery, Department of Surgery, Mackay Memorial Hospital, Taipei, Taiwan.Department of Internal Medicine, Medical College and Hospital, National Cheng-Kung University, Tainan, Taiwan.Division of Gastroenterology, Chung Shan Medical University, Taichung, Taiwan.Department of Gastroenterology, Kaohsiung Medical University, Kaohsiung, Taiwan.Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan.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.Division of Gastroenterology, Department of Medicine, Show Chwan Memorial Hospital, Changhuan, Taiwan.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.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.Department of Gastroenterology, Kaohsiung Medical University, Kaohsiung, Taiwan.Department of Pediatrics, National Taiwan University, Taipei, Taiwan.Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.Background/AimsOnly 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.MethodsA 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.ResultsA 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.ConclusionsEven under the stringent criteria for using adalimumab, the response rate was comparable to those without stringent criteria.http://www.irjournal.org/upload/pdf/ir-12-287.pdfCrohn diseaseAdalimumabEfficacySafety |