Intestinal Research  
Outcomes of limited period of adalimumab treatment in moderate to severe Crohn’s disease patients: Taiwan Society of Inflammatory Bowel Disease Study
Wei-Chen Lin1, Jen-Wei Chou2, Hsu-Heng Yen3 , Wen-Hung Hsu4, Hung-Hsin Lin5,6, Jen-Kou Lin5, Chiao-Hsiung Chuang7, Tien-Yu Huang8, Horng-Yuan Wang1, Shu-Chen Wei9, Jau-Min Wong9
1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, 2Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Hospital, Taichung, 3Department of Gastroenterology, Changhua Christian Hospital, Changhua, 4Department of Gastroenterology, Kaohsiung Medical University, Kaohsiung, 5Division of Colon and Rectal Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei, 6Institute of Clinical Medicine, National Yang-Ming University School of Medicine, Taipei, 7Department of Internal Medicine, National Cheng-Kung University Hospital, National Cheng-Kung University Medical College, Tainan, 8Department of Gastroenterology, Tri-Service General Hospital, Taipei, 9Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan
Correspondence to: Shu-Chen Wei, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, No. 7, Chung-Shan South Road, Taipei 100, Taiwan. Tel: +886-2-23123456 (ext 65768), Fax: +886-2-23947927, E-mail:
Received: March 23, 2017; Revised: July 14, 2017; Accepted: July 20, 2017; Published online: August 25, 2017.
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Background/Aims: In Taiwan, due to budget limitations, the National Health Insurance only allows for a limited period of biologics use in treating moderate to severe Crohn’s disease (CD). We aimed to access the outcomes of CD patients following a limited period use of biologics, specifically focusing on the relapse rate and remission duration; also the response rate to second use when applicable. Methods: This was a multicenter, retrospective, observational study and we enrolled CD patients who had been treated with adalimumab (ADA) according to the insurance guidelines from 2009 to 2015. Results: A total of 54 CD patients, with follow-up of more than 6 months after the withdrawal of ADA, were enrolled. The average period of treatment with ADA was 16.7±9.7 months. After discontinuing ADA, 59.3% patients suffered a clinical relapse. In the univariate analysis, the reason for withdrawal was a risk factor for relapse (P=0.042). In the multivariate analysis, current smoker became an important risk factor for relapse (OR, 3.9; 95% CI, 1.2−14.8; P=0.044) and male sex was another risk factor (OR, 2.9; 95% CI, 1.1−8.6; P=0.049). For those 48 patients who received a second round of biologics, the clinical response was seen in 60.4%, and 1 anaphylaxis occurred. Conclusions: Fifty-nine percent of patients experienced a relapse after discontinuing the limited period of ADA treatment, and most of them occurred within 1 year following cessation. Male sex and current smoker were risk factors for relapse. Though 60.4% of the relapse patients responded to ADA again.
Keywords: Crohn disease; Adalimumab; Withdraw

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