Intest Res.  2017 Oct;15(4):487-494. 10.5217/ir.2017.15.4.487.

Outcomes of limited period of adalimumab treatment in moderate to severe Crohn's disease patients: Taiwan Society of Inflammatory Bowel Disease Study

Affiliations
  • 1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.
  • 2Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
  • 3Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan.
  • 4Department of Gastroenterology, Kaohsiung Medical University, Kaohsiung, Taiwan.
  • 5Division of Colon and Rectal Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.
  • 6Institute of Clinical Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan.
  • 7Department of Internal Medicine, National Cheng-Kung University Hospital, National Cheng-Kung University Medical College, Tainan, Taiwan.
  • 8Department of Gastroenterology, Tri-Service General Hospital, Taipei, Taiwan.
  • 9Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. shuchenwei@ntu.edu.tw

Abstract

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.

Keyword

Crohn disease; Adalimumab; Withdraw
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