Suboptimal Outcomes and Retreatment Rate of Patients With Crohn's Disease After Forced Discontinuation of Biologics: A Nationwide Population‐Based Study

Author:

Chen Nai‐Yu12,Chuang Chiao‐Hsiung3,Chang Yu‐Ching4,Kao Yang Yea‐Huei24,Chen Peng‐Hsu5,Cheng Ching‐Lan246

Affiliation:

1. Department of Pharmacy Kaohsiung Veterans General Hospital Kaohsiung Taiwan

2. School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine National Cheng Kung University Tainan Taiwan

3. Department of Internal Medicine National Cheng Kung University Hospital, College of Medicine National Cheng Kung University Tainan Taiwan

4. Health Outcome Research Center National Cheng Kung University Tainan Taiwan

5. Takeda Pharmaceuticals Taiwan, Ltd. Taipei City Taiwan

6. Department of Pharmacy, National Cheng Kung University Hospital, College of Medicine National Cheng Kung University Tainan Taiwan

Abstract

Taiwan's National Health Insurance (NHI) program forced discontinuation of biologic use in Crohn's disease (CD) after a limited treatment duration, regardless of disease activity. This study investigated the retreatment rate and suboptimal outcomes (i.e., CD‐related surgeries, hospitalizations, emergency room visits, and oral steroid flare‐ups) after forced discontinuation. This retrospective cohort study was conducted using data from the NHI Database. Patients who received ≥40 weeks of biologic treatment followed by a forced discontinuation were included. The time of biologic retreatment and the cumulative incidence of suboptimal outcomes after the forced discontinuation as well as related risk factors were analyzed. Included were 215 patients (68% male). At the beginning of biologic therapy, the mean age (±SD) was 35.7 (±13.5) years, and the disease duration was 4.46 (±3.52) years. The median (interquartile range) biologic treatment duration was 57.86 (50.3–83.3) weeks. Within the first year after forced discontinuation, 67% of patients (n = 144) were retreated with a second course of biologics, and 53% of patients (n = 114) experienced at least one suboptimal outcome. The independent risk factors associated with the occurrence of suboptimal outcomes were CD‐related emergency room visits and hospitalizations during biologic therapy (hazard ratio: 2.49; 95% confidence interval: 1.59–3.89). More than two‐thirds of patients with CD required biological retreatment within 1 year after a forced discontinuation. The substantial proportion of patients with poor disease outcomes highlights the need to continue the biologic.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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