Drug Adherence,Adverse Events,And Impacts on Quality of Life in the Use of Biologic Agents among Patients with Immune-Mediated Inflammatory Diseases

Inflammation is an important and growing area of biomedical research and health care. Basic research in cytokine expression and signaling has identified tumor necrosis factor (TNF) as one of the key players in the pathophysiology of Immune‐mediated inflammatory diseases (IMIDs). These findings led to the development of treatment strategies to block its effects. TNF‐α antagonists have been proved to be effective in treating rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), Crohn’s disease (CD), and psoriasis (PsO). Starting from March 2003, the National Health Insurance (NHI) program in Taiwan started reimbursing TNF‐α antagonists. By now there are two TNF‐α antagonists‐‐adalimumab and etanercept available for use for NHI beneficiery. However, drug compliance is a crucial issue to ensure the effectiveness of use of TNF‐α antagonists. In addition, recent literature has raised the safety concerns on using TNF‐α antagonists, especially on its higher incidence of serious infection, cardiovascular diseases and cancer events. Moreover, changes in quality of life among TNF‐α antagonists users is also a very important dimension of effectiveness. Although there have been a few literature investigating the drug compliance, safety and quality of life impacts on TNF‐α antagonists users, most of them focused on Caucasian population. The present research project is, therefore, aiming to 2 accomplish the following three tasks. In the 1st year, by using the NHI claims dataset 2003‐2010, compliance and pattern of use of adalimumab and etanercept will be examined. In the 2nd year, by using the NHI claims dataset 2003‐2011, adverse events resulted from the use of adalimumab and etanercept will be investigated. Finally in the 3rd year, changes in quality of life among users of adalimumab and etanercept will be explored and compared by using the data collected from patient interview. Stratified analyses will be performed based upon the six immune‐mediated inflammatory diseases and the two types of TNF‐ antagonists. Results of this research project can provide the reference for the health authorities concerned in Taiwan when making drug reimbursment and safe surveillance policy.