Abstract
Background
Biologic agents were initially introduced as treatment for rheumatoid arthritis (RA) but have since been used for other medical conditions. As new biologics become increasingly widespread in treatment regimens, it is important to understand their safety and utilization in the post-marketing context.
Purpose
The aim of this study was to investigate long-term prescribing patterns and the safety of biologics in real clinical settings in Hong Kong.
Methods
This was a population-based drug utilization study in Hong Kong using a territory-wide electronic medical database Clinical Data Analysis and Reporting System (CDARS). Patients who received biologic treatments from 2001 to 2015 were identified and their corresponding demographic and clinical details retrieved from CDARS. The annual prevalence of biologic prescriptions, the long-term retention rates and incidence rates of infections associated with biologic treatments were evaluated.
Results
A total of 30,298 patients (male: 44%) prescribed biologic treatments were identified from CDARS from 2001 to 2015. The annual prevalence of biologic prescriptions increased from 0.1 to 16.1 per 100 persons for both sexes. Infliximab had the highest first-year retention rate of 95.6% among all biologics and continuously attained the highest retention rate from second to fifth year. The overall incidence rate of serious infections was less than five per 100 person-years. Specifically, the incidence rates of tuberculosis, upper and lower respiratory infections and herpes zoster were 0.52, 3.24, 4.99 and 1.01 per 100 person-years, respectively.
Conclusion
This population-based study revealed an increasing prevalence of biologic prescribing. Results from the study described the long-term retention rates and incidence rates of serious infections of biologic treatments for all indications, and confirmed the safety of biologic treatments. Since this study provides an overview of all biologic utilization, further studies on cost effectiveness, safety and compliance of treatment in different patient groups are still warranted.
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The authors would like to thank Ms Lisa Lam for copyediting the manuscript.
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Funding
This study was supported by Pfizer Corporation Hong Kong Limited [project tracking number: W1198308].
Ethics Statement
The study protocol was approved by the Hospital Authority Hong Kong West Cluster and University of Hong Kong Institutional Review Board (UW14-602).
Conflict of Interest
Xue Li has received research funding from the Food and Health Bureau of the Government of Hong Kong. Kenneth Man received the CW Maplethorpe Fellowship and personal fees from IQVIA Holdings, Inc., unrelated to this work. Esther Chan has received research funding from Wellcome Trust, United Kingdom; National Natural Science Fund of China, China; The Hong Kong Research Grants Council; The Research Fund Secretariat of the Food and Health Bureau; Narcotics Division of the Security Bureau of The Government of the Hong Kong Special Administrative Region; and Bristol-Myers Squibb, Pfizer, Bayer and Janssen, a Division of Johnson & Johnson, for work unrelated to this study. Ian Wong has received grants from the Research Grants Council (RGC, Hong Kong), Innovative Medicines Initiative (IMI), Shire, Janssen-Cilag, Eli-Lily, Pfizer, Bayer, and the European Union FP7 program, outside the submitted work. Ian Wong is a member of the National Institute for Health and Clinical Excellence (NICE) ADHD Guideline Group, the British Association for Psychopharmacology ADHD guideline group, and advisor to Shire. Mengqin Ge and Celine Chui declare no conflict of interest.
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Mengqin Ge and Kenneth K. Man are co-first author.
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Ge, M., Man, K.K., Chui, C.S. et al. Prevalence, Safety and Long-Term Retention Rates of Biologics in Hong Kong from 2001 to 2015. Drug Saf 42, 1091–1102 (2019). https://doi.org/10.1007/s40264-019-00844-z
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DOI: https://doi.org/10.1007/s40264-019-00844-z