Background Biologic disease modifying anti-rheumatic drugs (DMARDs) have also become an important arsenal in treating inflammatory arthritides in Korea; nearly ten agents are currently used nationwide in daily clinical practice. Despite numerous studies describing adverse events or treatment strategies of biologics have been published in the literature, long-term data or guidelines tailored for Korean patients are absent at this point.
Objectives To establish a multi-arm nationwide Korean biologics registry for patients with systemic rheumatic disease
Methods The committee for Korean Biologics Registry for patients with systemic rheumatic disease (KOBIO) was launched supported by the Korean College of Rheumatology (KCR) in 2012. Rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) were the target systemic rheumatic diseases. The primary endpoint of the registry was to assess the adverse events (terminology defined by Meddra) associated with biologic use in Korea nationwide. Clinical data was first obtained via paper forms in each clinic, followed by data upload to the web-based electronic form (www.rheum.or.kr/kobio, clinicaltrials.gov NCT01965132). Patients to start or switch to any biologic were eligible for registration. KOBIO-RA patients was paired with age- and gender- matched patients prescribed with non-biologic DMARDs. Considering the primary goal of KOBIO, follow up data was obtained upon switching or discontinuation of the registered primary biologic agent.
Results The ten arms of KOBIO (RA, AS, PsA) consisted of 1. Patient demographic data, 2. Comorbidities, 3. Disease activity, 4. Biologic agent, 5. Risk factor for adverse events, 6. Medications, 7. Imaging, 8. Extraarticular function, 9. Patient function, and 10. Laboratory findings (Figure). Thirty eight institutes nationwide enlisted to the KOBIO network. In the first year, total 1064 patients were registered (2013.1.1- 2013.12.31). The baseline demographic data of the patients are depicted below (Table). A unique feature of this registry is that the submenu of each arm is accustomed to respective disease entities; thus the data of KOBIO-RA, AS, and PsA can be filed and even compared between one another efficiently. On every patient follow up, biologics-related, or non-related adverse events was recorded in arm 5, under a new title 5. Outcome.
Conclusions KOBIO is a recently established web-based nationwide biologics registry focusing on the prevalence and characteristics of adverse events in Korean RA, AS, and PsA patients using biologics. Ongoing data acquisition will be analyzed to elucidate any dissimilarities in adverse events between Korean patients and other ethnic groups.
Acknowledgements The KOBIO registry is supported by the Korean College of Rheumatology.
Disclosure of Interest None declared