AB1066 Korean Biologics Registry of Patients with Systemic Rheumatic Disease (KOBIO): A Nationwide Registry to Assess Adverse Events Associated with Biologic Treatment in Korea

Abstract

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 (, 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 DOI 10.1136/annrheumdis-2014-eular.3505

Machine learning model for identifying important clinical features for predicting remission in patients with rheumatoid arthritis treated with biologics

“…This study used data from the KOBIO registry, which is a nationwide multicenter cohort in Korea that was established to evaluate the effectiveness and side effects of biologic therapies in patients with RA [ 13 ]. Patients in the registry were recruited from 38 hospitals since 2012, and their demographics, medications, comorbidities, extra-articular manifestations, disease activities, radiographic findings, and laboratory findings performed within 4 weeks prior to the patient’s visit were recorded with the date.…”

“…In this study, we established a machine learning model using data from the Korean College of Rheumatology Biologics and Targeted Therapy Registry (KOBIO) [ 13 ] and show its application to identifying clinical variables predictive of remission in RA patients treated with biologics using the concept of XAI.…”

Explainable artificial intelligence for predicting remission in patients with rheumatoid arthritis treated with biologics

“…This study used data from the KOBIO registry, which is a nationwide multicenter cohort in Korea that was established to evaluate the effectiveness and side effects of biologic therapies in patients with RA. [13] Patients in the registry were recruited from 38 hospitals since 2012, and their demographics, medications, comorbidities, extra-articular manifestations, disease activities, radiographic ndings, and laboratory ndings have been recorded by investigators from each of the participating hospitals. The data from patients who were followed up annually were recorded on the KOBIO website (http://www.kobio.or.kr/kobio/), and these patients provided informed consent prior to registration.…”

“…Explainable arti cial intelligence (XAI), which presents the reasons for a prediction in a manner that can be understood, suggests the relationships between several variables necessary for predicting outcomes. [12] In this study, we established a machine learning model using data from the Korean College of Rheumatology Biologics and Targeted Therapy Registry (KOBIO), [13] and show its application to identifying clinical variables predictive of remission in RA patients treated with biologics using the concept of XAI.…”

Predictive Factors for the Long-Term Clinical Course in Patients with Rheumatoid Arthritis Receiving Second-Line Anti-Rheumatic Drugs in Real-World Practice: An Analysis Using Disease Activity Trajectory-Based Clustering Approach

“…This study used data from the KOBIO registry, which is a nationwide multicenter cohort in Korea that was established to evaluate the effectiveness and side effects of bDMARDs (ie, abatacept, adalimumab, etanercept, golimumab, in iximab, rituximab, and tocilizumab) and tsDMARDs (ie, tofacitinib and baricitinib) in patients with RA [17]. Patients in the registry were recruited from 38 hospitals since 2012, and their demographics, medications, comorbidities, extra-articular manifestations, disease activities, radiographic ndings, and laboratory ndings have been recorded by investigators from each participating hospital.…”