Switching profiles in a population-based cohort of rheumatoid arthritis receiving biologic therapy: results from the KOBIO registry
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Despite improved quality of care for rheumatoid arthritis (RA) patients, many still experience treatment failure with a biologic agent and eventually switch to another biologic agent. We investigated patterns of biologic treatment and reasons for switching biologics in patients with RA. Patients with RA who had started on a biologic agent or had switched to another biologic agent were identified from the prospective observational Korean nationwide Biologics (KOBIO) registry. The KOBIO registry contained 1184 patients with RA at the time of initiation or switching of biologic agents. Patients were categorized according to the chronological order of the introduction of biologic agents, and reasons for switching biologics were also evaluated. Of the 1184 patients with RA, 801 started with their first biologic agent, 228 were first-time switchers, and 89 were second-time or more switchers. Second-time or more switchers had lower rheumatoid factor and anti-CCP positivity, and higher disease activity scores at the time of enrollment than the other groups. Among these patients, tocilizumab was the most commonly prescribed biologic agent, followed by adalimumab and etanercept. The most common reason for switching biologics was inefficacy, followed by adverse events, including infusion reactions, infections, and skin eruptions. Furthermore, the proportion of inefficacy, as a reason for switching, was significantly higher with respect to switching between biologics with different mechanisms of action than between biologics with similar mechanisms. In this registry, we showed diverse prescribing patterns and differing baseline profiles based on the chronological order of biologic agents.
KeywordsBiologic agents Registry Rheumatoid arthritis Switching
The authors acknowledge the enthusiastic collaboration of all rheumatologists and their nurses in Korea in providing the data. In addition, the authors acknowledge support from the KCR board members and the members of the KCR Clinical Trials Committee for establishing the national registry. The authors also thank the patients and their families for their participation.
Compliance with ethical standards
This research complied with the Helsinki Declaration. Informed consent was obtained from all enrolled participants. The same informed consent form (ICF) and study protocol were provided to the independent institutional review boards/ethics committees (IRB/EC) at each medical center, and each IRB/EC reviewed the appropriateness of the protocol and risks and benefits to the study participants. Ultimately, the IRB/EC at each medical center independently approved this study without revision of the ICF or study protocol.
This study was supported by a grant (CRI 16039–22) Chonnam National University Hospital Biomedical Research Institute. The KCR commissioned the KOBIO as a Korea nationwide project to investigate the safety of biologic agents in routine medical practice. KCR receives restricted grant from Korean pharmaceutical companies, presently Abbvie, BMS, Celltrion, Janssen, JW Pharmaceutical, and Pfizer. The investigators and their team have full academic freedom and are able to work independently of pharmaceutical industry influence. All decisions concerning analyses, interpretation, and publication are made autonomously of any industrial contribution.
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