Switching profiles in a population-based cohort of rheumatoid arthritis receiving biologic therapy: results from the KOBIO registry
- 672 Downloads
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.
- 6.Bae SC, Kim J, Choe JY et al (2017) A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study. Ann Rheum Dis 76:65–71CrossRefPubMedGoogle Scholar
- 7.Yoo DH, Hrycaj P, Miranda P et al (2013) A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 72:1613–1620CrossRefPubMedPubMedCentralGoogle Scholar
- 13.Navarro Coy NC, Brown S, Bosworth A et al (2014) The ‘Switch’ study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug. BMC Musculoskelet Disord 15:452CrossRefPubMedPubMedCentralGoogle Scholar
- 16.Hyrich KL, Lunt M, Watson KD, Symmons DP, Silman AJ, British Society for Rheumatology Biologics R (2007) Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study. Arthritis Rheum 56:13–20CrossRefPubMedGoogle Scholar
- 22.Pincus T, Swearingen CJ, Bergman M, Yazici Y (2008) RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol 35:2136–2147CrossRefPubMedGoogle Scholar
- 26.Hetland ML, Christensen IJ, Tarp U et al (2010) Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum 62:22–32CrossRefPubMedGoogle Scholar
- 36.Strand V, Williams S, Miller PSJ, Saunders K, Grant S, Kremer JM (2013) Discontinuation of biologic therapy in rheumatoid arthritis (Ra): analysis from the Consortium of Rheumatology Researchers of North America (Corrona) database. Ann Rheum Dis 72:71–72Google Scholar
- 37.Potter C, Hyrich KL, Tracey A et al (2009) Association of rheumatoid factor and anti-cyclic citrullinated peptide positivity, but not carriage of shared epitope or PTPN22 susceptibility variants, with anti-tumour necrosis factor response in rheumatoid arthritis. Ann Rheum Dis 68:69–74CrossRefPubMedGoogle Scholar
- 40.Gottenberg JE, Courvoisier DS, Hernandez MV et al (2016) Brief report: association of rheumatoid factor and anti-citrullinated protein antibody positivity with better effectiveness of abatacept: results from the Pan-European Registry Analysis. Arthritis Rheumatol 68:1346–1352CrossRefPubMedGoogle Scholar
- 42.Hetland ML, Lindegaard HM, Hansen A et al (2008) Do changes in prescription practice in patients with rheumatoid arthritis treated with biological agents affect treatment response and adherence to therapy? Results from the nationwide Danish DANBIO Registry. Ann Rheum Dis 67:1023–1026CrossRefPubMedGoogle Scholar
- 45.Nusslein HG, Alten R, Galeazzi M et al (2014) Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. BMC Musculoskelet Disord 15:14CrossRefPubMedPubMedCentralGoogle Scholar