Background and Objective
Biologic disease-modifying anti-rheumatic drugs (bDMARDs) are used either when conventional synthetic DMARDs are ineffective or when disease activity is high and with poor prognostic factors, based on various clinical guidelines. The purpose of this study was to investigate the prescribing trends of bDMARDs for patients with rheumatoid arthritis in Japan, and to clarify whether the pharmacological therapy of bDMARDs is administered based on guidelines.
We conducted a descriptive epidemiological study from 2012 to 2018 using the JMDC Claims Database, a nationwide claims database, and described the annual changes based on the number of patients prescribed bDMARDs. Anti-rheumatic drugs were identified based on the Anatomical Therapeutic Chemical codes, including methotrexate, glucocorticoids, non-steroidal anti-inflammatory drugs and bDMARDs.
From the database including 6,862,244 people, the data of 6407 patients with rheumatoid arthritis were extracted. The present study demonstrated that the proportion of patients prescribed bDMARDs was 1.0 per 1000 people, with those aged ≥ 65 years being the most common age group. The proportion of patients with rheumatoid arthritis who were prescribed bDMARDs increased significantly over time (p < 0.0001). Additionally, the concomitant proportions of methotrexate (p < 0.0001), non-steroidal anti-inflammatory drugs (p < 0.0001) and glucocorticoids (p = 0.0001) prescribed with bDMARDs decreased significantly over time.
The increase in bDMARD monotherapy may be attributed to the new bDMARDs that have been launched sequentially; furthermore, physicians have come to recognise monotherapy as the mainstay of treatment. Future studies must accumulate evidence on the long-term efficacy and safety of bDMARDs.
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This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.
Conflict of interest
Atsushi Hirata, Ryosuke Ota, Takeo Hata, Takeshi Hamada, Masami Nishihara, Kazuhisa Uchiyama and Takahiro Katsumata have no conflicts of interest that are directly relevant to the content of this article.
All procedures in this study involving human participants were performed in accordance with the ethical standards of the institutional research committee, and with the 1964 Declaration of Helsinki, its later amendments and comparable ethical standards. This study was approved by the Ethics Committee of Osaka Medical and Pharmaceutical University (Approval ID: RIN-41, 2762) on 6 August, 2019.
Consent to participate
This study used anonymised information from the JMDC Claims Database; therefore, in accordance with the ethical guidelines for medical and health research involving human subjects in Japan, informed consent was not required.
Consent for publication
Availability of data and material
The data that support the findings of this study are available from JMDC Inc. but were used under license for the current study; therefore, restrictions apply and the data are not publicly available. For inquiries about access to the dataset used in this study, please contact JMDC (https://www.jmdc.co.jp).
Atsushi Hirata: conceptualisation, methodology, validation, formal analysis, investigation, writing—original draft. Ryosuke Ota: conceptualisation, methodology, validation, writing—review and editing. Takeo Hata: conceptualisation, methodology, validation, formal analysis, writing—review and editing, supervision. Takeshi Hamada: writing—review and editing. Masami Nishihara: writing—review and editing. Kazuhisa Uchiyama: writing—review and editing. Takahiro Katsumata; writing—review and editing, project administration.
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Hirata, A., Ota, R., Hata, T. et al. Prescribing Trends of Biologic Disease-Modifying Anti-rheumatic Drugs Using a Claims Database from 6 Million People in Japan. Clin Drug Investig 41, 967–974 (2021). https://doi.org/10.1007/s40261-021-01082-x