Hata Takeo, Hirata Atsushi, Ota Ryosuke, Hosohata Keiko, Nishihara Masami, Neo Masashi, Katsumata Takahiro
Department of Pharmacy, Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Osaka, Japan.
Department of Pharmacy, Kindai University Nara Hospital, Ikoma, Nara, Japan.
Ther Clin Risk Manag. 2022 Aug 24;18:843-853. doi: 10.2147/TCRM.S375890. eCollection 2022.
Biologic disease-modifying anti-rheumatic drugs (bDMARDs) are highly effective and safe against juvenile idiopathic arthritis (JIA), which is classified into systemic JIA (sJIA) and the other JIA categories (non-sJIA) according to differences in clinical symptoms and pathophysiology. The purpose of the current study was to investigate trends in patterns of prescribing bDMARDs for moderate-to-severe JIA using a relatively large sample size in Japan.
A descriptive epidemiological study based on a nationwide claims database in Japan was conducted from 2012 to 2018 using the "JMDC Claims Database" to explain annual changes based on the number of patients prescribed bDMARDs. Study drugs were identified based on the Anatomical Therapeutic Chemical codes, such as methotrexate, glucocorticoids, non-steroidal anti-inflammatory drugs, and bDMARDs.
From a database of 6,862,244 patients, the following exclusion criteria were applied: aged ≥16 years, without "M08" in their ICD-10 code as disease, and missing the information of prescription date in the database during the study period, resulting in a final number of 111 JIA patients. We found an increasing trend for adalimumab and tocilizumab and a decreasing trend for methotrexate. Differences in medication use between sJIA and non-sJIA patients were also evident, being consistent with national and international guidelines.
Although the introduction of bDMARDs has markedly improved the efficacy of JIA therapy, there are still many short- and long-term safety issues to be examined, including the risk of infection and potential risk of associated malignancy. Future studies are needed to clarify these issues.
生物性疾病改善抗风湿药物(bDMARDs)对幼年特发性关节炎(JIA)具有高效性和安全性,JIA根据临床症状和病理生理学差异分为全身型JIA(sJIA)和其他JIA类别(非sJIA)。本研究的目的是在日本使用相对较大的样本量调查中重度JIA患者使用bDMARDs的处方模式趋势。
基于日本全国性索赔数据库进行了一项描述性流行病学研究,研究时间为2012年至2018年,使用“JMDC索赔数据库”,根据开具bDMARDs的患者数量解释年度变化。根据解剖治疗化学代码识别研究药物,如甲氨蝶呤、糖皮质激素、非甾体抗炎药和bDMARDs。
从6,862,244名患者的数据库中,应用了以下排除标准:年龄≥16岁、ICD-10疾病代码中无“M08”以及在研究期间数据库中缺少处方日期信息,最终得到111名JIA患者。我们发现阿达木单抗和托珠单抗呈上升趋势,甲氨蝶呤呈下降趋势。sJIA和非sJIA患者在用药方面的差异也很明显,这与国内和国际指南一致。
尽管bDMARDs的引入显著提高了JIA治疗的疗效,但仍有许多短期和长期安全性问题需要研究,包括感染风险和相关恶性肿瘤的潜在风险。未来需要开展研究以阐明这些问题。