Department of Pharmacy, Kindai University Nara Hospital, 1248-1, Otoda-cho, Ikoma, Nara, 630-0293, Japan.
Department of Pharmacy, Osaka Medical and Pharmaceutical University Hospital, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan.
Clin Drug Investig. 2021 Nov;41(11):967-974. doi: 10.1007/s40261-021-01082-x. Epub 2021 Sep 22.
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.
生物疾病修饰抗风湿药物(bDMARDs)在常规合成 DMARDs 无效或疾病活动度高且存在预后不良因素时使用,这是基于各种临床指南的。本研究旨在调查日本类风湿关节炎患者使用 bDMARDs 的处方趋势,并阐明 bDMARDs 的药物治疗是否基于指南进行。
我们使用全国性的索赔数据库 JMDC 索赔数据库,进行了 2012 年至 2018 年的描述性流行病学研究,并根据开具 bDMARDs 的患者数量描述了年度变化。抗风湿药物是根据解剖治疗化学代码确定的,包括甲氨蝶呤、糖皮质激素、非甾体抗炎药和 bDMARDs。
从包括 6862244 人的数据库中,提取了 6407 例类风湿关节炎患者的数据。本研究表明,开具 bDMARDs 的患者比例为每 1000 人 1.0 例,年龄≥65 岁的患者最常见。随着时间的推移,开具 bDMARDs 的类风湿关节炎患者比例显著增加(p<0.0001)。此外,与 bDMARDs 同时开具的甲氨蝶呤(p<0.0001)、非甾体抗炎药(p<0.0001)和糖皮质激素(p=0.0001)的比例也随着时间的推移显著下降。
bDMARD 单药治疗的增加可能归因于新的 bDMARDs 相继推出;此外,医生已经认识到单药治疗是治疗的主要方法。未来的研究必须积累关于 bDMARDs 的长期疗效和安全性的证据。