1 Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
2 Division of Pharmacoepidemiology and Pharmacoeconomics and Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
J Manag Care Spec Pharm. 2017 Aug;23(8):809-814. doi: 10.18553/jmcp.2017.23.8.809.
Ten biologic disease-modifying antirheumatic drugs (bDMARDs) are available as treatment for rheumatoid arthritis (RA), but relatively little is known about population-level time trends in the use of these agents.
To describe time trends in the use of bDMARDs in RA patients with private or public insurance in the United States.
Claims data from private (Optum Clinformatics, 2004-2015) and public (Medicaid Analytic eXtract [MAX], 2000-2010) insurance programs were used. Patients with RA diagnosis codes and continuous health plan enrollment for 1-year baseline and 1-year follow-up periods were identified into 2 separate cohorts: (1) patients not using any bDMARD or (2) patients using a single bDMARD during the baseline period. Initiation of the first bDMARD from group 1 and switch to a second bDMARD from group 2 was identified as the outcome of interest during the 1-year follow-up period. Using mixed-effects regression models, we calculated yearly rates of initiation and switch for bDMARDs, adjusted for case-mix. We also described the proportion of all initiations and switches accounted for by each agent.
There were 113,031 RA patients with public insurance and 97,751 RA patients with private insurance who were included in the study. The rates of initiation of bDMARDs (per 100 patients) increased significantly over time in Medicaid data for incident RA patients (from 1.1 to 3.1, P = 0.0006) and prevalent RA patients (from 4.6 to 10.9, P = 0.008). In Optum Clinformatics data, the rates were stable, with 7.7 to 8.3 per 100 incident RA patients (P = 0.10) and 11.0 to 11.5 per 100 prevalent RA patients (P = 0.12). The rates of switching (per 100 patients) increased over time from 6.4 to 16.0 (P = 0.04) in Medicaid data and 9.1 to 17.0 (P = 0.00003) in Optum Clinformatics data. Use of etanercept as the most common first-line agent was stable at approximately 50% of all biologic initiations, but use of infliximab decreased and the use of newer agents increased.
More RA patients used bDMARDs in recent years, and use of newer agents, including certolizumab, golumumab, and tocilizuamab, is rising, which highlights a need for further comparative safety and effectiveness research of these agents to better guide evidence-based decision making.
This study was supported by an investigator-initiated research grant from Pfizer. The study was conducted by the authors independent of the sponsor. The sponsor was given the opportunity to make nonbinding comments on a draft of the manuscript, but the authors retained the right of publication and determined the final wording. Solomon receives salary support through research support to his hospital from Amgen, Pfizer, AstraZeneca, Genentech, Lilly, Bristol-Myers Squibb, and CORRONA. Kim receives research grants from AstraZeneca, Lilly, Pfizer, Bristol-Myers Squibb, and Genentech. Desai receives research grants from Merck. Study concept and design were contributed by Desai and Kim. Liu took the lead in data collection, along with Jin, Desai, and Kim. All authors contributed equally in the interpretation of the results. The manuscript was written and revised primarily by Desai, along with Kim and the other authors.
有十种生物疾病修正抗风湿药物(bDMARDs)可用于治疗类风湿关节炎(RA),但对于这些药物在人群水平上的使用时间趋势,我们知之甚少。
描述在美国私人或公共保险的 RA 患者中使用 bDMARD 的时间趋势。
使用私人(Optum Clinformatics,2004-2015)和公共(Medicaid Analytic eXtract [MAX],2000-2010)保险计划的索赔数据。确定有 RA 诊断代码且在基线和随访 1 年期间持续参加健康计划的患者进入 2 个单独队列:(1)未使用任何 bDMARD 的患者,或(2)在基线期间使用单一 bDMARD 的患者。从第 1 组开始使用第一支 bDMARD,从第 2 组转换为第二支 bDMARD,这被认为是随访 1 年内的结果。使用混合效应回归模型,我们计算了 bDMARD 的年起始和转换率,同时调整了病例组合。我们还描述了每个药物在所有起始和转换中的比例。
有 113031 名有公共保险的 RA 患者和 97751 名有私人保险的 RA 患者被纳入研究。 Medicaid 数据中,新发 RA 患者(从 1.1 增加到 3.1,P=0.0006)和现患 RA 患者(从 4.6 增加到 10.9,P=0.008)的 bDMARD 起始率(每 100 例患者)显著增加。Optum Clinformatics 数据中,这些比率稳定,新发 RA 患者为 7.7 至 8.3 例(P=0.10),现患 RA 患者为 11.0 至 11.5 例(P=0.12)。从 6.4 增加到 16.0(P=0.04)在 Medicaid 数据中,从 9.1 增加到 17.0(P=0.00003)在 Optum Clinformatics 数据中,转换率(每 100 例患者)也随时间增加。依那西普作为最常用的一线药物,约占所有生物制剂起始治疗的 50%,但使用英夫利昔单抗的比例下降,使用新型药物的比例上升。
近年来,更多的 RA 患者使用了 bDMARDs,新型药物的使用,包括 certolizumab、golumumab 和 tocilizumab,正在增加,这突显了需要进一步进行这些药物的安全性和有效性的比较研究,以更好地指导基于证据的决策。
这项研究得到了辉瑞公司的一项由研究者发起的研究资助。作者独立于赞助商进行了这项研究。赞助商有机会对稿件草案提出非约束性意见,但作者保留出版权,并确定最终措辞。Solomon 的薪酬由 Amgen、Pfizer、AstraZeneca、Genentech、Lilly、Bristol-Myers Squibb 和 CORRONA 的研究支持提供。Kim 接受来自 AstraZeneca、Lilly、Pfizer、Bristol-Myers Squibb 和 Genentech 的研究赠款。Desai 接受来自 Merck 的研究赠款。研究概念和设计由 Desai 和 Kim 提出。Liu 与 Jin、Desai 和 Kim 一起带头进行数据收集。所有作者对结果的解释都做出了同等贡献。手稿主要由 Desai 编写,同时 Kim 和其他作者也对其进行了修订。