Harnett James, Curtis Jeffrey R, Gerber Robert, Gruben David, Koenig Andrew
Pfizer Inc, New York, New York.
The University of Alabama, Birmingham, Alabama.
Clin Ther. 2016 Jun;38(6):1451-1463. doi: 10.1016/j.clinthera.2016.03.038. Epub 2016 Apr 21.
Tofacitinib is an oral Janus kinase inhibitor indicated for the treatment of rheumatoid arthritis (RA). Tofacitinib can be administered as a monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (DMARDs). This study describes RA patients' characteristics, treatment patterns, and costs for those initiating tofacitinib treatment as monotherapy or combination therapy, using US claims data from clinical practice.
A retrospective cohort analysis of patients aged ≥18 years with RA (International Classification of Diseases, Ninth Revision code 714.xx) and with ≥1 tofacitinib claim in the Truven Marketscan (TM) or the Optum Clinformatics (OC) database. Index was defined as the first tofacitinib fill date (November 2012-June 2014). Patients were continuously enrolled for ≥12 months before and after index. Adherence was assessed using the proportion of days covered (PDC) and medication possession ratio (MPR). Persistence was evaluated using a 1.5× days' supply gap or switch. All-cause and RA-related costs in the 12-month pre- and post-index periods were evaluated. Unadjusted and adjusted analyses were conducted on data on treatment patterns and costs stratified by monotherapy status.
A total of 337 (TM) and 118 (OC) tofacitinib patients met the selection criteria; 52.2% (TM) and 50.8% (OC) received monotherapy and 83.7% (TM) and 76.3% (OC) had pre-index biologic DMARD experience. Twelve-month mean PDC values were 0.56 (TM) and 0.53 (OC), and 12-month mean MPR was 0.84 (TM) and 0.80 (OC), with persistence of 140.0 (TM) and 124.6 (OC) days. Between 12-month pre- and post-index periods, mean (SD) 12-month RA-related medical costs decreased by $5784 ($31,832) in TM and $6103 ($25,897) in OC (both, P < 0.05), whereas total costs increased by $3996 ($30,397) in TM (P < 0.05) and $1390 ($26,603) in OC. There were no significant differences in adherence, persistence, or all-cause/RA-related costs between monotherapy and combination therapy in unadjusted/adjusted analyses.
This analysis adds to the existing tofacitinib knowledge base and will enable informed clinical and policy decision making based on valuable datasets independent of randomized controlled trials.
托法替布是一种口服的 Janus 激酶抑制剂，用于治疗类风湿关节炎（RA）。托法替布可作为单一疗法给药，也可与传统合成抗风湿药物（DMARDs）联合使用。本研究利用美国临床实践中的索赔数据，描述了开始使用托法替布单一疗法或联合疗法治疗的 RA 患者的特征、治疗模式和费用。
对年龄≥18 岁、患有 RA（国际疾病分类第九版代码 714.xx）且在 Truven Marketscan（TM）或 Optum Clinformatics（OC）数据库中有≥1 次托法替布索赔记录的患者进行回顾性队列分析。索引定义为首次托法替布配药日期（2012 年 11 月 - 2014 年 6 月）。患者在索引前后连续入组≥12 个月。使用覆盖天数比例（PDC）和药物持有率（MPR）评估依从性。使用 1.5 倍的日供应量差距或换药情况评估持续性。评估索引前和索引后 12 个月内的全因成本和与 RA 相关的成本。对按单一疗法状态分层的治疗模式和成本数据进行未调整和调整分析。
共有 337 名（TM）和 118 名（OC）托法替布患者符合入选标准；52.2%（TM）和 50.8%（OC）接受单一疗法，83.7%（TM）和 76.3%（OC）在索引前有生物 DMARD 治疗经历。12 个月的平均 PDC 值分别为 0.56（TM）和 0.53（OC），12 个月的平均 MPR 为 0.84（TM）和 0.80（OC），持续性分别为 140.0（TM）和 124.6（OC）天。在索引前和索引后 12 个月期间，TM 组的平均（标准差）12 个月与 RA 相关的医疗成本下降了 5784 美元（31832 美元），OC 组下降了 6103 美元（25897 美元）（两者均 P < 0.05），而 TM 组的总成本增加了 3996 美元（30397 美元）（P < 0.05），OC 组增加了 1390 美元（26603 美元）。在未调整/调整分析中，单一疗法和联合疗法在依从性、持续性或全因/与 RA 相关的成本方面没有显著差异。
该分析丰富了现有的托法替布知识库，并将基于独立于随机对照试验的有价值数据集，为临床和政策决策提供依据。
