Faculty of Medicine, Memorial University of Newfoundland , St. Johns , NL , USA.
Health Access and Outcomes, IQVIA , Kanata , ON , USA.
Curr Med Res Opin. 2019 Nov;35(11):2025-2033. doi: 10.1080/03007995.2019.1636543. Epub 2019 Jul 10.
To evaluate whether initiation of etanercept therapy among patients with rheumatoid arthritis (RA) impacts use of co-therapy with methotrexate or prednisone, and to describe etanercept dosing dynamics compared to product monograph in the Canadian real-world setting. A retrospective cohort study was conducted using claims-level data from IQVIA Private Drug Plan database, Ontario Public Drug Plan database and Régie de l'assurance maladie du Québec database. Bio-naïve RA patients initiating etanercept between July 2014 and June 2015 were identified and their claims for methotrexate or prednisone were analyzed. Utilization of methotrexate or prednisone was calculated as average weekly dose in milligrams, and compared in the 6 months pre-initiation versus 12 months post-initiation of etanercept. Weekly etanercept dosing of each patient was calculated and analyzed to determine whether patients had at least 20% higher or lower average dose than monograph recommended dose (50 mg/week), and were then flagged as above-monograph or below-monograph, respectively. A total of 2876 patients with RA (66% female, 76% aged 18-65) were included; 62% ( = 1,140) used methotrexate and 27% used prednisone ( = 498) both pre- and post-initiation of etanercept. In methotrexate patients, the average weekly dose dispensed was 25.4 mg in the 6 months pre-etanercept, and 25.0 mg in the 12 months post-etanercept initiation ( = .5282). In prednisone patients, the average weekly dose dispensed reduced from 122.6 mg pre-etanercept to 107.1 mg post-etanercept initiation ( = .2173). Among patients who were already on methotrexate or prednisone, after initiating on etanercept 16% ( = 213) and 34% ( = 254) of patients stopped methotrexate and prednisone, respectively. When compared to the recommended dose, 12% ( = 168) of patients were below-monograph and 7.1% of patients were above-monograph during their first year of etanercept therapy. Average etanercept dosing was consistently lower than product monograph during the follow-up year. Patients had a modest but not statistically significant decrease in prescribed doses of co-therapy with methotrexate and prednisone when etanercept was added to patients' therapy. In addition, 12-14% of patients stopped their co-therapy with methotrexate or prednisone. Further study is needed to understand the impact on patient outcomes and safety.
为了评估类风湿关节炎(RA)患者开始接受依那西普治疗是否会影响甲氨蝶呤或泼尼松的联合治疗,以及描述在加拿大真实环境中与产品说明书相比,依那西普的剂量动态。本研究采用 IQVIA 私人药物计划数据库、安大略省公共药物计划数据库和魁北克省医疗保险监管局数据库中的索赔水平数据进行了回顾性队列研究。确定了 2014 年 7 月至 2015 年 6 月间开始接受依那西普治疗的生物初治 RA 患者,并分析了他们的甲氨蝶呤或泼尼松的用药情况。以毫克为单位计算了甲氨蝶呤或泼尼松的平均每周剂量,并比较了依那西普治疗前 6 个月和治疗后 12 个月的剂量。计算并分析了每位患者的每周依那西普剂量,以确定患者的平均剂量是否比说明书推荐剂量(50mg/周)至少高出或低出 20%,然后分别标记为高于或低于说明书剂量。共纳入 2876 例 RA 患者(66%为女性,76%年龄在 18-65 岁之间);62%(n=1140)在开始依那西普治疗前和治疗后都使用了甲氨蝶呤,27%(n=498)使用了泼尼松。在使用甲氨蝶呤的患者中,依那西普治疗前 6 个月的平均每周剂量为 25.4mg,依那西普治疗后 12 个月的平均每周剂量为 25.0mg(n=0.5282)。在使用泼尼松的患者中,依那西普治疗前 122.6mg 的平均每周剂量降至治疗后 107.1mg(n=0.2173)。在已经使用甲氨蝶呤或泼尼松的患者中,分别有 16%(n=213)和 34%(n=254)的患者在开始依那西普治疗后停止使用甲氨蝶呤和泼尼松。与推荐剂量相比,12%(n=168)的患者低于说明书剂量,7.1%的患者在依那西普治疗的第一年高于说明书剂量。在随访期间,依那西普的平均剂量一直低于产品说明书。当依那西普被添加到患者的治疗中时,患者的甲氨蝶呤和泼尼松联合治疗的处方剂量有适度但无统计学意义的降低。此外,12-14%的患者停止了他们的甲氨蝶呤或泼尼松联合治疗。需要进一步研究以了解对患者结局和安全性的影响。