Rendas-Baum Regina, Kosinski Mark, Singh Amitabh, Mebus Charles A, Wilkinson Bethany E, Wallenstein Gene V
QualityMetric Incorporated Lincoln, RI.
Pfizer Inc, Collegeville, PA.
Rheumatology (Oxford). 2017 Aug 1;56(8):1386-1394. doi: 10.1093/rheumatology/kex087.
RA causes high disability levels and reduces health-related quality of life, triggering increased costs and risk of unemployment. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. These post hoc analyses of phase 3 data aimed to assess monthly medical expenditure (MME) and risk of job loss for tofacitinib treatment vs placebo.
Data analysed were from two randomized phase 3 studies of RA patients (n = 1115) with inadequate response to MTX or TNF inhibitors (TNFi) receiving tofacitinib 5 or 10 mg twice daily, adalimumab (one study only) or placebo, in combination with MTX. Short Form 36 version 2 Health Survey physical and mental component summary scores were translated into predicted MME via an algorithm and concurrent inability to work and job loss risks at 6, 12 and 24 months, using Medical Outcomes Study data.
MME reduction by month 3 was $100 greater for tofacitinib- than placebo-treated TNFi inadequate responders (P < 0.001); >20 and 6% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾16%, and risk of future job loss decreased ∼20% (P < 0.001 vs placebo). MME reduction by month 3 was $70 greater for tofacitinib- than placebo-treated MTX inadequate responders (P < 0.001); ⩾23 and 13% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾31% and risk of future job loss decreased ⩾25% (P < 0.001 vs placebo).
Tofacitinib treatment had a positive impact on estimated medical expenditure and risk of job loss for RA patients with inadequate response to MTX or TNFi.
类风湿关节炎(RA)会导致高度残疾,并降低健康相关生活质量,引发成本增加和失业风险。托法替布是一种用于治疗RA的口服Janus激酶抑制剂。这些对3期数据的事后分析旨在评估托法替布治疗与安慰剂相比的每月医疗支出(MME)和失业风险。
分析的数据来自两项针对对甲氨蝶呤(MTX)或肿瘤坏死因子抑制剂(TNFi)反应不足的RA患者(n = 1115)的随机3期研究,这些患者接受每日两次5或10 mg托法替布、阿达木单抗(仅一项研究)或安慰剂,并联合MTX治疗。通过算法将简明健康调查问卷第2版的身体和精神成分汇总得分转化为预测的MME,并利用医学结局研究数据评估6、12和24个月时同时出现的无法工作情况和失业风险。
对于TNFi反应不足且接受托法替布治疗的患者,与接受安慰剂治疗的患者相比,到第3个月时MME减少了100美元(P < 0.001);分别较基线水平降低了20%以上和6%。在托法替布治疗的第3个月,无法工作的几率降低了至少16%,未来失业风险降低了约20%(与安慰剂相比,P < 0.001)。对于MTX反应不足且接受托法替布治疗的患者,与接受安慰剂治疗的患者相比,到第3个月时MME减少了70美元(P < 0.001);分别较基线水平降低了23%以上和13%。在托法替布治疗的第3个月,无法工作的几率降低了至少31%,未来失业风险降低了至少25%(与安慰剂相比,P < 0.001)。
托法替布治疗对MTX或TNFi反应不足的RA患者的估计医疗支出和失业风险产生了积极影响。