Feldman Steven R, Foster Shonda A, Zhu Baojin, Burge Russel, Al Sawah Sarah, Goldblum Orin M
J Drugs Dermatol. 2017 Dec 1;16(12):1246-1252.
Newer psoriasis treatments can achieve greater levels of efficacy than older systemic therapies; however, current psoriasis costs are substantial. We sought to estimate costs per additional responder associated with ixekizumab and etanercept, versus placebo, using efficacy data from phase 3 clinical trials (UNCOVER-2 and UNCOVER-3). METHODS: In UNCOVER-2/UNCOVER-3, patients received subcutaneous placebo, etanercept 50 mg twice weekly (BIW), or ixekizumab one 80 mg injection every 2 weeks (Q2W) after a 160-mg starting dose. Twelve-week induction-phase Psoriasis Area and Severity Index (PASI) 75, PASI 90, and PASI 100 response rates for ixekizumab, etanercept, and placebo were obtained from pooled data from the overall and United States (US) subgroup intention-to-treat (ITT) populations, and used to calculate numbers needed to treat (NNTs) to achieve one additional PASI 75, PASI 90, or PASI 100 response for ixekizumab Q2W and etanercept BIW versus placebo. Twelve-week drug costs per patient were calculated based on the UNCOVER-2/UNCOVER-3 dosing schedule and wholesale acquisition costs. Mean costs per additional responder for PASI 75, PASI 90, and PASI 100 for each treatment versus placebo were calculated for pooled UN-COVER-2/UNCOVER-3 overall and US subgroup ITT populations. RESULTS: Pooled overall ITT population: costs per additional PASI 75, PASI 90, or PASI 100 responder were US $37,540, US $46,299, or US $80,710 for ixekizumab Q2W and US $57,533, US $120,720, or US $404,695 for etanercept BIW, respectively. US subgroup ITT population: costs per additional PASI 75, PASI 90, or PASI 100 responder were US $38,165, US $49,740, or US $93,536 for ixekizumab Q2W and US $69,580, US $140,881, or US $631,875 for etanercept BIW, respectively. CONCLUSIONS: Twelve-week costs per additional responder were lower for ixekizumab Q2W than for etanercept BIW across all levels of clearance (PASI 75, PASI 90, and PASI 100) in the pooled UNCOVER-2/UNCOVER-3 overall and US subgroup ITT populations.
新型银屑病治疗方法比传统全身治疗具有更高的疗效;然而,目前银屑病的治疗费用相当高昂。我们试图利用3期临床试验(UNCOVER - 2和UNCOVER - 3)的疗效数据,估算与安慰剂相比,司库奇尤单抗和依那西普每增加一名有反应者的成本。
在UNCOVER - 2/UNCOVER - 3试验中,患者在起始剂量160mg后,接受皮下注射安慰剂、每周两次50mg依那西普或每2周一次80mg司库奇尤单抗注射。从总体和美国亚组意向性治疗(ITT)人群的汇总数据中获得司库奇尤单抗、依那西普和安慰剂的12周诱导期银屑病面积和严重程度指数(PASI)75、PASI 90和PASI 100缓解率,并用于计算与安慰剂相比,司库奇尤单抗每2周一次和依那西普每周两次治疗中,实现额外一名PASI 75、PASI 90或PASI 100缓解所需的治疗人数(NNT)。根据UNCOVER - 2/UNCOVER - 3给药方案和批发采购成本计算每位患者12周的药物成本。计算汇总的UNCOVER - 2/UNCOVER - 3总体和美国亚组ITT人群中,每种治疗与安慰剂相比,PASI 75、PASI 90和PASI 100每增加一名有反应者的平均成本。
汇总的总体ITT人群:司库奇尤单抗每2周一次治疗中,PASI 75、PASI 90或PASI 100每增加一名有反应者的成本分别为37,540美元、46,299美元或80,710美元;依那西普每周两次治疗中,相应成本分别为57,533美元、120,720美元或404,695美元。美国亚组ITT人群:司库奇尤单抗每2周一次治疗中,PASI 75、PASI 90或PASI 100每增加一名有反应者的成本分别为38,165美元、49,740美元或93,536美元;依那西普每周两次治疗中,相应成本分别为69,580美元、140,881美元或631,875美元。
在汇总的UNCOVER - 2/UNCOVER - 3总体和美国亚组ITT人群中,司库奇尤单抗每2周一次治疗在所有清除水平(PASI 75、PASI 90和PASI 100)下,每增加一名有反应者的12周成本均低于依那西普每周两次治疗。