Reich Kristian, Leonardi Craig, Lebwohl Mark, Kerdel Francisco, Okubo Yukari, Romiti Ricardo, Goldblum Orin, Dennehy Ellen B, Kerr Lisa, Sofen Howard
a Dermatologikum Hamburg and SCIderm GmbH , Hamburg , Germany.
b Department of Dermatology , Saint Louis University School of Medicine , St Louis , MO , USA.
J Dermatolog Treat. 2017 Jun;28(4):282-287. doi: 10.1080/09546634.2016.1249820. Epub 2016 Nov 13.
Scalp is a frequently affected and difficult-to-treat area in psoriasis patients.
We assessed the efficacy of ixekizumab in the treatment of patients with scalp psoriasis over 60 weeks using the Psoriasis Scalp Severity Index (PSSI).
In three Phase 3, multicenter, double-blind, placebo-controlled trials, patients with moderate-to-severe psoriasis in UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224) and UNCOVER-3 (N = 1346) were randomized to subcutaneous 80 mg ixekizumab every two weeks (Q2W) or every four weeks (Q4W) after a 160 mg starting dose, or placebo through Week 12. Additional UNCOVER-2 and UNCOVER-3 cohorts were randomized to 50 mg bi-weekly etanercept through Week 12. Patients entering the open-label long-term extension (LTE) (UNCOVER-3) received ixekizumab Q4W; UNCOVER-1 and UNCOVER-2 included a blinded maintenance period in which static physician global assessment (sPGA) 0/1 responders were re-randomized to placebo, ixekizumab Q4W, or 80 mg ixekizumab every 12 weeks (Q12W) through Week 60.
In patients with moderate-to-severe psoriasis with baseline scalp involvement, PSSI 90 and 100 were achieved at Week 12 in higher percentages of patients treated with ixekizumab Q2W (81.7% and 74.6%) or ixekizumab Q4W (75.6% and 68.9%) compared with patients treated with placebo (7.6% and 6.7%; p < .001 each ixekizumab arm versus placebo) or etanercept (55.5% and 48.1%; p < .001 each ixekizumab arm versus etanercept). These outcomes were maintained through Week 60 of the maintenance (UNCOVER-1 and UNCOVER-2) and LTE (UNCOVER-3) period in patients who continued on ixekizumab Q4W.
Ixekizumab was efficacious in treating scalp psoriasis in patients with moderate-to-severe psoriasis, with most patients achieving complete or near-complete resolution of scalp psoriasis and maintaining this response over 60 weeks.
头皮是银屑病患者中经常受累且难以治疗的部位。
我们使用银屑病头皮严重程度指数（PSSI）评估了ixekizumab在60周内治疗头皮银屑病患者的疗效。
在三项3期、多中心、双盲、安慰剂对照试验中，UNCOVER - 1（N = 1296）、UNCOVER - 2（N = 1224）和UNCOVER - 3（N = 1346）中中度至重度银屑病患者在起始剂量160mg后，被随机分为皮下注射每两周一次（Q2W）或每四周一次（Q4W）的80mg ixekizumab，或在第12周前给予安慰剂。UNCOVER - 2和UNCOVER - 3的其他队列在第12周前被随机分为每两周一次50mg的依那西普。进入开放标签长期扩展（LTE）（UNCOVER - 3）的患者接受每四周一次的ixekizumab；UNCOVER - 1和UNCOVER - 2包括一个盲法维持期，在此期间，静态医师整体评估（sPGA）为0/1的缓解者被重新随机分为安慰剂、每四周一次的ixekizumab或每12周一次（Q12W）的80mg ixekizumab，直至第60周。
在中度至重度银屑病且基线头皮受累的患者中，与接受安慰剂（7.6%和6.7%；各ixekizumab组与安慰剂相比p <.001）或依那西普（55.5%和48.
1%；各ixekizumab组与依那西普相比p <.001）治疗的患者相比，接受每两周一次（Q2W）或每四周一次（Q4W）的ixekizumab治疗的患者在第12周时达到PSSI 90和100的比例更高（分别为81.7%和74.6%以及75.6%和68.9%）。在继续接受每四周一次的ixekizumab治疗的患者中，这些结果在维持期（UNCOVER - 1和UNCOVER - 2）和LTE期（UNCOVER - 3）的第60周时得以维持。
Ixekizumab在治疗中度至重度银屑病患者的头皮银屑病方面有效，大多数患者实现了头皮银屑病的完全或接近完全缓解，并在60周内维持了这种反应。
