Yosipovitch Gil, Reich Adam, Steinhoff Martin, Beselin Anke, Kent Toby, Dossenbach Martin, Berggren Lovisa, Henneges Carsten, Luger Thomas
Department of Dermatology and Cutaneous Surgery, Itch Center, University of Miami, Miami, FL, USA.
Department of Dermatology, University of Rzeszow, Rzeszow, Poland.
Dermatol Ther (Heidelb). 2018 Dec;8(4):621-637. doi: 10.1007/s13555-018-0267-9. Epub 2018 Nov 21.
We evaluated baseline itch and its impact on the efficacy of ixekizumab (IXE) in clearing psoriasis and improving quality-of-life measures, and we explored the relationship between itch and psoriatic skin improvement.
Data were analyzed from two double-blind, randomized, controlled phase III studies (UNCOVER-2/3) comparing etanercept (ETN), IXE, and placebo (PBO) in patients with moderate-to-severe plaque psoriasis. Long-term analysis included UNCOVER-3 data from week 0 to week 156.
At week 12, a clinically meaningful improvement in itch [Itch Numeric Rating Scale (NRS) reduction ≥ 4] was seen in 70.0%, 88.6%, and 90.8% of the IXE-treated patients in the baseline Itch NRS 4-6, 7-8, and 9-10 groups, respectively (all itch severity groups p < 0.001 versus ETN and PBO). Also, 68.9%, 67.1%, and 73.6% of the IXE-treated patients in the baseline Itch NRS 4-6, 7-8, and 9-10 groups, respectively, showed an improvement of ≥ 90.0% in the Psoriatic Area and Severity Index (PASI) at week 12 as compared to the baseline (PASI 90) (all itch severity groups p < 0.001 versus ETN and PBO). For most patients, itch reduction preceded psoriatic plaque improvement. Sustained effects of IXE on itch and PASI were observed during 3 years of treatment.
Regardless of baseline itch severity, IXE treatment provided a rapid improvement in itch followed by clinically meaningful improvements in psoriasis.
Eli Lilly and Company.
ClinicalTrials.gov identifiers, NCT01597245 and NCT01646177.
我们评估了基线瘙痒及其对司库奇尤单抗（IXE）清除银屑病和改善生活质量指标疗效的影响，并探讨了瘙痒与银屑病皮肤改善之间的关系。
对两项双盲、随机、对照III期研究（UNCOVER - 2/3）的数据进行分析，该研究比较了中度至重度斑块状银屑病患者使用依那西普（ETN）、IXE和安慰剂（PBO）的疗效。长期分析纳入了UNCOVER - 3从第0周至第156周的数据。
在第12周时，基线瘙痒数字评定量表（NRS）为4 - 6、7 - 8和9 - 10组中，接受IXE治疗的患者分别有70.0%、88.6%和90.8%出现了具有临床意义的瘙痒改善（瘙痒NRS降低≥4）（所有瘙痒严重程度组与ETN和PBO相比，p < 0.001）。此外，基线瘙痒NRS为4 - 6、7 - 8和9 - 10组中，接受IXE治疗的患者分别有68.9%、67.1%和73.6%在第12周时银屑病面积和严重程度指数（PASI）较基线改善≥90.0%（PASI 90）（所有瘙痒严重程度组与ETN和PBO相比，p < 0.001）。对于大多数患者，瘙痒减轻先于银屑病斑块改善。在3年的治疗期间观察到IXE对瘙痒和PASI的持续疗效。
无论基线瘙痒严重程度如何，IXE治疗均可迅速改善瘙痒，随后使银屑病得到具有临床意义的改善。
礼来公司。
ClinicalTrials.gov标识符，NCT01597245和NCT01646177。
