Dermatologikum Berlin, Friedrichstraße 89, 10117, Berlin, Germany.
SCIderm Research Institute, Hamburg, Germany.
Br J Dermatol. 2019 Nov;181(5):954-966. doi: 10.1111/bjd.17351. Epub 2019 Jan 16.
Nail psoriasis is associated with functional impairment, pain and reduced quality of life.
To demonstrate the superiority of secukinumab over placebo in clearing nail psoriasis as assessed by the Nail Psoriasis Severity Index (NAPSI) at week 16 and over time up to week 132. Presented here is the week 32 interim analysis. Impact on quality of life was assessed by Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) patient questionnaires.
TRANSFIGURE is a double-blind, randomized, placebo-controlled study in patients with moderate-to-severe plaque and nail psoriasis.
The primary objective of this study was met: both doses of secukinumab were superior to placebo at week 16 (NAPSI improvements of -45·3%, -37·9% and -10·8% for secukinumab 300 mg and 150 mg and placebo, respectively, P < 0·001). Significant improvements were seen in patients' quality of life: the NAPPA-Quality of Life total score median decreases at week 16 were 60·9%, 49·9% and 15·8% for secukinumab 300 mg and 150 mg and placebo, respectively (P < 0·001). Improvement in nail psoriasis continued to week 32: NAPSI percentage change reached -63·2% and -52·6% for secukinumab 300 mg and 150 mg, respectively. Skin clearance measured by ≥ 90% improvement in Psoriasis Area and Severity Index was significant (rates of 72·5%, 54·0% and 1·7% for secukinumab 300 mg and 150 mg and placebo at week 16, respectively, P < 0·001) and was sustained to week 32. The most common adverse events were nasopharyngitis, headache and upper respiratory tract infections.
Secukinumab demonstrated significant and clinically meaningful efficacy and quality-of-life improvements for patients with nail psoriasis up to week 32. What's already known about this topic? Nail psoriasis is understudied and there is a lack of effective treatment options. Nail psoriasis is correlated with more severe psoriatic disease and the development of psoriatic arthritis. What does this study add? TRANSFIGURE is one of the few prospective placebo-controlled trials specifically in nail psoriasis and includes nail-specific quality-of-life measures such as Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA)-Quality of Life and NAPPA-Patient Benefit Index. In this trial, secukinumab demonstrates significant efficacy and quality-of-life improvements in this difficult-to-treat population.
指甲银屑病与功能障碍、疼痛和生活质量下降有关。
证明与安慰剂相比，司库奇尤单抗在第 16 周和第 132 周时通过指甲银屑病严重指数（NAPSI）清除指甲银屑病的优越性。这里呈现的是第 32 周的中期分析。指甲银屑病和银屑病关节炎患者问卷（NAPPA）评估了对生活质量的影响。
TRANSFIGURE 是一项针对中重度斑块状和指甲银屑病患者的双盲、随机、安慰剂对照研究。
本研究的主要目标达到了：司库奇尤单抗 300mg 和 150mg 组在第 16 周时均优于安慰剂组（NAPSI 改善分别为-45.3%、-37.9%和-10.8%，P<0.001）。患者的生活质量也得到了显著改善：第 16 周时，NAPPA-生活质量总分中位数分别下降了 60.9%、49.9%和 15.8%，分别为司库奇尤单抗 300mg 和 150mg 组和安慰剂组（P<0.001）。指甲银屑病的改善持续到第 32 周：司库奇尤单抗 300mg 和 150mg 组的 NAPSI 百分比变化分别达到了-63.2%和-52.6%。通过≥90%改善的银屑病面积和严重程度指数（PASI90）测量的皮肤清除率具有显著意义（司库奇尤单抗 300mg 和 150mg 组第 16 周时的达标率分别为 72.5%、54.0%和 1.7%，P<0.001），并持续到第 32 周。最常见的不良事件是鼻咽炎、头痛和上呼吸道感染。
司库奇尤单抗在第 32 周时为指甲银屑病患者提供了显著的、具有临床意义的疗效和生活质量改善。
关于这个主题已经了解了什么？指甲银屑病研究较少，治疗选择有限。指甲银屑病与更严重的银屑病疾病和银屑病关节炎的发展有关。这项研究增加了什么？TRANSFIGURE 是为数不多的专门针对指甲银屑病的前瞻性安慰剂对照试验之一，包括指甲特异性生活质量评估，如指甲银屑病和银屑病关节炎问卷（NAPPA）-生活质量和 NAPPA-患者获益指数。在这项试验中，司库奇尤单抗在这一治疗困难的人群中显示出显著的疗效和生活质量改善。
