Wasel Norman, Thaçi Diamant, French Lars E, Conrad Curdin, Dutronc Yves, Gallo Gaia, Berggren Lovisa, Lacour Jean-Philippe
Stratica Medical and Probity Medical Research, Edmonton, AB, Canada.
Research Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Dermatol Ther (Heidelb). 2020 Aug;10(4):663-670. doi: 10.1007/s13555-020-00383-x. Epub 2020 May 15.
Patients with plaque psoriasis often have nail psoriasis, which is difficult to treat. Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis. We present post hoc data from a head-to-head trial of IXE and UST (IXORA-S) to examine the efficacy in nail psoriasis in patients with moderate-to-severe plaque psoriasis over 52 weeks.
In IXORA-S, randomised patients received IXE (N = 136) or UST (N = 166) per label for 52 weeks. Eighty-four (61.8%) and 105 (63.3%) of the patients treated with IXE or UST, respectively, had baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI] > 0); of these, 54 (64.3%) and 63 (60.0%) patients, respectively, had significant baseline fingernail psoriasis (defined as NAPSI ≥ 16 with ≥ 4 fingernails involved). The proportion of patients achieving NAPSI = 0, a NAPSI score change from baseline and correlations in Psoriasis Area of Severity Index (PASI) and NAPSI improvement over 52 weeks were examined.
Progressive improvement occurred in both treatment groups over 52 weeks. Statistically significantly more patients achieved NAPSI = 0 with IXE versus UST by week 16-20, and the proportions continued to increase through week 52 among patients with baseline nail psoriasis (61.9 vs. 28.6%, respectively; P < 0.001), including those with significant nail psoriasis (57.4 vs. 17.5%, respectively; P < 0.001). Similar results were observed for NAPSI score improvement from baseline to week 52. Interestingly, the presence of nail psoriasis was associated with lower skin response with UST but not with IXE.
Ixekizumab was superior to UST in the clearance of nail psoriasis, with earlier improvement continued through 52 weeks regardless of baseline nail severity.
ClinicalTrials.gov identifier; NCT02561806.
斑块状银屑病患者常伴有甲银屑病，后者难以治疗。司库奇尤单抗（IXE）和优特克单抗（UST）是在甲银屑病治疗中已证实有疗效的生物制剂。我们展示了IXE和UST头对头试验（IXORA-S）的事后分析数据，以研究中重度斑块状银屑病患者在52周内甲银屑病的治疗效果。
在IXORA-S试验中，随机分组的患者按照标签说明接受IXE（N = 136）或UST（N = 166）治疗52周。接受IXE或UST治疗的患者中，分别有84例（61.8%）和105例（63.3%）有基线指甲银屑病（指甲银屑病严重程度指数[NAPSI]＞0）；其中，分别有54例（64.3%）和63例（60.0%）患者有显著的基线指甲银屑病（定义为NAPSI≥16且累及≥4个指甲）。研究了达到NAPSI = 0的患者比例、NAPSI评分相对于基线的变化以及银屑病面积和严重程度指数（PASI）与52周内NAPSI改善情况的相关性。
两个治疗组在52周内均有逐步改善。在第16至20周时，与UST相比，接受IXE治疗达到NAPSI = 0的患者在统计学上显著更多，且在有基线甲银屑病的患者中（分别为61.9%和28.6%；P＜0.001），包括有显著甲银屑病的患者（分别为57.4%和17.5%；P＜0.001），这一比例在第52周时持续增加。从基线到第52周，NAPSI评分改善情况也观察到类似结果。有趣的是，甲银屑病的存在与UST治疗的皮肤反应较低有关，但与IXE无关。
在清除甲银屑病方面，司库奇尤单抗优于优特克单抗，无论基线甲严重程度如何，均可在52周内持续实现早期改善。
ClinicalTrials.gov标识符；NCT02561806。
