背景:指甲牛皮癣是一种常见的牛皮癣,生理上,和心理上的破坏性,但经常治疗不足的牛皮癣表现。这项分析的目的是调查指甲牛皮癣的轨迹,银屑病关节炎(PsA)的危险因素,guselkumab与阿达木单抗治疗后停药,并确定与使用guselkumab治疗的患者的指甲反应相关的特征。
方法:这项对III期试验VOYAGE2的事后分析包括中度至重度斑块型银屑病和基线指甲受累的患者。在随机接受guselkumab或adalimumab的患者中,分析了48周的指甲牛皮癣严重程度指数(NAPSI)和牛皮癣面积和严重程度指数(PASI)。多元逻辑回归分析了guselkumab治疗后第24周/第48周与NAPSI0/1相关的因素。在单独的分析中,根据先前的生物学经验对患者进行分层.
结果:总体而言,272例接受guselkumab和阿达木单抗的患者在基线时患有指甲牛皮癣。较低的基线NAPSI和第16周PASI与在第24周实现NAPSI0/1相关(NAPSI,优势比0.685[95%置信区间:0.586,0.802];第16周PASI,0.469[0.281,0.782])和第48周(NAPSI,0.784[0.674,0.914];第16周PASI,0.557[0.331,0.937])与guselkumab。先前的生物学经验不影响NAPSI反应。在第28周停药后,guselkumab臂的平均NAPSI维持(第24周1.7,第48周1.9),而在阿达木单抗臂中略有增加(第24周1.4,第48周2.3)。平均PASI在两个治疗组中增加。
结论:在第16周更高的皮肤功效与guselkumab治疗期间更好的指甲反应相关。指甲牛皮癣的改善反映了皮肤的改善。guselkumab停药后,指甲反应比皮肤反应维持的时间更长。未来的研究应该调查这种指甲反应的改善是否会降低患者后期PsA发展的风险。
背景:ClinicalTrials.gov,NCT02207244。2014年7月31日注册
Nail psoriasis is a common, physiologically, and psychologically disruptive, and yet often under-treated manifestation of psoriasis. The objectives of this analysis were to investigate the trajectory of nail psoriasis, a risk factor for psoriatic arthritis (PsA), with guselkumab vs adalimumab treatment followed by withdrawal, and determine characteristics associated with nail response in patients treated with guselkumab.
This post hoc analysis of the phase III
trial VOYAGE 2 included patients with moderate-to-severe plaque psoriasis and baseline nail involvement. Nail Psoriasis Severity Index (NAPSI) and Psoriasis Area and Severity Index (PASI) were analyzed through week 48 in patients randomized to guselkumab or adalimumab. Multiple logistic regression analyzed factors associated with NAPSI 0/1 at week 24/week 48 following guselkumab treatment. In a separate analysis, patients were stratified by prior biologic experience.
Overall, 272 vs 132 patients receiving guselkumab vs adalimumab had nail psoriasis at baseline. Lower baseline NAPSI and week 16 PASI were associated with achieving NAPSI 0/1 at week 24 (NAPSI, odds ratio 0.685 [95% confidence interval: 0.586, 0.802]; week 16 PASI, 0.469 [0.281, 0.782]) and week 48 (NAPSI, 0.784 [0.674, 0.914]; week 16 PASI, 0.557 [0.331, 0.937]) with guselkumab. Previous biologic experience did not impact NAPSI response. Following treatment withdrawal at week 28, mean NAPSI was maintained in the guselkumab arm (week 24 1.7, week 48 1.9) and increased slightly in the adalimumab arm (week 24 1.4, week 48 2.3). Mean PASI increased across both treatment arms.
Higher skin efficacy at week 16 was associated with better nail responses during guselkumab treatment. Nail psoriasis improvements reflected skin improvements. Following guselkumab withdrawal, nail response was maintained longer than skin response. Future studies should investigate whether such improvements in nail response reduce patients\' risk of later PsA development.
ClinicalTrials.gov, NCT02207244. Registered July 31, 2014.