Herlev and Gentofte Hospital, Hellerup, Denmark.
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California.
J Am Acad Dermatol. 2018 Jul;79(1):104-109.e8. doi: 10.1016/j.jaad.2018.02.074. Epub 2018 Mar 13.
The impact of ixekizumab treatment for psoriasis on cardiovascular-related parameters in patients is unknown.
To investigate cardiovascular-related parameters in patients with psoriasis treated with ixekizumab.
In phase 3 trials, patients with moderate-to-severe psoriasis were randomized and treated with placebo, ixekizumab, or etanercept during the induction period (weeks 0-12; UNCOVER-1, UNCOVER-2, and UNCOVER-3). At week 12, responders were rerandomized to receive placebo or ixekizumab through the maintenance period (weeks 12-60; UNCOVER-1 and UNCOVER-2). Laboratory measures (fasting lipid profiles, glucose level, or high-sensitivity C-reactive protein [hsCRP] level), weight, blood pressure, and electrocardiograms were obtained through 60 weeks.
Baseline parameters were within normal ranges with the exception of elevated triglyceride and hsCRP levels. After maintenance dosing, no significant changes were observed versus placebo for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, triglyceride, apolipoprotein A1, apolipoprotein B, or fasting glucose levels or for systolic/diastolic blood pressure at 60 weeks. Importantly, low-density lipoprotein-to-high-density lipoprotein ratios remained stable during the induction and maintenance periods. HsCRP concentrations were significantly reduced versus placebo at 12 weeks and remained reduced at 60 weeks, although not significantly. Although transient changes were observed for some parameters during the induction period, these changes did not persist into the maintenance period.
A lack of echocardiogram evaluations.
Ixekizumab had a neutral impact on cardiovascular-related parameters in patients with psoriasis.
依奇珠单抗治疗银屑病对心血管相关参数的影响尚不清楚。
研究依奇珠单抗治疗银屑病患者的心血管相关参数。
在 3 期临床试验中，中度至重度银屑病患者在诱导期（第 0-12 周；UNCOVER-1、UNCOVER-2 和 UNCOVER-3）随机接受安慰剂、依奇珠单抗或依那西普治疗。在第 12 周，应答者在维持期（第 12-60 周；UNCOVER-1 和 UNCOVER-2）中重新随机接受安慰剂或依奇珠单抗治疗。在 60 周内获取实验室指标（空腹血脂谱、血糖或高敏 C 反应蛋白[hsCRP]水平）、体重、血压和心电图。
除了甘油三酯和 hsCRP 水平升高外，基线参数均在正常范围内。与安慰剂相比，维持剂量后总胆固醇、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇、极低密度脂蛋白胆固醇、甘油三酯、载脂蛋白 A1、载脂蛋白 B 或空腹血糖水平或 60 周时的收缩压/舒张压无显著变化。重要的是，在诱导和维持期间，低密度脂蛋白与高密度脂蛋白的比值保持稳定。与安慰剂相比，hsCRP 浓度在第 12 周时显著降低，并在第 60 周时仍保持降低，尽管差异无统计学意义。尽管在诱导期观察到一些参数的短暂变化，但这些变化在维持期并未持续。
缺乏超声心动图评估。
依奇珠单抗对银屑病患者的心血管相关参数无明显影响。
