Initial results of ixekizumab efficacy and safety in real-world plaque psoriasis patients: a multicentre retrospective study
Initial results of ixekizumab efficacy and safety in real-world plaque psoriasis patients: a multicentre retrospective study
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DOI：
10.1111/jdv.15288
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发表时间：
2019-03-01
影响因子：
9.2
通讯作者：
Gallardo, F.
中科院分区：
文献类型：
--
作者：
Deza, G.;Notario, J.;Gallardo, F.
背景：Ixekizumab(抗IL17A)是治疗中重度斑块型银屑病的有效药物，但目前有关有效性和安全性的实际数据非常有限。目的评价ixekizumab治疗斑块型银屑病的疗效和安全性。方法对西班牙7个皮肤科中心使用Ixekizumab治疗的100例中重度斑块型银屑病患者的临床资料进行回顾性分析。结果按观察分析，12~16周银屑病面积和严重程度指数(PASI)较基线评分下降75%和90%的患者分别为87.5%~50.0%，24周和52周分别为88.3%~58.4%和82.9%~58.5%。治疗前PASI平均+/-标准差(SD)为12.9+/-9.2，用药后12-16周迅速下降至1.9+/-4.0(P<；0.001)，24周和52周分别维持在1.7+/-4.1和1.8+/-2.9。Ixekizumab的疗效不受体重指数、病程或牛皮癣关节炎等临床变量的影响。然而，与以前接触生物制剂的患者相比，在12-16周时，生物朴素组的PASI 75应答率显著高于先前暴露于生物制剂的患者(P=0.037)。26例(26%)患者在随访期内经历了不良事件(AEs)，其中大多数为轻度至中度强度。最常见的是注射部位的局部反应(14/26；53.8%)。在观察期结束时，15名患者(15%)因临床改善有限(n=11)、不良事件(n=3)或失去随访(n=1)而停止使用ixekizumab治疗，平均+/-SD时间为6.0+/-3.9个月。结论本研究展示了ixekizumab在临床实践中的初步经验，证实了其在斑块型银屑病患者治疗中的有效性和安全性。
Background Ixekizumab (anti-IL17A) is effective as treatment for moderate-to-severe plaque psoriasis, but real-life data on effectiveness and safety are currently very limited. Objective To evaluate the efficacy and safety of ixekizumab in a cohort of real-life plaque psoriasis patients. Methods Retrospective chart review of 100 patients with moderate-to-severe plaque psoriasis treated with ixekizumab at seven Spanish dermatological centres. Results According to the as observed analysis, the percentage of patients achieving a 75% and 90% of reduction from the baseline score of Psoriasis Area and Severity Index (PASI) was 87.5%-50.0% at week 12-16; 88.3%-58.4% at week 24 and 82.9%-58.5% at week 52, respectively. The mean +/- standard deviation (SD) score of PASI at baseline was 12.9 +/- 9.2, and it declined rapidly after ixekizumab administration to 1.9 +/- 4.0 (P < 0.001) at week 12-16 and was maintained at 1.7 +/- 4.1 and 1.8 +/- 2.9 at week 24 and 52, respectively. Ixekizumab response was not affected by clinical variables like body mass index, disease duration or the presence of psoriatic arthritis. However, the bio-naive group showed significantly higher PASI 75 response rate at week 12-16 compared to patients previously exposed to biologic agents (P = 0.037). Twenty-six (26%) patients experienced adverse events (AEs) during the follow-up period, being most of them of mild-to-moderate intensity. The most common AE was local reaction at the site of injection (14/26; 53.8%). At the end of the observational period, 15 (15%) patients discontinued ixekizumab treatment due to limited clinical improvement (n = 11), adverse events (n = 3) or lost to follow-up (n = 1) within a mean +/- SD time of 6.0 +/- 3.9 months. Conclusion The present study illustrates the initial experience with ixekizumab in real-world clinical practice confirming its usefulness and safety in the management of plaque psoriasis patients.