Maarouf Melody, Clark Ashley K, Lee Dylan E, Shi Vivian Y
a College of Medicine , University of Arizona , Tucson , AZ , USA.
b School of Medicine , University of California , Davis, Sacramento , CA , USA.
J Dermatolog Treat. 2018 Aug;29(5):441-449. doi: 10.1080/09546634.2017.1395806. Epub 2017 Nov 10.
Targeted, immune-modulating drugs are at the forefront of therapy for HS, and a comprehensive clinical trial registry is needed to facilitate data pooling and clinical efficacy comparison.
A systematic review of the ClinicalTrials.gov database was searched for planned, in-progress, completed, or terminated trials investigating the effect of targeted biologic therapies for hidradenitis suppurativa (HS). When results of RCTs were not available, case reports or series were included.
Inflammatory mediators that are targeted by biologic agents include tumor necrosis factor-alpha (TNF-α), interleukin-1 (IL-1), IL-17, IL-12, IL-23, phosphodiesterase 4 (PDE4), lymphocyte function-associated antigen 1 (LFA-1), and complement component 5a (C5a). Clinical efficacy was measured by reduction in Sartorius score, Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology Life Quality Index (DLQI), or pain Visual Analog Scale (VAS). TNF inhibitors (adalimumab, etanercept, and infliximab), IL-1 receptor antagonist (Anakinra), IL-17A inhibitor (secukinumab), IL-12/23 inhibitor (ustekinumab), and PDE4 inhibitor (apremilast) show promise due to statistically significant improvements in disease severity.
Currently, adalimumab is the only FDA-approved biologic available for the treatment of HS. However, results from trials of other biologic agents targeting downstream mediators are promising. Large-scale, randomized, placebo-controlled trials in patients with skin of color, as well as weight-based dosing trials, are needed.
靶向免疫调节药物处于化脓性汗腺炎(HS)治疗的前沿,需要一个全面的临床试验注册库来促进数据汇总和临床疗效比较。
对ClinicalTrials.gov数据库进行系统检索,以查找计划中、进行中、已完成或已终止的研究靶向生物疗法治疗化脓性汗腺炎(HS)效果的试验。当随机对照试验(RCT)结果不可用时,纳入病例报告或病例系列。
生物制剂靶向的炎症介质包括肿瘤坏死因子-α(TNF-α)、白细胞介素-1(IL-1)、IL-17、IL-12、IL-23、磷酸二酯酶4(PDE4)、淋巴细胞功能相关抗原1(LFA-1)和补体成分5a(C5a)。临床疗效通过萨托里乌斯评分降低、化脓性汗腺炎临床反应(HiSCR)、皮肤病生活质量指数(DLQI)或疼痛视觉模拟量表(VAS)来衡量。肿瘤坏死因子抑制剂(阿达木单抗、依那西普和英夫利昔单抗)、IL-1受体拮抗剂(阿那白滞素)、IL-17A抑制剂(司库奇尤单抗)、IL-12/23抑制剂(乌司奴单抗)和PDE4抑制剂(阿普斯特)由于疾病严重程度有统计学意义的改善而显示出前景。
目前,阿达木单抗是唯一获美国食品药品监督管理局(FDA)批准用于治疗HS的生物制剂。然而,针对下游介质的其他生物制剂试验结果很有前景。需要对有色人种患者进行大规模、随机、安慰剂对照试验以及基于体重的给药试验。