Florida Academic Dermatology Centers, Miami, Florida 33136, USA.
J Am Acad Dermatol. 2010 Feb;62(2):205-17. doi: 10.1016/j.jaad.2009.06.050.
Biologic therapies with anti-tumor necrosis factor agents are promising treatments for hidradenitis suppurativa (HS).
We assessed the efficacy and safety of infliximab (IFX) for the treatment of moderate to severe HS.
A prospective double-blind treatment phase of 8 weeks where patients received IFX or placebo was followed by an open-label phase where patients taking placebo were given the opportunity to cross over to IFX, and an observational phase. Primary treatment efficacy was based on HS Severity Index. Secondary end points included Dermatology Life Quality Index, visual analog scale, and Physician Global Assessment scores. Inflammatory markers erythrocyte sedimentation rate and C-reactive protein were also assessed.
More patients in the IFX than in the placebo group showed a 50% or greater decrease from baseline HS Severity Index score. In addition, statistically and clinically significant improvement from baseline was observed at week 8 in Dermatology Life Quality Index score, visual analog scale score, erythrocyte sedimentation rate, and C-reactive protein compared with placebo. Patients in the placebo group treated with IFX after week 8 (crossover) responded similarly to the original IFX group. Many patients withdrew during the observational phase to continue anti-tumor necrosis factor-alfa therapy. No unexpected serious adverse events were observed.
Results are representative of a single center, patients were treated by a single physician, some patients did not return after their last infusion, and the HS Severity Index requires validation.
This clinical study represents the first formal assessment of IFX for treatment of moderate to severe HS. IFX was well tolerated, no unexpected safety issues were identified, and improvements in pain intensity, disease severity, and quality of life were demonstrated with concomitant reduction in clinical markers of inflammation.
生物制剂抗肿瘤坏死因子药物是治疗化脓性汗腺炎（HS）的有前途的治疗方法。
我们评估英夫利昔单抗（IFX）治疗中重度 HS 的疗效和安全性。
前瞻性双盲治疗 8 周，患者接受 IFX 或安慰剂，随后进行开放标签期，安慰剂组患者有机会交叉至 IFX，并进行观察期。主要治疗疗效基于 HS 严重程度指数。次要终点包括皮肤病生活质量指数、视觉模拟评分和医生整体评估评分。还评估了炎症标志物红细胞沉降率和 C 反应蛋白。
IFX 组比安慰剂组有更多的患者从基线 HS 严重程度指数评分下降 50%或更多。此外，与安慰剂相比，在第 8 周观察到皮肤病生活质量指数评分、视觉模拟评分、红细胞沉降率和 C 反应蛋白从基线开始有统计学和临床意义的改善。在第 8 周（交叉）接受 IFX 治疗的安慰剂组患者对原始 IFX 组的反应相似。许多患者在观察期退出，以继续接受抗肿瘤坏死因子-α治疗。未观察到意外的严重不良事件。
结果代表单个中心，患者由单一医生治疗，部分患者最后一次输注后未返回，HS 严重程度指数需要验证。
这项临床研究代表了英夫利昔单抗治疗中重度 HS 的首次正式评估。IFX 耐受性良好，未发现意外的安全性问题，并且在减轻炎症的同时，疼痛强度、疾病严重程度和生活质量得到改善。
