University of California Irvine Medical Center, Irvine, CA, USA.
J Dermatolog Treat. 2012 Apr;23(2):103-8. doi: 10.3109/09546634.2010.500323. Epub 2011 Jan 22.
Alefacept is a remittive treatment for generalized psoriasis but is rarely used due to its erratic efficacy.
To determine if psoriasis plaques will respond to intralesional alefacept and if this predicts a systemic response to intramuscular (IM) alefacept.
We describe a 25-week, single-center, open-label study. Patients received weekly intralesional alefacept of increasing concentrations into target plaques for 3 weeks followed by IM injections for 12 weeks and concluded with an observation period of 9 weeks. The psoriasis area and severity index (PASI) was used to assess the efficacy of IM alefacept.
Interim results are reported for the first seven patients enrolled. Two patients responded intralesionally to the most dilute 1:100 concentration of alefacept to sterile water and achieved a 59% and 100% improvement in PASI. Five patients did not respond intralesionally to the most dilute form of alefacept and none achieved PASI 75. Two of these five patients did not respond to any concentration and achieved a 26% and 38% improvement in PASI. Limitations to this study include a small sample size and being non-placebo-controlled.
Alefacept is effective intralesionally and may predict a systemic response - challenging the concept that biologics must work systemically.
阿法赛普是一种治疗泛发性银屑病的缓解性药物，但由于疗效不稳定，很少使用。
确定局部注射阿法赛普是否能使银屑病斑块得到缓解，以及这是否能预测肌肉内（IM）注射阿法赛普的全身反应。
我们描述了一项为期 25 周、单中心、开放性标签研究。患者接受每周一次的递增浓度局部注射阿法赛普，持续 3 周，然后进行 12 周的 IM 注射，最后进行 9 周的观察期。使用银屑病面积和严重程度指数（PASI）评估 IM 阿法赛普的疗效。
报告了前 7 名入组患者的中期结果。2 名患者对最稀释的 1:100 浓度的阿法赛普对无菌水有反应，PASI 改善了 59%和 100%。5 名患者局部注射最稀释的阿法赛普没有反应，没有患者达到 PASI75。这 5 名患者中的 2 名对任何浓度都没有反应，PASI 改善了 26%和 38%。这项研究的局限性包括样本量小且没有安慰剂对照。
阿法赛普局部注射有效，可能预测全身反应，这挑战了生物制剂必须全身起效的概念。
