Papp Kim A, Miller Bruce, Gordon Kenneth B, Caro Ivor, Kwon Paul, Compton Peter G, Leonardi Craig L
Probity Medical Research, Waterloo, Ontario, Canada.
J Am Acad Dermatol. 2006 Apr;54(4 Suppl 1):S164-70. doi: 10.1016/j.jaad.2005.10.032.
Efalizumab targets T cell-mediated steps important in psoriasis immunopathogenesis.
We sought to evaluate the efficacy and safety of efalizumab retreatment in patients with moderate to severe plaque psoriasis.
In this open-label, phase III study, 365 patients who received efalizumab therapy during an earlier clinical trial were retreated with 12 weeks of subcutaneous efalizumab (1 mg/kg/wk) 35 days or more after their last dose of efalizumab.
After 12 weeks of efalizumab retreatment, 56.9% of patients achieved 50% or more improvement from baseline Psoriasis Area and Severity Index (PASI) and 25.3% achieved at least 75% reduction in PASI score. The mean percentage PASI improvement from baseline was 51.2%. Overall, 76.1% of patients surveyed were "very satisfied" or "satisfied" with the efficacy of efalizumab. The safety profile of efalizumab retreatment was similar to that observed in patients receiving efalizumab for the first time.
Not all patients received sufficient exposure to efalizumab during their previous efalizumab clinical trial to allow for determination of their initial response to efalizumab. Of 365 patients enrolled in the study, 282 received at least 12 weeks of prior efalizumab therapy; of these patients, 208 (73.8%) achieved a PASI-50 response from their previous therapy.
These results suggest that retreatment with efalizumab therapy is an efficacious option for patients who have previously discontinued treatment.
依法利珠单抗作用于银屑病免疫发病机制中重要的T细胞介导步骤。
我们旨在评估依法利珠单抗再治疗对中度至重度斑块状银屑病患者的疗效和安全性。
在这项开放标签的III期研究中，365例在早期临床试验中接受过依法利珠单抗治疗的患者，在最后一剂依法利珠单抗给药35天或更长时间后，接受为期12周的皮下注射依法利珠单抗（1毫克/千克/周）再治疗。
依法利珠单抗再治疗12周后，56.9%的患者银屑病面积和严重程度指数（PASI）较基线改善50%或更多，25.3%的患者PASI评分至少降低75%。PASI较基线改善的平均百分比为51.2%。总体而言，76.1%接受调查的患者对依法利珠单抗的疗效“非常满意”或“满意”。依法利珠单抗再治疗的安全性与首次接受依法利珠单抗治疗的患者相似。
并非所有患者在之前的依法利珠单抗临床试验中都充分接触过依法利珠单抗，无法确定他们对依法利珠单抗的初始反应。在该研究纳入的365例患者中，282例接受过至少12周的依法利珠单抗前期治疗；在这些患者中，208例（73.8%）在前期治疗中达到了PASI-50反应。
这些结果表明，对于之前中断治疗的患者，依法利珠单抗再治疗是一种有效的选择。
