Cafardi Jennifer A, Cantrell Wendy, Wang Wenquan, Elmets Craig A, Elewski Boni E
Department of Dermatology, University of Alabama at Birmingham, Birmingham, AL, USA.
Skinmed. 2008 Mar-Apr;7(2):67-72. doi: 10.1111/j.1751-7125.2008.07346.x.
Alefacept is a biologic response modifier indicated for moderate to severe psoriasis; it has been available since 2003. It is typically administered in a dosing regimen of 15 mg intramuscularly (IM) weekly for 12 weeks. The purpose of this study was to determine whether a higher dose may be more beneficial in achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI 75). A secondary objective of this study was to examine whether increasing the dose during the initial course of alefacept would reduce the time to onset of efficacy and overall response rate. Two separate dosing regimens are evaluated in this study: 30 mg IM for 6 weeks followed by 15 mg IM for 6 weeks (group 1) and alefacept 30 mg IM weekly for 12 weeks (group 2).
Efficacy was assessed using the PASI, Physician Global Assessment, body surface area, and photographic evaluation of a target lesion. A total of 20 patients enrolled and were randomized, 16 of whom completed the study. Data analyses were performed on a per-protocol basis.
Overall, the mean PASI scores progressively decreased, with 43.8% reaching a 50% reduction in the PASI (PASI 50) at week 14 evaluation. Of these participants, 37.5% were in group 1 and 50% were treated with alefacept 30 mg IM for 12 weeks (group 2). Although our sample size was small, 12.5% of patients (one patient in each treatment arm) reached PASI 75. The most common adverse events encountered in this trial were mild infection, headache, pruritus, and erythroderma. There were no infections associated with a CD4(+) cell count <250 cells/mm(3).
There was no difference between the treatment groups in achieving PASI 50 or PASI 75. In addition, in our small population, the higher doses of alefacept were associated with increased adverse effects, including erythroderma.
阿法赛特是一种生物反应调节剂，适用于中度至重度银屑病；自2003年起可用。其通常的给药方案是每周肌肉注射（IM）15毫克，共12周。本研究的目的是确定更高剂量是否在实现银屑病面积和严重程度指数（PASI）降低75%（PASI 75）方面更有益。本研究的次要目的是检查在阿法赛特初始疗程中增加剂量是否会减少起效时间和总体缓解率。本研究评估了两种不同的给药方案：30毫克IM注射6周，随后15毫克IM注射6周（第1组）和阿法赛特30毫克IM每周注射12周（第2组）。
使用PASI、医生整体评估、体表面积和目标皮损的照片评估来评估疗效。共有20名患者入组并随机分组，其中16名完成了研究。数据分析按符合方案集进行。
总体而言，PASI平均得分逐渐降低，在第14周评估时，43.8%的患者达到PASI降低50%（PASI 5）。在这些参与者中，37.5%在第1组，50%接受了12周的30毫克IM阿法赛特治疗（第2组）。尽管我们的样本量较小，但12.5%的患者（每个治疗组各一名患者）达到了PASI 75。本试验中遇到的最常见不良事件是轻度感染、头痛、瘙痒和红皮病。没有与CD4(+)细胞计数<250个细胞/立方毫米相关的感染。
治疗组在实现PASI 50或PASI 75方面没有差异。此外，在我们的小样本人群中，更高剂量的阿法赛特与不良反应增加有关，包括红皮病。
