An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis
An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis
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DOI：
10.1001/archderm.139.6.719
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发表时间：
2003-06-01
影响因子：
--
通讯作者：
Griffiths, CEM
中科院分区：
文献类型：
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作者：
Lebwohl, M;Christophers, E;Griffiths, CEM
背景：Alefacept，人类淋巴细胞功能相关抗原3/免疫球蛋白I融合蛋白，与活化的T细胞表面的CD2分子结合，选择性靶向记忆效应(CD45RO(+))T细胞，占银屑病斑块中T细胞的75%以上。目的：观察肌肉注射Alefacept的疗效和耐受性。设计：国际随机、双盲、安慰剂对照、平行对照试验。患者：共507例慢性斑块型银屑病患者。干预：安慰剂，Alefacept 10 mg，或每周服用15 mg阿莱法普，持续12周，然后观察12周。主要结果：银屑病面积严重程度指数(HASTO)。结果：ALEFEPT治疗与剂量相关的过去显着改善相关基线。在整个研究过程中，与安慰剂组相比，服用15毫克组的患者在过去实现显著减少的比例更大。在15毫克组的患者中，在最后一次服药2周后，过去至少减少了75%，在整个12周的随访中，71%的患者保持了过去至少50%的改善。结论：肌肉注射阿莱法特治疗慢性斑块型银屑病是一种耐受性好、有效的治疗方法，是一种替代静脉给药的简便方法。
Background: Alefacept, human lymphocyte function-associated antigen 3/immunoglobulin I fusion protein, binds to CD2 molecules on the surface of activated T cells, selectively targeting memory-effector (CD45RO(+)) T cells, which comprise more than 75% of T cells in psoriatic plaques.Objective: To examine the efficacy and tolerability of intramuscular alefacept.Design: International, randomized, double-blind, placebo-controlled, parallel-group trial.Patients: A total of 507 patients with chronic plaque psoriasis.Intervention: Placebo, 10 mg of alefacept, or 15 mg of alefacept administered once weekly for 12 weeks followed by 12 weeks of observation.Main Outcome Measure: Psoriasis Area Severity Index (PAST).Results: Alefacept treatment was associated with dose-related significant improvements in PAST from baseline. Throughout the study, a greater percentage of patients in the 15-mg group than in the placebo group achieved a significant reduction in PAST. Of patients in the 15-mg group who achieved at least 75% PAST reduction 2 weeks after the last dose, 71% maintained at least 50% improvement in PAST throughout the 12-week follow-up. There were no opportunistic infections and no cases of disease rebound.Conclusion: Intramuscular administration of alefacept was a well-tolerated and effective therapy for chronic plaque psoriasis and thus represents a convenient alternative to intravenous dosing.