Gordon Kenneth B, Langley Richard G
Loyola University Medical Center, Maywood, Illinois 60153, USA.
J Drugs Dermatol. 2003 Dec;2(6):624-8.
Alefacept is the first biologic agent approved for the treatment of chronic plaque psoriasis in the United States. Alefacept, administered intravenously (i.v.) or intramuscularly (i.m.), was found to be well tolerated, safe, and efficacious in two pivotal phase 3 studies in patients with moderate to severe psoriasis. Treatment with i.v. alefacept was associated with a median duration of off-treatment response of 216 days (approximately 7 months). In a follow-up extension study to the phase 3 i.m. study, duration of therapeutic response was also examined. Patients who achieved a > or = 75% reduction in baseline Psoriasis Area and Severity Index (PASI 75) with the first course of alefacept 15 mg i.m. in the phase 3 study maintained a PASI 50 for a median duration of 209 days. In addition, the extension study demonstrated that a second course of i.m. alefacept is safe and well tolerated in patients with psoriasis.
阿法赛特是美国首个被批准用于治疗慢性斑块状银屑病的生物制剂。在两项针对中重度银屑病患者的关键3期研究中，静脉注射（i.v.）或肌肉注射（i.m.）阿法赛特耐受性良好、安全且有效。静脉注射阿法赛特治疗的停药反应中位持续时间为216天（约7个月）。在3期肌肉注射研究的随访扩展研究中，也对治疗反应的持续时间进行了检查。在3期研究中，接受第一疗程15mg肌肉注射阿法赛特治疗后银屑病面积和严重程度指数（PASI）较基线降低≥75%（PASI 75）的患者，维持PASI 50的中位持续时间为209天。此外，扩展研究表明，银屑病患者接受第二疗程肌肉注射阿法赛特安全且耐受性良好。
