Katsambas Andreas, Peris Ketty, Vena Gino, Freidmann Peter, Wozel Gottfried, Daudén Esteban, Licu Daiana, Placchi Mauro, De La Brassinne Michel
Arch Drug Inf. 2009 Dec;2(4):66-70. doi: 10.1111/j.1753-5174.2009.00023.x.
This post-approval, open-label trial (n = 1266) assessed the efficacy of efalizumab, administered in accordance with the European label at that time, in patients with concomitant nail, scalp or palmoplantar psoriasis. Patients received subcutaneous efalizumab 1.0 mg/kg weekly for up to 20 weeks. By Week 12, an improvement from baseline of 50% or more was observed in 21.4% (181/844) of patients with nail psoriasis, 62.4% (718/1150) of patients with scalp psoriasis, and 51.4% (127/247) of patients with palmoplantar psoriasis. Quality of life improved throughout the trial, with a 50% median improvement in DLQI score after 12 weeks of treatment. Efalizumab showed promising efficacy in the treatment of nail, scalp and palmoplantar psoriasis, which was reflected in improvements in quality of life.
这项批准后开放标签试验(n = 1266)评估了依法利珠单抗(按照当时欧洲说明书给药)对合并甲、头皮或掌跖部银屑病患者的疗效。患者每周皮下注射1.0 mg/kg依法利珠单抗,持续20周。到第12周时,甲银屑病患者中有21.4%(181/844)、头皮银屑病患者中有62.4%(718/1150)、掌跖部银屑病患者中有51.4%(127/247)观察到自基线改善50%或更多。在整个试验过程中生活质量得到改善,治疗12周后DLQI评分中位数改善50%。依法利珠单抗在治疗甲、头皮和掌跖部银屑病方面显示出有前景的疗效,这在生活质量改善方面得到体现。