Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey.
Department of Dermatology, University of Utah, Salt Lake City, Utah.
J Am Acad Dermatol. 2017 Oct;77(4):667-674. doi: 10.1016/j.jaad.2017.05.033. Epub 2017 Aug 2.
BACKGROUND: Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis. OBJECTIVE: Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis. METHODS: In this 24-week, double-blind, phase 3b study, 102 patients were randomized 1:1 to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was 90% improvement of Psoriasis Scalp Severity Index (PSSI 90) score from baseline to week 12. RESULTS: At week 12, PSSI 90 (secukinumab 300 mg vs placebo, 52.9% vs 2.0%) and Investigator's Global Assessment modified 2011 scalp responses of 0 or 1 (secukinumab 300 mg vs placebo, 56.9% vs 5.9%) were significantly greater with secukinumab 300 mg than placebo (P < .001 for both). In addition, significantly more patients achieved complete clearance of scalp psoriasis at week 12 with secukinumab 300 mg than placebo (35.3% vs 0%; P < .001). The median time to 50% reduction in PSSI score was 3.29 weeks with secukinumab 300 mg. The safety profile of secukinumab was consistent with previous phase 3 studies. LIMITATIONS: There was no active comparator arm. CONCLUSION: Secukinumab is efficacious and well-tolerated for patients with extensive moderate-to-severe scalp psoriasis.
背景:中重度头皮银屑病患者在不伴中重度体银屑病的患者的前瞻性研究中尚未得到评估。
目的:评估司库奇尤单抗治疗中重度头皮银屑病的疗效和安全性。
方法:在这项为期 24 周的、双盲、3b 期研究中,102 例患者按 1:1 的比例随机分组,分别于基线、第 1、2 和 3 周及第 4 周开始每 4 周皮下注射司库奇尤单抗 300mg 或安慰剂,直至第 20 周。主要疗效变量为从基线到第 12 周时头皮银屑病严重程度指数(PSSI 90)评分改善 90%。
结果:第 12 周时,司库奇尤单抗 300mg 组 PSSI 90(52.9% vs. 2.0%)和改良 2011 年研究者全球评估头皮反应 0 或 1(56.9% vs. 5.9%)的比例显著高于安慰剂组(均 P < 0.001)。此外,司库奇尤单抗 300mg 组在第 12 周时达到头皮银屑病完全清除的患者比例显著高于安慰剂组(35.3% vs. 0%;P < 0.001)。司库奇尤单抗 300mg 组 PSSI 评分降低 50%的中位数时间为 3.29 周。司库奇尤单抗的安全性与之前的 3 期研究一致。
局限性:没有活性对照臂。
结论:司库奇尤单抗治疗广泛中重度头皮银屑病患者疗效确切,耐受性良好。
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