Division of Clinical Dermatology and Cutaneous Science, Department of Medicine, Dalhousie University, Halifax, NS, Canada.
Department of Dermatology, Oregon Health & Science University School of Medicine, Portland, OR, USA.
J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1763-70. doi: 10.1111/jdv.12996. Epub 2015 Feb 18.
Scalp and nail psoriasis have a major impact on quality of life and are traditionally resistant to therapy. Ixekizumab is a monoclonal antibody that targets IL-17A, a key cytokine in psoriasis pathogenesis.
Changes in nail and scalp psoriasis associated with ixekizumab treatment were evaluated in a post hoc analysis of a phase 2 study comprising a 20-week randomized, placebo-controlled (RCT) period and 48 weeks of an open-label extension (OLE) period.
There were 142 patients with moderate-to-severe plaque psoriasis at baseline of the RCT. Patients were randomized to receive placebo, 10, 25, 75 or 150 mg of ixekizumab injected subcutaneously at weeks 0, 2, 4, 8, 12 and 16. In the OLE, all patients received 120 mg ixekizumab every 4 weeks. Nail Psoriasis Severity Index (NAPSI) and Psoriasis Scalp Severity Index (PSSI) were used to evaluate nail and scalp psoriasis respectively. Fifty-eight (41.0%) patients had nail psoriasis (NAPSI > 0) and 105 (74.0%) had scalp psoriasis (PSSI > 0) at baseline; these cases were evaluated for the present analyses.
At RCT week 20, patients with scalp psoriasis in the 25-, 75- and 150-mg groups had significant mean change and percent improvement from baseline PSSI of -16.3 (75.3%; P = 0.001), -11.6 (83.7%; P = 0.001) and -18.2 (82.2%; P < 0.001) respectively compared to -6.0 (18.8%) in placebo. Patients with nail psoriasis in the 75- and 150-mg groups had significant improvements from baseline NAPSI of -26.3 (63.8%; P = 0.003) and -23.1 (52.6%; P = 0.009) respectively compared to 0.4 (-1.7%) in placebo. By OLE week 48, 78.0% of patients with scalp psoriasis and 51.0% of patients with nail psoriasis experienced complete resolution of lesions (PSSI = 0 or NAPSI = 0).
Ixekizumab monotherapy improved scalp psoriasis quickly with maintenance of clinical response and complete resolution of plaques in the majority of patients. Additionally, over 50.0% of patients with nail psoriasis experienced complete resolution of nail lesions by OLE week 48.
头皮和指甲银屑病严重影响生活质量，且传统疗法对此类疾病疗效不佳。依奇珠单抗是一种靶向白细胞介素 17A 的单克隆抗体，后者是银屑病发病机制中的关键细胞因子。
在一项包括 20 周随机、安慰剂对照（RCT）期和 48 周开放标签扩展（OLE）期的 2 期研究的事后分析中，评估依奇珠单抗治疗与头皮和指甲银屑病相关的变化。
RCT 基线时有 142 例中重度斑块状银屑病患者。患者随机接受安慰剂、10、25、75 或 150mg 依奇珠单抗皮下注射，分别在第 0、2、4、8、12 和 16 周。OLE 期间，所有患者均接受每 4 周 120mg 依奇珠单抗治疗。指甲银屑病严重程度指数（NAPSI）和头皮银屑病严重程度指数（PSSI）分别用于评估指甲和头皮银屑病。基线时，58 例（41.0%）患者有指甲银屑病（NAPSI>0），105 例（74.0%）患者有头皮银屑病（PSSI>0）；这些病例用于本次分析。
在 RCT 第 20 周时，25、75 和 150mg 组的头皮银屑病患者的 PSSI 与基线相比有显著的平均变化和改善率，分别为-16.3（75.3%；P=0.001）、-11.6（83.7%；P=0.001）和-18.2（82.2%；P<0.001），而安慰剂组为-6.0（18.8%）。75 和 150mg 组的指甲银屑病患者的 NAPSI 分别改善了-26.3（63.8%；P=0.003）和-23.1（52.6%；P=0.009），而安慰剂组为 0.4（-1.7%）。在 OLE 第 48 周时，78.0%的头皮银屑病患者和 51.0%的指甲银屑病患者达到了完全缓解（PSSI=0 或 NAPSI=0）。
依奇珠单抗单药治疗能迅速改善头皮银屑病，且多数患者可维持临床疗效并完全清除斑块。此外，OLE 第 48 周时，超过 50.0%的指甲银屑病患者达到了指甲病变的完全缓解。
