Comprehensive Centre of Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Department of Dermatology, University Hospital Essen, Essen, Germany.
J Eur Acad Dermatol Venereol. 2020 Feb;34(2):310-318. doi: 10.1111/jdv.15962. Epub 2019 Oct 17.
Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate-to-severe psoriasis. Trial protocols specify transition periods and prohibit concomitant psoriasis medication. Data are therefore needed on secukinumab effectiveness and safety in routine clinical practice.
The PROSPECT study assesses prior and concomitant psoriasis treatments and transition periods in subjects receiving secukinumab. Here, we report interim effectiveness and safety data for secukinumab in the context of prior and concomitant treatments.
PROSPECT is an ongoing 24-week, single-cohort, non-interventional study. Subjects with moderate-to-severe psoriasis with a decision to receive secukinumab 300 mg were included.
Of 1988 subjects, 1238/1988 (62.4%) were male, and mean age was 48.1 ± 13.7 years. Mean baseline Psoriasis Area and Severity Index (PASI) score was 17.7 ± 12.5. 90.9% of subjects had prior systemic treatment. Concomitant treatment was recorded in 44.3% of subjects. Median duration of transition period was 14.0, 30.0 and 44.5 days from prior topical, conventional systemic and biologic treatments. At Week 24, PASI75/90/100 was reached by 86.1%, 68.5% and 39.7% of subjects who started secukinumab treatment at baseline. No unexpected safety signals were observed.
PROSPECT provides a large prospective real-world analysis of secukinumab treatment and includes prior and concomitant use of psoriasis treatments in subjects receiving secukinumab in a real-world setting. Secukinumab effectiveness and safety were comparable to that seen in the phase 2/3 secukinumab clinical trial programme.
司库奇尤单抗是一种全人源抗白细胞介素-17A 单克隆抗体，已在中重度银屑病患者中显示出疗效和安全性。试验方案规定了过渡期，并禁止同时使用银屑病药物。因此，需要在常规临床实践中获得司库奇尤单抗的有效性和安全性数据。
PROSPECT 研究评估了接受司库奇尤单抗治疗的患者的既往和同时治疗的银屑病药物及过渡期。在此，我们报告了既往和同时治疗背景下司库奇尤单抗的中期有效性和安全性数据。
PROSPECT 是一项正在进行的 24 周、单队列、非干预性研究。纳入了有接受司库奇尤单抗 300mg 治疗决策的中重度银屑病患者。
1988 例患者中，1238/1988（62.4%）为男性，平均年龄为 48.1±13.7 岁。平均基线银屑病面积和严重程度指数（PASI）评分为 17.7±12.5。90.9%的患者有既往全身治疗。44.3%的患者有同时治疗。从既往局部、传统全身和生物治疗开始，过渡期的中位数分别为 14.0、30.0 和 44.5 天。在第 24 周，86.1%、68.5%和 39.7%的基线开始接受司库奇尤单抗治疗的患者达到了 PASI75/90/100。未观察到意外的安全性信号。
PROSPECT 提供了司库奇尤单抗治疗的大型前瞻性真实世界分析，包括在真实世界环境中接受司库奇尤单抗治疗的患者的既往和同时使用银屑病治疗。司库奇尤单抗的有效性和安全性与 2/3 期司库奇尤单抗临床试验方案中观察到的相似。
