Department of Dermatology, University Hospital Essen, Essen, Germany.
Comprehensive Center of Inflammation Medicine, University Medical Center Schleswig-Holstein, Lübeck, Germany.
J Eur Acad Dermatol Venereol. 2018 Mar;32(3):411-419. doi: 10.1111/jdv.14604. Epub 2017 Nov 22.
Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe psoriasis. However, as per study protocols, transition periods from prior psoriasis treatments of a defined minimal length were required and use of concomitant psoriasis medication was prohibited. There is therefore a lack of data on the effect of shorter transition periods and concomitant psoriasis treatment with other pharmacologically active substances on the effectiveness and safety of secukinumab in routine clinical practice.
The PROSPECT study was designed to assess prior and concomitant use of psoriasis treatments in subjects receiving secukinumab and the duration of transition periods from prior treatments to secukinumab. Here, we report the baseline characteristics and the duration of transition period in an interim analysis of the first 805 subjects.
PROSPECT is an ongoing 24-week, single-cohort, non-interventional study. Subjects with moderate to severe psoriasis with a decision to receive secukinumab were included.
The majority of subjects were male (491/796, 61.7%), with a mean age of 47.7 years (SD 13.7). The baseline Psoriasis Area and Severity Index (PASI) was available for 92.4% (744/805) of subjects, and mean baseline PASI was 17.5 (SD 13.1); 93.4% (752/805) of subjects had signs of high disease severity. Use of concomitant treatment increased with the number of signs. Within the last 12 months prior to inclusion, 10%, 40%, and 28% of subjects had received topical, conventional systemic, or biologic treatments as their last prior psoriasis therapy, respectively, and 22% of subjects had not received any psoriasis therapy. Discontinuation of prior treatment due to adverse events was high in subjects with conventional systemic treatment (93/413, 22.5%) compared to biologic treatment (5/210, 2.4%). The median duration of the transition period was 14.0, 30.5, and 38.0 days for prior topical, conventional systemic, and biologic treatments, respectively.
PROSPECT is the first study to investigate prior and concomitant use of psoriasis treatments in subjects receiving secukinumab in a real-world setting. The majority of the subjects had a high disease burden and use of concomitant treatment increased with disease severity. The duration of the transition period depended on prior treatment.
司库奇尤单抗是一种全人源抗白细胞介素-17A 单克隆抗体，已证明其在中重度银屑病患者中的疗效和安全性。然而，根据研究方案，需要有先前银屑病治疗的规定最短时间的过渡期，且禁止同时使用银屑病药物。因此，在常规临床实践中，关于较短的过渡期和同时使用其他具有药理活性的物质治疗银屑病对司库奇尤单抗的疗效和安全性的影响缺乏数据。
PROSPECT 研究旨在评估接受司库奇尤单抗治疗的受试者中先前和同时使用银屑病治疗药物的情况，以及从先前治疗到司库奇尤单抗的过渡期持续时间。在此，我们报告了前 805 名受试者的中期分析中的基线特征和过渡期持续时间。
PROSPECT 是一项正在进行的 24 周、单队列、非干预性研究。纳入了决定接受司库奇尤单抗治疗的中重度银屑病患者。
大多数受试者为男性（491/796，61.7%），平均年龄为 47.7 岁（SD 13.7）。92.4%（744/805）的受试者可获得基线银屑病面积和严重程度指数（PASI），平均基线 PASI 为 17.5（SD 13.1）；93.4%（752/805）的受试者有高疾病严重程度的迹象。随着体征数量的增加，同时使用治疗的比例也增加。在纳入前的最近 12 个月内，10%、40%和 28%的受试者分别接受了局部、传统全身和生物治疗作为其最后一次先前的银屑病治疗，而 22%的受试者未接受任何银屑病治疗。与生物治疗（5/210，2.4%）相比，接受传统全身治疗的受试者（413/93，22.5%）因不良事件而停止先前治疗的比例较高。局部、传统全身和生物治疗的过渡期中位持续时间分别为 14.0、30.5 和 38.0 天。
PROSPECT 是第一项在真实环境中研究接受司库奇尤单抗治疗的受试者中先前和同时使用银屑病治疗药物的研究。大多数受试者疾病负担较重，且随着疾病严重程度的增加，同时使用治疗的比例也增加。过渡期的持续时间取决于先前的治疗。
