Hölsken Stefanie, Krefting Frederik, Mühlhaus Senta, Bese Daniela, Schedlowski Manfred, Sondermann Wiebke
Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Department of Dermatology, Venereology and Allergology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Psoriasis (Auckl). 2025 Jan 10;15:9-22. doi: 10.2147/PTT.S486338. eCollection 2025.
Patients' treatment expectations significantly influence the effectiveness of medical and pharmacological treatments. This clinical proof-of-concept study aimed to enhance treatment outcomes by targeting positive treatment expectations of psoriasis patients beginning systemic anti-psoriatic therapy with secukinumab, an interleukin (IL)-17A antagonist.
We randomly assigned patients to three groups: a treatment as usual (TAU) group receiving the standard 300mg dose of secukinumab, a dose-control (DC) group with 75% dose reduction and an experimental (EXP) group receiving the same reduced dose along with a "cover story" designed to positively influence treatment expectations. We evaluated skin symptoms using the Psoriasis Area and Severity Index (PASI), the Dermatology Life Quality Index (DLQI), perceived itch, mood and plasma IL-17A levels at baseline and at 1, 2, 3, 4, 8, 12, and 16 weeks post intervention.
The study included N = 120 patients (average age = 45.78 years, 34% female). A high baseline expectation level (8.1 of 10 points) was observed across all groups which could not be further increased by the EXP-group's "cover story". The EXP and DC groups did not differ with regard to reaching 75% improvement in PASI scores (PASI75), a DLQI score of 0 or 1 or at least 4 points improvement in itch. Over time, the EXP-group showed a faster decline in PASI scores and anxiety symptoms compared to the DC-group, but less improvement in quality of life. IL-17A levels significantly increased throughout the treatment, with no significant differences between groups despite the 75% dose reduction.
This study demonstrates an attempt to modify patients' treatment expectations to enhance the effectiveness of pharmacological therapy with secukinumab in psoriasis patients. However, verbal suggestion alone did not significantly improve clinical outcomes, suggesting that future studies should explore alternative approaches to leverage placebo effects to the benefit of patients with psoriasis.
患者的治疗期望对药物治疗和非药物治疗的效果有显著影响。这项临床概念验证研究旨在通过针对开始使用白细胞介素（IL）-17A拮抗剂司库奇尤单抗进行系统性抗银屑病治疗的银屑病患者的积极治疗期望，来提高治疗效果。
我们将患者随机分为三组：接受标准300mg剂量司库奇尤单抗的常规治疗（TAU）组、剂量减少75%的剂量对照（DC）组以及接受相同减少剂量并伴有旨在积极影响治疗期望的“掩饰故事”的试验（EXP）组。我们在基线以及干预后1、2、3、4、8、12和16周时，使用银屑病面积和严重程度指数（PASI）、皮肤病生活质量指数（DLQI）、感知瘙痒、情绪和血浆IL-17A水平评估皮肤症状。
该研究纳入了N = 120名患者（平均年龄 = 45.78岁，女性占34%）。所有组均观察到较高的基线期望水平（满分10分，平均为8.1分），试验组的“掩饰故事”未能进一步提高该水平。在达到PASI评分改善75%（PASI75）、DLQI评分为0或1或瘙痒至少改善4分方面，试验组和剂量对照组没有差异。随着时间推移，与剂量对照组相比，试验组的PASI评分和焦虑症状下降更快，但生活质量改善较少。在整个治疗过程中，IL-17A水平显著升高，尽管剂量减少了75%，但各组之间没有显著差异。
本研究表明试图改变患者的治疗期望，以提高司库奇尤单抗对银屑病患者药物治疗的效果。然而，仅通过言语暗示并不能显著改善临床结果，这表明未来的研究应探索其他方法来利用安慰剂效应，使银屑病患者受益。
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