Tada Yayoi, Imafuku Shinichi, Sugiura Kazumitsu, Fujita Hideki, Tsuruta Noriko, Mitsuma Teruyuki, Yoshizaki Ayumi, Abe Masatoshi, Yamaguchi Yukie, Morita Akimichi
Department of Dermatology, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-Ku, Tokyo, Japan.
Fukuoka University Hospital, Fukuoka, Japan.
Dermatol Ther (Heidelb). 2025 Apr;15(4):1009-1024. doi: 10.1007/s13555-025-01377-3. Epub 2025 Mar 22.
Generalized pustular psoriasis (GPP) is a chronic, inflammatory disease characterized by the sudden and recurrent development of widespread sterile pustules on the skin. The treatment of GPP includes non-biologic and biologic therapies. In Japan, biologic agents are being increasingly used as first-line treatment, with more biologics approved in Japan than in other countries. A previous secondary data-based study utilizing data in the Medical Data Vision database and the Japan Medical Data Center in Japan demonstrated heterogeneity in real-world biologic treatment patterns, with at least one switch during the follow-up period (mean n switches 3.8; mean length of follow-up 3.3 years) for approximately one third of patients with GPP treated with a biologic drug. The aim of this study was to evaluate where consensus lies among experts regarding switching biologic treatments for patients with GPP in Japan.
A Delphi exercise that consists of three survey rounds was performed with ten Japanese dermatologists. Participants were asked to respond to questions related to experts' experience with specific biologics, experience with switching, timing of switches and importance of specific criteria (drivers) when making the decision to switch. The consensus threshold was 70%.
Based on the results of the Delphi exercise, most experts rarely (60%) or never (20%) switch a biologic agent and only 20% switch often during acute symptoms/GPP flare driven by the short time of the flare; this result may be different during the maintenance phase. Lack of efficacy, loss of efficacy due to long-term use, side effects, contraindications, new products with better efficacy and safety evidence, risk of infection, and lack of adherence play an important role in making the decision to switch.
Switches may occur for patients on biologics when flares occur (loss of effectiveness) or when there is insufficient response (lack of effectiveness). The decision to switch a biologic is impacted by several other criteria, including safety and the availability of more efficacious and better tolerated therapies. Overall, there is still an unmet need for robust evidence to inform GPP treatment choice.
泛发性脓疱型银屑病(GPP)是一种慢性炎症性疾病,其特征为皮肤突然反复出现广泛的无菌性脓疱。GPP的治疗包括非生物治疗和生物治疗。在日本,生物制剂正越来越多地被用作一线治疗,在日本获批的生物制剂比其他国家更多。此前一项基于二次数据的研究利用日本医疗数据视觉数据库和日本医疗数据中心的数据,证明了现实世界中生物治疗模式的异质性,接受生物药物治疗的GPP患者中约三分之一在随访期间(平均换药次数3.8次;平均随访时长3.3年)至少换药一次。本研究的目的是评估日本皮肤科专家在GPP患者生物治疗换药方面的共识。
对十名日本皮肤科医生进行了三轮德尔菲调查。参与者被要求回答与专家使用特定生物制剂的经验、换药经验、换药时机以及换药决策时特定标准(驱动因素)的重要性相关的问题。共识阈值为70%。
根据德尔菲调查结果,大多数专家很少(60%)或从不(20%)更换生物制剂,只有20%的专家在急性症状/GPP发作(发作时间短)期间经常换药;在维持期可能会有所不同。疗效不佳、长期使用导致疗效丧失、副作用、禁忌症、有更好疗效和安全性证据的新产品、感染风险以及依从性差在换药决策中起重要作用。
接受生物制剂治疗的患者在发作(疗效丧失)或反应不足(疗效不佳)时可能会换药。更换生物制剂的决策还受到其他几个标准的影响,包括安全性以及更有效和耐受性更好的治疗方法的可用性。总体而言,仍需要有力证据来指导GPP治疗选择,这一需求尚未得到满足。