Department of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Department of Dermatology, Osaka General Medical Center, Osaka, Japan.
J Dermatol Sci. 2022 Mar;105(3):176-184. doi: 10.1016/j.jdermsci.2022.02.007. Epub 2022 Feb 15.
Real-life evidence on the quality of treatment with brodalumab in patients with plaque psoriasis based on patient-reported outcomes remains limited.
To assess the effectiveness of brodalumab in achieving treatment satisfaction for real-life Japanese patients with psoriasis.
As part of a single-arm, open-label, multicenter, prospective study (ProLOGUE), Psoriasis Area and Severity Index (PASI) scores, body surface area (BSA), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) domain scores were assessed at baseline and Weeks 12 and 48 of brodalumab treatment. Patient Global Assessment (PtGA) scores were captured at Weeks 12 and 48.
Seventy-five patients were enrolled, of whom 73 received brodalumab. PASI scores and BSA significantly reduced from baseline at Weeks 12 and 48 (all P < 0.0001). Most (90%) patients felt the treatment was effective on the PtGA scale at Weeks 12 and 48. TSQM-9 domain scores significantly improved at Weeks 12 and 48 (all P < 0.0001). A PASI score of ≤ 2 was suggested as a treatment goal for biologic treatment of psoriasis from a receiver operating characteristic curve analysis, although some of the TSQM-9 domain scores did not improve in patients achieving this goal. No new safety signals were observed.
Treatment with brodalumab was associated with improved objective symptoms and satisfaction in Japanese patients with psoriasis. A PASI score of ≤ 2 as a goal for biologic treatment of psoriasis may be feasible, although achieving this PASI goal alone may be insufficient to clearly improve long-term patient satisfaction (Japan Registry of Clinical Trials identifier: jRCTs031180037).
基于患者报告结局的真实世界证据表明，在斑块状银屑病患者中，布罗达umab 的治疗质量仍有限。
评估布罗达umab 治疗日本真实世界银屑病患者的治疗满意度。
作为一项单臂、开放标签、多中心、前瞻性研究（ProLOGUE）的一部分，在布罗达umab 治疗的第 12 周和第 48 周评估了银屑病面积和严重程度指数（PASI）评分、体表面积（BSA）和治疗满意度问卷-9（TSQM-9）域评分，并在第 12 周和第 48 周评估了患者整体评估（PtGA）评分。
共纳入 75 例患者，其中 73 例接受了布罗达umab 治疗。PASI 评分和 BSA 在第 12 周和第 48 周均较基线显著降低（均 P<0.0001）。在第 12 周和第 48 周，大多数（90%）患者在 PtGA 量表上认为治疗有效。在第 12 周和第 48 周，TSQM-9 域评分均显著改善（均 P<0.0001）。从接受者操作特征曲线分析来看，PASI 评分≤2 被建议作为生物治疗银屑病的治疗目标，尽管在达到这一目标的患者中，一些 TSQM-9 域评分没有改善。未观察到新的安全性信号。
布罗达umab 治疗可改善日本银屑病患者的客观症状和满意度。PASI 评分≤2 作为生物治疗银屑病的目标可能是可行的，尽管仅达到这一 PASI 目标可能不足以明显改善长期患者满意度（日本临床试验注册编号：jRCTs031180037）。
