OBJECTIVE: To assess the effectiveness of brodalumab in achieving treatment satisfaction for real-life Japanese patients with psoriasis.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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).
目的:评估brodalumab在实现现实生活中的日本银屑病患者治疗满意度方面的有效性。
方法:作为单臂的一部分,开放标签,多中心,前瞻性研究(ProLOGUE),银屑病面积和严重程度指数(PASI)评分,体表面积(BSA),在基线和Brodalumab治疗的第12周和第48周评估药物治疗满意度问卷-9(TSQM-9)领域评分。在第12周和第48周获取患者总体评估(PtGA)评分。
结果:纳入75例患者,其中73人接受了brodalumab。在第12周和第48周,PASI评分和BSA从基线显著降低(所有P<0.0001)。大多数(90%)患者在第12周和第48周的PtGA量表上认为治疗有效。TSQM-9域得分在第12周和第48周显著改善(所有P<0.0001)。根据受试者工作特征曲线分析,建议将PASI评分≤2作为银屑病生物学治疗的治疗目标。尽管TSQM-9领域的一些评分在实现这一目标的患者中没有改善。没有观察到新的安全信号。
结论:在日本银屑病患者中,使用brodalumab治疗与客观症状改善和满意度相关。PASI评分≤2作为银屑病生物治疗的目标可能是可行的,尽管仅实现PASI目标可能不足以明显改善患者的长期满意度(日本临床试验注册标识符:jRCTs031180037).