Abstract：
BACKGROUND: Real-life evidence on the quality of treatment with brodalumab in patients with plaque psoriasis based on patient-reported outcomes remains limited.
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).
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).
摘要：
背景：基于患者报告的结果，关于布罗达单抗治疗斑块状银屑病患者的治疗质量的真实证据仍然有限。
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).
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).
