依奇珠单抗可改善生物制剂初治的活动性银屑病关节炎（SPIRIT-P1）患者的患者报告结局，最长可达 52 周。

Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1).

机构信息

Department of Dermatology, New York Medical College, Metropolitan Hospital, New York, NY.

Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.

出版信息

Rheumatology (Oxford). 2018 Oct 1;57(10):1777-1788. doi: 10.1093/rheumatology/key161.

OBJECTIVE

To report patient-reported outcomes of patients with PsA treated with ixekizumab up to 52 weeks.

METHODS

In SPIRIT-P1, biologic-naïve patients with active PsA were randomized to ixekizumab 80 mg every 4 weeks (IXEQ4W; N = 107) or every 2 weeks (IXEQ2W; N = 103) following a 160 mg starting dose, adalimumab 40 mg every 2 weeks (ADA; N = 101) or placebo (PBO; N = 106) during the initial 24-week double-blind treatment period. At week 24 (week 16 for inadequate responders), ADA (8-week washout before starting ixekizumab) and PBO patients were re-randomized to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at week 24 received the same dose during the extension period (EP) to week 52. Patients completed measures including the Dermatology Life Quality Index (DLQI), Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions Visual Analogue Scale and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem.

RESULTS

The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in DLQI at week 24; 22% (PBO), 53% (IXEQ4W), 63% (IXEQ2W) and 54% (ADA) of patients reported DLQI scores of 0/1. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2 physical component summary and some domain scores, and European Quality of Life 5 Dimensions Visual Analogue Scale at weeks 12 and 24; and in three of four Work Productivity and Activity Impairment Questionnaire-Specific Health Problem domains at week 24. Results are also presented through week 52 for the EP.

CONCLUSION

In biologic-naïve patients with active PsA, ixekizumab significantly improved skin symptoms, health-related quality of life and work productivity.

TRIAL REGISTRATION

ClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239; EU Clinical Trials Register, https://www.clinicaltrialsregister.eu, EudraCT2011-002326-49.

目的

报告接受依奇珠单抗治疗的银屑病关节炎（PsA）患者的患者报告结局，随访时间长达 52 周。

方法

在 SPIRIT-P1 研究中，生物初治的活动性 PsA 患者被随机分配至依奇珠单抗 80mg 每 4 周（IXEQ4W；N=107）或每 2 周（IXEQ2W；N=103）治疗组，给药剂量为 160mg 起始剂量，在最初的 24 周双盲治疗期间，阿达木单抗 40mg 每 2 周（ADA；N=101）或安慰剂（PBO；N=106）组。在第 24 周（对于应答不足的患者为第 16 周），ADA（在开始依奇珠单抗治疗前进行 8 周洗脱期）和 PBO 患者重新随机分配至 IXEQ2W 或 IXEQ4W 组。第 24 周接受依奇珠单抗治疗的患者在扩展期（EP）至第 52 周继续接受相同剂量治疗。患者完成包括皮肤病生活质量指数（DLQI）、瘙痒数字评分量表、36 项简明健康调查量表第 2 版、欧洲五维健康量表视觉模拟评分和工作效率和活动障碍问卷-特异性健康问题在内的各项指标的评估。

结果

IXEQ4W、IXEQ2W 和 ADA 组在第 24 周时 DLQI 显著改善；22%（PBO）、53%（IXEQ4W）、63%（IXEQ2W）和 54%（ADA）的患者报告 DLQI 评分为 0/1。IXEQ4W、IXEQ2W 和 ADA 组在第 12 周和第 24 周时瘙痒数字评分量表、36 项简明健康调查量表第 2 版的身体成分综合评分和部分领域评分以及欧洲五维健康量表视觉模拟评分也有显著改善；在第 24 周时，工作效率和活动障碍问卷-特异性健康问题的四个领域中的三个领域也有显著改善。在 EP 期间，还对第 52 周的结果进行了呈现。