Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR)

Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR)
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DOI:
10.1111/jdv.13611
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发表时间:
2016-07-01
影响因子:
9.2
通讯作者:
Krueger, G. G.
Krueger, G. G.
中科院分区:
医学2区
文献类型:
--
作者:
Menter, A.;Papp, K. A.;Krueger, G. G.

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背景:药物生存期是慢性疾病如牛皮癣治疗可持续性的标志。目的分析银屑病纵向评估与登记(PSOLAR)中生物治疗的生存率。spsolar是一个大型的、前瞻性的、国际性的、基于疾病的牛皮癣患者登记,在现实世界中接受(或符合条件)全身治疗。药物生存期定义为从登记开始到停止(停止/切换)生物治疗的时间。记录每种治疗停止的患者人数和治疗持续时间。使用Kaplan-Meier生存曲线和cox -回归分析[风险比(HR)和95%可信区间(CIs)],对接受ustekinumab、英夫利昔单抗、阿达木单抗或依那西普一线、二线或三线治疗的队列进行停药时间的比较。结果截至2013年数据削减,12095例银屑病患者纳入PSOLAR。在4000名开始任何新的生物治疗的患者中,大约3500名在登记期间开始一线,二线或三线生物治疗。缺乏有效性是中断生物治疗的最常见原因。基于多因素分析,英夫利昔单抗的停药时间显著缩短[HR (95%CI) = 2.73 (1.48-5.04), P = 0.0014];阿达木单抗[4.16 (2.80-6.20),P < 0.0001];和依那西普[4.91 (3.28-7.35)P < 0.0001]相比ustekinumab[参考治疗])用于一线生物用药;二线/三线疗法的治疗效果结果相似。虽然研究结果有限,但风湿病学家证实对并发银屑病关节炎患者的分析反映了对整体银屑病人群的观察。结论与英夫利昔单抗、阿达木单抗和依那西普相比,乌斯特金单抗治疗银屑病患者的药物生存期更佳。修订日期:2015年7月14日;录用日期:2016年1月6日
BackgroundDrug survival is a marker for treatment sustainability in chronic diseases such as psoriasis.ObjectiveThe aim of these analyses was to assess survival of biologic treatments in the PSOriasis Longitudinal Assessment and Registry (PSOLAR).MethodsPSOLAR is a large, prospective, international, disease-based registry of patients with psoriasis receiving (or eligible for) systemic therapy in a real-world setting. Drug survival is defined as the time from initiation to discontinuation (stop/switch) of biologic therapy on registry. The number of patients who discontinued each treatment and the duration of therapy were recorded. Using Kaplan-Meier survival curves and Cox-regression analyses [hazard ratios (HR) and 95% confidence intervals (CIs)], time to discontinuation was compared across cohorts undergoing first-, second- or third-line treatment with ustekinumab, infliximab, adalimumab or etanercept.ResultsAs of the 2013 data cut, 12 095 patients with psoriasis were enrolled in PSOLAR. Of the 4000 patients initiating any new biologic therapy, approximately 3500 started a first-line, second-line or third-line biologic therapy during the registry. Lack of effectiveness was the most common reason for discontinuation across biologic therapies. Based on the multivariate analysis, significantly shorter times to discontinuation were observed for infliximab [HR (95%CI) = 2.73 (1.48-5.04), P = 0.0014]; adalimumab [4.16 (2.80-6.20), P < 0.0001]; and etanercept [4.91 (3.28-7.35) P < 0.0001] compared with ustekinumab [reference treatment]) for first-line biologic use; results were similar for treatment effects for second/third-line therapies. Although limited in power, analyses in patients with concurrent psoriatic arthritis confirmed by a rheumatologist reflect observations in the overall psoriasis population.ConclusionDrug survival was superior for ustekinumab compared with infliximab, adalimumab and etanercept in patients with psoriasis. revised: 14 July 2015; Accepted: 6 January 2016