OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results.
OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results.
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DOI：
10.1016/j.jaad.2014.08.050
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发表时间：
2015-01
影响因子：
13.8
通讯作者：
Gelfand JM
中科院分区：
文献类型：
--
作者：
Kimball AB;Rothman KJ;Kricorian G;Pariser D;Yamauchi PS;Menter A;Teller CF;Aras G;Accortt NA;Hooper M;Rice KC;Gelfand JM
OBSERVE-5是一项为期5年的FDA强制性银屑病患者监测登记研究。评估依那西普的长期安全性和有效性。入组了中重度银屑病患者;需要单次基线剂量的依那西普。关键结局指标包括严重不良事件（SAE）、严重感染事件（SIE）、医学关注事件、银屑病影响的体表面积、医生总体评估和皮肤病生活质量指数。根据MarketScan数据库中的数据评估安全性结局。对于2，510例患者，5年累积发生率（95%置信区间[CI]）为22.2%（20.3%，24.2%）SAE; 6.5%（5.4%，7.7%）;（2.3%，4.1%）恶性肿瘤，不包括非黑色素瘤皮肤癌（NMSC）; 3.6%（2.7%，4.5%）NMSC; 2.8%冠状动脉疾病（2.0%，3.6%）; 0.7%（0.3%，1.2%）银屑病恶化; 0.2%（0.0%，0.4%）;淋巴瘤和结核病为0.1%（0.0%，0.3%）;机会性感染和狼疮为0.1%（0.0%，0.2%）;报告了55起致死性事件。相对于行政索赔数据，恶性肿瘤、淋巴瘤、NMSC和住院相关感染的发生率不高于预期。基线时被评定为清除/几乎清除的患者百分比为12%，第6个月时增加至51%，并在5年内保持相对稳定。未纳入内部对照组;可能未检测到罕见事件。长期、真实世界使用依那西普未观察到新的安全性信号。
OBSERVE-5 was a 5-year FDA-mandated surveillance registry of psoriasis patients. To assess long-term etanercept safety and effectiveness. Patients with moderate to severe psoriasis enrolled; a single baseline dose of etanercept was required. Key outcome measures included serious adverse events (SAEs), serious infectious events (SIEs), events of medical interest, psoriasis-affected body surface area, physician global assessment, and Dermatology Life Quality Index. Safety outcomes were assessed relative to data from the MarketScan database. For 2,510 patients, 5-year cumulative incidence (95% confidence interval [CI]) was 22.2% (20.3%, 24.2%) for SAEs; 6.5% (5.4%, 7.7%) for SIEs; 3.2% (2.3%, 4.1%) for malignancies excluding nonmelanoma skin cancer (NMSC); 3.6% (2.7%, 4.5%) for NMSC; 2.8% (2.0%, 3.6%) for coronary artery disease; 0.7% (0.3%, 1.2%) for psoriasis worsening; 0.2% (0.0%, 0.4%) for CNS demyelinating disorder; 0.1% (0.0%, 0.3%) for lymphoma and for tuberculosis; 0.1% (0.0%, 0.2%) for opportunistic infection and for lupus; 55 fatal events were reported. Rates of malignancies, lymphomas, NMSC, and hospitalization-associated infections were not higher than expected relative to administrative claims data. The percentage of patients rated as clear/almost clear was 12% at baseline, which increased to 51% at month 6 and remained relatively stable throughout 5 years. No internal comparator group was included; rare events may not have been detected. No new safety signals were observed with long-term, real-world etanercept use.