乌斯特基努马
医学
狼牙棒
银屑病
阿达木单抗
英夫利昔单抗
恶性肿瘤
依那西普
队列
银屑病性关节炎
内科学
疾病
观察研究
皮肤病科
心肌梗塞
类风湿性关节炎
传统PCI
作者
Kim Papp,Gottlieb Ab,Luigi Naldi,David M. Pariser,S. L. Ho,Kavitha Goyal,Steven Fakharzadeh,Marc Chévrier,Stephen Calabro,Wayne Langholff,GG Krueger
出处
期刊:PubMed
日期:2015-07-01
卷期号:14 (7): 706-14
被引量:91
摘要
Safety surveillance is needed for biologic therapies for psoriasis.To assess the risk of adverse events of special interest (AEoSIs) with ustekinumab and other psoriasis treatments in a real-world setting using 2014 Psoriasis Longitudinal Assessment and Registry (PSOLAR) data. AEoSIs included malignancy (excluding nonmelanoma skin cancer), major adverse cardiovascular events (MACE), serious infection, and all-cause mortality.Cumulative rates of AEoSIs/100 patient-years (PY) are reported for ustekinumab, infliximab, other biologics (mostly adalimumab/etanercept), and non-biologics based on pre-specified analyses using attribution rules biased against ustekinumab. Risk factors for AEoSIs, including treatments, were determined using multivariate statistical analysis.A total of 12,093 patients (40,388 PY) were enrolled in PSOLAR. Overall incidence rates were 0.68/100PY for malignancy, 0.33/100PY for MACE, 1.60/100PY for serious infection, and 0.46/100PY for mortality. Unadjusted rates of serious infection for infliximab (2.91/100PY) and other biologics (1.91/100PY) were numerically higher compared with ustekinumab (0.93/100PY). Exposure to the combined group of biologics other than ustekinumab was significantly associated with serious infection (hazard ratio=1.96, P<.001). None of the biologics was associated with increased risk of malignancy, MACE, or mortality.Observational data have inherent biases.Analysis of 2014 PSOLAR data identified no increased risk of malignancy, MACE, serious infection, or mortality with ustekinumab.
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