Positive impact of omalizumab on angioedema and quality of life in patients with refractory chronic idiopathic/spontaneous urticaria: analyses according to the presence or absence of angioedema
Positive impact of omalizumab on angioedema and quality of life in patients with refractory chronic idiopathic/spontaneous urticaria: analyses according to the presence or absence of angioedema
复制标题
DOI：
10.1111/jdv.14075
复制
发表时间：
2017-06-01
影响因子：
9.2
通讯作者：
Bernstein, J. A.
中科院分区：
文献类型：
--
作者：
Maurer, M.;Sofen, H.;Bernstein, J. A.
BackgroundApproximately 50%的慢性特发性/自发性荨麻疹（CIU/CSU）患者报告荨麻疹和血管性水肿;一些经验荨麻疹/血管性水肿ONLY. ESTA评估奥马珠单抗对血管性水肿和生活质量（QoL）在亚组难治性CIU/CSU：那些与无血管性水肿。评估血管性水肿和QoL [荨麻疹患者每日日记和皮肤病生活质量指数（DLQI）]。亚组的基础上的存在/不存在的基线血管性水肿7天前randomization. ResultsBaseline血管性水肿患者随机omalizumab 300毫克有一个更大的减少，平均每周血管性水肿的发病率和平均天数/周血管性水肿与安慰剂在12和24周。奥马珠单抗300 mg治疗与安慰剂相比，DLQI评分平均降低3.3- 4.5分，高于最小临床重要差异阈值。结果与较低的剂量与安慰剂是variable.ConclusionCompared相比，安慰剂，omalizumab 300毫克治疗超过12-24周导致显着减少的发病率和天数/周血管性水肿伴随着临床相关的改善生活质量。
BackgroundApproximately 50% of patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) report hives and angioedema; some experience hives/angioedema only.ObjectiveAssess omalizumab's effect on angioedema and quality of life (QoL) in subgroups with refractory CIU/CSU: those with and without angioedema.MethodsPatients received omalizumab (75, 150 or 300 mg) or placebo every 4 weeks for 12/24 weeks. Angioedema and QoL were assessed [Urticaria Patient Daily Diary and Dermatology Quality of Life Index (DLQI)]. Subgroups were based on the presence/absence of baseline angioedema 7 days prior to randomization.ResultsPatients with baseline angioedema randomized to omalizumab 300 mg had a greater reduction in mean weekly incidence of angioedema and mean number of days/week with angioedema vs. placebo at 12 and 24 weeks. A 3.3- to 4.5-point greater mean reduction in DLQI score was achieved with omalizumab 300 mg treatment vs. placebo, above the minimal clinically important difference threshold. Results with lower doses vs. placebo were variable.ConclusionCompared with placebo, omalizumab 300 mg treatment over 12-24 weeks resulted in marked reduction in incidence and number of days/week with angioedema accompanied by clinically relevant improvement in QoL.