Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria
Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria
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DOI：
10.1111/jdv.14384
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发表时间：
2017-10-01
影响因子：
9.2
通讯作者：
Maurer, M.
中科院分区：
文献类型：
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作者：
Finlay, A. Y.;Kaplan, A. P.;Maurer, M.
背景慢性自发性/特发性荨麻疹（CSU/CIU）对健康相关生活质量（HRQoL）具有实质性的不利影响，其影响与许多其他皮肤病相当或更差。目的评估奥马珠单抗对CSU患者HRQoL的影响，通过三项III期研究ASTERIA I、ASTERIA II和GLACIAL中的皮肤病生活质量指数（DLQI）测量。Omalizumab 300 mg与安慰剂相比显著改善了DLQI总评分，从基线至第12周平均降低了-10.3 vs. -6.1（P < 0.0001），在ASTERIA I中为-10.2 vs. -6.1（P = 0.0004），在ASTERIA II中为-9.7 vs. -5.1（P < 0.0001）。奥马珠单抗300 mg与安慰剂相比，从基线时对生活的高疾病影响到第12周时的低影响的显著变化（P < 0.001;所有研究）。ASTERIA I、II和GLACIAL中，平均DLQI总分从基线至第12周的变化达到MCID 4的患者比例分别为74.1%、76.0%和77.2%（P < 0.01; P < 0.01）。所有研究）结论这项额外的分析评估了CSU的影响和奥马珠单抗治疗的益处，在多个评估点按治疗组显示DLQI数据的不同方面。分析的原始方面包括应用DLQI的MCID的最近验证分数的概念、DLQI领域分数的变化以及基于验证的总DLQI分数带的受试者分布。研究一致表明，奥马珠单抗在HRQoL的许多方面提供了显著和临床相关的改善，这些改善对CSU患者很重要。这些结果有助于更好地了解CSU及其治疗对患者的影响，并可支持常规医疗实践中的临床决策。
BackgroundChronic spontaneous/idiopathic urticaria (CSU/CIU) has substantial detrimental effects on health-related quality of life (HRQoL) with an effect comparable to or worse than many other skin diseases.ObjectiveTo assess the effect of omalizumab on CSU patients' HRQoL, measured by the Dermatology Life Quality Index (DLQI) in three phase III studies ASTERIA I, ASTERIA II and GLACIAL.MethodsA post hoc analysis examined changes in DLQI scores, distribution of patients across DLQI bands and the proportion reaching minimal clinically important difference (MCID) following omalizumab vs. placebo.ResultsOmalizumab 300 mg significantly improved total DLQI scores vs. placebo, with a mean decrease from baseline to week 12 of -10.3 vs. -6.1 (P < 0.0001) in ASTERIA I, -10.2 vs. -6.1 (P = 0.0004) in ASTERIA II and -9.7 vs. -5.1 (P < 0.0001) in GLACIAL. A significant shift from high disease impact on life at baseline towards less impact at week 12 was seen with omalizumab 300 mg vs. placebo (P < 0.001; all studies). The proportion of patients where change in mean total DLQI score from baseline to week 12 reached an MCID of 4 was 74.1%, 76.0% and 77.2% in ASTERIA I, II and GLACIAL, respectively (P < 0.01; all studies).LimitationsMaximum duration of omalizumab treatment was 24 weeks.ConclusionThis additional analysis assessed the impact of CSU and benefit of treatment with omalizumab by exploring different facets of DLQI data by treatment arm at multiple assessment points. The original aspects of analysis included applying the concept of the recently validated score for the MCID of the DLQI, changes in DLQI domain scores and in the distribution of subjects based on validated total DLQI score bands. It showed consistently that omalizumab provides significant and clinically relevant improvements in many aspects of HRQoL that are important to patients with CSU. These results contribute to a better understanding of the impact of CSU and its treatment on patients and can support clinical decision-making in routine medical practice.